marked.bio

anti-PD-1 antibody · antibody

nivolumab

73 active trials across 16 of our biomarkers, targeting PD-1. 6 active approvals for a biomarker on marked.bio.

Also known as BMS-936558, ONO-4538, MDX-1106, Opdivo.

Counts only trials that select patients by one of the biomarkers on marked.bio, not every trial of this drug.

Approvals and pivotal results

Biomarker-selected approvals in the United States and the European Union, with the pivotal trial's results and side effects where we have them. Results from different trials are not directly comparable.

TherapyBiomarkerTumourUnited StatesEuropean Union
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
Opdivoipilimumab page 		MSI-H / dMMR colorectal Approved 2018 Approved 2021

CheckMate 142 (combination cohort) single-arm, 119 patients
Response 49% (39-58)Lasting not reached

Trial details and side effects
Patients
MSI-H or dMMR metastatic colorectal cancer, previously treated (NCT02060188)
Notes
Nivolumab with ipilimumab. From the 2018 approval report.
Source
US approval report
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 First approved 27/12/2024 with the CRC indication under accelerated approval. FDA converted single-agent nivolumab for this setting to regular approval on 08/04/2025; the current label (rev. 5/2026, section 1.9) no longer carries the accelerated-approval statement. Not indicated with ipilimumab for MSI-H CRC. Source
Opdivo, Opdivo Qvantig 		MSI-H / dMMR colorectal Approved 2017 Not approved

CheckMate 142 (nivolumab cohort) single-arm, 53 patients
Response 28% (17-42)Lasting 67% of responses lasted 6 months or more

Trial details and side effects
Patients
MSI-H or dMMR metastatic colorectal cancer after fluoropyrimidine, oxaliplatin and irinotecan (NCT02060188)
Most common side effects
fatigue, rash, musculoskeletal pain, pruritus, diarrhoea, nausea
Notes
First approved as accelerated in 2017; converted to regular approval in 2025. ORR 32% in all 74 patients.
Source
US approval report

Biomarkers

BiomarkerActive trialsAll trialsFurthest active phase
MSI-H / dMMR 32 53 Phase 3
BRAF V600E 15 33 Phase 3
KRAS G12C 7 12 Phase 3
Claudin 18.2 expression 6 6 Phase 3
ALK fusion 5 12 Phase 2
EGFR exon 19 deletion / L858R 5 16 Phase 1/2
IDH1/2 mutation 3 9 Phase 2
KRAS G12D 3 8 Phase 2
BRCA1/2 mutation 2 5 Phase 1/2
ROS1 fusion 2 5 Phase 3
HER2 (ERBB2) activating mutation 1 1 Phase 3
RET fusion or mutation 1 2 Phase 3
FGFR2 fusion or rearrangement 0 1 –
FLT3 mutation (ITD/TKD) 0 1 –
HER2-low / ultralow (IHC 1+ or 2+/ISH-) 0 2 –
MET exon 14 skipping 0 2 –

Sponsors

Industry sponsors leading active biomarker-selected trials of nivolumab.

  1. Bristol Myers Squibb 3
  2. Replimune 2
  3. I-Mab Biopharma US 2
  4. Vivace Therapeutics 1
  5. AbbVie 1
  6. Roche 1
  7. Orion Pharma 1
  8. Scancell 1
  9. Aulos Bioscience 1
  10. Boehringer Ingelheim 1
  11. Novartis 1
  12. AstraZeneca 1

Trials

73 of 142 trials shown

  1. A Study to Evaluate the Efficacy and Safety of Divarasib Compared With Investigator's Choice of Immunotherapy or Observation in Participants With Resected Stage II-III KRAS G12C-Positive Non-Small Cell Lung Cancer (NSCLC)

    Recruiting Phase 3 Roche Started 2026Primary completion 2032-01 NCT07541170

    divarasibpembrolizumabnivolumab

    Documentation of the presence of a KRAS G12C mutation

    KRAS G12CNon-small Cell Lung Cancer

  2. iSCIB1+ in Combination With Ipilimumab and Nivolumab as First-Line Treatment for Advanced Unresectable Melanoma

    Not yet recruiting Phase 3 Scancell Started 2026Primary completion 2028-12 NCT07815574

    iSCIB1+nivolumabipilimumab

    Participant has BRAF mutation positive disease with evidence of rapid PD.

    BRAF V600EMelanoma (Skin Cancer), Advanced Melanoma, Metastatic Melanoma, Skin Cancer

  3. Beamion LUNG-3: Adjuvant Zongertinib vs Standard Treatment in People With Completely Resected Stage II-IIIB NSCLC Harboring Activating HER2 TKD Mutations

    Recruiting Phase 3 Boehringer Ingelheim Started 2026Primary completion 2032-02 NCT07195695

    zongertinib FDApembrolizumabatezolizumabdurvalumabnivolumab

    HER2 mutation: Documented Tyrosine kinase domain (TKD) activating Human epidermal growth factor recepto…

    HER2 (ERBB2) activating mutationNon-small Cell Lung Cancer

  4. Sonesitatug Vedotin in Combination With Capecitabine With or Without Rilvegostomig in Participants With Advanced or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma Expressing Claudin18.2

    Recruiting Phase 3 AstraZeneca Started 2026Primary completion 2029-08 NCT07431281

    AZD0901Rilvegostomignivolumabcapecitabinefluorouraciloxaliplatinzolbetuximab FDA EUleucovorin

    Positive CLDN18.2 expression, as determined prospectively by central IHC testing

    Claudin 18.2 expressionGastric Cancer, Gastroesophageal Junction Adenocarcinoma, Esophageal Cancer

  5. Combination of Immune Checkpoint in Locally Advanced or Metastatic MSI/dMMR Esogastric Adenocarcinomas

    Recruiting Phase 3 Centre Leon Berard Started 2025Primary completion 2028-05 NCT06346197

    balstilimabbotensilimabFOLFOXXELOXnivolumab FDA EU

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

    MSI-H / dMMRGastric Cancer, MSI-H, Metastatic Cancer, Advanced Cancer

  6. VO and Nivolumab vs Physician's Choice in Advanced Melanoma That Progressed on Anti-PD-1 & Anti-CTLA-4 Drugs [IGNYTE-3]

    Recruiting Phase 3 Replimune Started 2024Primary completion 2030-09 NCT06264180

    Vusolimogene OderparepvecnivolumabrelatlimabpembrolizumabSingle-agent chemotherapy

    …apy must be the immediate prior line of treatment before randomization (for patients with BRAF mutation, see I 4).

    BRAF V600EAdvanced Melanoma

  7. Identification and Treatment Of Micrometastatic Disease in Stage III Colon Cancer

    Active, not recruiting Phase 3 Massachusetts General Hospital Started 2020Primary completion 2026-12 NCT03803553

    FOLFIRIleucovorinfluorouracilirinotecannivolumab FDA EUencorafenibbinimetinibcetuximabtrastuzumabpertuzumab

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

    MSI-H / dMMRMetastatic Colon Cancer, Stage III Colon Cancer

  8. 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 2019Primary completion 2024-08 NCT04008030

    ipilimumab FDA EUoxaliplatinleucovorinfluorouracilirinotecanbevacizumabcetuximabnivolumab FDA EU

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

    MSI-H / dMMRMetastatic Colorectal Cancer

  9. Nivolumab and Ipilimumab With or Without Local Consolidation Therapy in Treating Patients With Stage IV Non-Small Cell Lung Cancer

    Active, not recruiting Phase 3 M.D. Anderson Cancer Center Started 2017Primary completion 2027-03 NCT03391869

    ipilimumabnivolumab

    Also, note that patients with ROS1/RET alterations can be enrolled, as tyrosine kinase inhibitor such as crizotinib aren't established as fi…

    ROS1 fusionRET fusion or mutationLung Adenocarcinoma, Lung Non-Small Cell Carcinoma, Stage IV Lung Cancer AJCC v8

  10. Dabrafenib and Trametinib Followed by Ipilimumab and Nivolumab or Ipilimumab and Nivolumab Followed by Dabrafenib and Trametinib in Treating Patients With Stage III-IV BRAFV600 Melanoma

    Active, not recruiting Phase 3 National Cancer Institute (NCI) Started 2015Primary completion 2023-09 NCT02224781

    dabrafenib FDA EUipilimumabnivolumabtrametinib FDA EU

    Patients must have BRAF V600 mutation, identified by a Food and Drug Administration (FDA)-approved test at a Clinical …

    BRAF V600EClinical Stage III Cutaneous Melanoma AJCC v8, Clinical Stage IV Cutaneous Melanoma AJCC v8, Metastatic Melanoma, Recurrent Melanoma

  11. A 2-part Phase 1/2 Open-label Trial on ODM-212

    Recruiting Phase 1/2 Orion Pharma Started 2026Primary completion 2029-09 NCT07563738

    ODM-212ipilimumabnivolumabgemcitabinenab-paclitaxelsotorasib FDA EU

    …ically or cytologically confirmed diagnosis of locally advanced or metastatic NSCLC and a KRAS G12C mutation, confirmed using a validated test, who have documented progression on a prior KR…

    KRAS G12CMesothelioma, Pancreatic Cancer, NSCLC (Advanced Non-small Cell Lung Cancer)

  12. Givastomig Combined With Nivolumab and Chemotherapy in Adults With CLDN18.2 Positive Metastatic Gastric Cancer (GIVA-2)

    Recruiting Phase 2 I-Mab Biopharma US Started 2026Primary completion 2030-03 NCT07432295

    Givastomignivolumabfluorouracilleucovorinoxaliplatincapecitabine

    CLDN18.2 positive (membrane intensity score ≥1+ on ≥1% of tumor cells).

    Claudin 18.2 expressionSolid Tumor, Advanced Cancer, Metastatic Cancer, Gastric Cancer

  13. Neoadjuvant Immunotherapy ± Radiotherapy in MSI-H/dMMR Locally Advanced Colorectal Cancer

    Not yet recruiting Phase 2 Fudan University Started 2026Primary completion 2031-12 NCT07403877

    nivolumab FDA EUipilimumab FDA EU

    MSI-H or dMMR.

    MSI-H / dMMRColorectal Cancer (MSI-H)

  14. 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 2026Primary completion 2029-08 NCT07576725

    nivolumab FDA EU

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

    MSI-H / dMMRClinical 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

  15. A Study to Evaluate the Safety, Tolerability, Drug Levels, and Preliminary Efficacy of BMS-986507 Combinations in Adult Participants With Advanced Solid Tumors

    Recruiting Phase 1/2 Bristol Myers Squibb Started 2025Primary completion 2031-02 NCT06618287

    izalontamab brengitecanosimertinib FDA EUpembrolizumabnivolumabpumitamig

    …ants must have pathologically confirmed locally advanced or metastatic NSCLC with an EGFR exon 19 deletion or L858R mutation in exon 21, either alone or in combination with other EGFR mutations, w…

    EGFR exon 19 deletion / L858RLung Cancer, Breast Cancer

  16. MAPK Inhibition Combined With Anti-PD1 Therapy for BRAF-altered Pediatric Gliomas

    Recruiting Phase 1/2 Ann & Robert H Lurie Children's Hospital of Chicago Started 2025Primary completion 2028-12 NCT06712875

    trametinib FDA EUnivolumabdabrafenib FDA EU

    …atients with histologically confirmed diagnosis of pediatric low-grade glioma harboring a BRAFV600 mutation that is recurrent or progressive OR

    BRAF V600ELow Grade Glioma, High Grade Glioma

  17. Chemoimmunotherapy for ALK+ Relapsed/Refractory ALCL

    Recruiting Phase 2 New York Medical College Started 2025Primary completion 2029-07 NCT07013565

    vinblastinebrentuximab vedotinnivolumab

    Patients with relapsed or refractory histologically or cytologically proven ALK-positive anaplastic large cell lymphoma meeting Low or High Risk Criteria:

    ALK fusionAnaplastic Large Cell Lymphoma, ALK-Positive

  18. Patient Preference for Subcutaneous vs. Intravenous Immune Therapy

    Recruiting Phase 2 Diwakar Davar Started 2025Primary completion 2030-11 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 …

    MSI-H / dMMRRenal Cell Carcinoma, Non Small Cell Lung Cancer, Melanoma, Colo-rectal Cancer (dMMR/MSI-H CRC)

  19. 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 2025Primary completion 2028-03 NCT07542262

    nivolumab FDA EU

    Presence of MSI/dMMR in the tumor;

    MSI-H / dMMRColorectal Cancer, Gastric Cancer

  20. Defactinib, Avutometinib and Nivolumab for the Treatment of Anti-PD1 Refractory LKB1-Mutant Advanced Non-Small Cell Lung Cancer

    Recruiting Phase 2 Emory University Started 2024Primary completion 2029-03 NCT06495125

    avutometinib FDAdefactinib FDAnivolumab

    COHORT A ONLY: Patients must have known KRAS mutation

    KRAS G12CKRAS G12DAdvanced Lung Adenocarcinoma, Refractory Lung Adenocarcinoma, Stage III Lung Cancer AJCC v8, Stage IV Lung Cancer AJCC v8

  21. Neoadjuvant Low-dose Immunotherapy in Locally Advanced MMR-deficient Colorectal Cancer

    Active, not recruiting Phase 2 Blokhin's Russian Cancer Research Center Started 2024Primary completion 2025-12 NCT07523763

    nivolumab FDA EUpembrolizumab FDA EU

    Presence of MSI/dMMR in the tumor;

    MSI-H / dMMRColorectal Cancer (MSI-H), Colorectal Cancer (CRC)

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

    Recruiting Phase 1/2 7 Hills Pharma Started 2024Primary completion 2027-12 NCT06362369

    Alintegimodipilimumab FDA EUnivolumab 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…

    MSI-H / dMMRAdvanced Cancer, Advanced Solid Tumor, Melanoma, Metastasis

  23. 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 2024Primary completion 2027-05 NCT06265285

    nivolumab FDA EU

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

    MSI-H / dMMRAdvanced Esophageal Squamous Cell Carcinoma, Advanced Renal Cell Carcinoma, Clinical Stage II Esophageal Squamous Cell Carcinoma AJCC v8, Clinical Stage IIB Cutaneous Melanoma AJCC v8

  24. Pre-operative Targeted Treatments in Molecularly Selected Resectable Colorectal Cancer (UNICORN)

    Recruiting Phase 2 Gruppo Oncologico del Nord-Ovest Started 2023Primary completion 2027-05 NCT05845450

    trastuzumab deruxtecandurvalumabpanitumumab FDAbotensilimabbalstilimabsotorasib FDA EUVorbipiprantnivolumabamivantamab

    COHORT 8: pMMR/MSS status and KRAS G12C mutation, absence of HER2 overexpression/amplification and wild-type status for BRAF.

    KRAS G12CMSI-H / dMMRColorectal Cancer, Resectable Colorectal Carcinoma

  25. Phase 1/2 Clinical Trial of CP-506 (HAP) in Monotherapy or With Carboplatin or ICI

    Recruiting Phase 1/2 Maastricht University Medical Center Started 2023Primary completion 2027-02 NCT04954599

    CP-506carboplatinipilimumabnivolumabpembrolizumabatezolizumabavelumabdurvalumabcemiplimab

    BRCA1/2 carriers), dedicated HRD genomic assays (including exome-sequencing) from liquid or tissue biopsie…

    BRCA1/2 mutationUnspecified Adult Solid Tumor, Protocol Specific

  26. A LM-302 Combination With Other Anti-Tumor Therapies Phase ll Study

    Recruiting Phase 2 LaNova Medicines Zhejiang Started 2023Primary completion 2031-08 NCT05934331

    LM-302toripalimabcapecitabineTegafur, Gimeracil and Oteracil Potassium Capsulesnivolumabapatinibgemcitabinetislelizumabanlotinibbenmelstobart

    CLDN18.2-positive subjects.

    Claudin 18.2 expressionMalignant Neoplasms of Digestive Organs

  27. Immunotherapy in Patients With Early dMMR Rectal Cancer

    Recruiting Phase 2 Odense University Hospital Started 2023Primary completion 2027-07 NCT05732389

    nivolumab FDA EUipilimumab FDA EU

    Histologically verified dMMR or MSI.

    MSI-H / dMMRCancer of Rectum

  28. FOG-001 in Locally Advanced or Metastatic Solid Tumors

    Recruiting Phase 1/2 Parabilis Medicines Started 2023Primary completion 2027-04 NCT05919264

    FOG-001mFOLFOX6leucovorinfluorouraciloxaliplatinnivolumab FDA EUtrifluridine/tipiracilbevacizumab

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

    MSI-H / dMMRCancer, Colorectal Cancer, Solid Tumor, Locally Advanced Solid Tumor

  29. 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 2023Primary completion 2029-12 NCT05795244

    nivolumab FDA EU

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

    MSI-H / dMMREndometrial Neoplasms, Endometrial Cancer

  30. 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 2022Primary completion 2026-02 NCT05308446

    cetuximab FDA EUencorafenib FDA EUnivolumab

    Participants must have BRAF\^V600E mutated colorectal cancer as tested in a Clinical Laboratory Improvement Act (CLIA)-certi…

    BRAF V600EMSI-H / dMMRMetastatic Colon Adenocarcinoma, Metastatic Rectal Adenocarcinoma, Stage III Colon Cancer AJCC v8, Stage III Rectal Cancer AJCC v8

  31. Study of AU-007, A Monoclonal Antibody That Binds to IL-2 and Inhibits IL-2Rα Binding, in Patients With Unresectable Locally Advanced or Metastatic Cancer

    Recruiting Phase 1/2 Aulos Bioscience Started 2022Primary completion 2027-02 NCT05267626

    AU-007aldesleukinavelumabnivolumab

    BRAF mutation: patients who refused BRAF+MEK inhibitor

    BRAF V600EALK fusionAdvanced Solid Tumor, Metastatic Cancer, Cutaneous Melanoma, Non-Small Cell Lung Cancer

  32. 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 2022Primary completion 2027-01 NCT05584670

    SAR445877cetuximabADG126bevacizumabnivolumab FDA EUipilimumab FDA EU

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

    MSI-H / dMMRSolid Tumor

  33. Testing Nivolumab With or Without Ipilimumab in Deficient Mismatch Repair System (dMMR) Recurrent Endometrial Carcinoma

    Recruiting Phase 2 National Cancer Institute (NCI) Started 2022Primary completion 2032-07 NCT05112601

    ipilimumab FDA EUnivolumab FDA EU

    Patients must have endometrial cancer with deficient mismatch repair system.

    MSI-H / dMMREndometrial Adenocarcinoma, Endometrial Clear Cell Adenocarcinoma, Endometrial Dedifferentiated Carcinoma, Endometrial Endometrioid Adenocarcinoma

  34. Testing Nivolumab and Ipilimumab With Short-Course Radiation in Locally Advanced Rectal Cancer

    Active, not recruiting Phase 2 National Cancer Institute (NCI) Started 2022Primary completion 2027-06 NCT04751370

    ipilimumab FDA EUnivolumab FDA EU

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

    MSI-H / dMMRLocally Advanced Rectal Adenocarcinoma, Stage II Rectal Cancer AJCC v8, Stage III Rectal Cancer AJCC v8

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

    Recruiting Phase 2 GERCOR - Multidisciplinary Oncology Cooperative Group Started 2022Primary completion 2025-09 NCT05310643

    nivolumab FDA EUipilimumab FDA EU

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

    MSI-H / dMMRMetastatic Colorectal Cancer

  36. Study to Evaluate VT3989 in Patients With Metastatic Solid Tumors

    Recruiting Phase 1/2 Vivace Therapeutics Started 2021Primary completion 2029-11 NCT04665206

    VT3989nivolumabipilimumabosimertinib FDA EUpemetrexedcarboplatin

    … diagnosed incurable locally advanced (inoperable or recurrent), or metastatic NSCLC with exon 19 deletions or exon 21 L858R mutations, with or without prior treatment with Osimertinib.

    EGFR exon 19 deletion / L858RSolid Tumor, Adult, Mesothelioma, NSCLC

  37. Tocilizumab, Ipilimumab, and Nivolumab for the Treatment of Advanced Melanoma, Non-Small Cell Lung Cancer, or Urothelial Carcinoma

    Active, not recruiting Phase 2 M.D. Anderson Cancer Center Started 2021Primary completion 2027-12 NCT04940299

    ipilimumabnivolumabtocilizumab

    …CLC with EGFR mutation known to be associated with EGFR TKI sensitivity (including G719X, exon 19 deletion, L858R, L861Q).

    EGFR exon 19 deletion / L858RClinical Stage III Cutaneous Melanoma AJCC v8, Clinical Stage IV Cutaneous Melanoma AJCC v8, Locally Advanced Bladder Carcinoma, Locally Advanced Bladder Urothelial Carcinoma

  38. A Study to Compare the Administration of Encorafenib + Binimetinib + Nivolumab Versus Ipilimumab + Nivolumab in BRAF-V600 Mutant Melanoma With Brain Metastases

    Recruiting Phase 2 SWOG Cancer Research Network Started 2021Primary completion 2027-06 NCT04511013

    binimetinib FDA EUencorafenib FDA EUipilimumabnivolumab

    Participants must have BRAF-V600 mutant melanoma documented by a Clinical Laboratory Improvement Act (CLIA)-certified labo…

    BRAF V600EAcral Lentiginous Melanoma, Clinical Stage IV Cutaneous Melanoma AJCC v8, Metastatic Cutaneous Melanoma, Metastatic Malignant Neoplasm in the Brain

  39. 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 2021Primary completion 2027-12 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:

    MSI-H / dMMRMetastatic Colorectal Adenocarcinoma, Metastatic Small Intestinal Adenocarcinoma, Stage IV Colorectal Cancer AJCC v8, Stage IV Small Intestinal Adenocarcinoma AJCC v8

  40. Combination Immunotherapy in Rare Cancers Under InvesTigation

    Active, not recruiting Phase 2 Olivia Newton-John Cancer Research Institute Started 2021Primary completion 2025-03 NCT04969887

    ipilimumab FDA EUnivolumab FDA EU

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

    MSI-H / dMMRAdvanced Biliary Tract Cancer, Neuroendocrine Tumors, Female Reproductive System Neoplasm, MSI-H Solid Malignant Tumor

  41. 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 2021Primary completion 2027-04 NCT04730544

    nivolumab FDA EUipilimumab FDA EU

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

    MSI-H / dMMRColorectal Cancer Metastatic, MSI-H Colorectal Cancer

  42. Encorafenib and Binimetinib With or Without Nivolumab in Treating Patients With Metastatic Radioiodine Refractory BRAF V600 Mutant Thyroid Cancer

    Active, not recruiting Phase 2 Providence Health & Services Started 2020Primary completion 2027-12 NCT04061980

    binimetinib FDA EUencorafenib FDA EUnivolumab

    …cally (or cytologically) confirmed diagnosis of metastatic, radioiodine (RAI) refractory, BRAFV600E/M mutant differentiated thyroid cancer (DTC)

    BRAF V600EBRAF NP_004324.2:p.V600M, BRAF V600E Mutation Present, Metastatic Thyroid Gland Carcinoma, Refractory Thyroid Gland Carcinoma

  43. A Study Testing the Effect of Immunotherapy (Ipilimumab and Nivolumab) in Patients With Recurrent Glioma With Elevated Mutational Burden

    Active, not recruiting Phase 2 National Cancer Institute (NCI) Started 2020Primary completion 2027-06 NCT04145115

    ipilimumabnivolumab

    Astrocytoma, IDH-mutant CNS WHO grade 4

    IDH1/2 mutationAstrocytoma, IDH-Mutant, Grade 4, Diffuse Glioma, Glioblastoma, IDH-Wildtype, Secondary Glioblastoma

  44. A Trial to Evaluate Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of TST001 in Advanced or Metastatic Solid Tumors

    Active, not recruiting Phase 1/2 Transcenta Therapeutics Started 2020Primary completion 2027-06 NCT04495296

    osemitamaboxaliplatincapecitabinepaclitaxelgemcitabinecisplatinnivolumab

    …pansion study: The subjects with positive CDLN18.2 expression in tumor tissue (defined as CLDN18.2 membranous staining ≥1+ in ≥10% of tumor cells by immunohistochemistry (IHC) in the centr…

    Claudin 18.2 expressionAdvanced Cancer

  45. Nivolumab + Docetaxel + ADT in mHSPC Patients With DDRD or Inflamed Tumors

    Active, not recruiting Phase 2 Xiao X. Wei, MD Started 2020Primary completion 2025-07 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

    MSI-H / dMMRHormone Sensitive Prostate Cancer, Prostate Adenocarcinoma, Metastasis Prostate Adenocarcinoma

  46. INFORM2 Study Uses Nivolumab and Entinostat in Children and Adolescents With High-risk Refractory Malignancies

    Recruiting Phase 1/2 University Hospital Heidelberg Started 2020Primary completion 2026-06 NCT03838042

    nivolumab 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…

    MSI-H / dMMRStatus may be outdated, last updated 2024-02-07CNS Tumor, Solid Tumor

  47. Anti-PD-1 mAb Plus Metabolic Modulator in Solid Tumor Malignancies

    Recruiting Phase 2 Dan Zandberg Started 2020Primary completion 2032-04 NCT04114136

    nivolumab FDA EUpembrolizumab 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…

    MSI-H / dMMRMelanoma, NSCLC, Hepatocellular Carcinoma, Urothelial Cancer

  48. Encorafenib, Cetuximab, and Nivolumab in Treating Patients With Microsatellite Stable, BRAFV600E Mutated Unresectable or Metastatic Colorectal Cancer

    Active, not recruiting Phase 1/2 M.D. Anderson Cancer Center Started 2019Primary completion 2027-12 NCT04017650

    cetuximab FDA EUencorafenib FDA EUnivolumab

    Confirmation of BRAFV600E tumor as detected by a CLIA-certified laboratory.

    BRAF V600EBRAF NP_004324.2:p.V600E, Metastatic Colon Adenocarcinoma, Metastatic Microsatellite Stable Colorectal Carcinoma, Metastatic Rectal Adenocarcinoma

  49. Nivolumab in Patients With IDH-Mutant Gliomas With and Without Hypermutator Phenotype

    Active, not recruiting Phase 2 National Cancer Institute (NCI) Started 2019Primary completion 2024-11 NCT03718767

    nivolumab

    Nivolumab in Patients With IDH-Mutant Gliomas With and Without Hypermutator Phenotype

    IDH1/2 mutationGlioma, Glioblastoma, High Grade Glioma, Low Grade Glioma

  50. Nivolumab for Pediatric and Adult Relapsing/Refractory ALK+, for Evaluation of Response in Patients With Progressive Disease (Cohort 1) or as Consolidative Immunotherapy in Patients in Complete Remission After Relapse (Cohort 2)

    Active, not recruiting Phase 2 Gustave Roussy, Cancer Campus, Grand Paris Started 2019Primary completion 2026-04 NCT03703050

    nivolumab

    Histologically confirmed evidence of relapsed/refractory ALK+ ALCL.

    ALK fusionRelapsing/Refractory ALK+ Anaplastic Large Cell Lymphoma

  51. 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 2019Primary completion 2025-10 NCT04006262

    nivolumab FDA EUipilimumab FDA EU

    …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),

    MSI-H / dMMRLocalized Oesogastric Adenocarcimona, MSI and or dMMR

  52. Melanoma Metastasized to the Brain and Steroids

    Recruiting Phase 2 Inge Marie Svane Started 2018Primary completion 2024-06 NCT03563729

    pembrolizumabipilimumabnivolumabencorafenib FDA EUbinimetinib FDA EUdabrafenib FDA EUtrametinib FDA EU

    For arm E specifically: Tumor cells must harbor BRAF mutation.

    BRAF V600EStatus may be outdated, last updated 2023-07-13Malignant Melanoma

  53. Immunotherapy With Ipilimumab and Nivolumab Preceded or Not by a Targeted Therapy With Encorafenib and Binimetinib

    Active, not recruiting Phase 2 European Organisation for Research and Treatment of Cancer - EORTC Started 2018Primary completion 2023-10 NCT03235245

    nivolumabipilimumabencorafenib FDA EUbinimetinib FDA EU

    …te Combination of Immunotherapy in Patients With Unresectable or Metastatic Melanoma With BRAF V600 Mutation : an EORTC Randomized Phase II Study (EBIN)

    BRAF V600EUnresectable Stage III Melanoma, Stage IV Melanoma

  54. A Study of Zolbetuximab (IMAB362) in Adults With Gastric Cancer

    Active, not recruiting Phase 2 Astellas Started 2018Primary completion 2027-06 NCT03505320

    zolbetuximab FDA EUoxaliplatinleucovorinfluorouracilpembrolizumabnivolumabdocetaxel

    Subject's tumor is positive for CLDN18.2 expression demonstrating moderate to strong membranous staining as determined by central …

    Claudin 18.2 expressionPharmacokinetics of Zolbetuximab, Gastric Cancer, Gastro-esophageal Junction (GEJ) Cancer, Pharmacokinetics of Oxaliplatin

  55. 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 2018Primary completion 2027-10 NCT03607890

    nivolumab FDA EUrelatlimab

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

    MSI-H / dMMRRefractory MSI - H Solid Tumors Prior of PD-(L) 1 Therapy, MSI-H Tumors

  56. Study of RP1 Monotherapy and RP1 in Combination With Nivolumab (IGNYTE)

    Active, not recruiting Phase 2 Replimune Started 2017Primary completion 2028-06 NCT03767348

    RP1nivolumab FDA EU

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

    MSI-H / dMMRNon-Small Cell Lung Cancer (NSCLC), Microsatellite Instability-High (MSI-H), Non-melanoma Skin Cancer (NMSC), Cutaneous Melanoma

  57. Neoadjuvant Immune Checkpoint Inhibition and Novel IO Combinations in Early-stage Colon Cancer

    Recruiting Phase 2 The Netherlands Cancer Institute Started 2017Primary completion 2032-03 NCT03026140

    nivolumab FDA EUipilimumab FDA EUCelecoxib 200mgBMS-986253relatlimab

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

    MSI-H / dMMRColon Carcinoma

  58. 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 2017Primary completion 2020-01 NCT03350126

    ipilimumab FDA EUnivolumab FDA EU

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

    MSI-H / dMMRMetastatic Cancer Colorectal

  59. Nivolumab With Trametinib and Dabrafenib, or Encorafenib and Binimetinib in Treating Patients With BRAF Mutated Metastatic or Unresectable Stage III-IV Melanoma

    Active, not recruiting Phase 2 M.D. Anderson Cancer Center Started 2016Primary completion 2027-12 NCT02910700

    binimetinib FDA EUdabrafenib FDA EUencorafenib FDA EUnivolumabtrametinib FDA EU

    … With Trametinib and Dabrafenib, or Encorafenib and Binimetinib in Treating Patients With BRAF Mutated Metastatic or Unresectable Stage III-IV Melanoma

    BRAF V600EMetastatic Malignant Neoplasm in the Brain, Metastatic Melanoma, Stage III Cutaneous Melanoma AJCC v7, Stage IIIA Cutaneous Melanoma AJCC v7

  60. Cisplatin Plus Romidepsin & Nivolumab in Locally Recurrent or Metastatic Triple Negative Breast Cancer (TNBC)

    Active, not recruiting Phase 1/2 Priyanka Sharma Started 2015Primary completion 2026-07 NCT02393794

    Romidepsincisplatinnivolumab

    …of Cisplatin Plus Romidepsin and Nivolumab in Metastatic Triple Negative Breast Cancer or BRCA Mutation-Associated Locally Recurrent or Metastatic Breast Cancer

    BRCA1/2 mutationTriple-Negative Breast Cancer, Breast Cancer

  61. A Study of BMS-986488 as Monotherapy and Combination Therapy in Participants With Advanced Malignant Tumors

    Recruiting Phase 1 Bristol Myers Squibb Started 2025Primary completion 2027-10 NCT06764771

    BMS-986488adagrasib FDA EUcetuximabnivolumab

    i) Part 1B: solid tumors with KRAS G12C mutation.

    KRAS G12CAdvanced Malignant Tumors

  62. Intrathecal Azacitidine and Nivolumab in Patients With Recurrent High-grade Glioma

    Enrolling by invitation Phase 1 Andrew P. Groves Started 2025Primary completion 2028-03 NCT06896110

    nivolumabazacitidine

    …t with at least radiotherapy (and temozolomide in the case of glioblastoma or astrocytoma IDH-mutant (grade 4))

    IDH1/2 mutationGlioblastoma (GBM), Diffuse Midline Glioma (DMG), Astrocytoma, IDH-Mutant, Grade 4, Diffuse Hemispheric Glioma, H3 G34-Mutant

  63. 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 2025Primary completion 2027-10 NCT07376707

    nivolumab FDA EU

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

    MSI-H / dMMRCRC (Colorectal Cancer), Melanoma (Skin Cancer), HCC - Hepatocellular Carcinoma, NSCLC (Non-small Cell Lung Cancer)

  64. Intrathecal Double Checkpoint Inhibition

    Active, not recruiting Phase 1 University of Zurich Started 2022Primary completion 2025-12 NCT05598853

    nivolumabipilimumab

    …ncogenic driver alteration: sensitising Epidermal Growth Factor Receptor (EGFR) mutation (exon 19-del and 21-L858R), anaplastic lymphoma kinase (ALK) or ROS proto-oncogene-1 (ROS1) rearrangem…

    EGFR exon 19 deletion / L858RROS1 fusionLeptomeningeal Metastasis, Non-small Cell Lung Cancer Stage IV, Melanoma Stage IV

  65. KRAS-Targeted Vaccine With Chemoimmunotherapy, Nivolumab and Ipilimumab for Patients With NSCLC

    Recruiting Phase 1 Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Started 2022Primary completion 2027-04 NCT05254184

    nivolumabipilimumabcarboplatinpaclitaxelpemetrexed

    Have one of the KRAS mutations (KRASG12C, KRASG12V, KRASG12D, KRASG12A, KRASG13D or KRASG12R) included in the vaccine at the time …

    KRAS G12CKRAS G12DNon-Small Cell Lung Cancer

  66. Study of TJ033721 (Givastomig) in Subjects With Advanced or Metastatic Solid Tumors

    Recruiting Phase 1 I-Mab Biopharma US Started 2021Primary completion 2026-12 NCT04900818

    TJ033721 (givastomig)nivolumabTJ033721 (givastomig), chemotherapydurvalumab

    Must have CLDN18.2-positive tumor expression

    Claudin 18.2 expressionSolid Tumor, Advanced Cancer, Metastatic Cancer, Gastric Cancer

  67. Pooled Mutant KRAS-Targeted Long Peptide Vaccine Combined With Nivolumab and Ipilimumab for Patients With Resected Mismatch Repair Protein (MMR-p) Colorectal and Pancreatic Cancer

    Active, not recruiting Phase 1 Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Started 2020Primary completion 2027-06 NCT04117087

    KRAS peptide vaccinenivolumabipilimumab

    …ecurrence or distant metastasis noted on imaging \> 12 months after the first dose of the mutant KRAS peptide vaccine with poly-ICLC adjuvant.

    KRAS G12CKRAS G12DColorectal Cancer, Pancreatic Cancer

  68. 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 2019Primary completion 2022-10 NCT03816332

    ipilimumabnivolumabprednisonetacrolimus

    BRAF-mutant melanoma: prior therapies include BRAF/MEK inhibitors

    BRAF V600EMSI-H / dMMRClinical 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

  69. Study of Safety and Efficacy of Ceritinib in Combination With Nivolumab in Patients With ALK-positive Non-small Cell Lung Cancer

    Active, not recruiting Phase 1 Novartis Started 2015Primary completion 2027-04 NCT02393625

    ceritinib FDA EUnivolumab

    Histologically or cytologically confirmed diagnosis of NSCLC that carries an ALK rearrangement

    ALK fusionALK-positive NSCLC

  70. A Study Evaluating the Safety, Pharmacokinetics (PK), and Preliminary Efficacy of ABBV-399 in Participants With Advanced Solid Tumors

    Active, not recruiting Phase 1 AbbVie Started 2014Primary completion 2026-08 NCT02099058

    osimertinib FDA EUnivolumabtelisotuzumab vedotinerlotinib FDA EU

    …ced nonsquamous NSCLC with documented Epidermal Growth Factor Receptor (EGFR) mutation(s) del19 or L858R, with or without T790M mutation, and none of the EGFR mutations known to be resi…

    EGFR exon 19 deletion / L858RAdvanced Solid Tumors Cancer

  71. Adjuvant Therapy Based on Pathologic Response After Neoadjuvant Encorafenib Binimetinib in Melanoma

    Recruiting Early Phase 1 H. Lee Moffitt Cancer Center and Research Institute Started 2021Primary completion 2027-04 NCT04741997

    encorafenib FDA EUbinimetinib FDA EUnivolumab

    Melanoma must have a BRAFV600 mutation (using a CLIA-validated assay), either stage III (B/C/D) or Stage IV (AJCC 8th e…

    BRAF V600EMelanoma Stage III, Melanoma Stage IV, BRAF V600 Mutation

  72. Adaptive BRAF-MEK Inhibitor Therapy for Advanced BRAF Mutant Melanoma

    Active, not recruiting Early Phase 1 H. Lee Moffitt Cancer Center and Research Institute Started 2018Primary completion 2024-12 NCT03543969

    encorafenib FDA EUbinimetinib FDA EUnivolumab

    … must have cytologically or histologically-confirmed unresectable melanoma that harbors a BRAF V600E mutation determined by pyrosequencing assay or equivalent genotyping assay in a Clinical …

    BRAF V600EMelanoma (Skin), Skin Cancer, Skin Melanoma, Skin Carcinoma

  73. Genetic Testing in Screening Patients With Stage IB-IIIA Non-small Cell Lung Cancer That Has Been or Will Be Removed by Surgery (The ALCHEMIST Screening Trial)

    Active, not recruiting No phase National Cancer Institute (NCI) Started 2014Primary completion 2025-12 NCT02194738

    carboplatincisplatincrizotinib FDA EUerlotinibgemcitabinenivolumabpaclitaxelpembrolizumabpemetrexed

    No prior treatment with agents targeting EGFR mutation, ALK rearrangement, and PD-1/PD-L1/CTLA-4

    ALK fusionStage IB Lung Non-Small Cell Carcinoma AJCC v7, Stage II Lung Non-Small Cell Cancer AJCC v7, Stage IIA Lung Cancer AJCC v8, Stage IIB Lung Cancer AJCC v8