Genomic signature in MLH1 and MSH2 and MSH6 and PMS2

MSI-H / dMMR

240 active trials select patients by MSI-H / dMMR or a broader group, and 110 of them are recruiting. 16 FDA and 9 EU approvals name it.

Trials as of 2026-10-27. Seen most often in colorectal, endometrial, tumor-agnostic.

Active trials by phase

Trials started per year (2026 so far)

Approved therapies

Approvals in the United States (FDA) and the European Union (EMA), one row per drug, regimen and tumour type. Open a row for the exact indication and source.

Therapy	Tumour	United States	European Union
atezolizumab with fluoropyrimidine + oxaliplatin FDA, 2026 adjuvant, stage III dMMR colon cancer, adults and children >=2 years FDA approval 08/10/2026; not yet on the DailyMed label (revised 5/2026). Source Tecentriq	colon	Approved 2026	Not approved
nivolumab with ipilimumab FDA, 2018 metastatic MSI-H or dMMR, after fluoropyrimidine, oxaliplatin and irinotecan AA 10/07/2018; converted to regular approval 08/04/2025, when the combination indication was broadened to unresectable or metastatic MSI-H/dMMR CRC regardless of line (see A099). Source FDA, 2025 unresectable or metastatic MSI-H or dMMR, adults and children >=12 (any line; based on first-line CheckMate 8HW) FDA approval 08/04/2025. Label wording does not restrict line. Source EU (EMA), 2021 metastatic dMMR or MSI-H, after prior fluoropyrimidine-based combination chemotherapy WS/1840 (Opdivo + Yervoy), EC decision 24/06/2021. Source EU (EMA), 2024 first line, unresectable or metastatic dMMR or MSI-H WS/2672 (Opdivo + Yervoy): CHMP opinion 14/11/2024, EC decision 19/12/2024. Source Opdivo	colorectal	Approved 2018	Approved 2021
nivolumab FDA, 2017 metastatic MSI-H or dMMR, after fluoropyrimidine, oxaliplatin and irinotecan AA 31/07/2017, converted to regular approval 08/04/2025. Source FDA, 2024 MSI-H or dMMR metastatic CRC after fluoropyrimidine, oxaliplatin and irinotecan; also maintenance after IV nivolumab + ipilimumab; age >=12 and >=30 kg FDA approved Opdivo Qvantig on 27/12/2024 across Opdivo monotherapy and maintenance indications. Whether this CRC indication was in the initial approval or added later was not confirmed. Not approved with ipilimumab for MSI-H CRC. Source Opdivo, Opdivo Qvantig	colorectal	Approved 2017To verify	Not approved
pembrolizumab FDA, 2020 unresectable or metastatic MSI-H or dMMR colorectal cancer (label no longer states line; first approved 2020 for first line) Current label 1.9 has no line restriction. Year not checked against an FDA approval announcement (FDA's pre-2023 announcement archive was not reachable). Source FDA, 2025 unresectable or metastatic MSI-H or dMMR colorectal cancer, adults FDA approval 19/09/2025; label 1.7. Source EU (EMA), 2021 first line, metastatic MSI-H or dMMR II/0091, EC decision 21/01/2021. Source EU (EMA), 2022 unresectable or metastatic MSI-H or dMMR, after fluoropyrimidine-based combination therapy II/0109, EC decision 25/04/2022. EU has no tumour-agnostic MSI-H indication. Source Keytruda, Keytruda Qlex	colorectal	Approved 2020To verify	Approved 2021
dostarlimab FDA, 2021 recurrent or advanced dMMR, progressed on or after platinum AA 22/04/2021, converted to regular approval 09/02/2023 (after platinum in any setting, not candidates for curative surgery or radiation). Source EU (EMA), 2021 recurrent or advanced dMMR/MSI-H, progressed after platinum Conditional MA 21/04/2021, switched to standard MA 07/12/2023. Source Jemperli	endometrial	Approved 2021	Approved 2021
dostarlimab with carboplatin + paclitaxel FDA, 2023 primary advanced or recurrent dMMR/MSI-H dMMR/MSI-H restricted approval 2023; on 01/08/2024 FDA broadened it to all primary advanced or recurrent EC (no longer biomarker-restricted). Kept because dMMR/MSI-H patients remain covered. Exact 2023 date not checked against its own FDA announcement. Source EU (EMA), 2023 first line, primary advanced or recurrent dMMR/MSI-H EC, candidates for systemic therapy II/0023, EC decision 07/12/2023. Broadened to all primary advanced or recurrent EC by II/0032 (EC decision 15/01/2025), so the current EU wording is no longer biomarker-restricted. Kept because dMMR/MSI-H patients remain covered (same approach as FDA row A104). Source Jemperli	endometrial	Approved 2023	Approved 2023
durvalumab with carboplatin + paclitaxel, then durvalumab FDA, 2024 primary advanced or recurrent dMMR FDA approval 14/06/2024. Source EU (EMA), 2024 primary advanced or recurrent dMMR EU 4.1 checked: durvalumab + carboplatin/paclitaxel then durvalumab monotherapy for dMMR primary advanced or recurrent EC (pMMR patients get durvalumab + olaparib). The EC decision date for this extension could not be found in the procedural-steps documents, so the year is not verified. Source Imfinzi	endometrial	Approved 2024	Approved 2024To verify
pembrolizumab FDA, 2022 advanced MSI-H or dMMR endometrial carcinoma, progressed after prior systemic therapy in any setting, not candidates for curative surgery/radiation Label 1.17 (single agent). Year not checked against an FDA approval announcement (FDA's pre-2023 announcement archive was not reachable). Source FDA, 2025 advanced MSI-H or dMMR endometrial carcinoma, progressed after prior systemic therapy, not candidates for curative surgery/radiation FDA approval 19/09/2025; label 1.15 (single agent). Source EU (EMA), 2022 advanced or recurrent MSI-H or dMMR, progressed after platinum, not candidates for surgery/radiation II/0109, EC decision 25/04/2022. EU has no tumour-agnostic MSI-H indication. Source Keytruda, Keytruda Qlex	endometrial	Approved 2022To verify	Approved 2022
pembrolizumab EU (EMA), 2022 unresectable or metastatic MSI-H or dMMR, progressed after >=1 prior therapy II/0109, EC decision 25/04/2022. EU has no tumour-agnostic MSI-H indication. Source Keytruda	gastric; small intestine; biliary	Not approved	Approved 2022
dostarlimab FDA, 2026 stage II/III locally advanced MSI-H or dMMR rectal cancer AA 19/10/2026 (AZUR-1); on FDA Ongoing accelerated approvals list. Source Jemperli	rectal	Approved 2026 accelerated	Not approved
dostarlimab FDA, 2021 recurrent or advanced dMMR, progressed after prior treatment, no satisfactory alternatives AA 17/08/2021; still on the current label (1.2) and the FDA Ongoing accelerated approvals list. Source Jemperli	solid tumours (tumour-agnostic)	Approved 2021 accelerated	Not approved
pembrolizumab FDA, 2017 unresectable or metastatic MSI-H or dMMR, progressed after prior treatment AA 23/05/2017, converted to regular approval 28/03/2023. Current label: MSI-H/dMMR solid tumours progressed after prior treatment, adults and children (CRC is now a separate indication). Source FDA, 2025 unresectable or metastatic MSI-H or dMMR, progressed after prior treatment, no satisfactory alternatives, age >=12 Subcutaneous pembrolizumab approved 19/09/2025 for IV Keytruda solid-tumour indications (adults and >=12 years); label 1.6. Source Keytruda, Keytruda Qlex	solid tumours (tumour-agnostic)	Approved 2017	Not approved

Companies

Industry sponsors leading active trials, by number of trials. Each square is one trial, shaded by phase.

GSK 9
MSD (Merck & Co.) 7
Vividion Therapeutics 3
Exelixis 2
Chipscreen Biosciences 2
Novartis 2
Akeso 1
Bristol Myers Squibb 1
Innovent Biologics 1
Jiangsu Hengrui 1
Qilu Pharmaceutical 1
Shanghai JMT-Bio 1
Taizhou Hanzhong biomedical 1
3D Medicines (Sichuan) 1
BeOne Medicines (BeiGene) 1

Trials

Matched automatically from registry text, so a few trials may only mention MSI-H / dMMR rather than require it. Check the quoted criterion, and the registry entry before relying on a match.

240 of 442 trials shown

A Study to Evaluate the Safety of Dostarlimab in Adult Participants in India With Recurrent or Advanced Endometrial Cancer (EC)

Not yet recruiting Phase 4 GSK Started 2025 NCT06897527

Dostarlimab FDA EU

Documented case of dMMR/MSI-H recurrent or advanced EC that has progressed on or following prior treatment with platinu…

Neoplasms, Endometrial
SIS-Reinforced vs. Conventional Anastomosis for Mid-to-Low Rectal Cancer: A Multicenter RCT on Anastomotic Leak

Recruiting Phase 4 Beijing Chao Yang Hospital Started 2025 NCT07209787

…clearly refuse neoadjuvant therapy (for advanced rectal cancer) and/or immunotherapy (for MSI - H/dMMR rectal cancer) and request direct surgery, they are generally not included in this s…

Rectal Cancer
JSKN003 Versus Physician Choiced Treatment in Patients With HER2-positive and Advanced Colorectal Cancer Who Had Failed to Respond to Oxaliplatin, 5-Fu, and Irinotecan

Not yet recruiting Phase 3 Shanghai JMT-Bio Started 2026 NCT07384377

JSKN003Physician choiced treatment, include: TAS-102, Regorafenib, Fruquintinib.

…reatment with oxaliplatin, 5-fluorouracil (such as 5-FU, Capecitabine) , irinotecan (DMMR/MSI-H subjects also need anti-PD-1/PD-L1 antibody treatment failure).

HER2-positive Colorectal Cancer
A Study of the Duration of Dostarlimab in Untreated Mismatch Repair Deficient (dMMR)/ Microsatellite Instability-high (MSI-H) Locally Advanced Rectal Cancer

Not yet recruiting Phase 3 GSK Started 2026 NCT07740720

Dostarlimab FDA EU

…MR protein expression (MLH1, MSH2, MSH6, PMS2) where loss of 1 or more proteins indicates dMMR

Neoplasms, Rectal
Pressurized Intraperitoneal Aerosolized Chemotherapy With Mitomycin for the Treatment of Unresectable Appendix or Colorectal Cancer With Peritoneal Metastases, The IMPACT Trial

Recruiting Phase 3 City of Hope Medical Center Started 2026 NCT07271355

BevacizumabFluorouracilIrinotecan HydrochlorideLeucovorin CalciumMitomycin

Mismatch repair-deficient patients are permissible if they have progressed on first-line immunotherapy

Metastatic Appendix Carcinoma, Metastatic Colorectal Carcinoma, Metastatic Malignant Neoplasm in the Peritoneum, Stage IV Appendix Carcinoma AJCC v8
Refining Fertility-sparing Treatment in Endometrial Carcinoma Based on Molecular Classification

Recruiting Phase 2/3 Fudan University Started 2026 NCT07319429

PD1 antibodyMedroxyprogesterone Acetate 500 MGMegestrol Acetate 160 MGGnRH agonist and Letrozole

2). dMMR (deficient mismatch repair)/MSI-H endometrial cancer: Pathologically and radiologically evaluated as FIGO 2023 Stage I-II e…

Endometrial Cancer, Fertility
Neoadjuvant/Adjuvant AK104 in Microsatellite Instability-high or Mismatch Repair-deficient, Resectable Colon Cancer

Recruiting Phase 3 Akeso Started 2026 NCT07412613

Cadonilimab (AK104)OxaliplatinCapecitabine5- FluorouracilCalcium Folinate

Microsatellite instability detection demostrates MSI-H (with 5 NCI-recommended microsatellite detection sites: BAT25, BAT26, D5S346, D2S123, D17…

Resectable Colon Cancer, MSI-H/dMMR Colorectal Cancer
Preventive Dendritic Cell Vaccination for Lynch Syndrome Carriers

Not yet recruiting Phase 3 Radboud University Medical Center Started 2026 NCT07609901

Arm A: DC vaccinationArm B: Placebo vaccination

MSH6 subjects with a history of MMR-D cancer have to be cancer-free for more than 1 year.

Lynch Syndrome
Combination of Immune Checkpoint in Locally Advanced or Metastatic MSI/dMMR Esogastric Adenocarcinomas

Recruiting Phase 3 Centre Leon Berard Started 2025 NCT06346197

BalstilimabBotensilimabFolfox ProtocolXELOXNivolumab FDA EU

Patient with MSI-H/dMMR, HER2 negativeadvanced or metastatic gastric, gastro-oesophageal junction or oesopha…

Gastric Cancer, MSI-H, Metastatic Cancer, Advanced Cancer
Testing Olaparib for One or Two Years, With or Without Bevacizumab, to Treat Ovarian Cancer

Recruiting Phase 3 NRG Oncology Started 2025 NCT06580314

BevacizumabOlaparib

…ng tumors that are known mismatch repair deficient/microsatellite instability high (MMR-D/MSI-H) or POLE ultramutated)

Fallopian Tube Endometrioid Adenocarcinoma, Fallopian Tube High Grade Serous Adenocarcinoma, Fallopian Tube Malignant Mixed Mesodermal (Mullerian) Tumor, FIGO Stage III Ovarian Cancer 2014
PRODIGE 90 - (FFCD 2204) Neoadjuvant Dostarlimab with Short Course Radiotherapy in a Watch-and-wait Strategy for Microsatellite Unstable or Mismatch Repair-deficient Locally Advanced Rectal Cancer Patients

Recruiting Phase 3 Centre Hospitalier Universitaire Dijon Started 2025 NCT06762405

Dostarlimab FDA EUBiological study on circulating tumor DNA (optional for the patient)

…al adenocarcinoma with Mismatch-repair Deficient (dMMR)/ microsatellite instability-high (MSI-H).

Rectal Adenocarcinoma with Mismatch-repair Deficient (dMMR)/ Microsatellite Instability-high (MSI-H)
Adjuvant PD-1 Blockade for High-risk Stage-II DMMR/MSI-H Colorectal Cancer

Recruiting Phase 3 Sun Yat-sen University Started 2024 NCT06520683

TislelizumabAdjuvant chemotherapy

dMMR and/or MSI-H colorectal carcinoma that undergo surgical resection

Colorectal Cancer, Microsatellite Instability High
A Study of Neoadjuvant QL1706 in Participants With Untreated dMMR/MSI-H Resectable Colon Cancer

Recruiting Phase 3 Qilu Pharmaceutical Started 2024 NCT06686576

QL1706CAPEOX/Capecitabine

Has a tumor demonstrating the presence of MSI-H/ dMMR

Colon Cancer
Injection of SHR-A1811 Versus Physician Choiced Treatment in Patients With Advanced Colorectal Cancer Who Had Failed to Respond to Oxaliplatin, 5-fu, and Irinotecan

Active, not recruiting Phase 3 Jiangsu Hengrui Started 2024 NCT06199973

SHR-A1811TAS-102, Regorafenib , Fruquintinib

…reatment with oxaliplatin, 5-fluorouracil (such as 5-FU, Capecitabine) , irinotecan (DMMR/MSI-H subjects also need anti-PD-1/PD-L1 antibody treatment failure) ;

Advanced Colorectal Cancer
COLLISION RELAPSE Trial

Recruiting Phase 3 Amsterdam UMC, location VUmc Started 2023 NCT05861505

Neoadjuvant systemic therapy (CAPOX+/-B FOLFOX+/-B FOLFIRI+/-B)

MSI/dMMR

Status may be outdated, last updated 2023-05-17Colorectal Cancer, Liver Metastases, Liver Metastasis Colon Cancer, Chemotherapy Effect
Study of Perioperative Dostarlimab in Participants With Untreated T4N0 or Stage III dMMR/MSI-H Resectable Colon Cancer

Recruiting Phase 3 GSK Started 2023 NCT05855200

Dostarlimab FDA EUCAPEOXFOLFOX

Has a tumor demonstrating the presence of either dMMR status or MSI-H

Colonic Neoplasms, Neoplasms, Colon
A Study of HX008 Compared to Chemotherapy in the First-Line Treatment of Subjects With MSI-H/dMMR Metastatic Colorectal Cancer

Active, not recruiting Phase 3 Taizhou Hanzhong biomedical Started 2023 NCT05652894

HX008(Pucotenlimab)

A Study of HX008 Compared to Chemotherapy in the First-Line Treatment of Subjects With MSI-H/dMMR Metastatic Colorectal Cancer

Metastatic Colorectal Cancer
DETERMINE Trial Treatment Arm 02: Atezolizumab in Adult, Paediatric and Teenage/Young Adult Patients With Cancers With High Tumour Mutational Burden (TMB) or Microsatellite Instability-high (MSI-high) or Proven Constitutional Mismatch Repair Deficiency (CMMRD) Disposition

Recruiting Phase 2/3 Cancer Research UK Started 2023 NCT05770102

Atezolizumab FDA

Confirmed diagnosis of a malignancy that is high TMB (defined as ≥10 mut/Mb), MSI-high or of proven (previously diagnosed) CMMRD disposition using an analytically validated nex…

Malignancy, Malignant Neoplasm, Lymphoproliferative Disorders, Neoplasms by Histologic Type
A Clinical Trial Evaluating the Efficacy and Safety of IBI310 in Combination With Sintilimab, for Neoadjuvant Treatment of MSI-H/dMMR Resectable Colon Cancer

Active, not recruiting Phase 3 Innovent Biologics Started 2023 NCT05890742

SintilimabIBI310&Sintilimab

MSI-H or dMMR.

MSI-H
Study Comparing the Standard Administration of IO Versus the Same IO Administered Each 3 Months in Patients in Response After 6 Months of Standard IO

Active, not recruiting Phase 3 UNICANCER Started 2022 NCT05078047

Reduced dose intensity of IO

…east cancer, Merkel cancer, hepatocellular carcinoma, melanoma, colorectal carcinoma with microsatellite instability \[MSI\], esophageal squamous cell carcinoma, endometrial carcinoma,cervical cancer, gastr…

Lung Cancer Metastatic, Renal Cell Carcinoma, Head and Neck Cancer, Triple Negative Breast Cancer
Study of XL092 + Atezolizumab vs Regorafenib in Participants With Metastatic Colorectal Cancer

Active, not recruiting Phase 3 Exelixis Started 2022 NCT05425940

XL092Atezolizumab FDARegorafenib

Documented NOT to have microsatellite instability-high (MSI-high) or mismatch repair deficient (dMMR) CRC by tissue-based analysis.

Colorectal Cancer
Study of Pembrolizumab (MK-3475) Versus Chemotherapy in Chinese Participants With Stage IV Colorectal Cancer (MK-3475-C66)

Active, not recruiting Phase 3 MSD (Merck & Co.) Started 2022 NCT05239741

Pembrolizumab FDA EUOxaliplatinLeucovorin5-fluorouracilIrinotecanBevacizumab

…ersus Chemotherapy in Chinese Participants With Stage IV Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Colorectal Cancer (MK-3475-C66)

Colorectal Neoplasms
Endometrial Cancer Patientes MMR Deficient Comparing Chemotherapy vs Dostarlimab in First Line

Active, not recruiting Phase 3 ARCAGY/ GINECO GROUP Started 2022 NCT05201547

Carboplatin-PaclitaxelDostarlimab FDA EU

MMRd/MSI-H tumor (first diagnosed by routine local IHC performed either on primitive tumour tissue o…

Endometrial Cancer
Study of Pembrolizumab (MK-3475) Versus Chemotherapy in Mismatch Repair Deficient (dMMR) Advanced or Recurrent Endometrial Carcinoma (MK-3475-C93/KEYNOTE-C93/GOG-3064/ENGOT-en15)

Active, not recruiting Phase 3 MSD (Merck & Co.) Started 2022 NCT05173987

pembrolizumab FDA EUcarboplatinpaclitaxeldocetaxelcisplatin

…l Carcinoma (EC) or carcinosarcoma (mixed Mullerian tumor) that is centrally confirmed as dMMR.

Endometrial Neoplasms
PACE: PD-1 Antibody For dMMR/MSI-H Stage III Colorectal Cancer

Recruiting Phase 3 Sun Yat-sen University Started 2022 NCT05236972

SintilimabOxaliplatincapecitabine

Locally confirmed defective mismatch repair (dMMR) tumour (as defined by the lack of staining on either the pre-operative biopsy samples or…

Status may be outdated, last updated 2022-12-30Colorectal Carcinoma
Refining Adjuvant Treatment IN Endometrial Cancer Based On Molecular Features

Recruiting Phase 3 Leiden University Medical Center Started 2021 NCT05255653

ChemotherapyDurvalumab FDA EU

Molecular classification: MMRd EC

Endometrial Cancer
Identification and Treatment Of Micrometastatic Disease in Stage III Colon Cancer

Active, not recruiting Phase 3 Massachusetts General Hospital Started 2020 NCT03803553

FOLFIRI ProtocolNivolumab Protocol FDA EUEncorafenib/Binimetinib/Cetuximab ProtocolTrastuzumab + Pertuzumab

Presence of deficient (d) DNA mismatch repair (dMMR) may be assessed by IHC for MMR protein expression (MLH1, MSH2, MSH6, PMS2) where loss of…

Metastatic Colon Cancer, Stage III Colon Cancer
Testing the Addition of the Immunotherapy Drug, Pembrolizumab, to the Usual Radiation Treatment for Newly Diagnosed Early Stage High Intermediate Risk Endometrial Cancer

Active, not recruiting Phase 3 National Cancer Institute (NCI) Started 2020 NCT04214067

Pembrolizumab FDA EU

Patients must have deficient mismatch repair as demonstrated by lack of expression of at least one mismatch repair protein by immunohi…

Endometrial Endometrioid Adenocarcinoma, Stage I Uterine Corpus Carcinoma or Carcinosarcoma AJCC v8, Stage II Uterine Corpus Carcinoma or Carcinosarcoma AJCC v8
A Study of Nivolumab, Nivolumab Plus Ipilimumab, or Investigator's Choice Chemotherapy for the Treatment of Participants With Deficient Mismatch Repair (dMMR)/Microsatellite Instability High (MSI-H) Metastatic Colorectal Cancer (mCRC)

Active, not recruiting Phase 3 Bristol Myers Squibb Started 2019 NCT04008030

IpilimumabOxaliplatinLeucovorinFluorouracilIrinotecanBevacizumab

Known tumor microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) status per local standard of practice

Metastatic Colorectal Cancer
Testing the Addition of Atezolizumab to Combination Chemotherapy or Atezolizumab Alone for Metastatic Colon or Rectal Cancer, the COMMIT Study

Active, not recruiting Phase 3 National Cancer Institute (NCI) Started 2018 NCT02997228

Atezolizumab FDABevacizumabFluorouracilLeucovorinOxaliplatin

Tumor determined to be mismatch-repair deficient (dMMR) by Clinical Laboratory Improvement Act (CLIA)-certified immunohistochemical (IHC) …

Metastatic Colorectal Adenocarcinoma, Stage IV Colorectal Cancer AJCC v7
Combination Chemotherapy With or Without Atezolizumab in Treating Patients With Stage III Colon Cancer and Deficient DNA Mismatch Repair

Active, not recruiting Phase 3 National Cancer Institute (NCI) Started 2017 NCT02912559

Atezolizumab FDAFluorouracilLeucovorin CalciumOxaliplatin

Presence of deficient (d) DNA mismatch repair (dMMR)

Colon Adenocarcinoma, DNA Repair Disorder, Lynch Syndrome, Stage III Colon Cancer AJCC v8
Study of Relatlimab and Nivolumab (Opdualag) in Replication Repair Deficient HGG and DIPG

Not yet recruiting Phase 2 Nationwide Children's Hospital Starts 2027 NCT07644312

Opdualag

Genetic diagnosis of germline Constitutional Mismatch Repair Deficiency (CMMRD), Lynch Syndrome, or Polymerase-Proofreading Deficiency (PPD)

High Grade Glioma, Diffuse Intrinsic Pontine Glioma, WHO Grade 3 Glioma, WHO Grade 4 Glioma
Neoadjuvant Immunotherapy ± Radiotherapy in MSI-H/dMMR Locally Advanced Colorectal Cancer

Not yet recruiting Phase 2 Fudan University Started 2026 NCT07403877

Nivolumab FDA EUIpilimumab (1mg/kg)

MSI-H or dMMR.

Colorectal Cancer (MSI-H)
Lactulose to Improve Gut Health in Cancer Patients Receiving Immunotherapy

Recruiting Phase 1/2 University of Chicago Started 2026 NCT07354100

Lactulose

…sical Hodgkin lymphoma, primary mediastinal large B-cell lymphoma, urothelial cancer, MSI/MMRd cancer, cancers with high tumor mutational burden (\>=10 muts/mB), esophageal cancer, hep…

Cancer
Neoadjuvant Immunotherapy and Organ-sparing Treatment in Patients With Stage I-III dMMR Colon Cancer

Not yet recruiting Phase 2 Ismail Gögenur Started 2026 NCT07409844

1 Cycle of Pembrolizumab FDA EU2 Cycles of Pembrolizumab FDA EU3 Cycles of Pembrolizumab FDA EUAdditional Cycle of Pembrolizumab FDA EU

Clinical UICC stage I-III dMMR colon carcinoma

DMMR Colorectal Cancer, Colon Cancer Stage I, Colon Cancer Stage II/III, Pembrolizumab
A Study to Evaluate the Efficacy of VVD-133214 in Combination With Pembrolizumab Compared With Pembrolizumab Alone in Participants With Advanced Cancer of the Colon or Rectum

Recruiting Phase 2 Vividion Therapeutics Started 2026 NCT07811193

VVD-133214Pembrolizumab FDA EU

Have a known microsatellite instability (MSI) and/or deficient mismatch repair (dMMR) tumor status confirmed per local standard o…

Colorectal Adenocarcinoma
Mazdutide Plus LNG-IUS for Fertility-Sparing Treatment of AEH or Early Endometrial Cancer

Not yet recruiting Phase 2 Tongji Hospital Started 2026 NCT07781150

Mazdutide(Dual GLP-1R/GCGR Agonist)

For participants with POLE-ultramutated or mismatch repair-deficient tumors, suitability for fertility-sparing treatment should be determined based on age, fa…

Obesity, Overweight, Atypical Endometrial Hyperplasia, Endometrial Carcinoma Stage I
Trial of 5-Fluorouracil (5FU)-Based Therapy in Combination With Fruquintinib in Patients With Locally Advanced Unresectable or Metastatic Colorectal Cancer

Recruiting Phase 2 The Methodist Hospital Research Institute Started 2026 NCT07042685

Fruquintinib Combined With Chemotherapy

… be excluded based on specific molecular markers such as microsatellite instability-high (MSI-H) or B-Raf proto-oncogene mutations (BRAF mutations).

Metastatic Colorectal Cancer (CRC)
Neoadjuvant SHR-A1811 and SHR-A1701 ± Pertuzumab for Potentially Immunotherapy-Sensitive GC or GEJ Adenocarcinoma

Not yet recruiting Phase 2 The First Affiliated Hospital with Nanjing Medical University Started 2026 NCT07716111

Trastuzumab Rezatecan and Retlirafusp alfaTrastuzumab Rezatecan and Retlirafusp alfa+Pertuzumab

Biomarker Status: PD-L1 CPS ≥1, EBV-positive, or dMMR/MSI-H

Gastric or Gastroesophageal Junction Adenocarcinoma
A Study of DES-1357 in People With Deficient Mismatch Repair (dMMR)/Microsatellite Instability-High (MSI-H) Metastatic Colorectal Cancer (mCRC)

Not yet recruiting Phase 1/2 D. E. Shaw Research Started 2026 NCT07807800

DES-1357

…dence of metastases, that has been cytologically or genetically confirmed as dMMR, and/or MSI-H.

Metastatic Colorectal Cancer (CRC)
A Study of Pembrolizumab in Japanese Pediatric Participants With Solid Tumors or Lymphomas and Japanese Adult Participants With Merkel Cell Carcinoma (MK-3475-G21/KEYNOTE-G21)

Recruiting Phase 1/2 MSD (Merck & Co.) Started 2026 NCT07302347

Pembrolizumab FDA EU

For participants with microsatellite instability-high (MSI-H)/mismatch repair deficiency (dMMR) solid tumors:

Malignant Neoplasm, Carcinoma, Merkel Cell, Lymphoma
Low Dose, Reduced Frequency Nivolumab for the Treatment of Unresectable or Metastatic Cancer, AFFORD IO Trial

Not yet recruiting Phase 2 Fred Hutchinson Cancer Center Started 2026 NCT07576725

Nivolumab FDA EU

Colorectal cancer with high microsatellite instability (MSI) or mismatch repair deficiency

Clinical Stage III Cutaneous Melanoma AJCC v8, Clinical Stage III Cutaneous Merkel Cell Carcinoma AJCC v8, Clinical Stage IV Cutaneous Melanoma AJCC v8, Clinical Stage IV Cutaneous Merkel Cell Carcinoma AJCC v8
An Exploratory Study of Zanidatamab in HER2-positive Advanced Tumor After at Least One Line of Standard Therapy

Not yet recruiting Phase 2 Haihua Yuan Started 2026 NCT07631871

Zanidatamab

anti-PD-L1 therapy for MSI-H/dMMR tumors if clinically indicated.

Neoplasms, Solid Tumors, HER2 Positive Solid Tumor, Endometrial Neoplasm
SKB264 Plus KL-A167 in MSI-H/dMMR Advanced Gynecological Malignancies

Not yet recruiting Phase 2 Peking Union Medical College Hospital Started 2026 NCT07738757

Sacituzumab Tirumotecan (Sac-TMT)Tagitanlimab

3\. dMMR or MSI-H subtype (defined as: deficiency/loss of mismatch repair (MMR) proteins MLH1, PMS2, MSH2, …

Recurrent or Metastatic MSI-H/dMMR Gynecological Malignancies
Factors Influencing Immunotherapy Response in dMMR/MSI-H Gastric/Gastroesophageal Junction Adenocarcinoma

Not yet recruiting Phase 2 Shanghai Zhongshan Hospital Started 2026 NCT07259473

ImmunotherapyInduction chemotherapy

Factors Influencing Immunotherapy Response in dMMR/MSI-H Gastric/Gastroesophageal Junction Adenocarcinoma

Gastric / Gastroesophageal Junction Adenocarcinoma, Mismatch Repair Deficient or MSI-High Solid Tumors, Immunotherapy
Phase 1/2 Clinical Study of HY07121 for Injection (Subcutaneous) in Patients With Advanced Solid Tumors

Not yet recruiting Phase 1/2 Sichuan Huiyu Pharmaceutical Started 2026 NCT07789327

Test Product HY07121 for Injection (Subcutaneous)Test Product HY07121 for Injection (Subcutaneous)

…phageal cancer, Microsatellite Instability-High / Mismatch Repair-Deficient Solid Tumors (MSI-H/dMMR) solid tumors, cervical cancer, non-muscle-invasive bladder cancer, head and neck sq…

Safety, Tolerability, Efficacy
EIK1005-002: A Clinical Research Study Evaluating EIK1005, a Werner Helicase Inhibitor, as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced Solid Tumors Including Microsatellite Instability High (MSI-H) Tumors

Recruiting Phase 1/2 Eikon Therapeutics Started 2026 NCT07262619

EIK1005pembrolizumab (KEYTRUDA® ) FDA EU

Part 1B and Part 2: participant has locally confirmed Microsatellite Instability High (MSI-H) or Mismatch Repair Deficient (dMMR) tumor.

Advanced Solid Tumors, MSI-H or dMMR Advanced Solid Tumors, MSI-H/dMMR Gastric Cancer, MSI-H/dMMR Colorectal Cancer
A Phase II Study of Ipilimumab N01 Plus Sintilimab for MSI-H or dMMR Gastric and Gastroesophageal Junction Cancer

Not yet recruiting Phase 2 Fudan University Started 2026 NCT07878221

Ipilimumab N01Sintilimab

MSI-H by microsatellite instability testing (using the 5 microsatellite loci recommended by the…

Gastric / Gastroesophageal Junction Adenocarcinoma
Single-arm, Phase II Clinical Study Evaluating the Safety and Efficacy of Sintilimab Combined With IBI-310 and Chemotherapy as Neoadjuvant Therapy for Locally Advanced Rectal Cancer

Recruiting Phase 2 Xijing Hospital Started 2026 NCT07750951

Cindilimab、IBI310、Capecitabine、Oxaliplatin

…ary lesion is a locally advanced rectal adenocarcinoma with histopathologically confirmed MSI-H/dMMR characteristics.;

MSI-H/dMMR Locally Advanced Rectal Adenocarcinoma
Iparomlimab Tolvorlimab as Neoadjuvant Immunotherapy for Locally Advanced Gastric Adenocarcinoma With Microsatellite Instability/Mismatch Repair Deficiency

Not yet recruiting Phase 2 Peking University Cancer Hospital & Institute Started 2026 NCT07595523

Iparomlimab/Tuvonralimab (QL1706)

Tumor biopsy demonstrates dMMR status and concurrently meets the criteria for MSI-H.

Gastric Cancer
Adjuvant Therapy for Potentially Immunotherapy-Responsive Gastric or Gastroesophageal Junction Adenocarcinoma

Not yet recruiting Phase 2 The First Affiliated Hospital with Nanjing Medical University Started 2026 NCT07772557

Standard Treatment Group: SOX regimen for up to 6 cycles Oxaliplatin: 130 mg/m², i.v., D1, Q3W; S-1 (Tegafur-Gimeracil-Oteracil Potassium): Oral administration: 40 mg per dose for BSA < 1.25, 50 mg peExperimental Immunotherapy Group: Phase I: Combination Therapy Period (First 3 Cycles) Oxaliplatin: 130 mg/m², intravenous infusion, Day 1, every 3 weeks (Q3W), for 3 cycles. Serplulimab: 300 mg, i

…perative testing of gastric cancer specimens indicates: PD-L1 CPS ≥5, or EBV-positive, or dMMR.

Gastric or Gastroesophageal Junction Adenocarcinoma
Immunotherapy for Surgery Avoidance in Vulnerable dMMR Endometrial Cancer

Not yet recruiting Phase 2 Women's Hospital School Of Medicine Zhejiang University Started 2026 NCT07369986

Iparomlimab and Tuvonralimab (QL1706)

Confirmed dMMR or MSI-H, defined by either loss of expression of one or more mismatch repair proteins (MLH1, PMS2…

Endometrial Cancer, Immunotherapy, Mismatch Repair Deficiency
Sintilimab Monotherapy in Patients With Stage I-II MSI-H/dMMR Endometrial Cancer

Not yet recruiting Phase 2 Wang Jianliu Started 2026 NCT07731607

Sintilimab monotherapy

…etrial cancer (loss of MLH1/PMS2/MSH2/MSH6 protein expression by immunohistochemistry) or MSI-H (microsatellite instability-high by PCR or NGS).

MMRd Endometrial Cancer of Stage I~II
Preventive Dendritic Cell Vaccination for Lynch Syndrome

Not yet recruiting Phase 1/2 Radboud University Medical Center Started 2026 NCT07412197

DC vaccination

MSH6 subjects with a history of MMR-D cancer have to be cancer-free for more than 1 year.

Lynch Syndrome
ctDNA-Guided Immunotherapy for dMMR/MSI-H Colon Cancer

Recruiting Phase 2 Fudan University Started 2026 NCT07841236

PD-1 inhibitorCTLA-4 inhibitor

ctDNA-Guided Immunotherapy for dMMR/MSI-H Colon Cancer

Colon Cancer, Deficient Mismatch Repair, Microsatellite Instability-High (MSI-H)
A Phase IIa Study Evaluating Injectable ALK-N001 in Patients With Advanced Gastrointestinal Tumors

Not yet recruiting Phase 2 Zhejiang Anglikang Pharmaceutical Started 2026 NCT07826195

Injectable ALK-N001

For MSI-H/dMMR tumors, prior PD-(L)1 inhibitor is required.

Advanced Gastrointestinal Tumors
Phase Ib/IIa Open-label Study, to Evaluate Safety, Tolerability, and Antitumor Activity of HCB101 in Combination With Multiple Agents in Subjects With Advanced Gastric or Gastro-esophageal (GEJ) Adenocarcinoma

Not yet recruiting Phase 1/2 Kaohsiung Medical University Chung-Ho Memorial Hospital Started 2026 NCT07680569

ZolbetuximabOxaliplatin + 5-Fluorouracil/LeucovorinCAPOX (oxaliplatin/capecitabine)

Subjects must have tumors that are not microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR).

GC/GEJC
Clinical Trial of TB511 in Advanced Solid Tumors

Not yet recruiting Phase 1/2 Twinpig Biolab Started 2026 NCT06400160

TB511Keytruda

…hageal cancer, renal cell carcinoma, endometrial cancer, microsatellite instability-high (MSI-H) cancer, MSI-H colorectal cancer, triple-negative breast cancer, cervical cancer, biliary…

NSCLC, Prostate Cancer, Colorectal Cancer, Hepatocellular Carcinoma
A Study of TAK-505 in Adults With Solid Tumors

Recruiting Phase 1/2 Takeda Started 2026 NCT07436728

TAK-505

…tor receptor 2 (HER2) positive, PD-L1 positive or having microsatellite instability-high (MSI-H) should have received anti-HER2 and anti-PD-1/PD-L1 treatment, respectively.

Malignant Solid Tumors
A Clinical Study of Sintilimab Combined With Chemothrapy Versus Chemotherapy as Adjuvant Therapy for Gastric/Gastroesophageal Junction Adenocarcinoma

Recruiting Phase 2 Fudan University Started 2026 NCT07492615

SintilimabS-1 & Oxaliplatin

…(dMMR) by immunohistochemistry (IHC) of biopsy tissue or microsatellite instability-high (MSI-H) by genetic sequencing.

Gastric Cancer or Gastroesophageal Junction Adenocarcinoma
Adebrelimab Combined With Induction Chemotherapy or SHR-8068 for Mismatch Repair-Deficient/Microsatellite Instability-High (dMMR/MSI-H) Locally Advanced Gastric/Gastroesophageal Junction Adenocarcinoma：A Randomized, Non-comparative Phase 2 Study

Not yet recruiting Phase 2 Shanghai Zhongshan Hospital Started 2026 NCT07266025

AdebrelimabXELOXSHR-8068

dMMR confirmed by IHC or MSI-H confirmed by PCR

Gastric Adenocarcinoma, Gastroesophageal Adenocarcinoma, Mismatch Repair Deficient or MSI-High Solid Tumors, Immunotherapy
A Phase Ib/II Study of BM230 in Combination With PD-1 Inhibitor for HER2-related Advanced Solid Tumors

Not yet recruiting Phase 1/2 Suzhou Biomissile Pharmaceuticals Started 2026 NCT07698587

BM230 & PD-1 inhibitorBM230 & PD-1 inhibitor

Cohort A: Unresectable or metastatic high microsatellite instability (MSI-H) or mismatch repair-deficient (dMMR) advanced solid tumors in adult patients:

Solid Tumor
Immunotherapy (Toripalimab) for Reducing Recurrence Risk After Surgery for Mismatch Repair Deficient Stage IIB, IIC, or III Colon Cancer

Recruiting Phase 2 Emory University Started 2025 NCT07140679

Toripalimab

Patients with resected pathologic stage IIB, IIC and III dMMR colon cancer (American Joint Committee on Cancer \[AJCC\] 8)

Localized Colon Carcinoma, Stage IIB Colon Cancer AJCC v8, Stage IIC Colon Cancer AJCC v8, Stage III Colon Cancer AJCC v8
QL1706 Plus Bevacizumab for Unresectable or Metastatic MSI-H/dMMR CRC

Not yet recruiting Phase 2 Qianfoshan Hospital Started 2025 NCT07009145

QL1706Bevacizumab

QL1706 Plus Bevacizumab for Unresectable or Metastatic MSI-H/dMMR CRC

Unresectable Colorectal Cancer, Metastatic Colorectal Cancer (CRC), MSI-H/dMMR Colorectal Cancer
Patient Preference for Subcutaneous vs. Intravenous Immune Therapy

Recruiting Phase 2 Diwakar Davar Started 2025 NCT07223424

nivolumab FDA EUpembrolizumab FDA EU

…lumab is FDA-approved in the following indications: RCC, melanoma, NSCLC, SCCHN, UC, dMMR/MSI-H CRC, HCC, esophageal cancer, and gastric, gastroesophageal and esophageal adenocarcinoma …

Renal Cell Carcinoma, Non Small Cell Lung Cancer, Melanoma, Colo-rectal Cancer (dMMR/MSI-H CRC)
Assessing Iparomlimab and Tuvonralimab in Recurrent or Metastatic MSI-H/dMMR Gastric Cancer

Recruiting Phase 2 Peking University Started 2025 NCT07127822

Iparomlimab and TuvonralimabFirst line chemotherapy plus PD-1/PD-L1 antibody

Confirmed by PCR or next-generation sequencing(NGS) as microsatellite instability-high(MSI-H) .

Gastric / Gastroesophageal Junction Adenocarcinoma, MSI-H Cancer
A Study of LM-108 in Combination With Toripalimab in Subjects With Advanced Solid Tumours

Not yet recruiting Phase 2 LaNova Medicines Limited Started 2025 NCT06873854

LM-108Toripalimab

…s or sequential) with other systemic treatments and unresectable or metastatic late stage MSI-H/dMMR solid tumors.

Advanced Solid Tumor
A Study of Dostarlimab in Combination With Carboplatin-paclitaxel in Chinese Participants With Primary Advanced or Recurrent Endometrial Cancer (EC)

Recruiting Phase 2 GSK Started 2025 NCT07108270

Dostarlimab FDA EUCarboplatinPaclitaxel

…molecular subtype of defective mismatch repair (dMMR) or microsatellite instability high (MSI-H) determined by the central reference laboratory before study intervention.

Neoplasms, Endometrial
pReOperative Dostarlimab and Novel Therapies in EndOmetrial Cancer

Not yet recruiting Phase 2 University College, London Started 2025 NCT07115927

Dostarlimab FDA EU

… protein expression (MLH1, MSH2, MSH6, PMS2) where loss of one or more proteins indicates dMMR

Endometrial Cancer
Irinotecan Liposomes Combined with Cetuximab + Vermofenib in First-line Failure of Advanced Colorectal Cancer

Recruiting Phase 2 Fudan University Started 2025 NCT06763029

Irinotecan liposomes combined with cetuximab + vermofenib

For BRAF V600E mutated patients with MSI-H, first-line immunotherapy with PD-1 or PD-L1 is required;

Colorectal Cancer Metastatic
The Efficacy and Safety of Neoadjuvant Therapy With Iparomlimab and Tuvonralimab in Locally Advanced MSI-H/dMMR Colorectal Cancer: An Prospective, Single-Arm Study (Neo-IT)

Active, not recruiting Phase 2 Sir Run Run Shaw Hospital Started 2025 NCT07160647

Ipalolimab and Tovorilimab

…y and Safety of Neoadjuvant Therapy With Iparomlimab and Tuvonralimab in Locally Advanced MSI-H/dMMR Colorectal Cancer: An Prospective, Single-Arm Study (Neo-IT)

dMMR/MSI-H-type Rectal Adenocarcinoma
Neoadjuvant Pembrolizumab With a Watch-and-wait Strategy for dMMR/MSI-H Localized Colon Cancer: PREMICES Study.

Not yet recruiting Phase 2 GERCOR - Multidisciplinary Oncology Cooperative Group Started 2025 NCT06646445

Pembrolizumab Injection [Keytruda] FDA EUAdjuvant chemotherapy

Neoadjuvant Pembrolizumab With a Watch-and-wait Strategy for dMMR/MSI-H Localized Colon Cancer: PREMICES Study.

Colon Cancer
Ph II Study of Enfortumab Vedotin in Patients With Advanced or Metastatic CRC or HCC

Recruiting Phase 2 H. Lee Moffitt Cancer Center and Research Institute Started 2025 NCT06553885

Enfortumab Vedotin

For patients with microsatellite instability high (MSI-H) CRC, previous lines of therapy should include a PD-1/PD-L1 immune checkpoint inhibitor i…

Metastatic Colorectal Cancer, Hepatocellular Carcinoma
A Study of Irinotecan With Dabrafenib Plus Trametinib and Anti-EGFR in the Second Line of Therapy in People With Metastatic Colorectal Cancer

Active, not recruiting Phase 2 Blokhin's Russian Cancer Research Center Started 2025 NCT06967155

• Drug: Dabrafenib • Drug: Trametinib • Drug: Cetuximab • Drug: Рanitumumab • Drug: Oxaliplatin • Drug: Irinotecan • Drug: Leucovorin • Drug: 5-FU

It is possible to include patients with MSI or dMMR if they have received first-line immune checkpoint therapy.

Neoplasms
TL938 and Trastuzumab for Patients With HER2-positive Metastatic Colorectal Cancer

Recruiting Phase 2 Suzhou Teligene Started 2025 NCT06589830

TL938 CapsulesTrastuzumab

…ere deficient in mismatch repair (dMMR) proteins or were microsatellite instability-high (MSI-H) must also have received an ant-programmed cell death protain-1 mAb;

Colorectal Cancer Metastatic, Advanced Colorectal Cancer
A Study to Investigate the Safety and Preliminary Efficacy of GSK5460025 Alone or in Combination With Other Anti-cancer Agents in Participants With Solid Tumors

Recruiting Phase 1/2 GSK Started 2025 NCT07213609

GSK5460025

…lt Participants With Mismatch Repair-deficient (dMMR) or Microsatellite Instability-High (MSI-H) Solid Tumors

Neoplasms, Colorectal, Neoplasms
Azenosertib in Uterine Serous Carcinoma: Biomarker Study

Recruiting Phase 2 Joyce Liu, MD Started 2025 NCT06369155

Azenosertib

…nally, participants must have a known tumor MSI or MMR status and those participants with MSI-high or MMR-deficient tumors must have already received prior therapy with a PD1 or PD-L1 immu…

Uterine Serous Carcinoma, Uterine Carcinoma, Uterine Cancer
Immunotherapy Combined With Anti-angiogenic Therapy and Chemotherapy for Potentially Resectable MSI-H, dMMR Locally Advanced Gastric or Gastroesophageal Junction Adenocarcinoma

Not yet recruiting Phase 2 The First Affiliated Hospital with Nanjing Medical University Started 2025 NCT07151209

Iparomlimab and Tuvonralimab combined with lenvatinib and SOX

…therapy Combined With Anti-angiogenic Therapy and Chemotherapy for Potentially Resectable MSI-H, dMMR Locally Advanced Gastric or Gastroesophageal Junction Adenocarcinoma

Gastric or Gastroesophageal Junction Adenocarcinoma
Amplitude-Modulated Radiofrequency Electromagnetic Fields (AM RF EMF) in Combination With Fruquintinib in Refractory Metastatic Colorectal Cancer

Recruiting Phase 2 Barbara Ann Karmanos Cancer Institute Started 2025 NCT07130903

Fruquintinib

…AS (Rat sarcoma mutation), BRAF (B-Raf proto-oncogene, Serine/threonine kinase), MSI/MMR (microsatellite instability, mismatch repair) , and HER2 (Human epidermal growth factor receptor 2) status.

Metastatic Colorectal Adenocarcinoma
Toripalimab Plus Celecoxib for dMMR/MSI-H Locally Advanced Colorectal Cancer

Recruiting Phase 2 Sun Yat-sen University Started 2025 NCT06903858

Toripalimab plus celecoxib

Toripalimab Plus Celecoxib for dMMR/MSI-H Locally Advanced Colorectal Cancer

Colorectal Cancer, Microsatellite Instability High, Mismatch Repair Deficiency
A Study on Immunotherapy Combined With Radiotherapy for Esophagogastric Junction/Gastric Adenocarcinoma

Not yet recruiting Phase 2 Jiangsu Cancer Institute & Hospital Started 2025 NCT07053332

PD-1/CTLA-4 combination antibody with low-dose radiotherapy

…eoadjuvant PD-1/CTLA-4 Combination Antibody With Low-dose Radiotherapy in Resectable dMMR/MSI-H Esophagogastric Junction/Gastric Adenocarcinoma.

Esophagogastric Junction/Gastric Adenocarcinoma
Phase Ⅱ Clinical Trial of Cadonilimab Combined With Anti-angiogenic Agents in Metastatic dMMR/MSI-H CRC

Recruiting Phase 2 Fudan University Started 2025 NCT07003022

cadonilimab combined with an anti-angiogenic agent, which is selected by the investigator from bevacizumab, regorafenib, or fruquintinib.

Age 18-80 years. dMMR or MSI-H Diagnosis confirmed by histological examination and/or cytological examination combined w…

Colo-rectal Cancer, MSIhi or dMMR Advanced Unresectable or Metastatic Solid Tumors, Including Colorectal Cancers
Phase II Study of Anti-PD-1/VEGF Bispecific Antibody Ivonescimab in Patients With Previously Treated Metastatic Colorectal Cancer

Recruiting Phase 2 M.D. Anderson Cancer Center Started 2025 NCT06959550

Ivonescimab

Cohort 1: MSI-H/dMMR: ICI-refractory

Metastatic Colorectal Cancer
Clinical Trial to Assess the Efficacy of Dostarlimab as Neoadjuvant Therapy in Patients With MMRd/MSI-H Stage II-III Endometrial Cancer

Not yet recruiting Phase 2 Grupo Español de Investigación en Cáncer de Ovario Started 2025 NCT07013851

Dostarlimab FDA EU

… Trial to Assess the Efficacy of Dostarlimab as Neoadjuvant Therapy in Patients With MMRd/MSI-H Stage II-III Endometrial Cancer

MMRd/MSI-H Stage II-III Endometrial Cancer
TQB2450 Plus Progestin for Fertility-sparing Treatment in MMRd EC

Recruiting Phase 2 Fudan University Started 2025 NCT06914297

TQB2450 injection + oral progestin

EC molecular typing, resulting in MMRd type (molecular typing is based on the World Health Organization (WHO) classification cri…

Endometrial Cancer
Pembrolizumab With Olaparib as Combined Therapy in Metastatic Pancreatic Cancer

Recruiting Phase 2 Cambridge University Hospitals NHS Foundation Trust Started 2025 NCT05093231

Pembrolizumab FDA EUOlaparib

Confirmation that the PDA has TMB \>4 mutations/Mb, or dMMR gene mutation, or MSI-H by IHC.

Pancreatic Cancer
Low-dose Immunotherapy in Metastatic and Locally Advanced Colorectal and Gastric MSI/dMMR Cancers

Enrolling by invitation Phase 2 Blokhin's Russian Cancer Research Center Started 2025 NCT07542262

Low-dose nivolumab FDA EULow-dose nivolumab with/without chemotherapy FDA EULow-dose nivolumab combined with chemotherapy FDA EU

Presence of MSI/dMMR in the tumor;

Colorectal Cancer, Gastric Cancer
The Phoenix Trial: Phase II Trial of Cemiplimab for the Non-operative Management of Localized dMMR Colon Cancer

Active, not recruiting Phase 2 M.D. Anderson Cancer Center Started 2024 NCT05961709

Cemiplimab

…on cancer that is deficient in mismatch repair (dMMR) or microsatellite Instability high (MSI-H) as determined by one of three methods:

Colon Cancer
Dostarlimab for Locally Advanced or Metastatic Cancer (Non-colorectal/Non-endometrial) With Tumor dMMR/MSI

Recruiting Phase 2 UNICANCER Started 2024 NCT06333314

Dostarlimab FDA EUChemotherapy

Histologically proven, dMMR/MSI-H solid tumors that are not colorectal or endometrial cancers and including one of the foll…

Pancreatic Adenocarcinoma, Ampulla of Vater Carcinoma, Adrenocortical Carcinoma, Neuroendocrine Carcinoma
Neoadjuvant Immunotherapy for T4 dMMR Colon Cancer

Active, not recruiting Phase 2 Peking Union Medical College Hospital Started 2024 NCT06215677

Camrelizumab

Adenocarcinoma confirmed by pathology and dMMR confirmed by IHC or PCR;

Colon Cancer, Mismatch Repair Deficiency, Immunotherapy
Neoadjuvant Low-dose Immunotherapy in Locally Advanced MMR-deficient Colorectal Cancer

Active, not recruiting Phase 2 Blokhin's Russian Cancer Research Center Started 2024 NCT07523763

Nivolumab FDA EUPembrolizumab FDA EU

Presence of MSI/dMMR in the tumor;

Colorectal Cancer (MSI-H), Colorectal Cancer (CRC)
DEWI: Watch-and-Wait With Dostarlimab in Localized dMMR/MSI-H Gastric/GEJ Adenocarcinoma Phase II Study

Recruiting Phase 2 GERCOR - Multidisciplinary Oncology Cooperative Group Started 2024 NCT06059495

Dostarlimab FDA EU

Tumor status confirmed to be dMMR/MSI-H as follows:

Adenocarcinoma - GEJ, Gastric Adenocarcinoma
Psilocybin-Assisted Psychotherapy in Patients With Advanced Cancer on Maintenance Therapy

Recruiting Phase 2 M.D. Anderson Cancer Center Started 2024 NCT06200155

Psilocybin

…ous cell carcinoma, ovarian cancer, breast cancer, gastric/GEJ cancer, cervical, anal, or MSI-high

Depression, Anxiety, Psilocybin-Assisted Psychotherapy, Advanced Cancer
A Study to Investigate the Safety, Pharmacokinetics, and Preliminary Effectiveness of GSK4418959 Alone or in Combination With Other Anti-cancer Agents in Participants With Solid Tumors

Active, not recruiting Phase 1/2 GSK Started 2024 NCT06710847

GSK4418959PD-1 inhibitor

…lt Participants With Mismatch Repair-deficient (dMMR) or Microsatellite Instability-High (MSI-H) Solid Tumors (SYLVER)

Neoplasms, Colorectal, Solid Tumor, Colon Cancer, Rectal Cancer
AK104 in Locally Advanced MSI-H/dMMR Gastric Carcinoma and Colorectal Cancer

Active, not recruiting Phase 2 Peking University Started 2024 NCT04556253

AK104

AK104 in Locally Advanced MSI-H/dMMR Gastric Carcinoma and Colorectal Cancer

MSI-H/dMMR Gastric Carcinoma and Colorectal Cancer
An Open-label, Multicenter, Single-arm Clinical Study on the Use of Doxorubicin Liposome in Combination With CapOX and Bevacizumab Regimen for First-line Treatment of Advanced Colorectal Adenocarcinoma With SMAD4R361H/C Mutation.

Not yet recruiting Phase 1/2 Nanfang Hospital, Southern Medical University Started 2024 NCT06753721

Doxorubicin liposome combined with CapOX and Bevacizumab

Non-dMMR/MSI-H;

Advanced Colorectal Adenocarcinoma
Sintilimab Combined With LDRT for Neoadjuvant Treatment of Locally Advanced dMMR/MSI-H Gastric Cancer

Not yet recruiting Phase 1/2 West China Hospital Started 2024 NCT06426654

sintiliman plus LDRT

4. dMMR and/or MSI-H.

Status may be outdated, last updated 2024-05-23Gastric Cancer
Phase II Study of ctDNA-guided Encorafenib Plus Cetuximab Retreatment in Patients BRAF V600E Mutated mCRC

Active, not recruiting Phase 2 Gruppo Oncologico del Nord-Ovest Started 2024 NCT06578559

CetuximabEncorafenib

…hibitors (anti-PD-1/PD-L1 alone or in combination with anti-CTLA-4 agent), in the case of MSI-H or dMMR mCRC;

Colorectal Cancer
A Study of Dostarlimab in Participants With Untreated Locally Advanced Rectal Cancer in China

Active, not recruiting Phase 2 GSK Started 2024 NCT06640049

Dostarlimab FDA EU

Participant has a tumor which can be categorized as dMMR or MSI-H by central assessment

Neoplasms, Rectal
Cemiplimab With or Without Fianlimab to Treat Older Patients With Localized or Locally Advanced MSI-H Colorectal Cancer

Recruiting Phase 2 Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Started 2024 NCT06205836

CemiplimabFianlimab

…ocalized or locally advanced mismatch repair deficient (dMMR) or microsatellite unstable (MSI-H) colorectal cancer.

Colorectal Cancer
Tislelizumab in People With Colorectal Cancer

Recruiting Phase 2 Memorial Sloan Kettering Cancer Center Started 2024 NCT06529523

Tislelizumab

Confirmation of dMMR by immunohistochemistry

Colorectal Cancer
A Study of Oral 7HP349 (Alintegimod) in Combination With Ipilimumab Followed by Nivolumab Monotherapy

Recruiting Phase 1/2 7 Hills Pharma Started 2024 NCT06362369

AlintegimodIpilimumabNivolumab FDA EU

…dvanced or metastatic solid tumors: melanoma, pleural mesothelioma, renal cell carcinoma, MSI-high or mismatch repair-deficient colorectal cancer, hepatocellular carcinoma, and non-small c…

Advanced Cancer, Advanced Solid Tumor, Melanoma, Metastasis
A Study to Evaluate the Safety and the Activity of S095029 as Part of Combination Therapy in Advanced Gastroesophageal Junction/Gastric Cancers.

Active, not recruiting Phase 1/2 Servier Bio-Innovation Started 2024 NCT06116136

S095029pembrolizumab 200 mg (KEYTRUDA ®) FDA EU

… Combination Therapy in Participants With Locally Advanced and Unresectable or Metastatic MSI-H/dMMR Gastro-esophageal Junction /Gastric Cancer

MSI-H/dMMR Gastroesophageal-junction Cancer, MSI-H/dMMR Gastric Cancer
Immune Checkpoint Inhibitors for Organ Preservation in Non-metastatic dMMR/MSI-H Gastric or Colon Cancers

Recruiting Phase 2 Peking University Started 2024 NCT06580574

PD1/PDL1 antibody monotherapy, up to 24 weeksIntensive immunotherapy plus anti-VEGF treatment, up to 24 weeks

dMMR confirmed by immunohistochemistry or MSI-H confirmed by PCR and NGS.

Gastric Cancer, Colon Cancer, MSI-H, DMMR Cancer
SATELLITE Study (feaSibility sAfeTy Efficacy dostarLimab earLy-stage defIcient endomeTrial cancEr)

Recruiting Phase 2 Queensland Centre for Gynaecological Cancer Started 2024 NCT06278857

Dostarlimab-Gxly 50 MG/1 ML Intravenous Solution [JEMPERLI] FDA EU

i. histologically or cytologically proven Stage 1, FIGO grade 1 or 2, MMR deficient (Absence of at least one MMR protein (MLH1, PMS2, MSH2, MSH6) by immunohistochemistry.) e…

Endometrial Cancer Stage I, Mmr Deficiency, Endometrioid Endometrial Adenocarcinoma, Immune-related Adverse Event
Platform Study of Immunotherapy Combinations in Colorectal Cancer Liver Metastases

Recruiting Phase 2 Weill Medical College of Cornell University Started 2024 NCT06300463

BotensilimabBalstilimabAGEN1423

Tumor is non-MSI-H/dMMR

Colorectal Cancer Metastatic, Liver Metastases, Colorectal Cancer
Efficacy and Safety of Neoadjuvant Sintilimab Plus FLOT Versus Sintilimab Plus SOX Phase II Clinical Trial for Patients With Locally Advanced Gastric Cancer

Not yet recruiting Phase 2 Xijing Hospital Started 2024 NCT06459921

SOX+SintilimabFLOT+Sintilimab

5\. deficient mismatch repair identified by pathological detection.

Status may be outdated, last updated 2024-10-10Neoadjuvant Chemotherapy, Sintilimab, Locally Advanced Gastric Cancer
Comparison of In-Home Versus In-Clinic Administration of Subcutaneous Nivolumab Through Cancer CARE (Connected Access and Remote Expertise) Beyond Walls (CCBW) Program

Recruiting Phase 2 Mayo Clinic Started 2024 NCT06265285

Nivolumab FDA EU

Microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progress…

Advanced Esophageal Squamous Cell Carcinoma, Advanced Renal Cell Carcinoma, Clinical Stage II Esophageal Squamous Cell Carcinoma AJCC v8, Clinical Stage IIB Cutaneous Melanoma AJCC v8
Different Cycles of Preoperative Neoadjuvant Sintilimab in Mismatch-repair Deficient/microsatellite Instability-high, Locally Advanced Colorectal Cancer

Recruiting Phase 2 Yugui Lian Started 2024 NCT06698757

Sintilimab

immunohistochemistry of tumor biopsy indicating deficient mismatch repair (dMMR), defined by the loss of expression of one or more of the four proteins MSH1, MSH2,…

Colorectal Cancer
Immunotherapy in Patients With Early dMMR Rectal Cancer

Recruiting Phase 2 Odense University Hospital Started 2023 NCT05732389

Nivolumab FDA EUIpilimumab

Histologically verified dMMR or MSI.

Cancer of Rectum
Single Arm Study of Neoadjuvant Dostarlimab in Stage II and III Deficient Mismatch Repair Colon Cancers

Recruiting Phase 2 University of Iowa Started 2023 NCT05239546

Dostarlimab FDA EU

Biopsy proven dMMR (by IHC), Stage II or III colon cancer per CT imaging correlation with AJCC 8th edition, …

Colon Cancer, dMMR Colorectal Cancer
Chemotherapy Sequential Tislelizumab After Radical Resection in Patients With dMMR/MSI-H or POLE/POLD1 Mutations

Not yet recruiting Phase 2 China Medical University, China Started 2023 NCT06118658

tislelizumab

…or the study 2.Age and gender: ≥18 years old and≤75 years old, both men and women. 3.dMMR/MSI-H or POLE/POLD1 gene mutation was confirmed by immunohistochemical PCR or NGS 4.0-1 physica…

Status may be outdated, last updated 2023-11-07Gastric, Colorectal Adenocarcinoma
FOG-001 in Locally Advanced or Metastatic Solid Tumors

Recruiting Phase 1/2 Parabilis Medicines Started 2023 NCT05919264

FOG-001mFOLFOX-6Nivolumab FDA EUTrifluridine/tipiracilBevacizumabFOG-001

MSI-H CRC or solid tumors that are WPAM and resistant to a-PD-1/PD-L1

Cancer, Colorectal Cancer, Solid Tumor, Locally Advanced Solid Tumor
Cadonilimab for PD-1/PD-L1 Blockade-refractory, MSI-H/dMMR, Advanced Colorectal Cancer

Active, not recruiting Phase 1/2 Sun Yat-sen University Started 2023 NCT05426005

Cadonilimab

…deficient (dMMR) by immunohistochemistry (IHC) method or microsatellite instability-high (MSI-H) by polymerase chain reaction (PCR).

Colorectal Cancer Stage IV, Mismatch Repair-deficient (dMMR), Microsatellite Instability-high (MSI-H)
PD-1 Antibody Carilizumab Combined with Apatinib for Unresectable Stage III and IV DMMR Gastric Cancer

Recruiting Phase 2 Peking University Third Hospital Started 2023 NCT06792162

Carilizumab and Apatinib

Histologically confirmed unresectable stage III and IV dMMR (complete loss of at least one protein, MLH1, PMS2, MSH2, and MSH6), gastric adenocarcino…

Gastric Cancer
Testing Immunotherapy (Atezolizumab) With or Without Chemotherapy in Locoregional MSI-H/dMMR Gastric and Gastroesophageal Junction (GEJ) Cancer

Active, not recruiting Phase 2 National Cancer Institute (NCI) Started 2023 NCT05836584

Atezolizumab FDACapecitabineDocetaxelFluorouracilLeucovorin CalciumOxaliplatin

…ically confirmed diagnosis of gastric or gastroesophageal junction adenocarcinoma that is MSI-H/dMMR (microsatellite instability-high/mismatch repair deficient) as determined by one of …

Clinical Stage I Gastric Cancer AJCC v8, Clinical Stage I Gastroesophageal Junction Adenocarcinoma AJCC v8, Clinical Stage II Gastric Cancer AJCC v8, Clinical Stage II Gastroesophageal Junction Adenocarcinoma AJCC v8
A Study of a Selective T Cell Receptor (TCR) Targeting, Bifunctional Antibody-fusion Molecule STAR0602 in Participants With Advanced Solid Tumors

Recruiting Phase 1/2 Marengo Therapeutics Started 2023 NCT05592626

STAR0602Irinotecan (Camptosar)Docetaxel (Taxotere)

Microsatellite Instability (MSI-H)/DNA mismatch repair (dMMR)

Advanced Solid Tumors, Genital Neoplasm, Female, Urogenital Neoplasms, Lung Neoplasm
Study of Induction PD-1 Blockade (Nivolumab) in Patients With Surgically Complete Resectable Mismatch Repair Deficient Endometrial Cancer (NIVEC)

Recruiting Phase 2 Yonsei University Started 2023 NCT05795244

Nivolumab FDA EU

MMRd or MSI-H subtype (defined by either deficient/loss expression of mismatch repair (MMR) proteins ML…

Endometrial Neoplasms, Endometrial Cancer
Study of DECOY20 With or Without Tislelizumab in Patients With Advanced Solid Tumors

Active, not recruiting Phase 1/2 Indaptus Therapeutics Started 2023 NCT05651022

Decoy20Tislelizumab

…nd neck (SCCHN), adenocarcinoma of the pancreas, non-small cell lung cancer (NSCLC), dMMR/MSI-High tumor (Part 2c only).

Solid Tumor, Adult, HCC - Hepatocellular Carcinoma, CRC (Colorectal Cancer), Pancreatic Adenocarcinoma
A Phase IIa Randomized, Double-Blinded Clinical Trial of Naproxen or Aspirin for Cancer Immune Interception in Lynch Syndrome

Recruiting Phase 2 M.D. Anderson Cancer Center Started 2023 NCT05411718

NaproxenAspirin

…sporadic MMR deficient malignant tumor (where "non-sporadic MMR deficient" is defined by: microsatellite-instability high by either immunohistochemistry or MSI testing or both, but no evidence of MLH1 promoter m…

T Cells, Colorectal Cancer, Lynch Syndrome
KN046 Plus Regorafenib or Apatinib in MSI-H Digestive System Cancers Resistant to PD-1/PD-L1 Blockade

Active, not recruiting Phase 2 Peking University Cancer Hospital & Institute Started 2023 NCT06099821

KN046RegorafenibApatinib

dMMR/MSI-H cancers resistant to PD1/PDL1 blockade.

Digestive System Cancers
A Study of Dostarlimab in Untreated dMMR/MSI-H Locally Advanced Rectal Cancer

Active, not recruiting Phase 2 GSK Started 2023 NCT05723562

Dostarlimab FDA EU

Participant has a tumor which can be categorized as dMMR or MSI-H by local or central assessment

Neoplasms, Rectal
Perioperative Chemotherapy Plus Toripalimab for dMMR Locally Advanced Gastric or Esophagogastric Junction Adenocarcinoma

Recruiting Phase 2 Yu jiren Started 2023 NCT05729646

ToripalimabOxaliplatinS1

Mismatch repair deficient (dMMR) adenocarcinoma, which was determined by immunohistochemistry (ICH) test of endosco…

Status may be outdated, last updated 2023-07-25Adenocarcinoma of the Stomach, Adenocarcinoma of Esophagogastric Junction, Mismatch Repair Deficiency
Neo-adjuvant Pembrolizumab as an Alternative Treatment for MMRd Uterine Cancer

Active, not recruiting Phase 2 University Medical Center Groningen Started 2023 NCT06180733

Pembrolizumab Injection [Keytruda] FDA EU

… day of signing informed consent with histologically confirmed primary diagnosis of G3/CC MMRd uterine cancer who are intended to be treated with hysterectomy.

Endometrial Cancer
Tislelizumab Combined With Chemotherapy (CAPOX) in the Perioperative Treatment of MSI-H/dMMR Stage II or III Colorectal Cancer

Not yet recruiting Phase 2 The First Affiliated Hospital of Zhengzhou University Started 2023 NCT05841134

Tislelizumab

The tissue specimens are confirmed as MSI-H by PCR or NGS.

Status may be outdated, last updated 2023-05-09MSI-H Colorectal Cancer, Tislelizumab, Oxaliplatin, Capecitabine
Testing the Addition of Nivolumab to Standard Treatment for Patients With Metastatic or Unresectable Colorectal Cancer That Have a BRAF Mutation

Active, not recruiting Phase 2 National Cancer Institute (NCI) Started 2022 NCT05308446

CetuximabEncorafenibNivolumab FDA EU

Microsatellite instability can be determined by polymerase chain reaction (PCR)

Metastatic Colon Adenocarcinoma, Metastatic Rectal Adenocarcinoma, Stage III Colon Cancer AJCC v8, Stage III Rectal Cancer AJCC v8
A First-in-human, Dose Escalation and Dose Expansion Study of SAR445877 in Adult Participants With Advanced Solid Tumors

Recruiting Phase 1/2 Sanofi Started 2022 NCT05584670

SAR445877CetuximabADG126BevacizumabNivolumab FDA EUIpilimumab

HCC, colorectal cancer (MSI-H/dMMR), malignant pleural mesothelioma or esophageal squamous cell carcinoma (ESCC). and f…

Solid Tumor
Spartalizumab and Low-dose PAzopanib in Refractory or Relapsed Solid TumOrs of Pediatric and Adults

Active, not recruiting Phase 1/2 University Hospital, Bordeaux Started 2022 NCT05210413

Spartalizumab in Pediatric cohortLow-dose Pazopanib in Pediatric CohortSpartalizumab in Adult cohortLow-dose Pazopanib in Adult Cohort

…her) and/or tumor with High mutation rate (\>10 somatic mutations/Mb) and/or suffering of Mismatch repair-deficient syndrome.

Refractory or Recurrent Solid Tumor
Pembrolizumab for Locally Advanced, Irresectable, Non-metastatic dMMR Colorectal Cancers

Active, not recruiting Phase 2 The Netherlands Cancer Institute Started 2022 NCT05131919

Pembrolizumab FDA EU

Pembrolizumab for Locally Advanced, Irresectable, Non-metastatic dMMR Colorectal Cancers

Colorectal Cancer
Cancer Preventive Vaccine Nous-209 for Lynch Syndrome Patients

Active, not recruiting Phase 1/2 National Cancer Institute (NCI) Started 2022 NCT05078866

Adenoviral Tumor-specific Neoantigen Priming Vaccine GAd-209-FSPMVA Tumor-specific Neoantigen Boosting Vaccine MVA-209-FSP

A personal history of a non-sporadic MMR-deficient premalignant lesion (i.e., colorectal polyp) or a non-sporadic MMR-deficient malignant tu…

Colorectal Carcinoma, Lynch Syndrome
TT-702 in Patients With Advanced Solid Tumours.

Recruiting Phase 1/2 Cancer Research UK Started 2022 NCT05272709

TT-702Anti-PD-1 and PD-L1 agent

MMRd tumour, confirmed by either:

Advanced Solid Tumors
NEOadjuvant PembRolizumab In Stratified Medicine - ColoRectal Cancer

Active, not recruiting Phase 2 University College, London Started 2022 NCT05197322

Pembrolizumab FDA EUPembrolizumab FDA EU

Histologically proven adenocarcinoma of the colon or rectum which is MMR-d by IHC or MSI-H by PCR (or microsatellite testing if routine practice).

Adenocarcinoma of the Colon
Study of the Monoclonal Antibody IMT-009 in Patients With Advanced Solid Tumors or Lymphomas

Active, not recruiting Phase 1/2 Immunitas Therapeutics Started 2022 NCT05565417

IMT-009Fruquintinib

… bevacizumab, and a PD1/PD-L1 inhibitor alone or in combination with CTLA4 inhibitor (for MSI-H or dMMR tumors)

Non Small Cell Lung Cancer, Head and Neck Squamous Cell Carcinoma, Triple Negative Breast Cancer, Cutaneous Squamous Cell Carcinoma
A Study of Encorafenib Plus Cetuximab Taken Together With Pembrolizumab Compared to Pembrolizumab Alone in People With Previously Untreated Metastatic Colorectal Cancer

Active, not recruiting Phase 2 Pfizer Started 2022 NCT05217446

EncorafenibCetuximabPembrolizumab FDA EU

Locally confirmed microsatellite instability-high/ deficient mismatch repair (MSI-H/dMMR) stage IV colorectal carcinoma

Metastatic Colorectal Cancer
T-regulatory Cell Depletion With E7777 Combined With Pembrolizumab in Recurrent or Metastatic Solid Tumors

Active, not recruiting Phase 1/2 Alexander B Olawaiye, MD Started 2022 NCT05200559

Pembrolizumab FDA EUE7777

…ma, non-small cell lung cancer, renal cell carcinoma, endometrial cancer, ovarian cancer, MSI-H solid tumors (deficient mismatch repair system or other solid tumors) that have progresse…

Epithelial Ovarian Cancer
Testing Nivolumab With or Without Ipilimumab in Deficient Mismatch Repair System (dMMR) Recurrent Endometrial Carcinoma

Recruiting Phase 2 National Cancer Institute (NCI) Started 2022 NCT05112601

IpilimumabNivolumab FDA EU

Patients must have endometrial cancer with deficient mismatch repair system.

Endometrial Adenocarcinoma, Endometrial Clear Cell Adenocarcinoma, Endometrial Dedifferentiated Carcinoma, Endometrial Endometrioid Adenocarcinoma
Testing Nivolumab and Ipilimumab With Short-Course Radiation in Locally Advanced Rectal Cancer

Active, not recruiting Phase 2 National Cancer Institute (NCI) Started 2022 NCT04751370

IpilimumabNivolumab FDA EU

Patient must have MSI-H (microsatellite instability-high) or dMMR (deficient mismatch repair) tumors based on imm…

Locally Advanced Rectal Adenocarcinoma, Stage II Rectal Cancer AJCC v8, Stage III Rectal Cancer AJCC v8
A Study of XmAb20717 (Vudalimab)in Patients With Selected Advanced Gynecologic and Genitourinary Malignancies

Active, not recruiting Phase 2 Xencor Started 2022 NCT05032040

vudalimab

Advanced endometrial carcinoma that is not microsatellite instability-high (MSI-H) or deficient mismatch repair (dMMR) in patients who are not candidates for curative surgery or radiation, and that has…

Ovarian Cancer, Clear Cell Carcinoma, Endometrial Cancer, Cervical Carcinoma
Safety and Efficacy of PD-1 ± mFOLFOX6 Neoadjuvant Therapy in Local Advanced sMPCC

Recruiting Phase 2 Sixth Affiliated Hospital, Sun Yat-sen University Started 2022 NCT06002789

MSI-H/MSS (dMMR/pMMR) mixed sMPCC: combination of mFOLFOX6+PD-1 monoclonal antibody neoadjuvant therapyAll-MSI-H (dMMR) sMPCC: single-drug PD-1 monoclonal antibody neoadjuvant therapy

Tumor biopsy immunohistochemistry of at least one tumor lesion identified dMMR, including the expression loss of one or more of the four proteins MSH1, MSH2, MSH6 and P…

Multiple Cancer, Colorectal Cancer
A Phase II Study of Tislelizumab as Adjuvant Therapy for Patients With Stage Ⅱ and Stage Ⅲ Colon Cancer and dMMR/MSI.

Not yet recruiting Phase 2 The First Affiliated Hospital of Zhengzhou University Started 2022 NCT05231850

Tislelizumab

Locally confirmed defective mismatch repair (dMMR) tumour (as defined by the lack of staining on either the pre-operative biopsy samples or…

Status may be outdated, last updated 2022-02-09Colon Cancer
Camrelizumab Plus Anlotinib in Patients With Recurrent Sporadic MMRd Endometrial Cancer

Not yet recruiting Phase 2 Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University Started 2022 NCT05550558

Anlotinib + Camrelizumab

Tumors must demonstrate MMRd and MLH1 methylation.

Status may be outdated, last updated 2022-09-28Endometrial Cancer
Nivolumab and Ipilimumab in Anti-PD1-Resistant dMMR/MSI mCRC

Recruiting Phase 2 GERCOR - Multidisciplinary Oncology Cooperative Group Started 2022 NCT05310643

Nivolumab FDA EUIpilimumab

Nivolumab and Ipilimumab in Anti-PD1-Resistant dMMR/MSI mCRC

Metastatic Colorectal Cancer
PD-1 Antibody Adjuvant Therapy for GC Patients With MSI-H After D2 Radical Surgery

Active, not recruiting Phase 2 Fudan University Started 2022 NCT05468138

SOXXELOXPD-1 antibody

PD-1 Antibody Adjuvant Therapy for GC Patients With MSI-H After D2 Radical Surgery

MSI-H, PD-1 Immunotherapy, Gastric Cancer, Adjuvant Therapy
Phase 1a and Phase 2 Study for Safety, Preliminary Efficacy, PK and PD of ST-067

Recruiting Phase 1/2 Simcha IL-18 Started 2021 NCT04787042

ST-067Obinutuzumab 25 MG/1 ML Intravenous Solution [GAZYVA]pembrolizumab FDA EU

MSI high tumor should have mutations in 30% or more microsatellites by PCR or be negative for MSH1…

Cancer, Solid Tumor, Melanoma, Renal Cell Carcinoma
Atezolizumab in Patients With MSI-h/MMR-D Stage II High Risk and Stage III Colorectal Cancer Ineligible for Oxaliplatin

Active, not recruiting Phase 2 AIO-Studien-gGmbH Started 2021 NCT05118724

Atezolizumab FDAIMM-101

Tumor is MSI-high (MSI-H) or MMR-deficient (dMMR) For the main study: assessed from biopsy or from resected…

Colorectal Cancer
Pembrolizumab Plus Lenvatinib in Combination With Belzutifan in Solid Tumors (MK-6482-016)

Active, not recruiting Phase 2 MSD (Merck & Co.) Started 2021 NCT04976634

Pembrolizumab FDA EUBelzutifanLenvatinib

Colorectal cancer (CRC) (non-microsatellite instability-high \[non-MSI-H\]/deficient mismatch repair \[dMMR\])

Neoplasm Malignant
Evaluation of Co-formulated Pembrolizumab/Quavonlimab (MK-1308A) Versus Other Treatments in Participants With Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Stage IV Colorectal Cancer (CRC) (MK-1308A-008/KEYSTEP-008).

Active, not recruiting Phase 2 MSD (Merck & Co.) Started 2021 NCT04895722

Pembrolizumab FDA EUPembrolizumab/Quavonlimab FDA EUPembrolizumab/Favezelimab FDA EUPembrolizumab/Vibostolimab FDA EUMK-4830

Has locally confirmed dMMR/MSI-H

Colorectal Cancer
Anti-PD-1 and CapOx for the First-line Treatment of dMMR Esophagogastric Cancer (AuspiCiOus)

Recruiting Phase 2 Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) Started 2021 NCT05177133

CapecitabineOxaliplatinRetifanlimab

dMMR identified by IHC of mismatch repair proteins MLH1, PMS2, MSH2 en MSH6

Status may be outdated, last updated 2024-08-02Gastric Adenocarcinoma, Esophageal Adenocarcinoma
Fecal Microbiota Transplant and Re-introduction of Anti-PD-1 Therapy (Pembrolizumab or Nivolumab) for the Treatment of Metastatic Colorectal Cancer in Anti-PD-1 Non-responders

Active, not recruiting Phase 2 M.D. Anderson Cancer Center Started 2021 NCT04729322

Fecal Microbiota Transplantation CapsuleMetronidazoleNeomycinNivolumab FDA EUPembrolizumab FDA EUVancomycin

Tumor that is deficient in mismatch repair (dMMR) or microsatellite instability high (MSI-H) as determined by one of three methods:

Metastatic Colorectal Adenocarcinoma, Metastatic Small Intestinal Adenocarcinoma, Stage IV Colorectal Cancer AJCC v8, Stage IV Small Intestinal Adenocarcinoma AJCC v8
Combination Immunotherapy in Rare Cancers Under InvesTigation

Active, not recruiting Phase 2 Olivia Newton-John Cancer Research Institute Started 2021 NCT04969887

IpilimumabNivolumab FDA EU

Mismatch repair protein deficient (MSI-H) cancers (excluding colorectal carcinoma)

Advanced Biliary Tract Cancer, Neuroendocrine Tumors, Female Reproductive System Neoplasm, MSI-H Solid Malignant Tumor
Immunotherapy in MSI/dMMR Tumors in Perioperative Setting.

Active, not recruiting Phase 2 Centre Leon Berard Started 2021 NCT04795661

Pembrolizumab FDA EU

MSI/dMMR established by immunohistochemistry (IHC) \[MMR protein expression\] and polymerase chain…

Localized Resectable Tumor, MSI/dMMR
Two Combination Treatment Regimens of Nivolumab and Ipilimumab in Patients With dMMR and / or MSI mCRC.

Active, not recruiting Phase 2 GERCOR - Multidisciplinary Oncology Cooperative Group Started 2021 NCT04730544

Nivolumab 480mg + Ipilimumab FDA EUNivolumab 240 mg + Ipilimumab FDA EU

Deficient mismatch repair (dMMR) and/or Microsatellite instability (MSI) tumor status defined by:

Colorectal Cancer Metastatic, MSI-H Colorectal Cancer
Radiation and TSR-042 (Dostarlimab) in People With Endometrial Cancer After They Receive Surgery

Recruiting Phase 2 Memorial Sloan Kettering Cancer Center Started 2021 NCT04774419

Dostarlimab FDA EU

…ion In Locally Advanced, Mismatch Repair Deficient/Microsatellite Instability-High (MMR-D/MSI-H) Endometrial Cancer

Endometrial Cancer
PD-1 Blockade With JS001 Plus Neoadjuvant Chemotherapy for Gastric/Gastroesophageal Junction Cancer

Recruiting Phase 2 Wan He Started 2021 NCT05033392

Toripalimab Injection

… or fresh tumor tissues can be provided for PD-L1, TMB, tumor infiltrating T lymphocytes, MSI-H/dMMR and EBV detection.

Stomach Neoplasms
A Phase 1/2a Study of 23ME-00610 in Patients With Advanced Solid Malignancies

Active, not recruiting Phase 1/2 23andMe Started 2021 NCT05199272

23ME-00610

…forTMB assessment using a cutoff of greater than or equal to 10 mutations/megabase and/or MSI-H solid cancer that has been confirmed by immunohistochemistry for MMR proteins or polymera…

Solid Tumor, Clear Cell Renal Cell Carcinoma, Epithelial Ovarian Cancer, Fallopian Tube Cancer
Nivolumab + Docetaxel + ADT in mHSPC Patients With DDRD or Inflamed Tumors

Active, not recruiting Phase 2 Xiao X. Wei, MD Started 2020 NCT04126070

Androgen Deprivation TherapyNivolumab FDA EUDocetaxel

…umors identified as mismatch repair deficient (MMR-d) or microsatellite instability high (MSI-H) will also be included in Cohort 1

Hormone Sensitive Prostate Cancer, Prostate Adenocarcinoma, Metastasis Prostate Adenocarcinoma
Early-Line Anti-EGFR Therapy to Facilitate Retreatment for Select Patients With mCRC

Active, not recruiting Phase 2 University of Wisconsin, Madison Started 2020 NCT04587128

PanitumumabCetuximabIrinotecanFOLFIRI ProtocolBevacizumab

Tumor must be mismatch repair (MMR) proficient as determined by microsatellite instability or immunohistochemistry for MMR proteins

Metastatic Colorectal Cancer
A Study of CHeckpoint Inhibitors in Men With prOgressive Metastatic Castrate Resistant Prostate Cancer Characterized by a Mismatch Repair Deficiency or Biallelic CDK12 Inactivation

Active, not recruiting Phase 2 VA Office of Research and Development Started 2020 NCT04104893

Pembrolizumab FDA EU

dMMR or CDK12-/- as determined by somatic tumor DNA NGS.

Metastatic Castration Resistant Prostate Cancer
INFORM2 Study Uses Nivolumab and Entinostat in Children and Adolescents With High-risk Refractory Malignancies

Recruiting Phase 1/2 University Hospital Heidelberg Started 2020 NCT03838042

Nivolumab and Entinostat FDA EU

…olescents with newly diagnosed high grade glioma (HGG) in the context of a constitutional mismatch repair deficiency syndrome after maximum safe surgical resection with no established standard of care treat…

Status may be outdated, last updated 2024-02-07CNS Tumor, Solid Tumor
Anti-PD-1 mAb Plus Metabolic Modulator in Solid Tumor Malignancies

Recruiting Phase 2 Dan Zandberg Started 2020 NCT04114136

Nivolumab or Pembrolizumab (dependent upon approved indication) FDA EUMetforminRosiglitazone

… confirmed advanced melanoma, renal cell carcinoma, NSCLC, HCC (Child Pugh Class A only), MSI-High solid tumors, Urothelial Cancer, GE junction/Gastric Adenocarcinoma, or HNSCC for which c…

Melanoma, NSCLC, Hepatocellular Carcinoma, Urothelial Cancer
Nous-209 Genetic Vaccine for the Treatment of Microsatellite Unstable Solid Tumors

Active, not recruiting Phase 1/2 Nouscom SRL Started 2019 NCT04041310

GAd-209-FSP low doseMVA-209-FSP low doseGAd-209-FSP high doseMVA-209-FSP high doseGAd20-209-FSP, RP2DMVA-209-FSP, RP2D

Have previously proven microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) status (confirmatory testing is not required)…

Solid Tumor, Adult
Study of NEO-201 in Solid Tumors Expansion Cohorts

Active, not recruiting Phase 1/2 Precision Biologics Started 2019 NCT03476681

NEO-201 in combination with pembrolizumab FDA EU

…P \> 1%) as determined by an FDA-approved test and/or is microsatellite instability-high (MSI-H) or mismatch repair deficient, and/or is tumor mutational burden-high (TMB-H) \[≥10 mutat…

Non Small Cell Lung Cancer, Head and Neck Squamous Cell Carcinoma, Cervical Cancer, Uterine Cancer
Neoadjuvant Toripalimab With or Without Celecoxib in dMMR/MSI-H Colorectal Cancer

Recruiting Phase 2 Sun Yat-sen University Started 2019 NCT03926338

Neoadjuvant toripalimab plus celecoxib for 6 cyclesNeoadjuvant toripalimab monotherapy for 6 cyclesNeoadjuvant toripalimab plus celecoxib for 12 cyclesNeoadjuvant toripalimab monotherapy for 12 cyclesToripalimab plus celecoxib as neoadjuvant or definitive therapy

…deficient (dMMR) by immunohistochemistry (IHC) method or microsatellite instability-high (MSI-H) by polymerase chain reaction (PCR).

Colorectal Cancer, Mismatch Repair-deficient (dMMR), Microsatellite Instability-high (MSI-H), Neoadjuvant Therapy
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)

Recruiting Phase 1/2 Inhibrx Biosciences Started 2019 NCT04198766

INBRX-106 - Hexavalent OX40 agonist antibodypembrolizumab 200 mg FDA EUpembrolizumab 400 mg FDA EUCarboplatin AUC-5Carboplatin AUC-6Pemetrexed 500 mg/m2

…hout chemotherapy): Subjects with melanoma (all types), HNSCC, G/GEA, RCC, TCC, NSCLC, or MSI-high, TMB-high, MMR-deficient tumors, with histologically confirmed, locally advanced or metas…

Solid Tumor, Non-Small Cell Lung Cancer, Head and Neck Cancer, Melanoma
Adoptive Transfer of Tumor Infiltrating Lymphocytes for Advanced Solid Cancers

Active, not recruiting Phase 2 Udai Kammula Started 2019 NCT03935893

Tumor Infiltrating Lymphocytes (TIL)Fludarabine + Cyclophosphamide combination

…oma, 5.) mesothelioma, 6.) neuroendocrine, 7.) squamous cell cancer, 8.) Merkle cell, 9.) mismatch repair deficient and/or microsatellite unstable cancers, and 10.) patients who have exhausted conventional…

Gastric Cancer, Colorectal Cancer, Pancreatic Cancer, Sarcoma
Study of Induction PD-1 Blockade in Subjects With Locally Advanced Mismatch Repair Deficient Solid Tumors

Recruiting Phase 2 Memorial Sloan Kettering Cancer Center Started 2019 NCT04165772

TSR-042 or Dostarlimab FDA EUcapecitabine or 5-FU

Tumor specimen that demonstrates mismatch repair deficiency by Immunohistochemistry or microsatellite instability as demonstrated by NGS or PCR.

Rectal Adenocarcinoma, Clinical Stage: Stage II (T3-4, N-), Stage III (Any T, N+), Solid Tumor
A Study of E7386 in Combination With Other Anticancer Drug(s) in Participants With Solid Tumor

Active, not recruiting Phase 1/2 Eisai Started 2019 NCT04008797

E7386LenvatinibDoxorubicinPaclitaxel

Immune checkpoint inhibitor for participants with microsatellite instability-high (MSI-H) CRC

Endometrial Neoplasms, Neoplasms, Carcinoma, Hepatocellular, Liver Neoplasms
Pre-operative Nivolumab and Ipilimumab, Followed by Post-operative Nivolumab, for MSI/dMMR Oeso-gastric Adenocarcinoma.

Active, not recruiting Phase 2 GERCOR - Multidisciplinary Oncology Cooperative Group Started 2019 NCT04006262

Nivolumab 10 MG/ML FDA EUIpilimumab 200 MG in 40 ML Injection

…H6), MSH6, or PMS2 alone protein expression by IHC (dMMR), and/or tumor with ≥ 2 instable MSI-H markers on PCR: BAT25, BAT26, NR21, NR24, and NR27 (pentaplex panel is recommended),

Localized Oesogastric Adenocarcimona, MSI and or dMMR
Tislelizumab (Anti-Programmed Cell Death Protein-1 (PD-1) Antibody) in MSI-H or dMMR Solid Tumors

Recruiting Phase 2 BeOne Medicines (BeiGene) Started 2018 NCT03736889

Tislelizumab (BGB-A317)

Having locally advanced unresectable or metastatic solid tumors with MSI-H or dMMR

MSI-H/dMMR Solid Tumors
KN035 for dMMR/MSI-H Advanced Solid Tumors

Active, not recruiting Phase 2 3D Medicines (Sichuan) Started 2018 NCT03667170

KN035

KN035 for dMMR/MSI-H Advanced Solid Tumors

Solid Tumor
Study of Atezolizumab + FLOT vs. FLOT Alone in Patients With GC/GEJ and High Immune Responsiveness

Active, not recruiting Phase 2 Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest Started 2018 NCT03421288

Atezolizumab FDA5-FluorouracilCalciumfolinatOxaliplatinDocetaxel

…[and optional TMB/EBV\] must be performed locally and results for either of the following MSI-high, PD-L1 CPS≥1, TMB ≥10/MB or EBV+ must be available prior to randomization (for details, s…

Gastric Cancer, Gastroesophageal Junction Adenocarcinoma
Study of Nivolumab and Relatlimab in Advanced Mismatch Repair Deficient Cancers Resistant to Prior PD-(L)1 Inhibitor

Active, not recruiting Phase 2 Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Started 2018 NCT03607890

Nivolumab FDA EURelatlimabNivolumab FDA EURelatlimabNivolumab FDA EURelatlimab

Have metastatic or locally advanced mismatch repair deficient/MSI-H disease.

Refractory MSI - H Solid Tumors Prior of PD-(L) 1 Therapy, MSI-H Tumors
Study of an Immunotherapeutic, DPX-Survivac, in Combination With Low Dose Cyclophosphamide & Pembrolizumab, in Subjects With Selected Advanced & Recurrent Solid Tumors

Active, not recruiting Phase 2 ImmunoVaccine Technologies, Inc. (IMV Inc.) Started 2018 NCT03836352

CyclophosphamidePembrolizumab FDA EU

Microsatellite instability high solid tumours, other than the above indications

Status may be outdated, last updated 2022-03-31Ovarian Cancer, Hepatocellular Carcinoma, Non-small Cell Lung Cancer, Bladder Cancer
Cabozantinib Plus Durvalumab With or Without Tremelimumab in Patients With Gastroesophageal Cancer and Other Gastrointestinal Malignancies

Recruiting Phase 1/2 Anwaar Saeed Started 2018 NCT03539822

CabozantinibDurvalumab FDA EUTremelimumab

Patients should have known tumor results for microsatellite instability (MSI) or mismatch repair (MMR) proteins.

Gastric Cancer, Esophageal Adenocarcinoma, Hepatocellular Carcinoma, Colorectal Cancer
Danvatirsen and Durvalumab in Treating Patients With Advanced and Refractory Pancreatic, Non-Small Cell Lung Cancer, and Mismatch Repair Deficient Colorectal Cancer

Active, not recruiting Phase 2 M.D. Anderson Cancer Center Started 2017 NCT02983578

DanvatirsenDurvalumab FDA EU

…reating Patients With Advanced and Refractory Pancreatic, Non-Small Cell Lung Cancer, and Mismatch Repair Deficient Colorectal Cancer

Advanced Colorectal Carcinoma, Advanced Lung Non-Small Cell Carcinoma, Lung Non-Small Cell Carcinoma, Mismatch Repair Deficiency
Study of RP1 Monotherapy and RP1 in Combination With Nivolumab (IGNYTE)

Active, not recruiting Phase 2 Replimune Started 2017 NCT03767348

RP1nivolumab FDA EU

Subjects with MSI-H or dMMR tumors: has diagnosis of MSI-H or metatstatic dMMR tumor (according to protocol d…

Non-Small Cell Lung Cancer (NSCLC), Microsatellite Instability-High (MSI-H), Non-melanoma Skin Cancer (NMSC), Cutaneous Melanoma
Neoadjuvant Immune Checkpoint Inhibition and Novel IO Combinations in Early-stage Colon Cancer

Recruiting Phase 2 The Netherlands Cancer Institute Started 2017 NCT03026140

Nivolumab FDA EUIpilimumabCelecoxib 200mgBMS-986253Relatlimab (BMS-986016)

dMMR cohorts 3+6: \>cT3 and/or N+

Colon Carcinoma
iRECIST Evaluation's Relevance for DCR in MMR/MSI Metastatic Colorectal Cancer Patients on Nivolumab and Ipilimumab

Active, not recruiting Phase 2 GERCOR - Multidisciplinary Oncology Cooperative Group Started 2017 NCT03350126

Ipilimumab 200 MG in 40 ML InjectionNivolumab 10 MG/ML FDA EU

6. dMMR DNA (protein expression by ICH and/or MSI by PCR):

Metastatic Cancer Colorectal
Pembrolizumab, Capecitabine, and Radiation Therapy in Treating Patients With Mismatch-Repair Deficient and Epstein-Barr Virus Positive Gastric Cancer

Active, not recruiting Phase 2 Rutgers, The State University of New Jersey Started 2017 NCT03257163

CapecitabinePembrolizumab FDA EU

Mismatch repair deficiency as identified by immunohistochemistry or other institutional standard, or Epstein-Barr vi…

Epstein-Barr Virus Positive, Gastric Adenocarcinoma, Mismatch Repair Protein Deficiency, Stage IB Gastric Cancer AJCC v7
Avelumab in Patients With MSS, MSI-H and POLE-mutated Recurrent or Persistent Endometrial Cancer and of Avelumab/Talazoparib and Avelumab/Axitinib in Patients With MSS Recurrent or Persistent Endometrial Cancer

Active, not recruiting Phase 2 Dana-Farber Cancer Institute Started 2016 NCT02912572

AvelumabTalazoparibAxitinib

MSI-H as determined by immunohistochemical complete loss of expression (absence of nuclear immu…

Metastatic Endometrial Cancer
Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial)

Active, not recruiting Phase 2 National Cancer Institute (NCI) Started 2015 NCT02465060

AdavosertibAfatinibAfatinib DimaleateBinimetinibCapivasertibCopanlisib

…candidate for Z1M based on local Clinical Laboratory Improvement Act (CLIA) assessment of mismatch repair deficiency (MMRd) by immunohistochemistry (IHC) or microsatellite instability (MSI) status by polyme…

Advanced Lymphoma, Advanced Malignant Solid Neoplasm, Bladder Carcinoma, Breast Carcinoma
Study of Pembrolizumab (MK-3475) in Participants With Advanced Solid Tumors (MK-3475-158/KEYNOTE-158)

Active, not recruiting Phase 2 MSD (Merck & Co.) Started 2015 NCT02628067

pembrolizumab FDA EUpembrolizumab FDA EU

…r, with the exception of colorectal carcinoma (CRC), which is Microsatellite Instability (MSI)-High (MSI-H) OR

Advanced Cancer, Anal Carcinoma, Anal Cancer, Biliary Cancer
A Study of the Safety and Efficacy of the Intravenous and Intratumoral Injection of OVV-01 in Patients With Advanced Solid Tumours.

Recruiting Phase 1 Joint Biosciences Started 2026 NCT07648472

OVV-01 InjectionOVV-01 Injection

…chemotherapy, patients with wild-type KRAS who have received anti-EGFR, and patients with microsatellite instability-high disease who have received at least one prior immune checkpoint inhibitor

Advanced Solid Tumors
A Single-Arm, Open-Label Phase Ia/Ib Clinical Trial Evaluating the Safety, Tolerability, Pharmacokinetic Profile, and Preliminary Efficacy of FS-207 in Patients With Advanced Solid Tumors With High Microsatellite Instability (MSI-H)

Not yet recruiting Phase 1 Foresight Therapeutics (Hefei) Started 2026 NCT07593144

FS-207

…cy of FS-207 in Patients With Advanced Solid Tumors With High Microsatellite Instability (MSI-H)

Advanced Solid Tumors
This Study Aims to Evaluate the Efficacy and Safety of QLS1317 in Patients With MSI-H/dMMR Advanced Solid Tumors.

Not yet recruiting Phase 1 Shanghai Qilu Pharmaceutical Research and Development Center Started 2026 NCT07552376

QLS1317

Participants with advanced solid tumors of MSI-H/dMMR who have failed standard treatment.

MSI-H or dMMR Advanced Solid Tumors
Neoadjuvant SHR-A1811 and SHR-A1701 for Potentially Immunotherapy-Sensitive GC or GEJ Adenocarcinoma

Not yet recruiting Phase 1 The First Affiliated Hospital with Nanjing Medical University Started 2026 NCT07581574

Trastuzumab Rezatecan and Retlirafusp alfa

Biomarker Status: PD-L1 CPS ≥1, EBV-positive, or dMMR/MSI-H

Gastric or Gastroesophageal Junction Adenocarcinoma
A Phase 1 Study of the Safety and Tolerability of CTX-10726

Recruiting Phase 1 Compass Therapeutics Started 2026 NCT07419841

CTX-10726

Patients with MSI- high or deficient DNA mismatch repair (dMMR) tumors who have progressed after a minimum of 2 d…

Gastroesophageal Cancer (GC), Hepatocellular Carcinoma (HCC), Endometrial Cancer, Renal Cell Carcinoma (RCC)
A Study to Evaluate YF087 in Subjects With MSI-H or dMMR Advanced Solid Tumors

Not yet recruiting Phase 1 InventisBio Started 2026 NCT07809607

YF087

A Study to Evaluate YF087 in Subjects With MSI-H or dMMR Advanced Solid Tumors

Advanced Solid Tumor Cancer
AMG 436 as Monotherapy and Combination Therapy in Participants With MSI-H/dMMR Solid Tumors

Recruiting Phase 1 Amgen Started 2026 NCT07403721

AMG 436

Histologically confirmed MSI-H or dMMR metastatic or locally advanced solid tumor by local testing or central testing.

Metastatic or Locally Advanced Solid Tumors With Microsatellite Instability-high (MSI-H) or Mismatched Repair Deficiency (dMMR)
A Trial to Evaluate Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of BA1203 in Advanced Solid Tumors.

Recruiting Phase 1 Shandong Boan Biotechnology Started 2026 NCT07876609

BA1203

Patients with colorectal cancer must have a microsatellite instability (MSI) test report, and patients with other tumor types must have a prior Programmed Death…

Solid Tumors
Study of Orally Administered MOMA-341 in Participants With Advanced or Metastatic Solid Tumors

Recruiting Phase 1 MOMA Therapeutics Started 2025 NCT06974110

MOMA-341IrinotecanImmunotherapy

Participants have unresectable advanced or metastatic solid tumors with MSI-H or dMMR alterations and histologically confirmed disease.

Advanced Solid Tumor, Metastatic Solid Tumor, Endometrial Cancer, MSI-H Cancer
A Study of JMKX005425 in Patients With MSI-H/dMMR Advanced Solid Tumors

Recruiting Phase 1 Jemincare Started 2025 NCT07208136

JMKX005425

Have a microsatellite instability-high (MSI) and/or mismatch repair deficiency (dMMR), histologically or cytologically documente…

Advanced Solid Tumors
A Phase 1 Study of TGI-5 as Monotherapy and in Combination With Nivolumab in Subjects With Locally Advanced/Metastatic Solid Tumors

Recruiting Phase 1 Hefei TG ImmunoPharma Started 2025 NCT07376707

TGI-5 FDA EU

For subjects with a known microsatellite instability high (MSI-H):

CRC (Colorectal Cancer), Melanoma (Skin Cancer), HCC - Hepatocellular Carcinoma, NSCLC (Non-small Cell Lung Cancer)
Safety and Tolerability Evaluation of CEL001 Injection in Advanced Solid Tumors

Recruiting Phase 1 Guangzhou Xiling Biotechnology Started 2025 NCT07259889

NK cell preparation

…rinotecan, Subjects with BRAF V600E mutation have used BRAF inhibitors, and subjects with MSI-H/dMMR need to have used PD-1/PD-L1 treatment);

Advanced Solid Tumors (Phase 1)
Zanzalintinib in Combination With Paclitaxel in Recurrent High Grade Uterine Cancer

Recruiting Phase 1 Washington University School of Medicine Started 2025 NCT06795009

ZanzalintinibPaclitaxel

Patients with dMMR or MSI-H tumors or targetable HER2 alterations are required to have received prior therapy with ap…

Uterine Cancer, Endometrial Cancer
Safety and Efficacy of Canagliflozin in Patients With Metastatic High Microsatellite Instability (MSI-H) Colorectal Cancer

Recruiting Phase 1 West China Hospital Started 2025 NCT07076823

Canagliflozin

Patients with microsatellite instability-high (MSI-H) colorectal cancer confirmed by MSI testing.

Colorectal Cancer, SGLT-2 Inhibitor
A Phase I Study of [225Ac]-AZD2284 in Patients With Metastatic Castration-Resistant Prostate Cancer

Recruiting Phase 1 AstraZeneca Started 2025 NCT06879041

AZD2287AZD2275AZD2284

c)A checkpoint inhibitor for participants with known microsatellite instability-high (MSI-H), deficient mismatch pair (dMMR), or tumor mutational burden (TMB) ≥ 10 mut/Mb

Metastatic Castration-Resistant Prostate Cancer
The Safety, Tolerability, and Efficacy of KD01 in Gynecologic Malignancies

Recruiting Phase 1 Tongji Hospital Started 2024 NCT06552598

KD01(the recombinant oncolytic adenovirus)

…a or endometrial adenocarcinoma (FIGO Grade 1-Grade 2, FIGO 2023 Stage IA1 and IA2), with mismatch repair deficiency (MMRd) or no response to progestogen therapy.

Cervical Cancer, Gynecologic Malignancies, Endometrial Cancer
MAQ-001 in Patients With Advanced Solid Tumors

Recruiting Phase 1 MabQuest Started 2024 NCT06514651

MAQ-001Ipilimumab

…lanoma, NSCLC, SCLC, HNSCC, classical HD, primary mediastinal LBCL, urothelial carcinoma, MSI-H cancer, gastric cancer, esophageal cancer, cervical cancer, HCC, merkel, renal cell carci…

Status may be outdated, last updated 2024-07-23Advanced Solid Tumor
A Study of NWY001 in Subjects With Advanced Solid Tumors

Recruiting Phase 1 Chipscreen Biosciences Started 2024 NCT05979155

NWY001NWY001

For part 2f: Participant has a diagnosis of histologically confirmed advanced MSI-H/dMMR colorectal cancer

Status may be outdated, last updated 2024-07-16Advanced Solid Tumor
A Study of CS23546 in Subjects With Advanced Tumors

Recruiting Phase 1 Chipscreen Biosciences Started 2024 NCT06245122

CS23546

Cohort 4, Subjects with PD-L1 expression positive and/or microsatellite-instability-high (MSI-H) / mismatch-repair-deficient (dMMR) advanced solid tumors or lymphoma

Advanced Tumors
A First-in-Human Escalation and Expansion Study of Patients With Advanced Solid Tumors

Recruiting Phase 1 JiaRay Group Started 2024 NCT06783569

JR8603

… standard therapy for patients with MMR-deficient (dMMR)/microsatellite instability-high (MSI-H): pembrolizumab for 1st line therapy, no standard therapy for 2nd and 3rd line therapy.

Solid Tumors, Gastric Cancer, Esophagogastric Juction Cancer, Colorectal Cancer
A Study to Evaluate the Safety, Pharmacokinetics, and Anti-Tumor Activity of VVD-133214 as Monotherapy and in Combination in Participants With Advanced Solid Tumors

Recruiting Phase 1 Vividion Therapeutics Started 2024 NCT06004245

VVD-133214Pembrolizumab FDA EUBevacizumab

Have a microsatellite instability (MSI) and/or deficient mismatch repair (dMMR), histologically or cytologically documented…

Advanced Solid Tumors, Colorectal Cancer
Clinical Study of CVL006 Injection in Advanced Solid Tumors

Not yet recruiting Phase 1 Convalife (Shanghai) Started 2024 NCT06621615

CVL006 Injection

Queue 2: Malignant Solid Tumors of MSI-H/dMMR Subjects with locally advanced, recurrent, or metastatic MSI-H/dMMR malignant solid …

Status may be outdated, last updated 2024-10-01Advanced Solid Tumor
Study of HRO761 Alone or in Combination in Cancer Patients With Specific DNA Alterations Called Microsatellite Instability or Mismatch Repair Deficiency.

Active, not recruiting Phase 1 Novartis Started 2023 NCT05838768

HRO761pembrolizumab FDA EUirinotecan

Patients with advanced unresectable or metastatic MSIhi or MMR deficient (dMMR) solid tumors who have progressed after or are intolerant to prior standard therapy…

MSIhi or dMMR Advanced Unresectable or Metastatic Solid Tumors, Including Colorectal Cancers
JZP898 Intravenous Infusion as Monotherapy and Combination With Pembrolizumab in Adults With Advanced/Metastatic Solid Tumors

Recruiting Phase 1 Jazz Pharmaceuticals Started 2023 NCT06108050

JZP898Pembrolizumab FDA EU

NSCLC, melanoma, HNSCC, RCC, HCC, gastroesophageal carcinomas, UC, or CRC \[MSI-H\]) for whom, in the opinion of the investigator, there is no SoC available to convey clin…

Advanced Solid Tumor, Metastatic Solid Tumor
Study of MK-0472 in Participants With Advanced/Metastatic Solid Tumors (MK-0472-001)

Active, not recruiting Phase 1 MSD (Merck & Co.) Started 2023 NCT05853367

MK-0472Pembrolizumab FDA EUMK-1084

… (ALK)/ROS1 mutations, renal cell carcinoma, urothelial carcinoma, Merkel cell carcinoma, MSI-high CRC, endometrial cancer, cervical cancer, small cell lung cancer, triple negative breast …

Metastatic Solid Tumors, Advanced Solid Tumors
A First-in-Human (FIH) Study to Evaluate the Safety and Tolerability of VVD-130037 in Participants With Advanced Solid Tumors

Recruiting Phase 1 Vividion Therapeutics Started 2023 NCT05954312

VVD-130037DocetaxelPaclitaxelPembrolizumab FDA EU

…eckpoint inhibitor (for tumors with known programmed death-ligand 1 \[PD-L1\] expression, microsatellite instability-high, or mismatch repair deficiency, and an anti-epidermal growth factor receptor agent) (Comb…

Advanced Solid Tumors
A Phase 1-2 of ST316 With Selected Advanced Unresectable and Metastatic Solid Tumors

Active, not recruiting Phase 1 Sapience Therapeutics Started 2023 NCT05848739

ST316FOLFIRI regimen & bevacizumabFruquintinibLonsurf & bevacizumab

For all cohorts: Subjects with MSI-H/dMMR must have received, refused or be intolerant to a CPI.

Colon Cancer, Metastatic Colon Cancer
Cyclophosphamide and Dexamethasone for the Treatment of Metastatic Castration Resistant Prostate Cancer

Active, not recruiting Phase 1 Rashmi Verma, MD Started 2022 NCT05479578

CyclophosphamideDexamethasone

…/2 or homologous recombination (HR) deoxyribonucleic acid (DNA) repair mutations, and/ or microsatellite instability (MSI) must have received prior treatment (e.g., PARP \[poly adenosine diphosphate-ribose …

Castration-Resistant Prostate Carcinoma, Metastatic Prostate Adenocarcinoma, Stage IVB Prostate Cancer American Joint Committee on Cancer (AJCC) V8
A Study of Safety and Efficacy of KFA115 Alone and in Combo With Pembrolizumab in Patients With Select Advanced Cancers

Active, not recruiting Phase 1 Novartis Started 2022 NCT05544929

KFA115pembrolizumab FDA EU

…tive breast cancer, ovarian cancer (high-grade serous histology), anal cancer (squamous), MSI-H CRC, esophagogastric cancer, mesothelioma, and HNSCC.

Carcinoma, Non-Small-Cell Lung, Cutaneous Melanoma, Carcinoma, Renal Cell, Carcinoma, Ovarian Epithelial
Study With ABBV-CLS-484 in Participants With Locally Advanced or Metastatic Tumors

Recruiting Phase 1 Calico Life Sciences Started 2021 NCT04777994

ABBV-CLS-484Vascular Endothelial Growth Factor Receptor (VEGFR) Tyrosine Kinase Inhibitor (TKI)Programmed Cell Death-1 (PD-1) Inhibitor

Locally Advanced or metastatic MSI-H tumors

Advanced Solid Tumor Cancer
Sonidegib and Pembrolizumab in Treating Patients With Advanced Solid Tumors

Active, not recruiting Phase 1 Mayo Clinic Started 2020 NCT04007744

Pembrolizumab FDA EUSonidegib

Microsatellite instability-high (MSI-H) cancer.

Clinical Stage III Cutaneous Melanoma AJCC v8, Clinical Stage III Gastric Cancer AJCC v8, Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8, Clinical Stage IV Cutaneous Melanoma AJCC v8
Tacrolimus, Nivolumab, and Ipilimumab in Treating Kidney Transplant Recipients With Selected Unresectable or Metastatic Cancers

Active, not recruiting Phase 1 National Cancer Institute (NCI) Started 2019 NCT03816332

IpilimumabNivolumab FDA EUPrednisoneTacrolimus

… Merkel cell carcinoma, cutaneous squamous cell carcinoma, or microsatellite instability (MSI)-high cancers for which standard non-immunological medical, surgical, or radiation therapy woul…

Clinical Stage III Cutaneous Melanoma AJCC v8, Clinical Stage III Cutaneous Merkel Cell Carcinoma AJCC v8, Clinical Stage IV Cutaneous Melanoma AJCC v8, Clinical Stage IV Cutaneous Merkel Cell Carcinoma AJCC v8
A Study of XL092 as Single-Agent and Combination Therapy in Subjects With Solid Tumors

Active, not recruiting Phase 1 Exelixis Started 2019 NCT03845166

XL092Atezolizumab FDAAvelumab

…med via local testing report) and determined NOT to have microsatellite instability high (MSI-high) or mismatch repair deficient (dMMR) by local testing, who received the following standar…

Neoplasm Malignant, Renal Cell Carcinoma, Hormone Receptor Positive Breast Carcinoma, Metastatic Castration-resistant Prostate Cancer
Combination Study of Guadecitabine/ASTX727 and Pembrolizumab

Active, not recruiting Phase 1 Royal Marsden NHS Foundation Trust Started 2017 NCT02998567

GuadecitabinePembrolizumab FDA EUASTX727

Patients with microsatellite-instability-high (MSI-High) tumours, provided they have been defined by validated assays or patients with deficient …

Non Small Cell Lung Cancer
Phase 1 Study of CK-301 (Cosibelimab) as a Single Agent in Subjects With Advanced Cancers

Active, not recruiting Phase 1 Checkpoint Therapeutics Started 2017 NCT03212404

CK-301 (cosibelimab)

…of recurrent or metastatic colorectal cancer assessed as microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR).

Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Carcinoma, Small Cell, Malignant Mesothelioma, Advanced
Study of TSR-042, an Anti-programmed Cell Death-1 Receptor (PD-1) Monoclonal Antibody, in Participants With Advanced Solid Tumors

Active, not recruiting Phase 1 GSK Started 2016 NCT02715284

Dostarlimab FDA EU

…ib, ceritinib or experimental) 4) Cohort F - Participants with recurrent or advanced dMMR/MSI-H solid tumors except endometrial cancers and gastrointestinal cancers, who have received p…

Neoplasms
A Clinical Trial Evaluating the Safety and Efficacy of Intravenous HNF4α SrRNA in Treating Metastatic CRC Patients

Recruiting Early Phase 1 Shanghai Changzheng Hospital Started 2024 NCT06621173

HNF4α srRNA

…ients with confirmed deficient mismatch repair (dMMR) or high microsatellite instability (MSI-H) in tumor tissue, who have been treated with immune checkpoint inhibitors (anti-PD-1 or a…

Metastatic Colorectal Cancer (mCRC)
177Lu-anti-PD-L1 sdAb in Metastatic Solid Tumors

Recruiting Early Phase 1 Radiopharm Theranostics Started 2024 NCT06305962

177Lu-RAD204

…us melanoma, HNSCC, endometrial cancer or any cancer that is known to be MMR deficient or MSI high with documented disease progression during or after their most recent line of anticancer …

PDL1 Gene Mutation, Non Small Cell Lung Cancer, Small Cell Lung Cancer ( SCLC ), TNBC, Triple Negative Breast Cancer
Study of Pembrolizumab Following Surgery in Patients With Microsatellite Instability High (MSI-H) Solid Tumors

Active, not recruiting Early Phase 1 Memorial Sloan Kettering Cancer Center Started 2019 NCT03832569

Pembrolizumab FDA EU

…tudy of Pembrolizumab Following Surgery in Patients With Microsatellite Instability High (MSI-H) Solid Tumors

Solid Tumors, Identified by NGS, PCR or IHC
A Multicenter Randomized Open-Label Trial Evaluating ctDNA-Guided Interruption Versus Standard of Care Immune-Checkpoint Inhibitor (ICI) Therapy In Patients With Advanced / Metastatic Solid Tumors.

Not yet recruiting No phase Natera Starts 2027 NCT07689812

MSI-High/dMMR CRC: Metastatic

NSCLC (Advanced Non-small Cell Lung Cancer), NSCLC (Non-small Cell Lung Cancer), NSCLC (Non-small Cell Lung Carcinoma), NSCLC
Research on Colorectal Cancer Recurrence Monitoring and Individualized Treatment Based on MRD

Recruiting No phase Sun Yat-sen University Started 2026 NCT07775950

Histologically confirmed colorectal adenocarcinoma with mismatch repair deficiency (dMMR) or microsatellite instability-high (MSI-H) status.

Colorectal Cancer (MSI-H), Molecular Residual Disease
Pilot Study of Intermittent Fasting With Immune Checkpoint Inhibitors

Not yet recruiting No phase West Virginia University Started 2026 NCT07645742

…, gastric, non-small cell lung cancer (NSCLC), HCC, cholangiocarcinoma, melanoma, RCC, or MSI-H cancer

Cancer (Advanced Stage)
Neoadjuvant CAPEOX Versus Upfront Surgery for Locally Advanced Colon Cancer With Elevated CEA: A Single-Center, Open-Label, Randomized Controlled Trial

Not yet recruiting No phase Sun Yat-sen University Started 2026 NCT07413146

Neoadjuvant ChemotherapyAdjuvant chemotherapy

Histologically or cytologically confirmed colon adenocarcinoma, non-MSI-H/dMMR, with pathologic stage (AJCC/UICC TNM 8th edition) of:

Minimal Residual Disease, Immunoscore, Neoadjuvant Chemotherapy, Colon Cancer (Stage II &Amp; III)
Testing an Enhanced Digital Delivery Model for Inherited Cancer Genetic Testing in Young Adults With Cancer

Recruiting No phase Alliance for Clinical Trials in Oncology Started 2025 NCT07091617

Given targeted therapies for BRCA+ and microsatellite instability (MSI)-high/Lynch Syndrome patients and benefit to relatives, patients with metastatic cancer are inc…

Miscellaneous Neoplasm, Nos, Non-Neoplastic Condition, Nos
Reducing the Resection Range After Neoadjuvant Therapy for Locally Advanced Upper Rectal and Rectosigmoid Junction Cancers

Active, not recruiting No phase Sixth Affiliated Hospital, Sun Yat-sen University Started 2025 NCT07038122

For patients with dMMR (deficient Mismatch Repair

Locally Advanced Rectal Carcinoma
Clinical Utility of ctDNA in Detecting Resistance Mechanisms and Delivering Precision Medicine to Cancer Patients

Recruiting No phase Royal Marsden NHS Foundation Trust Started 2025 NCT07673861

…mutation/HER2 amplification/FGFR2 fusion or rearrangement/NTRK fusion/BRAF V600E mutation/MMR deficiency \[dMMR\]), AND

Non Small Cell Lung Cancer, Gastrointestinal Stromal Tumor (GIST), Colorectal Cancer, Biliary Tract Cancer
ctDNA Testing to Inform Standard-of-Care Treatment Decisions in People With Endometrial Cancer

Recruiting No phase Memorial Sloan Kettering Cancer Center Started 2025 NCT07270666

ctDNA Testing

MMR-D on immunohistochemistry OR MSI-H using any commercially available test

Endometrial Cancer
Smart Measurement of Circulating Tumor DNA

Recruiting No phase Erasmus Medical Center Started 2025 NCT06989814

… Syndrome (MMR-gene or EPCAM mutation), or have a proven microsatellite instability high (MSI-H)tumor;

Colorectal Neoplasms, Colorectal Neoplasms Malignant, Colorectal Neoplasms, Hereditary Nonpolyposis, Hereditary Nonpolyposis Colon Cancer
A Pilot Study Investigating Upfront Adaptive Immunotherapy Approach in Children, Adolescent and Young Adult (CAYA) Patients With Replication-Repair Deficient (RRD) High-Grade Gliomas (HGG)

Recruiting No phase Daniel Morgenstern Started 2024 NCT06519682

Nivolumab FDA EU

…ession (MLH1, MSH2, MSH6, PMS2), or based on prior germline testing confirming congenital mismatch repair deficiency (CMMRD) or Lynch syndrome.

High Grade Glioma, Replication Repair Deficient
PD-1 Inhibitor Combined With Progesterone Treatment in FST for Patients With MMRd Endometrial Cancer

Recruiting No phase Peking University People's Hospital Started 2024 NCT06549855

Sintilimab or Pembrolizumab and medroxyprogesterone acetate (MPA)/ megestrol acetate (MA) FDA EU

Molecular classification of MMRd, determined by immunohistochemical (IHC) for MMR proteins and by the second generation se…

Endometrial Cancer, Endometrioid Carcinoma, Mismatch Repair Deficiency
MRD-guided Deferred Adjuvant Therapy in Resectable Early-stage Colon Cancer

Recruiting No phase Sun Yat-sen University Started 2023 NCT06204484

…confirmed stage II high-risk and stage III low-risk none high microsatellite instability (MSI-H) colon adenocarcinoma according to the Union for International Cancer Control/American Jo…

Status may be outdated, last updated 2024-01-12Colorectal Cancer
Amplitude Modulated Radiofrequency Electromagnetic Field Treatment Combined With TAS-102 (Lonsurf) and Bevacizumab in Refractory Metastatic Colorectal Cancer

Recruiting No phase Charite University, Berlin, Germany Started 2023 NCT05991102

Patients with BRAF mutant tumors: BRAF inhibitor, MSI-H patients: Checkpoint-inhibition

Status may be outdated, last updated 2023-12-21Refractory Metastatic Colorectal Cancer
Circulating Tumor DNA Guided Adjuvant Chemotherapy for Colon Cancer

Recruiting No phase Peking University Cancer Hospital & Institute Started 2022 NCT05529615

c) Poor differentiation (except MSI-H)

Status may be outdated, last updated 2022-09-07Colon Cancer, Circulating Tumor DNA
Adjuvant Radiotherapy in Patients With Early Endometrial Cancer

Not yet recruiting No phase Peking University Third Hospital Started 2021 NCT04956601

Endometrial adenocarcinoma is confirmed by pathology, and the molecular types were microsatellite instability type and low copy type;

Status may be outdated, last updated 2021-07-09Endometrial Cancer, Pathology, Radiotherapy
Watch and Wait in PD-1 Monoclonal Antibody Treated dMMR/MSI-H Distal Rectal Cancer

Recruiting No phase Sixth Affiliated Hospital, Sun Yat-sen University Started 2021 NCT04643041

…d diagnosed as deficient mismatch repair(dMMR), or next generation sequencing identified (MSI-H)； MRI identified tumor inferior margin lower than peritoneal reflection,

Rectal Cancer
Testing the Addition of MEDI4736 (Durvalumab) to Chemotherapy Before Surgery for Patients With High-Grade Upper Urinary Tract Cancer

Recruiting Phase 2/3 National Cancer Institute (NCI) Started 2021 NCT04628767

CisplatinDoxorubicin HydrochlorideDurvalumab FDA EUGemcitabine HydrochlorideMethotrexatePegfilgrastim

…l histologic testing of UTUC with additional studies, such as immunohistochemistry and/or microsatellite instability, is strongly recommended to identify patients with high probability of Lynch-related or o…

Broad match: MSI-H / dMMRRenal Pelvis and Ureter Urothelial Carcinoma
The Necessity of Surgery in Patients With mGC Achieving Radiological Response After Conversion Therapy

Recruiting Phase 2 Fudan University Started 2025 NCT07757165

Without surgery, continuing with the original medical treatment

…patients) or immune checkpoint inhibitors (PD-1/PD-L1 inhibitors, such as when CPS ≥ 5 or MSI-H, etc.).

Broad match: MSI-H / dMMRAdvanced Metastatic Gastric Cancer
A First in Human Study of ALX2004 With Advanced or Metastatic Selected Solid Tumors

Recruiting Phase 1 ALX Oncology Started 2025 NCT07085091

ALX2004ALX2004ALX2004

CRC - For participants with a targetable molecular alteration (including dMMR or MSI-H): Received appropriate standard therapy for the alteration, at least 2 prior lines of sys…

Broad match: MSI-H / dMMRNSCLC (Advanced Non-small Cell Lung Cancer), HNSCC, CRC (Colorectal Cancer), ESCC
Botensilimab + Balstilimab vs Best Supportive Care as Therapy in Chemo-refractory, Unresectable, Colorectal Adenocarcinoma

Terminated Phase 3 Canadian Cancer Trials Group Started 2026 NCT07152821

BalstilimabBotensilimab

…arcinoma that is not deficient mismatch repair (dMMR) or microsatellite instability-high (MSI-H).

Colorectal Cancer
BAT1308 in Combination With Platinum-containing Chemotherapy is Used for the First-line Treatment of Advanced or Recurrent dMMR Endometrial Cancer

Terminated Phase 2/3 Bio-Thera Solutions Started 2024 NCT06321068

carboplatinPaclitaxelRecombinant humanized anti-PD-1 monoclonal antibody injection

Subjects should meet the requirements of mismatch repair protein deficiency (dMMR) detected by the central laboratory of tumor specimen.

Endometrial Cancer
Study of SMT-NK Inj. Plus Pembrolizumab vs Pembrolizumab Monotherapy in Patients With Advanced Biliary Tract Cancer

Unknown status Phase 2/3 SMT bio Started 2022 NCT05429697

SMT-NK inj.+Pembrolizumab FDA EUPembrolizumab FDA EU

② Patients who have a positive MSI-H or dMMR test

Biliary Tract Cancer
Study of Lenvatinib (MK-7902/E7080) in Combination With Pembrolizumab (MK-3475) Versus Standard of Care in Participants With Metastatic Colorectal Cancer (MK-7902-017/E7080-G000-325/LEAP-017)

Completed Phase 3 MSD (Merck & Co.) Started 2021 NCT04776148

pembrolizumab FDA EUlenvatinibregorafenibTAS-102 (trifluridine and tipiracil)

Note: Tumor must be determined to be NOT microsatellite instability-high (MSI-H)/mismatch repair deficient (dMMR) by local testing

Colorectal Neoplasms
A Study of Efficacy and Safety of Fruquintinib (HMPL-013) in Participants With Metastatic Colorectal Cancer

Completed Phase 3 HUTCHMED Started 2020 NCT04322539

Fruquintinib

RAS, BRAF, and microsatellite instability microsatellite instability (MSI)/mismatch repair (MMR) status for each patient must be do…

Metastatic Colorectal Cancer, Metastatic Colon Cancer
Adjuvant Chemotherapy in High Risk Stage II Colon Cancer

Unknown status Phase 3 Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine Started 2020 NCT04303429

FOLFOX/XELOX/Capecitabine

…wing factors:T4 staging,Number of examined lymph nodes \< 12,poor differentiation (except MSI-H),LVI or PNI,tumor perforation or occlusion

Stage II Colon Cancer, Adjuvant Chemotherapy
Herbal Treatment to Improve Chemotherapy Delivery

Unknown status Phase 3 Xiyuan Hospital of China Academy of Chinese Medical Sciences Started 2018 NCT03716518

Tonifying Spleen and Kidney Sequential Regimen

… histology ,exclusive of those cancers that are High degree of microsatellite instability(MSI-H),

Colon Cancer
Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy in Participants Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (MK-3475-859/KEYNOTE-859)-China Extension

Withdrawn Phase 3 MSD (Merck & Co.) Started 2018 NCT04859582

Pembrolizumab FDA EUCisplatin5-fluorouracilOxaliplatinCapecitabine

Has provided tumor tissue sample for microsatellite instability (MSI) biomarker analysis

Stomach Neoplasms
Avelumab Plus 5-FU Based Chemotherapy as Adjuvant Treatment for Stage 3 MSI-High or POLE Mutant Colon Cancer

Terminated Phase 3 Royal Marsden NHS Foundation Trust Started 2018 NCT03827044

Avelumab

Avelumab Plus 5-FU Based Chemotherapy as Adjuvant Treatment for Stage 3 MSI-High or POLE Mutant Colon Cancer

POLE Exonuclease Mutant Colon Cancer, Microsatellite Instability, Stage III Colon Cancer
Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy in Participants Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (MK-3475-859/KEYNOTE-859)

Completed Phase 3 MSD (Merck & Co.) Started 2018 NCT03675737

Pembrolizumab FDA EUCisplatin5-fluorouraciloxaliplatincapecitabine

Has provided tumor tissue sample for microsatellite instability (MSI) biomarker analysis

Stomach Neoplasms
Efficacy of Postoperative Adjuvant Chemotherapy for Stage II Colon Cancer With High Risk Factors(EPAC1)

Unknown status Phase 3 Peking University Cancer Hospital & Institute Started 2017 NCT03199989

CapeOX（Capecitabine+Oxaliplatin）

3. poor differentiation (except MSI-H)

Adjuvant Chemotherapy
Study of Pembrolizumab (MK-3475) vs Standard Therapy in Participants With Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Stage IV Colorectal Carcinoma (MK-3475-177/KEYNOTE-177)

Completed Phase 3 MSD (Merck & Co.) Started 2015 NCT02563002

mFOLFOX6FOLFIRIPembrolizumab FDA EUBevacizumabCetuximab

Locally confirmed dMMR or MSI-H stage IV colorectal carcinoma

Colorectal Carcinoma
Oxaliplatin, Leucovorin, and Fluorouracil With or Without Bevacizumab in Treating Patients Who Have Undergone Surgery for Stage II Colon Cancer

Completed Phase 3 National Cancer Institute (NCI) Started 2005 NCT00217737

BevacizumabFluorouracilLeucovorinOxaliplatin

Patients must have paraffin-embedded tumor specimen available for evaluation of microsatellite instability and loss of heterozygosity at 18q, to determine high risk versus low risk

Colon Adenocarcinoma, Stage IIA Colon Cancer AJCC v7, Stage IIB Colon Cancer AJCC v7, Stage IIC Colon Cancer AJCC v7
A Phase II Study Evaluating an Organ Preservation Strategy Using Immune Checkpoint Blockade for Participants With Primary Colorectal or Gastroesophageal Cancer

Withdrawn Phase 2 National Cancer Institute (NCI) Started 2025 NCT06410534

nivolumab FDA EUipilimumab

…R or Tumor Mutational Burden (TMB) status\] or stage I-III gastroesophageal cancer (GEC) (MMR deficient only).

Colorectal Cancer, Gastroesophageal Cancer
Zimberelimab Anti-PD1 +/- Domvanalimab in Resectable Mmrd Gastric Cancer

Suspended Phase 2 Royal Marsden NHS Foundation Trust Started 2025 NCT06250036

Single agent zimberelimabCombination zimberelimab + domvanalimab

MMRd/MSI-H.

Locally Advanced Gastric Adenocarcinoma, MSI-H/dMMR Gastric Cancer, MSI-H/dMMR Gastroesophageal-junction Cancer
Niraparib and Dostarlimab for Patients With MMR-D/MSI-H Colorectal Cancers

Withdrawn Phase 2 Ibrahim Halil Sahin Started 2025 NCT06365970

NiraparibDostarlimab FDA EU

Histologically confirmed mismatch repair deficient or microsatellite instability high advanced stage colorectal cancer

MMR-D/MSI-H Colorectal Cancers
AssociatiNG Bevacizumab bEmarituzumab for GynecoLogIcal CAncer

Withdrawn Phase 1/2 Centre Leon Berard Started 2025 NCT07146919

BemarituzumabBevacizumab

For dMMR endometrial carcinoma : immunotherapy

Endometrial Carcinoma, Ovarian Cancer, Cervix Cancer
A Study of Pembrolizumab in Combination With Investigational Agents in Pediatric and Young Adult Participants With Hematologic Malignancies or Solid Tumors (MK-9999-01B/LIGHTBEAM-U01)

Withdrawn Phase 1/2 MSD (Merck & Co.) Started 2025 NCT06395090

Pembrolizumab FDA EUFavezelimabFavezelimab/Pembrolizumab FDA EUVibostolimabPembrolizumab/Vibostolimab FDA EU

…y classical Hodgkin lymphoma (cHL) solid tumors that are microsatellite instability-high (MSI-H)/mismatch repair deficient (dMMR), or solid tumors that are tumor mutational burden-high …

Neoplasm Metastasis
A Phase II Trial of Neoadjuvant PD-1 Vaccine PD1-Vaxx in Operable MSI High Colorectal Cancer

Terminated Phase 2 University of Southampton Started 2025 NCT06692959

PD-1 vaccine IMU-201 (PD1-Vaxx)

In order in to be entered into the study, patients must be classified as MSI-High (confirmation of MMR deficiency or MSI-H).

Colorectal Cancer
A Study of Adjuvant Atezolizumab or Atezolizumab Plus Tiragolumab in Solid Tumors with Resectable Disease with Intermediate-High Risk of Recurrence and High Tumor Mutational Burden (TMB-H) or Microsatellite Instability (MSI-H)

Withdrawn Phase 2 Roche Started 2024 NCT06331598

Atezolizumab FDATiragolumab

…ancer, head and neck cancer and any other tumor type with known high TMB (≥ 13 mut/MB) or MSI-H

Solid Tumors
Study Evaluating Treatment of Sacituzumab-govitecan for Patients With Metastatic Esophagogastric Adenocarcinoma

Completed Phase 1/2 Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest Started 2024 NCT06123468

Sacituzumab govitecan

NOTE: patients with advanced MSI-h/dMMR tumors who have not previously been treated with pembrolizumab, nivolumab or any oth…

Esophagogastric Adenocarcinoma
Regorafenib in Combination With Pembrolizumab or Pembrolizumab for MSI-H Colorectal Cancer

Terminated Phase 2 Anwaar Saeed Started 2024 NCT06006923

RegorafenibPembrolizumab FDA EU

Histologically confirmed mismatch repair deficient or microsatellite instability high advanced stage colorectal cancer

MSI-H Colorectal Cancer
Monalizumab and MEDI5752 in Patients With MSI and/or dMMR Metastatic Cancer

Withdrawn Phase 2 Assistance Publique - Hôpitaux de Paris Started 2023 NCT06152523

Monalizumab/MEDI5257

Monalizumab and MEDI5752 in Patients With MSI and/or dMMR Metastatic Cancer

MSI, dMMR Colorectal Cancer
MNK Inhibitor AUM001 in Combination With Either Pembrolizumab or Irinotecan to Treat Metastatic Colorectal Cancer

Unknown status Phase 2 AUM Biosciences Pte Started 2023 NCT05462236

TinodasertibPembrolizumab FDA EUIrinotecan

CRC MSI-H patients should have been treated with a checkpoint inhibitor and have progressed on such…

Metastatic Colorectal Cancer
Neoadjuvant Toripalimab for dMMR/MSI-H Gastric Cancer

Unknown status Phase 2 Sun Yat-sen University Started 2023 NCT05994456

PD-1 inhibitor

…onfirmed adenocarcinoma of the stomach or gastroesophageal junction and confirmed dMMR or MSI-H 3.

Gastric or Gastroesophageal Junction Adenocarcinoma
NUC-3373 in Combination With Other Agents in Patients With Advanced Solid Tumours

Terminated Phase 1/2 NuCana Started 2023 NCT05714553

Fosifloxuridine NafalbenamideLeucovorinPembrolizumab FDA EUDocetaxel

…aneous squamous cell carcinoma (cSCC), oesophageal carcinoma, microsatellite instability (MSI) high colorectal (CRC), gastric cancer, triple negative breast cancer (TNBC), and endometrial c…

Advanced Cancer, Advanced Solid Tumor, Neoplasm Malignant, Metastatic Cancer
Study of MHB088C in Participants With Advanced or Metastatic Solid Tumors

Unknown status Phase 1/2 Minghui Pharmaceutical Pty Started 2023 NCT05652855

MHB088C for Injection

…containing oxaliplatin, irinotecan, fluorouracil and immunotherapy (for participants with MSI-H/dMMR).

Advanced or Metastatic Solid Tumors
Cadonilimab as Neoadjuvant Therapy in Resectable Stage II-III MSI-H/dMMR Colorectal Cancer

Unknown status Phase 2 LiuYing Started 2023 NCT05913570

Cadonilimab (®), a PD-1/CTLA-4 bi-specific antibody

…deficient (dMMR) by immunohistochemistry (IHC) method or microsatellite instability-high (MSI-H) by polymerase chain reaction (PCR) in local site

Colorectal Cancer, Mismatch Repair-deficient (dMMR), Microsatellite Instability-high (MSI-H), Neoadjuvant Therapy
A Study to Evaluate INCB099280 in Participants With Select Solid Tumors Who Are Immune Checkpoint Inhibitor Naive

Terminated Phase 2 Incyte Started 2023 NCT05879822

INCB099280

Advanced or metastatic microsatellite instability high (MSI-H) or deficient mismatch repair (dMMR) (as determined by an approved assay) solid tumors an…

Advanced Solid Tumor
Response to Immunotherapy in MMR-deficient Localized Colon Cancer

Completed Phase 2 Camilla Qvortrup Started 2023 NCT05662527

Pembrolizumab FDA EU

Histologically confirmed localized dMMR stage cT1N0M0 to cT4N2M0 (stage I to III) colon carcinoma.

Colon Cancer
A Study to Evaluate Serplulimab in Combination With Docetaxel +S-1 VS. Docetaxel +S-1 as Adjuvant Treatment Therapy in Stage IIIc Gastric Cancer

Unknown status Phase 2 RenJi Hospital Started 2023 NCT05769725

SerplulimabDocetaxelS1

…on of biomarkers in postoperative gastric cancer samples suggests that: PD-L1 + CPS ≥ 5 / MSI-H + / EBV+/dMMR No preoperative anti-tumor treatment for gastric cancer, including chemothe…

Serplulimab,Gastric Cancer, Adjuvant Therapy
Neoadjuvant Tisleizumab(BGB-A317) for dMMR/MSI-H Non-late Stage CRC Patients Before Surgery

Unknown status Phase 2 Sun Yat-sen University Started 2023 NCT06262581

Tisleizumab(BGB-A317)

Biopsy pathological diagnosis as MSI-H/dMMR( both IHC and PCR method required)

DMMR Colorectal Cancer, Anti PD-1, Immunotherapy
Cadonilimab in Locally Advanced MSI-H/dMMR Colorectal Cancer

Unknown status Phase 2 Cancer Institute and Hospital, Chinese Academy of Medical Sciences Started 2023 NCT05815290

Cadonilimab

Mismatch repair deficient determined by immunohistochemistry or microsatellite instable by PCR

dMMR Colorectal Cancer
A Phase II Clinical Trial to Evaluate Safety and Efficacy of XmAb20717 in Advanced Rare Cancers

Suspended Phase 2 M.D. Anderson Cancer Center Started 2022 NCT05337735

XmAb20717

MSI-H Cancers: Has not had anti-PD1 / anti-PDL1 / anti-CLTA4 therapyMSI-H/dMMR, locally advance…

Microsatellite High Cancers, Peritoneal Mesothelioma, Extrapulmonary High Grade, Neuroendocrine Carcinomas
Pembrolizumab With Sitravatinib in Recurrent Endometrial Cancer and Other Solid Tumors With Deficient Mismatch Repair System

Withdrawn Phase 2 Haider Mahdi Started 2022 NCT05419817

pembrolizumab FDA EUSitravatinib

Subjects must have recurrent endometrial cancer or other solid tumors with deficient mismatch repair system.

Recurrent Endometrial Cancer, Solid Tumors
Exploratory Single-arm, Single-center Adjuvant Treatment of Stage IIIB-IIIC Gastric Cancer With Combination of Palizumab and SOX Regimen

Unknown status Phase 2 Shanghai Minimally Invasive Surgery Center Started 2022 NCT06036745

Pembrolizumab + SOX FDA EU

Consistent with high-frequency microsatellite instability MSI-H

Gastric Cancer Stage IIIB-IIIC
Glycan Mediated Immune Regulation With a Bi-Sialidase Fusion Protein (GLIMMER-01)

Completed Phase 1/2 Palleon Pharmaceuticals Started 2022 NCT05259696

E-602Cemiplimab

Subjects with melanoma, NSCLC, head and neck cancer, urothelial cancer, or mMSI-H or dMMR colorectal cancer must have had prior anti-PD-(L)1 pathway therapy and been deemed resist…

Oncology, Melanoma, Ovarian Cancer, NSCLC
Efficacy and Safety of Tislelizumab (BGB-A317) as Neo-Adjuvant Treatment in Participants With Colorectal Cancer

Completed Phase 2 BeOne Medicines (BeiGene) Started 2022 NCT05116085

Tislelizumab

…nt Treatment in Patients With Early-Stage (Stage II-III) Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Colorectal Cancer

Colorectal Cancer
Envafolimab as Neoadjuvant Immuntherapy in Resectable Local Advanced dMMR/MSI-H Colorectal Cancer

Unknown status Phase 2 Third Affiliated Hospital, Sun Yat-Sen University Started 2022 NCT05371197

Neoadjuvant therapy with PD-L1 inhibitor

…deficient (dMMR) by immunohistochemistry (IHC) method or microsatellite instability-high (MSI-H) by polymerase chain reaction (PCR).

Colorectal Cancer, Mismatch Repair-deficient (dMMR), Microsatellite Instability-high (MSI-H), Neoadjuvant Therapy
Neoadjuvant Prolgolimab Monotherapy in Locally Advanced MMR-deficient Colorectal Cancer

Completed Phase 2 Blokhin's Russian Cancer Research Center Started 2022 NCT06428487

Prolgolimab

Presence of MSI/dMMR in the tumor;

Colorectal Cancer
Testing Nivolumab and BMS-986016 (Relatlimab) as Potentially Targeting Treatment in Cancers That Are LAG-3+ and Have Mismatch Repair Deficiency (MATCH - Subprotocol Z1M)

Withdrawn Phase 2 National Cancer Institute (NCI) Started 2022 NCT06400264

Nivolumab FDA EURelatlimab

Patients must have mismatch repair deficiency based on one of the following:

Advanced Lymphoma, Advanced Malignant Solid Neoplasm, Refractory Lymphoma, Refractory Malignant Solid Neoplasm
Trial of Ulixertinib in Combination With Hydroxychloroquine in Patients With Advanced Gastrointestinal (GI) Malignancies

Terminated Phase 2 BioMed Valley Discoveries Started 2022 NCT05221320

UlixertinibHydroxychloroquine

Patients with deficient MisMatch Repair/High levels of MicroSatellite Instability (dMMR/MSI-H) tumors must have progressed during or after pembrolizumab.

Tumor, Solid, Gastrointestinal Cancer
Safety and Efficacy of Retifanlimab (INCMGA00012) Alone or in Combination With Other Therapies in Participants With Advanced or Metastatic Endometrial Cancer Who Have Progressed on or After Platinum-based Chemotherapy.

Completed Phase 2 Incyte Started 2021 NCT04463771

retifanlimabepacadostatpemigatinibINCAGN02385INCAGN02390

Group A only: Tumor tissue tested as MSI-High

Endometrial Cancer
Combining Epigenetic And Immune Therapy to Beat Cancer.

Completed Phase 2 Institut Bergonié Started 2021 NCT04705818

Durvalumab FDA EUTazemetostat

…istologically confirmed solid tumors including pancreatic cancer (cohort A), non MSI-H or MMR-deficient colorectal cancer (cohort B), solid tumor with positive IFNG gene expression signature an…

Advanced Solid Tumor, Advanced Colorectal Carcinoma, Advanced Soft-tissue Sarcoma, Advanced Pancreatic Adenocarcinoma
Plinabulin in Combination With Radiation/Immunotherapy in Patients With Select Advanced Cancers After Progression on PD-1 or PD-L1 Targeted Antibodies

Terminated Phase 1/2 M.D. Anderson Cancer Center Started 2021 NCT04902040

Atezolizumab FDAAvelumabDurvalumab FDA EUNivolumab FDA EUPembrolizumab FDA EUPlinabulin

…, renal cell cancer, bladder cancer, Merkle cell cancer, microsatellite instability high (MSI-H) cancer (any histology), and melanoma) progressed on previous anti-PD-1/PD-L1 mAb treatme…

Advanced Bladder Carcinoma, Advanced Lung Non-Small Cell Carcinoma, Advanced Malignant Solid Neoplasm, Advanced Melanoma
Fruquitinib Combined With Camrelizumab in Non MSI-H/dMMR Refractory Colorectal Cancer

Unknown status Phase 2 The First Affiliated Hospital with Nanjing Medical University Started 2021 NCT04866862

Combination of Fruquintinib and Camrelizumab

Subjects with non MSI-H / dMMR metastatic colorectal cancer(CRC) (Stage IV)

Colorectal Neoplasm
Pevonedistat and Pembrolizumab for the Treatment of dMMR/MSI-H Metastatic or Locally Advanced Unresectable Solid Tumor

Terminated Phase 1/2 M.D. Anderson Cancer Center Started 2021 NCT04800627

Pembrolizumab FDA EUPevonedistat

Tumor that is deficient in mismatch repair (dMMR) or microsatellite instability high (MSI-H) as determined by one of three methods:

Locally Advanced Malignant Solid Neoplasm, Metastatic Malignant Solid Neoplasm, Unresectable Malignant Solid Neoplasm
Pembrolizumab With Axitinib in Recurrent Endometrial Cancer

Withdrawn Phase 2 Case Comprehensive Cancer Center Started 2021 NCT04197219

Pembrolizumab FDA EUAxitinib

Subjects must have recurrent endometrial cancer with deficient mismatch repair system.

Recurrent Endometrial Cancer
NP-G2-044 as Monotherapy and Combination Therapy in Patients With Advanced or Metastatic Solid Tumor Malignancies

Completed Phase 1/2 Novita Pharmaceuticals Started 2021 NCT05023486

NP-G2-044 MonotherapyAnti-PD-1 TherapyNP-G2-044 Combination therapy

…mbination Therapy Expansion Cohort E, patients must have microsatellite instability high (MSI-H) cancer;

Advanced or Metastatic Solid Tumor Malignancies
Tislelizumab+Lenvatinib+Gemox Regiment for Potentially Resectable Locally Advanced Malignant Tumors of Biliary System.

Unknown status Phase 2 Tianjin Medical University Cancer Institute and Hospital Started 2021 NCT05036798

Tislelizumab

Tumor tissue samples for PD-L1 expression analysis and microsatellite instability analysis.

Potentially Resectable Locally Advanced Malignant Tumors of Biliary System
Neoadjuvant Immunotherapy and Chemotherapy for Locally Advanced Esophagogastric Junction and Gastric Cancer Trial

Unknown status Phase 2 Nanfang Hospital, Southern Medical University Started 2021 NCT04744649

XELOX or SOXJS001+XELOX or SOX

3. mismatch repair-deficient (dMMR).

Gastric Cancer, Stomach Neoplasm
XmAb®20717 (Vudalimab) Alone or in Combination With Chemotherapy or Targeted Therapy in Patients With Metastatic Castration-Resistant Prostate Cancer

Completed Phase 2 Xencor Started 2021 NCT05005728

vudalimab + carboplatin + cabazitaxelvudalimab + olaparibvudalimab monotherapyvudalimab + docetaxelvudalimab + cabazitaxel or docetaxel

Cohort D (MSI-H/MMRD) - Microsatellite instability-high (MSI-H) or mismatch repair deficient (MMRD) tumor…

Metastatic Castration-Resistant Prostate Cancer
CRAFT: The NCT-PMO-1602 Phase II Trial

Completed Phase 2 German Cancer Research Center Started 2021 NCT04551521

VemurafenibCobimetinibAtezolizumab FDATrastuzumabPertuzumabAlectinib

DNA mismatch repair deficiency or PDL1 amplification and/or overexpression), ineligibility for the six specific arms

Metastatic or Locally Advanced Malignancies
Durvalumab and Olaparib for the Treatment of Prostate Cancer in Men Predicted to Have a High Neoantigen Load

Terminated Phase 2 University of Washington Started 2021 NCT04336943

Durvalumab FDA EUOlaparib

MMRd/MSI-high as documented using a clinical grade assay performed in a CLIA/CAP certified laboratory o…

Biochemically Recurrent Prostate Carcinoma, Prostate Adenocarcinoma
Immunotherapy Versus Chemotherapy as Adjuvant Therapy for Colon Cancer With MSI-H or POLE/ POLD1 Mutations

Unknown status Phase 2 Tianjin Medical University Cancer Institute and Hospital Started 2021 NCT04969029

Tirelizumab

MSI-H or POLE/ POLD1 gene mutation was confirmed by PRC or NGS sequencing.

Immunotherapy, Adjuvant Therapy, Colon Cancer, MSI-H
SI-B001 as a Single Agent or in Combination With Chemotherapy in the Treatment of Digestive System Malignancies

Terminated Phase 2 Baili-Bio / SystImmune Started 2021 NCT05039944

SI-B001IrinotecanFOLFIRI ProtocolFOLFOX Protocol

Cohort\_D: MSI-H KRASwt BRAFwt patients with unresectable or metastatic colorectal cancer and previous fir…

Colorectal Cancer
Ipilimumab With Nivolumab for Molecular-selected Patients With Castration-resistant Prostate Cancer

Completed Phase 2 Radboud University Medical Center Started 2021 NCT04717154

IpilimumabNivolumab FDA EU

An immunogenic phenotype, consisting of one of the next criteria: 1, mismatch repair deficiency and/or a high mutational burden of \>7 mutations per Mb (cluster A)

Prostatic Neoplasms, Castration-Resistant
A Study of AK104 in Subjects With Locally Advanced Unresectable or Metastatic MSI-H/dMMR Solid Tumors

Terminated Phase 2 Akeso Started 2020 NCT04547101

AK104

A Study of AK104 in Subjects With Locally Advanced Unresectable or Metastatic MSI-H/dMMR Solid Tumors

MSI-H/dMMR Solid Tumor
A Study to Evaluate the Efficacy and Safety of Toripalimab Injection in the Treatment of Recurrent or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Who Have Failed at Least Two Prior Lines of Therapy and Are Positive Specific Markers

Terminated Phase 2 Shanghai Junshi Bioscience Started 2020 NCT04603040

Toripalimab

4)Microsatellite instability-high (MSI-H): Tumor tissue is tested by whole exome sequencing (WES) to confirm MSI-H positivity

Recurrent or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Who Have Failed at Least Two Prior Lines of Therapy
IBI310 in Combination with Sintilimab in Patients with DNA Mismatch Repair Deficient (dMMR)/microsatellite Instability High (MSI-H) Locally-advanced or Metastatic Colorectal Cancer

Terminated Phase 2 Innovent Biologics Started 2020 NCT04258111

IBI310 (anti-CTLA-4 antibody)Sintilimab(anti-PD-1 antibody)

MSI-H confirmed by central lab

Colorectal Cancer
Ph II Study of Cabozantinib With Pembrolizumab in Metastatic Gastric and Gastroesophageal Adenocarcinoma

Completed Phase 2 University of California, Irvine Started 2020 NCT04164979

CabozantinibPembrolizumab FDA EU

Patients with known MSI-High or dMMR tumors must have disease progression after at least one line of immunotherapy

Gastric Adenocarcinoma, GastroEsophageal Cancer
QL1604 Monotherapy for dMMR or MSI-H Advanced Solid Tumors

Unknown status Phase 2 Qilu Pharmaceutical Started 2020 NCT04326829

QL1604

QL1604 Monotherapy for dMMR or MSI-H Advanced Solid Tumors

Advanced Malignant Tumor
Triplezumab Combined With CAPEOX Regimen in Neoadjuvant Therapy for Locally Advanced Colon Cancer

Unknown status Phase 2 The First Affiliated Hospital of Xiamen University Started 2020 NCT04389151

Toripalimab

Pathological diagnosis of msi-h /dMMR colon cancer.

Locally Advanced Colon Cancer
Nivolumab in Biochemically Recurrent dMMR Prostate Cancer

Completed Phase 2 Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Started 2020 NCT04019964

Nivolumab FDA EU

Nivolumab in Biochemically Recurrent dMMR Prostate Cancer

Prostate Cancer, Recurrent Prostate Cancer
A Phase Ib Trial to Evaluate the Safety and Efficacy of FMT and Nivolumab in Subjects With Metastatic or Inoperable Melanoma, MSI-H, dMMR or NSCLC

Unknown status Phase 1/2 Ella Therapeutics Started 2020 NCT04521075

Fecal Microbial Transplantation by capsules FDA EU

For MSI-H/dMMR patients -Histologically confirmed MSI-H/dMMR metastatic solid tumors including the …

Melanoma Stage IV, Unresectable Melanoma, NSCLC Stage IV
The Conversion Therapy of Chemotherapy Plus Camrelizumab in Metastatic Gastric Cancer

Completed Phase 2 Quan Wang Started 2020 NCT04694183

CamrelizumabS-1OxaliplatinPaclitaxel

Patients with gastric cancer who PD-L1+（CPS≥1）or MSI-H/dMMR, or EBV（+）.

Stomach Neoplasms
Study to Evaluate the Efficacy and Safety of Sirolimus in Subjects With Metastatic, Mismatch Repair Deficient Solid Tumors After Immunotherapy

Terminated Phase 2 Albert Einstein College of Medicine Started 2020 NCT04393454

Sirolimus 2mg Tablet

dMMR by immunohistochemistry (IHC) defined as the loss of expression in any of the four major …

Metastatic dMMR Solid Cancer, Solid Tumor, Cancer, Metastatic Solid Tumor
Study of Combination Therapy With the MEK Inhibitor, Cobimetinib, Immune Checkpoint Blockade, Atezolizumab, and the AUTOphagy Inhibitor, Hydroxychloroquine in KRAS-mutated Advanced Malignancies

Terminated Phase 1/2 Columbia University Started 2020 NCT04214418

CobimetinibHydroxychloroquineAtezolizumab FDA

MSI-H/dMMR or NTRK-fusion positive tumors Subjects must have received prior treatment with appr…

Gastrointestinal Cancer
Toripalimab Plus Bevacizumab and Chemotherapy as Neoadjuvant Therapy in Advanced MSI-H or dMMR Colorectal Cancer

Unknown status Phase 1/2 Peking University Started 2020 NCT04988191

ToripalimabBevacizumabIrinotecan

Microsatellite instability-high (MSI-H) or DNA mismatch repair-deficient (dMMR).

Colorectal Carcinoma
PD-1 Inhibitors Combined With VEGF Inhibitors for Locally Advanced dMMR/MSI-H Colorectal Cancer

Unknown status Phase 2 Sun Yat-sen University Started 2020 NCT04715633

PD-1 inhibitor plus VEGF inhibitors

Locally confirmed dMMR or MSI-H colorectal carcinoma

Colorectal Cancer, Microsatellite Instability High
The Combination of Immunotherapy and Neoadjuvant Chemoradiotherapy in MSI-H Locally Advanced Rectal Cancer

Unknown status Phase 2 Fudan University Started 2020 NCT04411524

PD-1 antibodyCapecitabineIrinotecan

8. the MSI status is MSI-H or d-MMR

Locally Advanced Rectal Cancer
Dose Escalation/Dose Expansion Study of YBL-006 in Patients With Advanced Solid Tumors

Unknown status Phase 1/2 Y Biologics Started 2020 NCT04450901

YBL-006YBL-006YBL-006YBL-006YBL-006YBL-006

Unresectable or metastatic solid tumours with MSI-H or dMMR, locally confirmed by polymerase chain reaction (PCR) or any other appropriate me…

Advanced Solid Tumors
A Study to Evaluate Camrelizumab in Combination With Docetaxel +S-1 as Adjuvant Treatment Therapy in Stage III Gastric Cancer

Unknown status Phase 2 RenJi Hospital Started 2020 NCT04152889

CamrelizumabS-1Docetaxel

… of biomarkers in postoperative gastric cancer samples suggests that: PD-L1 + CPS ≥ 10% / MSI-H + / EBV+/dMMR

Gastric Cancer Stage III
Sintilimab Plus Hypofractionated Radiotherapy for MSI-H/dMMR Rectal Cancer

Unknown status Phase 1/2 West China Hospital Started 2020 NCT04636008

Sintilimab

With DNA mismatch repair-deficient (dMMR) or microsatellite instability-high (MSI-H) status, whether or not being Lynch synd…

Anti-PD-1 Antibody, Radiotherapy, Rectal Cancer, MSI-H
PD1 Antibody Toripalimab and Chemoradiotherapy for dMMR/MSI-H Locally Advanced Colorectal Cancer

Unknown status Phase 2 Sun Yat-sen University Started 2020 NCT04301557

PD-1 AntibodyOxaliplatinCapecitabine

… loss of at least one of the four proteins ,MSH1,MSH2,MSH6,PMS2;or gene detection implies MSI-H;

DMMR Colorectal Cancer, MSI-H Colorectal Cancer, Locally Advanced Colorectal Cancer
A Study of Anlotinib Combined With AK105 Injection in Subjects With Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Advanced Solid Tumor

Unknown status Phase 2 Chia Tai Tianqing Started 2020 NCT04291248

AK105Anlotinib

Histopathologically confirmed MSI-H or dMMR advanced malignant solid tumors. 2.

MSI-H or dMMR Advanced Solid Tumors
A Study of Dazostinag as Single Agent and Dazostinag in Combination With Pembrolizumab in Adults With Advanced or Metastatic Solid Tumors

Completed Phase 1/2 Takeda Started 2020 NCT04420884

DazostinagPembrolizumab FDA EUPlatinum5-fluorouracil

Third-line or later MSI-H/dMMR CRC (Part 3A): Participants with histologically confirmed (cytological diagnosis is …

Solid Neoplasms
A Study of Poziotinib in Patients With Epidermal Growth Factor Receptor (EGFR) or Human Epidermal Growth Factor Receptor 2 (HER2) Activating Mutations in Advanced Malignancies

Terminated Phase 2 Spectrum Pharmaceuticals Started 2019 NCT04172597

Poziotinib HydrochlorideLoperamide

Patients with microsatellite instability-high (MSI-H) CRC must have had appropriate checkpoint inhibitor-based therapy.

Breast Cancer, Colorectal Cancer, Solid Tumor, Glioblastome Multiforme
Anti-PD-1 +/- RT for MSI-H Solid Tumors

Withdrawn Phase 2 University of Colorado, Denver Started 2019 NCT04001101

RT and Anti-PD-1Anti-PD-1

Anti-PD-1 +/- RT for MSI-H Solid Tumors

Microsatellite Instability High, Mismatch Repair Deficiency, Colorectal Cancer
Pembrolizumab Before Surgery for the Treatment of Mismatch Repair Deficient Locally Advanced Solid Cancers

Completed Phase 2 M.D. Anderson Cancer Center Started 2019 NCT04082572

Pembrolizumab FDA EU

…id cancer that is deficient in mismatch repair (dMMR) or microsatellite instability high (MSI-H) as determined by one of three methods:

Locally Advanced Malignant Solid Neoplasm
Savolitinib in Treating Patients With MET Amplified Metastatic or Unresectable Colorectal Cancer

Terminated Phase 2 National Cancer Institute (NCI) Started 2019 NCT03592641

Savolitinib

…lonal antibody (nivolumab or pembrolizumab) for patients with microsatellite instability (MSI)-high/mismatch repair (MMR) deficient tumors, or the treatments were not tolerated or contraind…

Colorectal Carcinoma, Metastatic Colon Adenocarcinoma, Metastatic Rectal Adenocarcinoma, Stage III Colon Cancer AJCC v8
Atezolizumab and Tiragolumab in Patients With NSCLC or Advanced Solid Tumors Having Had Prior Treatment With a PD-1 Inhibitor

Completed Phase 2 SCRI Development Innovations Started 2019 NCT03977467

Atezolizumab FDATiragolumab

MSI-high solid tumors as defined by local testing for MSI/MMR will also be included.

Non-Small Cell Lung Cancer, Solid Tumor
Pd1 Antibody Sintilimab ± Chemoradiotherapy for Locally Advanced Rectal Cancer

Unknown status Phase 2 Sun Yat-sen University Started 2019 NCT04304209

OxaliplatinCapecitabineSintilimab

… loss of at least one of the four proteins ,MSH1,MSH2,MSH6,PMS2;or gene detection implies MSI-H

Colorectal Cancer Stage II, Colorectal Cancer Stage III
Allogeneic NK Cell ("SMT-NK") in Combination With Pembrolizumab in Advanced Biliary Tract Cancer

Completed Phase 1/2 SMT bio Started 2019 NCT03937895

'SMT-NK' Inj (allogeneic Natural Killer cell)Pembrolizumab Injection [Keytruda] FDA EU

Patients who have a positive \*MSI-H or \*\*dMMR test.

Biliary Tract Cancer
A Clinical Study to Evaluate HLX10 Monotherapy for the Treatment of MSI-H or dMMR Solid Tumors That Failed to Respond to Standard Therapy

Unknown status Phase 2 Henlius Started 2019 NCT03941574

HLX10

Patients with unresectable or metastatic MSI-H or dMMR malignant solid tumors which are histopathologically or/and cytologically confirm…

MSI-H Solid Malignant Tumor
PD-1 Inhibitor Combined With Bevacizumab and FOLFIRI Regimen in the Second-line Treatment of Advanced Colorectal Cancer

Unknown status Phase 2 Tianjin Medical University Cancer Institute and Hospital Started 2019 NCT05035381

Pembrolizumab (PD-1 Inhibitor) Combined With Bevacizumab and FOLFIRI Regimen FDA EU

MSI-H patients confirmed by pathology, MSH2(-) or MSH6(-), for MLH1(-) or PMS2(-) patients need…

MSI-H Advanced Colorectal Cancer
A Study for PD-1 Antibody JS001 in MSI-H Advanced or Recurrent Colorectal Cancer

Unknown status Phase 2 Xu jianmin Started 2019 NCT04118933

JS001

…logically confirmed advanced or recurrent colorectal cancer, and MSI detection identified MSI-H;

Colorectal Cancer
A Phase I/II Study of Regorafenib Plus Avelumab in Solid Tumors

Unknown status Phase 1/2 Institut Bergonié Started 2018 NCT03475953

Phase 1 : RegorafenibPhase 1 : AvelumabPhase 2 : RegorafenibPhase 2 : AvelumabPhase 2: low-dose Regorafenib

or MSI-high solid tumors (cohort N) with status MSI-high already known

Colorectal Cancer Not MSI-H or MMR-deficient, GIST, Oesophageal or Gastric Carcinoma, Biliary Tract Cancer
Vactosertib in Combination with Pembrolizumab in Metastatic Colorectal or Gastric Cancer

Completed Phase 1/2 MedPacto Started 2018 NCT03724851

TEW-7197

…ly or cytologically confirmed advanced or metastatic non microsatellite instability high (MSI-H)/mismatch repair deficiency (dMMR) colorectal cancer who have disease progression after t…

Metastatic Colorectal Cancer, Gastric Cancer, Gastroesophageal Junction Adenocarcinoma
Investigating Cabozantinib in Patients With Refractory Metastatic Colorectal Cancer

Completed Phase 2 Academic Thoracic Oncology Medical Investigators Consortium Started 2018 NCT03542877

Oral Tablet: Cabozantinib

prior FDA-approved PD-1 inhibitor therapy is required for patients with MSI-H colorectal cancer.

Colorectal Cancer
Phase I/II Study of Immunotherapy Combination BN-Brachyury Vaccine, M7824, N-803 and Epacadostat (QuEST1)

Completed Phase 1/2 National Cancer Institute (NCI) Started 2018 NCT03493945

M7824N-803MVA-BN-BrachyuryFPV-BrachyuryEpacadostatAcetaminophen

Participants who have tumors known to be microsatellite instability high/mismatch repair deficient or tumor mutational burden high must have received prior pembro…

Metastatic Castration-resistant Prostate Cancer, Prostate Cancer, Prostate Neoplasm, Advanced Solid Tumor
A Study of Subcutaneous Nivolumab Monotherapy With or Without Recombinant Human Hyaluronidase PH20 (rHuPH20)

Completed Phase 1/2 Bristol Myers Squibb Started 2018 NCT03656718

nivolumab FDA EUrHuPH20nivolumab FDA EU

CRC, metastatic (MSI-H or dMMR)

Neoplasms by Site
Evaluate the Efficacy of Irinotecan Versus Oxaliplatin in the First-line Treatment of Refractory Metastatic Colorectal Cancer

Unknown status Phase 2 Peking University Started 2018 NCT03567629

IrinotecanOxaliplatin

…enocarcinoma or signet ring cell carcinoma. (3) Complicated by peritoneal metastasis. (4) MSI-H or dMMR, immune checkpoint inhibitor therapy is not acceptable. 4.

mCRC
Durvalumab for MSI-H or POLE Mutated Metastatic Colorectal Cancer

Completed Phase 2 Asan Medical Center Started 2018 NCT03435107

Durvalumab FDA EU

Mismatch repair deficient or microsatellite instable (defined below), or POLE mutated tumors A.

Metastatic Colorectal Cancer
Recombinant Human Anti-PD-1 Monoclonal Antibody HX008 Injection for the Treatment of Advanced Solid Tumors

Unknown status Phase 2 Taizhou Hanzhong biomedical Started 2018 NCT03704246

Anti-PD-1 monoclonal antibody

1.Advanced malignant solid tumors confirmed by histology or cytology and confirmed as msi-h or dMMR by the central laboratory designated by the sponsor.

Advanced Solid Tumor
PD-1 Antibody Combined With COX Inhibitor in MSI-H/dMMR or High TMB Colorectal Cancer

Unknown status Phase 2 Sun Yat-sen University Started 2018 NCT03638297

PD-1 antibody + cox inhibitor

Histologically confirmed metastatic or primary colorectal cancer as dMMR/MSI-H or whole exon sequence confirmed tumor mutation burden higher than 1000;

Colorectal Cancer
M7824 in Patients With Metastatic Colorectal Cancer or With Advanced Solid Tumors With Microsatellite Instability

Completed Phase 1/2 M.D. Anderson Cancer Center Started 2018 NCT03436563

Anti-PD-L1/TGFbetaRII Fusion Protein M7824

Confirmation of: a) Cohort A: microsatellite instability in colorectal cancer (CRC)

Colon Adenocarcinoma, High-Frequency Microsatellite Instability, Metastatic Malignant Solid Neoplasm, Rectal Adenocarcinoma
Standard Chemotherapy vs Immunotherapie in 2nd Line Treatment of MSI Colorectal Mestastatic Cancer

Completed Phase 2 Federation Francophone de Cancerologie Digestive Started 2018 NCT03186326

FOLFOX regimenFOLFIRI ProtocolAvelumabPanitumumabCetuximabBevacizumab

MSI-H determined by immunohistochemistry (loss of expression of MLH1, MSH2, MSH6 and/or PMS2) o…

Metastatic Colorectal Cancer, MSI
GC 2nd Line Durvalumab(MEDI4736)/Tremelimumab Plus Paclitaxel Study

Completed Phase 1/2 Asan Medical Center Started 2018 NCT03751761

durvalumab, tremelimumab, paclitaxel FDA EU

…PMS2, MLH1, MLH3, MSH2, MSH3, MSH6, POLD1, POLD2, or POLE) 3) microsatellite instability (MSI high) 4) somatic exonic mutation rate-high 5) EBV positive

Metastatic Gastric Cancer
Durvalumab in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer

Withdrawn Phase 2 University of Washington Started 2018 NCT02966587

Durvalumab FDA EU

Microsatellite instability as determined by MSI-plus assay

Castration Levels of Testosterone, Hormone-Resistant Prostate Cancer, Microsatellite Instability
A Study of DSP-7888 Dosing Emulsion in Combination With Immune Checkpoint Inhibitors in Adult Patients With Advanced Solid Tumors

Terminated Phase 1/2 Sumitomo Pharma America Started 2017 NCT03311334

DSP-7888 Dosing EmulsionNivolumab FDA EUPembrolizumab FDA EU

… and neck, locally advanced or metastatic urothelial carcinoma, hepatocellular carcinoma, MSI-H/dMMR colorectal cancer

Renal Cell Carcinoma (RCC), Urothelial Carcinoma, Primary Peritoneal Cancer, Platinum-resistant Ovarian Cancer (PROC)
Pilot Study of Nivolumab in Pediatric Patients With Hypermutant Cancers

Terminated Phase 1/2 The Hospital for Sick Children Started 2017 NCT02992964

Nivolumab FDA EU

1. high microsatellite instability (MSI-H) in current or previous tumour;

Refractory or Recurrent Hypermutated Malignancies, Biallelic Mismatch Repair Deficiency (bMMRD) Positive Patients
A Study of Durvalumab With or Without Tremelimumab in Endometrial Cancer

Completed Phase 2 Memorial Sloan Kettering Cancer Center Started 2017 NCT03015129

Durvalumab FDA EUTremelimumab

MSI-high patients will be identified based on immunohistochemistry or MSI testing of archival tumo…

Endometrial Cancer, Endometrial Carcinosarcoma, Endometrial Carcinoma, Endometrial Cancer Recurrent
A Study of Nivolumab in Selected Uterine Cancer Patients

Completed Phase 2 Memorial Sloan Kettering Cancer Center Started 2017 NCT03241745

Nivolumab FDA EU

MSI-high, or 2.

Uterine Cancer, Endometrial Carcinoma, Carcinosarcoma, Leiomyosarcoma
Phase Ib/II Study to Evaluate the Safety and Efficacy of Nivolumab in Combination With Paclitaxel in Epstein-Barr Virus(EBV)-Related, or Microsatellite Instability-High (MSI-H), or Programmed Cell Death Ligand 1 (PD-L1) Positive Advanced Gastric Cancer

Completed Phase 1/2 Yonsei University Started 2017 NCT05535569

Nivolumab, Paclitaxel FDA EU

Has documented EBV-related, MSI-high, or PD-L1 positive tumor in primary or metastatic tumor tissue

Recurrent/Metastatic Gastric Cancer
Nivolumab (Opdivo®) Plus ABI-009 (Nab-rapamycin) for Advanced Sarcoma and Certain Cancers

Completed Phase 1/2 Sarcoma Oncology Research Center Started 2017 NCT03190174

Nab-RapamycinNivolumab FDA EU

… cell carcinoma of head and neck, hepatocellular carcinoma, classical Hodgkin's lymphoma, MSI-H/dMMR metastatic colorectal cancer, and tumors with genetic mutations sensitive to mTOR in…

Ewing Sarcoma, PEComa, Epithelioid Sarcoma, Desmoid Tumor
K-Basket, Avelumab, Biomarker-driven, Advanced Solid Tumor

Unknown status Phase 2 Yonsei University Started 2017 NCT03491345

Avelumab

MSI-H by IHC or D.

PD-L1 Positive Mutation Tumor, EBV Positive Mutation Tumor, MSI-H Mutation Tumor, POLE/POLD1 Mutation Tumor
Avelumab With Hypofractionated Radiation Therapy in Adults With Isocitrate Dehydrogenase (IDH) Mutant Glioblastoma

Completed Phase 2 NYU Langone Health Started 2017 NCT02968940

Avelumab

High mutation burden or microsatellite instability (MSI) identified by Foundation Medicine panel next-generation sequencing (FoundationOne®,…

Glioblastoma
Secured Access to Nivolumab for Adult Patients With Selected Rare Cancer Types

Completed Phase 2 UNICANCER Started 2017 NCT03012581

Nivolumab FDA EU

Non-colorectal cancers with microsatellite instability determined locally by immunohistochemistry or polymerase chain-reaction (PCR)

Carcinoma, Renal Cell, Head and Neck Neoplasm, Skin Neoplasms, Microsatellite Instability
Avelumab for MSI-H or POLE Mutated Metastatic Colorectal Cancer

Unknown status Phase 2 Asan Medical Center Started 2017 NCT03150706

Avelumab

Mismatch repair deficient or microsatellite instable (defined below), or POLE mutated tumors A.

Metastatic Colorectal Cancer
Study of Pembrolizumab in Subjects With Advanced Gastric or Gastroesophageal Junction Adenocarcinoma Who Progressed After First-Line Therapy With Platinum and Fluoropyrimidine: Integration of Molecular Subtypes Through Integrative Genomic Analysis

Completed Phase 2 Samsung Medical Center Started 2016 NCT02589496

pembrolizumab FDA EU

13. (Only Cohort B) confirmed as MSI-H via the PCR or IHC staining by institutional standard.

Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma
Pembrolizumab in Ultramutated and Hypermutated Endometrial Cancer

Completed Phase 2 Yale University Started 2016 NCT02899793

Pembrolizumab FDA EU

…ng (NGS) and Comprehensive Genomic Profiling (CGP) testing, and/or standard PCR-based DNA microsatellite instability (MSI) and immunohistochemistry (IHC).

Recurrent Endometrial Cancer
Testing Nivolumab as a Potential Targeted Treatment in Cancers With Mismatch Repair Deficiency (MATCH-Subprotocol Z1D)

Completed Phase 2 National Cancer Institute (NCI) Started 2016 NCT04439214

Nivolumab FDA EU

Patients must have mismatch repair deficiency as determined via the MATCH Master Protocol

Advanced Lymphoma, Advanced Malignant Solid Neoplasm, Hematopoietic and Lymphoid Cell Neoplasm, Refractory Lymphoma
A Phase 1/2 Trial of SRA737 in Subjects With Advanced Cancer

Completed Phase 1/2 Sierra Oncology LLC - a GSK company Started 2016 NCT02797964

SRA737

For patients with CRC, MMR genetic alterations and/or high microsatellite instability are also considered for eligibility.

Advanced Solid Tumors or Non-Hodgkin's Lymphoma (NHL)
Study of Pembrolizumab (MK-3475) as Monotherapy in Participants With Previously-Treated Locally Advanced Unresectable or Metastatic Colorectal Cancer (MK-3475-164/KEYNOTE-164)

Completed Phase 2 MSD (Merck & Co.) Started 2015 NCT02460198

Pembrolizumab FDA EU

…ted Locally Advanced Unresectable or Metastatic (Stage IV) Mismatched Repair Deficient or Microsatellite Instability-High Colorectal Carcinoma (KEYNOTE-164)

Colorectal Carcinoma
A Study of Nivolumab Alone or Nivolumab Combination Therapy in Colon Cancer That Has Come Back or Has Spread

Completed Phase 2 Bristol Myers Squibb Started 2014 NCT02060188

IpilimumabNivolumab FDA EUCobimetinibDaratumumabBMS-986016

Microsatellite instability expression detected by an accredited laboratory

Microsatellite Unstable Colorectal Cancer, Microsatellite Stable Colorectal Cancer, Mismatch Repair Proficient Colorectal Cancer, Mismatch Repair Deficient Colorectal Cancer
Study to Explore the Safety, Tolerability and Efficacy of MK-3475 in Combination With INCB024360 in Participants With Selected Cancers

Completed Phase 1/2 Incyte Started 2014 NCT02178722

MK-3475INCB024360

…elanoma, NSCLC, transitional cell carcinoma of the GU tract, TNBC, SCCHN, ovarian cancer, MSI high colorectal cancer (CRC), RCC, gastric cancer, HCC and DLBCL (Phase 2).

Microsatellite-instability (MSI) High Colorectal Cancer (CRC), Endometrial Cancer, Head and Neck Cancer, Hepatocellular Carcinoma (HCC)
Evaluate the Efficacy of MEDI4736 in Immunological Subsets of Advanced Colorectal Cancer

Completed Phase 2 Memorial Sloan Kettering Cancer Center Started 2014 NCT02227667

MEDI4736

Microsatelite-high colorectal cancer (also known as MSI-H, DNA mismatch repair deficient, or sometimes Lynch syndrome)

Advanced Colorectal Cancer
Study of MK-3475 in Patients With Microsatellite Unstable (MSI) Tumors (Cohorts A, B and C)

Completed Phase 2 Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Started 2013 NCT01876511

MK-3475

Cohort A only: Patients with microsatellite instability (MSI) positive colorectal cancer

MSI Positive Colorectal Cancer, MSI Negative Colorectal Cancer, MSI Positive Non-Colorectal Cancers
Gemcitabine and Docetaxel in Patients With Relapsed or Refractory Metastatic Colorectal Adenocarcinoma

Terminated Phase 2 Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Started 2012 NCT01639131

GemcitabineDocetaxelFilgrastim or Pegfilgrastim

Microsatellite instability phenotype of archival tissue biopsy determined by treating institution by PCR and IHC ass…

Metastatic Colorectal Adenocarcinoma
Vaccination Against MSI Colorectal Cancer

Completed Phase 1/2 Oryx GmbH & Co. KG Started 2011 NCT01461148

FSP peptides

Detection of high level microsatellite instability (MSI-H) in the resected tumor sample according to the international consensus criteria (multiple…

Colorectal Cancer
Dendritic Cell Vaccination in Patients With Lynch Syndrome or Colorectal Cancer With MSI

Unknown status Phase 1/2 Radboud University Medical Center Started 2010 NCT01885702

DC vaccination

MSI high tumor

Colorectal Cancer
AVB-500 (Batiraxcept) in Combination With Paclitaxel in Recurrent High Grade Uterine Cancer

Withdrawn Phase 1 Washington University School of Medicine Started 2024 NCT05826015

PaclitaxelBatiraxcept

Patients with dMMR or MSI-H tumors or targetable HER2 alterations are required to have received prior therapy with ap…

Recurrent High Grade Uterine Cancer
First-in-Human Study of ATX-559, an Oral Inhibitor of DHX9, in Patients With Advanced or Metastatic Solid Tumors, and Molecularly Defined Cancers

Terminated Phase 1 Accent Therapeutics Started 2024 NCT06625515

ATX-559

dMMR or MSI-H with unresectable or metastatic solid tumors

Advanced Solid Tumors, Breast Cancer Recurrent, Colorectal Cancer Metastatic, Colon Cancer
Study of MT-8421 as Monotherapy and in Combination With Nivolumab in Patients With Selected Advanced Solid Cancer Types

Terminated Phase 1 Molecular Templates Started 2023 NCT06034860

MT-8421Nivolumab FDA EU

…cally confirmed, unresectable, locally advanced, or metastatic melanoma, HCC, NSCLC, RCC, MSI-H/dMMR malignancies, urothelial carcinoma, esophageal squamous cell carcinoma, mesothelioma…

Non Small Cell Lung Cancer, Hepatocellular Carcinoma, Melanoma, Renal Cell Carcinoma
Interventional Study of INCB 99280 With Ipilimumab in Participants With Select Solid Tumors

Terminated Phase 1 Incyte Started 2023 NCT05909995

INCB 99280 with Ipilimumab

MSI-H or dMMR metastatic CRC and able to provide fresh or archival tumor tissue for central con…

Melanoma, Hepatocellular Carcinoma (HCC), Renal Cell Carcinoma (RCC), Microsatellite Instability - High (MSI-H)
Combined MEK, STAT3 and PD-1 Inhibition in Metastatic Pancreatic Ductal Adenocarcinoma

Completed Phase 1 Peter Hosein, MD Started 2023 NCT05440942

TrametinibRuxolitinibRetifanlimab

Patients who are candidate for an anti-PD-1 antibody due to Microsatellite instability -High (MSI-H) or tumor mutational burden (TMB)-high status must have been treated with this dru…

Pancreatic Ductal Adenocarcinoma
A Study to Assess the Safety, Pharmacokinetics, and Antitumor Activity of Oral TACH101 in Participants With Advanced or Metastatic Cancer

Unknown status Phase 1 Tachyon Therapeutics Started 2023 NCT05076552

TACH101

…metastatic gastrointestinal tumors, or high microsatellite instability colorectal cancer (MSI-H CRC) that has progressed or was non-responsive or intolerant to standard therapy (e.g., f…

Advanced Cancer, Metastatic Solid Tumor, Solid Tumor
A Study of BGB-30813 Alone or in Combination With Tislelizumab in Participants With Advanced or Metastatic Solid Tumors

Terminated Phase 1 BeOne Medicines (BeiGene) Started 2023 NCT05904496

BGB-30813Tislelizumab

…ell carcinoma, melanoma, Merkel cell carcinoma, mesothelioma, microsatellite instability (MSI)-high, tumor mutation burden (TMB)-high, or mismatch repair deficient solid tumors

Advanced Solid Tumors
A Study to Investigate LYL845 in Adults With Solid Tumors

Terminated Phase 1 Lyell Immunopharma Started 2022 NCT05573035

LYL845

Microsatellite instability (MSI) high/mismatch repair deficient (dMMR) CRC participants must have disease progression following…

Melanoma, Non-small Cell Lung Cancer, Colorectal Cancer
First-in-human Safety and Tolerability of MP0317 in Patients With Relapsed/Refractory Advanced Solid Tumors

Terminated Phase 1 Molecular Partners Started 2021 NCT05098405

MP0317, a tri-specific fibroblast activation protein (FAP) x CD40 DARPin® drug candidate (q3w regimen)MP0317, a tri-specific fibroblast activation protein (FAP) x CD40 DARPin® drug candidate (q1w regimen)

Microsatellite instability high cancer of any type

Advanced Malignant Solid Tumor
The Safety and Pharmacokinetics Preliminary Efficacy of IMP7068 in Patients With Advanced Solid Tumors

Unknown status Phase 1 Impact Therapeutics Started 2021 NCT04768868

IMP7068

The patients with known microsatellite-instability high (MSI-H) or deficient in mismatch repair (dMMR) disease are required to have received prior PD 1/…

Advanced Solid Tumors
Testing the Combination of Two Immunotherapy Drugs (Nivolumab and Ipilimumab) in Children, Adolescent, and Young Adult Patients With Relapsed/Refractory Cancers That Have an Increased Number of Genetic Changes, The 3CI Study

Withdrawn Phase 1 National Cancer Institute (NCI) Started 2021 NCT04500548

IpilimumabNivolumab FDA EU

Microsatellite instability (MSI-H)

Constitutional Mismatch Repair Deficiency Syndrome, Hematopoietic and Lymphoid Cell Neoplasm, Lynch Syndrome, Recurrent Lymphoma
A Study of JNJ-78306358 in Participants With Advanced Stage Solid Tumors

Completed Phase 1 Johnson & Johnson Started 2021 NCT04991740

JNJ-78306358

…mmed cell death protein 1 (PD1) antibody is required for high microsatellite instability (MSI-H) CRC

Neoplasms
A Dose Escalation Study of APR003 in Patients With Advanced Colorectal Cancer (CRC) With Malignant Liver Lesions

Terminated Phase 1 Apros Therapeutics Started 2021 NCT04645797

APR003

Tumors that are MSI-H/dMMR must have previously received checkpoint inhibitor therapy

Advanced Colorectal Carcinoma
FT538 in Combination With Monoclonal Antibodies in Advanced Solid Tumors

Terminated Phase 1 Fate Therapeutics Started 2021 NCT05069935

FT538CyclophosphamideFludarabineMonoclonal antibody - Dose EscalationMonoclonal antibody - Dose Expansion

…ll cell/small cell lung cancer, renal cell carcinoma, head and neck squamous cell cancer, microsatellite instability-high/ mismatch repair deficient cancer, gastric cancer, esophageal cancer, cervical cancer, me…

Solid Tumor, Adult
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor

Unknown status Phase 1 Abbisko Therapeutics Started 2021 NCT04964375

ABSK043 oral capsule

MSI-H/dMMR cohort: Patients must have histologically confirmed solid tumors harboring MSI-H or …

Neoplasms
Study of VB10.NEO in Combination With Atezolizumab in Solid Tumors

Completed Phase 1 Nykode Therapeutics ASA Started 2021 NCT05018273

VB10.NEO FDA

…umor types: melanoma, NSCLC, RCC, UC, HNSCC, TNBC, gastric/GEJ cancer, cervical, anal, or MSI-high tumors.

Solid Tumors, Adult
A Phase Ia Clinical Study of QLF31907 Injection in Patients With Advanced Malignant Tumors

Unknown status Phase 1 Qilu Pharmaceutical Started 2021 NCT05150405

QLF31907

…lanoma, cervical cancer (CC), non-oncogene driver NSCLC and other solid tumors (requiring MSI-H/ dMMR signature gene) that are locally advanced, recurrent or metastatic that have failed…

Solid Tumor, Lymphoma, Non-Hodgkin
M1231 in Participants With Solid Tumors

Completed Phase 1 Merck KGaA Started 2021 NCT04695847

M1231M1231

…sed on at least 1 prior line of platinum therapy and for microsatellite instability-high (MSI-H) at least 1 prior line with pembrolizumab

Metastatic Solid Tumors, Esophageal Cancer, Non-Small Cell Lung Cancer
Study of Turning Point Therapeutics LM-302 in Patients With Advance Solid Tumors

Completed Phase 1 Bristol Myers Squibb Started 2021 NCT05001516

LM-302

Colorectal carcinoma with known Microsatellite instability-high(MSI-H)/Different Mismatch Repair(dMMR);

Advanced Solid Tumor
A Study of PY314 in Subjects With Advanced Solid Tumors

Terminated Phase 1 Ikena Oncology Started 2020 NCT04691375

PY314Combination Therapy: PY314 + Pembrolizumab FDA EU

…l, vaginal, vulvar\], gastric \[adenocarcinoma\], Colorectal (\[MSIlow and CPI refractory MSIhigh\]), lung \[non-small cell lung adenocarcinoma and squamous cell carcinoma\] who are recur…

Advanced Solid Tumor, Gynecologic Cancer, Breast Cancer, Colorectal Cancer
First In Human Study With ABBV-CLS-579 When Given Alone and In Combination In Participants With Locally Advanced Or Metastatic Tumors

Completed Phase 1 AbbVie Started 2020 NCT04417465

ABBV-CLS-579PD-1 inhibitorVEGFR TKI

MSI-H tumors

Advanced Solid Tumors Cancer
Study to Assess the Safety and Tolerability of Repeated Doses of an Investigational New Drug in Patients With Cancer and Cachexia.

Completed Phase 1 Pfizer Started 2020 NCT04299048

PF-06946860

Pembrolizumab for MSI-H • Will be entering the study at the first or second cycle of their current course of anti…

Cachexia, Non-Small-Cell Lung Cancer, Pancreatic Cancer, Colorectal Cancer
A Phase 1b Trial of ATRC-101 in Adults With Advanced Solid Malignancies

Terminated Phase 1 Atreca Started 2020 NCT04244552

ATRC-101Pembrolizumab FDA EUPegylated liposomal doxorubicin (PLD)

…b combination therapy cohort: Inoperable, locally advanced or metastatic NSCLC, CRC (only MSI-H or dMMR), melanoma (with the exception of uveal melanoma), HCC, HNSCC, ESCC,UC, or TNBC w…

Breast Cancer, Colorectal Cancer, Ovarian Cancer, Non-Small Cell Lung Cancer
A Phase 1a/1b FIH Study of PY159 and in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors

Terminated Phase 1 Ikena Oncology Started 2020 NCT04682431

PY159 Single agent dose level 1PY159 Single agent dose level 2PY159 Single agent dose level 3PY159 Single agent dose level 4PY159 Single agent dose level 5PY159 Single agent dose level 6

gastric and esophagogastric junction adenocarcinomas \[MSI low and CPI refractory MSI high\],

Advanced Solid Tumor, Gynecologic Cancer, Breast Cancer, Colorectal Cancer
Neo-adjuvant Pembrolizumab in dMMR/ POLE-EDM Uterine Cancer Patients: a Feasibility Study

Completed Phase 1 University Medical Center Groningen Started 2020 NCT04262089

Pembrolizumab (Keytruda) FDA EU

…on the day of signing informed consent with histologically confirmed primary diagnosis of dMMR/POLE-EDM uterine cancer who are intended to be treated with hysterectomy will be enrolled…

Uterine Cancer
Study of AMG 199 in Subjects With MUC17-Positive Solid Tumors Including Gastric, Gastroesophageal Junction, Colorectal, and Pancreatic Cancers

Terminated Phase 1 Amgen Started 2020 NCT04117958

AMG 199

For subjects with microsatellite instability high (MSI H) or mismatch repair deficient (dMMR) tumors a prior line of treatment should have include…

MUC17-positive Solid Tumors
Safety and Feasibility of PD-1 Blockade in the Treatment of dMMR or MSI-H Rectal Cancer

Completed Phase 1 Case Comprehensive Cancer Center Started 2020 NCT04357587

Pembrolizumab FDA EUCapecitabine

MMR-deficiency confirmed on immunohistochemistry or MSI status confirmed by PCR.

Rectal Neoplasms
SL-279252 (PD1-Fc-OX40L) in Subjects With Advanced Solid Tumors or Lymphomas

Completed Phase 1 Shattuck Labs Started 2019 NCT03894618

SL-279252

… of the skin, renal cell cancer, Hodgkin's lymphoma, and microsatellite instability high (MSI-H) or mismatch repair deficient (MMRD) solid tumors excluding CNS malignancies.

Squamous Cell Carcinoma of the Head and Neck, Melanoma, Non Small Cell Lung Cancer, Urothelial Carcinoma
Study of INBRX-105 and INBRX-105 With Pembrolizumab in Patients With Solid Tumors Including Head and Neck Cancer

Terminated Phase 1 Inhibrx Biosciences Started 2019 NCT03809624

INBRX-105 - PDL1x41BB antibodyPembrolizumab FDA EU

… relapsed or refractory to CPI cohorts: NSCLC, cutaneous melanoma, HNSCC, MSI/TMB-high or MMRd solid tumors

Metastatic Solid Tumors, Non-small Cell Lung Cancer, Melanoma, Head and Neck Squamous Cell Carcinoma
Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Efficacy of Evixapodlin (Formerly GS-4224) in Participants With Advanced Solid Tumors

Terminated Phase 1 Gilead Sciences Started 2019 NCT04049617

Evixapodlin

…calation cohort, individuals with melanoma, Merkel cell, microsatellite instability-high (MSI-H) cancers, and classical Hodgkin lymphoma (cHL) are not required to have archival or fresh…

Advanced Solid Tumors
First in Human Study of NG-350A (an Oncolytic Adenoviral Vector Which Expresses an Anti-CD40 Antibody)

Completed Phase 1 Akamis Bio Started 2019 NCT03852511

NG-350A

Tumour types eligible are: UC, SCCHN, MSI high/dMMR cancer, NSCLC, uterine/endometrial cancer, cervical cancer, oesophageal cancer, gast…

Metastatic Cancer, Epithelial Tumor
AMG 404 in Patients With Advanced Solid Tumors

Completed Phase 1 Amgen Started 2019 NCT03853109

AMG 404

Cohort 8: participant must be MSI-H or MMR-deficient

Advanced Solid Tumors
Study of Recombinant Human Anti-PD-1 Monoclonal Antibody in Patients With Advanced Tumours

Unknown status Phase 1 CSPC Started 2019 NCT03852823

SG001

… positive and/or deficiency in mismatch repair (dMMR) / Microsatellites instability-High (MSI-H) and/or EBV positive, and has failed at least first line standard therapy or for which st…

Advanced Solid Tumours, Cervical Cancer, Malignant Mesothelioma, Lymphoma
Study to Investigate the Safety, Blood Levels and Activity of MP0310 in Patients With Advanced Solid Tumors

Completed Phase 1 Molecular Partners Started 2019 NCT04049903

MP0310

…d neck, Mesothelioma, Prostate, Non-small cell lung cancer, Melanoma, Urothelial/bladder, Microsatellite instability high tumors of any type, Cutaneous squamous cell, Breast,

Advanced Solid Tumor
A Study of PSB205 in Subjects With Advanced Solid Tumors

Unknown status Phase 1 Qilu Puget Sound Biotherapeutics (dba Sound Biologics) Started 2019 NCT03986606

PSB205

MSI-high colon carcinoma

Neoplasm Malignant
A Study of Rivoceranib and Trifluridine/Tipiracil for Metastatic Colorectal Cancer (mCRC)

Terminated Phase 1 Elevar Therapeutics Started 2019 NCT04073615

RivoceranibTrifluridine/Tipiracil

…limumab), in participants with Microsatellite Instability High/Deficient Mismatch Repair (MSI-H/dMMR).

Metastatic Colorectal Cancer
A Study of mRNA-5671/V941 as Monotherapy and in Combination With Pembrolizumab (V941-001)

Terminated Phase 1 MSD (Merck & Co.) Started 2019 NCT03948763

V941Pembrolizumab FDA EU

… advanced or metastatic non-small cell lung cancer (NSCLC), non-mismatch repair deficient/microsatellite instability-high tumors colorectal cancers (non-MSI-H CRC), or pancreatic adenocarcinoma, and confirmed HL…

Neoplasms, Carcinoma, Non-Small-Cell Lung, Pancreatic Neoplasms, Colorectal Neoplasms
An Investigational Immunotherapy Study of BMS-986310 Administered Alone and in Combination With Nivolumab in Patients With Advanced Solid Tumors

Completed Phase 1 Bristol Myers Squibb Started 2018 NCT03661632

BMS-986310Nivolumab FDA EU

…ypes: Renal cell carcinoma, Melanoma, colorectal cancer (CRC) microsatellite instability (MSI)-High (determined by Clinical Laboratory Improvement Amendments (CLIA) validated assay, testing…

Advanced Cancer
Apatinib With Pembrolizumab in Previously Treated Advanced Malignancies

Terminated Phase 1 University of Utah Started 2018 NCT03407976

ApatinibPembrolizumab FDA EU

Unresectable or metastatic MSI-H or dMMR solid tumors that have progressed during or following prior treatment and have no…

Advanced Malignancies, Urothelial Carcinoma, MSI-H or dMMR Solid Tumors, Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma
A Safety and Tolerability Study of INCAGN02385 in Select Advanced Malignancies

Completed Phase 1 Incyte Started 2018 NCT03538028

INCAGN02385

Participants with advanced or metastatic cervical cancer, MSI-high endometrial cancer, gastric cancer (including stomach and GEJ), esophageal cancer, hepato…

Cervical Cancer, Microsatellite Instability (MSI)-High Endometrial Cancer, Gastric Cancer (Including Stomach and Gastroesophageal Junction [GEJ]), Esophageal Cancer
CPI-006 Alone and in Combination With Ciforadenant and With Pembrolizumab for Patients With Advanced Cancers

Completed Phase 1 Corvus Pharmaceuticals Started 2018 NCT03454451

CPI-006CPI-006 + ciforadenantCPI-006 + pembrolizumab FDA EUCPI-006CPI-006 + ciforadenantCPI-006 + pembrolizumab FDA EU

…ell lung cancer, renal cell cancer, triple negative breast cancer, colorectal cancer with microsatellite instability(MSI), bladder cancer, cervical cancer, uterine cancer, sarcoma, endometrial cancer, and m…

Non-Small Cell Lung Cancer, Renal Cell Cancer, Colorectal Cancer, Triple Negative Breast Cancer
A Study Exploring the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB086550 in Participants With Advanced Solid Tumors

Completed Phase 1 Incyte Started 2018 NCT03762447

INCB086550

Part 3 MSI-H or dMMR Expansion Cohort only (Enrolled ex-United States only): Participants with any MSI…

Solid Tumors
A Study of XmAb®20717 in Subjects With Selected Advanced Solid Tumors

Completed Phase 1 Xencor Started 2018 NCT03517488

XmAb20717

Microsatellite instability-high or mismatch repair deficient colorectal carcinoma or endometrial carcinoma;

Melanoma, Breast Carcinoma, Hepatocellular Carcinoma, Urothelial Carcinoma
Phase Ib of L-NMMA and Pembrolizumab

Completed Phase 1 The Methodist Hospital Research Institute Started 2018 NCT03236935

L-NMMAPembrolizumab FDA EU

OR MSI-H or dMMR unresectable or metastatic cancer that has relapsed after prior treatment and has…

Non-Small Cell Lung Cancer, Malignant Melanoma, Head and Neck Squamous Cell Carcinoma, Classical Hodgkin Lymphoma
APL-501 Study for Select Advanced or Relapsed/Recurrent Solid Tumors

Completed Phase 1 Apollomics (Australia) Pty Started 2017 NCT03053466

APL-501

MSI-H or dMMR per local laboratory and failed at least one prior line of standard of care chemo…

Solid Tumor, Microsatellite Instability, Mismatch Repair Deficiency, Cancer of Unknown Primary Site
A Study of SC-007 in Subjects With Advanced Cancer

Terminated Phase 1 AbbVie Started 2017 NCT03253185

SC-007

…setting, and as appropriate in patients whose tumors are microsatellite instability-high (MSI-H), pembrolizumab as well.

Colorectal Cancer (CRC), Gastric Cancer
Utomilumab, Cetuximab, and Irinotecan Hydrochloride in Treating Patients With Metastatic Colorectal Cancer

Completed Phase 1 M.D. Anderson Cancer Center Started 2017 NCT03290937

CetuximabIrinotecan HydrochlorideUtomilumab

High microsatellite instability (MSI-H) colorectal cancer patients must have received an approved PD-1 targeted agent prior to e…

Metastatic Colorectal Carcinoma, Stage IV Colorectal Cancer AJCC v8, Stage IVA Colorectal Cancer AJCC v8, Stage IVB Colorectal Cancer AJCC v8
Use of T-allo10 in Hematopoietic Stem Cell Transplantation (HSCT) for Blood Disorders

Terminated Phase 1 Roncarolo, Maria Grazia, MD Started 2017 NCT03198234

T-allo10

Available mismatched related donor (mMRD) or mismatched unrelated donor (mMUD), Human leukocyte antigen (HLA) matched 8/10 or 9/10

AML - Acute Myeloid Leukemia, MDS (Myelodysplastic Syndrome), Mixed Phenotype Acute Leukemia, NHL - Non-Hodgkin's Lymphoma
Immunization Strategy With Intra-tumoral Injections of Pexa-Vec With Ipilimumab in Metastatic / Advanced Solid Tumors.

Completed Phase 1 Centre Leon Berard Started 2017 NCT02977156

Pexa-VecIpilimumab

In part B, tumor types may include melanoma, MSI-High colorectal carcinoma (CRC), head and neck tumors, gastric cancers, triple negative breast…

Metastatic Tumor, Advanced Tumor
Phase I/Ib Study of Nivolumab & Veliparib in Patients With Advanced Solid Tumors & Lymphoma

Completed Phase 1 Northwestern University Started 2017 NCT03061188

Nivolumab FDA EUVeliparib

…Hodgkin's lymphoma, Merkel cell carcinoma, and high-frequency microsatellite instability (MSI-H) colorectal cancer

Advanced Solid Neoplasm, Aggressive Non-Hodgkin Lymphoma, Recurrent Solid Neoplasm, Refractory Mantle Cell Lymphoma
This Study Tests the New Medicine BI 754111 Alone or in Combination With Another New Substance BI 754091 in Patients With Advanced Cancer. The Study Tests Different Doses to Find the Best Dose for Continuous Treatment.

Completed Phase 1 Boehringer Ingelheim Started 2017 NCT03156114

EzabenlimabBI 754111

…Tumour mutational burden (TMB) (≥10 mutations/Mb) and/or Microsatellite instability high (MSI-H) and/or DNA MMRd solid tumours

Neoplasms, Carcinoma, Non-Small-Cell Lung
Pembrolizumab Combined With Itacitinib (INCB039110) and/or Pembrolizumab Combined With INCB050465 in Advanced Solid Tumors

Completed Phase 1 Incyte Started 2016 NCT02646748

Pembrolizumab FDA EUitacitinibINCB050465

…ancer, gastric cancer, melanoma, microsatellite unstable (MSI) colorectal cancer or other MMR-deficient tumors, non-small cell lung cancer, renal cell carcinoma, head and neck squamous cell car…

Colorectal Cancer (CRC), Endometrial Cancer, Melanoma, Head and Neck Cancer
A Phase 1 Study of INCMGA00012 in Patients With Advanced Solid Tumors

Completed Phase 1 Incyte Started 2016 NCT03059823

retifanlimab

Patients enrolled to Cohort H (endometrial cancer 500 mg Q4W) must have MSI-H or dMMR endometrial cancer, as determined by a local laboratory using IHC or PCR methods …

Locally Advanced Solid Tumors, Metastatic Solid Tumors
A Study of Anti-PD-L1 Checkpoint Antibody (LY3300054) Alone and in Combination in Participants With Advanced Refractory Solid Tumors

Completed Phase 1 Eli Lilly Started 2016 NCT02791334

LY3300054RamucirumabAbemaciclibMerestinibLY3321367

For LY3300054 + LY3321367 in PD-1/PD-L1-naive, MSI-H/MMR-deficient advanced solid tumors:

Solid Tumor, Microsatellite Instability-High (MSI-H) Solid Tumors, Cutaneous Melanoma, Pancreatic Cancer
Antibody DS-8273a Administered in Combination With Nivolumab in Subjects With Advanced Colorectal Cancer

Terminated Phase 1 Daiichi Sankyo Started 2016 NCT02991196

DS-8273a + nivolumab FDA EU

Is MMR-proficient \[selected by the site based on microsatellite instability assay (MSI) and/or immunohistochemistry (IHC) for MMR proteins\]

Colorectal Neoplasm
PI Pembro in Combination With Stereotactic Body Radiotherapy for Liver Metastatic Colorectal Cancer

Completed Phase 1 University of Wisconsin, Madison Started 2016 NCT02837263

Pembrolizumab FDA EU

Tumor must be mismatch repair (MMR) proficient as determined by microsatellite instability or immunohistochemistry for for MMR proteins

Colorectal Cancer, Colorectal Adenocarcinoma, Stage IVA Colorectal Cancer, Stage IVB Colorectal Cancer
Dose Escalation and Expansion Study of GSK3359609 in Participants With Selected Advanced Solid Tumors (INDUCE-1)

Completed Phase 1 GSK Started 2016 NCT02723955

feladilimab (GSK3359609)GSK3174998Pembrolizumab FDA EUDocetaxelPemetrexedPaclitaxel plus Carboplatin

Microsatellite Instability-High/deficient mismatch repair (MSI-H/dMMR) tumor (Part 1B and Part 2B) and Human Papilloma Virus (HPV)-positive or Epstein-Bar…

Neoplasms
The Safety, Pharmacokinetics and Antitumor Activity of BGB-A317 in Combination With BGB-290 in Participants With Advanced Solid Tumors

Completed Phase 1 BeOne Medicines (BeiGene) Started 2016 NCT02660034

TislelizumabPamiparib

…ancers (endometrial cancer, cancer of the cervix and participants with tumors known to be mismatch repair deficient or HRD positive) must have met the following criteria:

Solid Tumors
Study of the CD40 Agonistic Monoclonal Antibody APX005M

Completed Phase 1 Apexigen America Started 2015 NCT02482168

APX005M

…n-small cell lung cancer, or any solid tumor with high microsatellite instability status (MSI-high)

Cancer, NSCLC, Melanoma, Urothelial Carcinoma
Combination of Interferon-gamma and Nivolumab for Advanced Solid Tumors

Completed Phase 1 Fox Chase Cancer Center Started 2015 NCT02614456

interferon-gamma and nivolumab FDA EU

…ma, triple negative breast cancer, gastric cancer, microsatellite instability expressing (MSI-high) colon cancer, hepatocellular carcinoma, mesothelioma, gastrointestinal stromal tumors, e…

Advanced Solid Tumors
Naproxen in Preventing DNA Mismatch Repair Deficient Colorectal Cancer in Patients With Lynch Syndrome

Completed Phase 1 National Cancer Institute (NCI) Started 2014 NCT02052908

Naproxen

…sporadic MMR deficient malignant tumor (where "non-sporadic MMR deficient" is defined by: microsatellite-instability high by either immunohistochemistry or microsatellite instability \[MSI\] testing or both, but…

Lynch Syndrome
Tislelizumab for the Treatment of Recurrent Mismatch Repair Deficient Endometrial Cancer

Terminated Early Phase 1 Floor Backes, MD Started 2021 NCT04906382

CarboplatinPaclitaxelTislelizumab

Patients must have deficient mismatch repair as demonstrated by lack of expression of at least 1 mismatch repair protein by immunohist…

Lynch Syndrome, Recurrent Endometrial Carcinoma, Recurrent Endometrial Clear Cell Adenocarcinoma, Recurrent Uterine Corpus Carcinosarcoma
A Clinical Study of Laparoscopic Proximal Gastrectomy Based on PTST(Parachute-tunnel- Style Technique) Esophagogastric Anastomose.

Unknown status No phase Tang-Du Hospital Started 2023 NCT06217991

Patients with advanced upper gastric cancer (MSI-H) achieved cCR by neoadjuvant immunochemotherapy.

Gastroesophageal-junction Cancer, Proximal Gastrectomy, Gastroesophagostomy
Assessments of Genetic Counseling Augmented With an Educational Video or Pamphlet Versus Traditional Counseling

Completed No phase Stanford University Started 2021 NCT05132868

…d positive for Lynch Syndrome based on either an immunohistochemistry test or evidence of mismatch repair deficiency in their tumor cohort.

Quality, Prostate Cancer, Gastrointestinal Cancer, Gynecologic Cancer
Profiling Program of Cancer Patients With Sequential Tumor and Liquid Biopsies (PLANET)

Unknown status No phase Centre Leon Berard Started 2021 NCT05099068

Blood and tumor samples

For MSI-High, any tumor types : treatment by Immunotherapy

Advanced / Metastic Solid Tumors, Glioblastoma, Chronic Leukemia Lymphocytic
Assessment of a Serious Illness Conversation Guide (SICG) in Advanced Gastro-Intestinal Cancers

Terminated No phase Stanford University Started 2019 NCT04077372

Exception: Patients whose tumors are MSI-H must have experience progression through immunotherapy in addition to the therapies menti…

Gastrointestinal Cancer, Colorectal Cancer, Pancreatic Adenocarcinoma, Gastric Cancer
Cycling in Preventing Colorectal Cancer in Participants With Lynch Syndrome

Completed No phase M.D. Anderson Cancer Center Started 2018 NCT03495674

…n sporadic MMR deficient malignant tumor (where non-sporadic MMR deficient is defined by: microsatellite instability high by either immunohistochemistry or microsatellite instability (MSI) testing or both, but n…

High-Frequency Microsatellite Instability, Mismatch Repair Gene Mutation, Mutation-Negative Lynch Syndrome, Mutation-Positive Lynch Syndrome
Universal Endometrial Cancer DNA Sequencing for Detection of Lynch Syndrome and Personalized Care

Completed No phase Ohio State University Comprehensive Cancer Center Started 2018 NCT03460483

…ntion and Treatment of Endometrial Cancer (OPTEC) Initiative: Universal Screening for DNA Mismatch Repair Deficiency and Personalized Cancer Treatment

Endometrial Adenocarcinoma, Endometrial Carcinoma, Lynch Syndrome, Relatives
I-Scan For Colon Polyp Detection In HNPCC

Completed No phase Universitaire Ziekenhuizen KU Leuven Started 2010 NCT01823471

Colon cancer with high microsatellite instability on histology before the age of 60

Hereditary Non-polyposis Colon Carcinoma, HNPCC, Lynch Syndrome
Educational CD-ROM Compared With Standard Informed Consent for Patients With Colorectal Cancer or a Family History of Colorectal Cancer

Completed No phase Fox Chase Cancer Center Started 2007 NCT00450424

Diagnosis of CRC with pathologic features suggestive of microsatellite instability (MSI) and \< 60 years of age

Colorectal Cancer, Hereditary Non-polyposis Colon Cancer
Study of the Results of Education and Counseling for Persons Undergoing Genetic Testing for Hereditary Nonpolyposis Colon Cancer

Completed No phase National Human Genome Research Institute (NHGRI) Started 2000 NCT00004210

HNPCC-associated cancer/polyps\* under age 41 with a microsatellite instability (MSI) phenotype

Colorectal Cancer
A Study of CTX-009 in Adult Patients With Metastatic Colorectal Cancer

Completed Phase 2 Compass Therapeutics Started 2022 NCT05513742

CTX-009

BRAF V600E, HER2-positive, MSI-H/dMMR, etc.) must have also received the relevant approved targeted therapies.

Broad match: MSI-H / dMMRMetastatic Colorectal Cancer, Colon Cancer, Rectal Cancer
Tislelizumab Plus Anlotinib for Immunotherapy Resistant Gastrointestinal Cancer

Unknown status Phase 2 Peking University Started 2021 NCT04777162

TislelizumabAnlotinib

…nosed with special pathology subtypes, that are sensitive to immunotherapy, such as dMMR, MSI-H tumors, or gastric cancer with PD-L1 CPS≥10, PFS≥6 months in the last treatment line;

Broad match: MSI-H / dMMRGastric Cancer, Colo-rectal Cancer
Study of BGB-10188 as Monotherapy, and in Combination With Zanubrutinib, and Tislelizumab

Completed Phase 1/2 BeOne Medicines (BeiGene) Started 2020 NCT04282018

BGB-10188ZanubrutinibTislelizumab

…oma, urothelial carcinoma or participant with confirmed microsatellite instability-high \[MSI-H\] or mismatch repair deficient \[dMMR\] solid tumor, etc.).

Broad match: MSI-H / dMMRChronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Follicular Lymphoma, Marginal Zone Lymphoma
Phase I-II Study of Intratumoral Urelumab Combined With Nivolumab in Patients With Solid Tumors

Unknown status Phase 1/2 Clinica Universidad de Navarra, Universidad de Navarra Started 2019 NCT03792724

Urelumab + Nivolumab FDA EU

…e.g: melanoma, renal cancer, lung cancer, urothelial cancer, colorectal cancer presenting microsatellite instability (MSI), …).

Broad match: MSI-H / dMMRNeoplasms
Sym004 Versus Futuximab or Modotuximab in Patients With mCRC

Terminated Phase 2 Symphogen A/S Started 2018 NCT03549338

Sym004FutuximabModotuximab

Microsatellite instability-high (MSI-H) / mismatch repair-deficient (dMMR) tumors must have received prior therapy with pembroli…

Broad match: MSI-H / dMMRMetastatic Colorectal Cancer, Colorectal Cancer Metastatic, Carcinoma
Trial of Pembrolizumab in Metastatic Castration Resistant Prostate Cancer

Unknown status Phase 2 Institute of Cancer Research, United Kingdom Started 2018 NCT03506997

Pembrolizumab FDA EU

…eneration sequencing and/or a DNA repair defect that can increase mutation load including MMR deficiency and/or high MSI by next generation sequencing.

Broad match: MSI-H / dMMRCastration-resistant Prostate Cancer
A Phase 1/2 Trial SRA737 in Combination With Gemcitabine and Cisplatin or Gemcitabine Alone in Advanced Cancer Subjects

Completed Phase 1/2 Sierra Oncology LLC - a GSK company Started 2016 NCT02797977

SRA737, gemcitabine, cisplatinSRA737, gemcitabine

… response pathway including ATM, BRCA1, BRCA2, mismatch repair genetic alterations and/or high microsatellite instability.

Broad match: MSI-H / dMMRAdvanced Solid Tumors
A Phase 1 Clinical Study of AZD4635 in Patients With Advanced Solid Malignancies

Completed Phase 1 AstraZeneca Started 2016 NCT02740985

AZD4635Durvalumab FDA EUAbiraterone AcetateEnzalutamideOleclumabDocetaxel

… an immune checkpoint resistant malignancy (for example, RCC, head and neck carcinoma, or MSI high cancers which have approved settings for anti-PD1 treatment), confirmed histologically or…

Broad match: MSI-H / dMMRAdvanced Solid Malignancies, Non-Small Cell Lung Cancer (NSCLC), Metastatic Castrate-Resistant Prostate Carcinoma (mCRPC), Colorectal Carcinoma (CRC)
Clinical Study of mRNA Vaccine in Patients With Advanced Malignant Solid Tumors

Unknown status No phase Stemirna Therapeutics Started 2023 NCT05949775

Neoantigen mRNA Personalised Cancer vaccine

…ut not limited to gastric cancer, esophageal cancer, and other gastrointestinal tumors of MSI-H

Broad match: MSI-H / dMMRAdvanced Malignant Solid Tumors