marked.bio

anti-CTLA-4 antibody · antibody

ipilimumab

34 active trials across 12 of our biomarkers, targeting CTLA-4. 4 active approvals for a biomarker on marked.bio.

Also known as MDX-010, BMS-734016, Yervoy.

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
Opdivonivolumab 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

Biomarkers

BiomarkerActive trialsAll trialsFurthest active phase
MSI-H / dMMR 16 22 Phase 3
BRAF V600E 7 20 Phase 3
EGFR exon 19 deletion / L858R 4 8 Phase 1/2
KRAS G12C 4 5 Phase 1/2
KRAS G12D 3 4 Phase 1
BRCA1/2 mutation 2 2 Phase 1/2
ROS1 fusion 2 4 Phase 3
IDH1/2 mutation 1 2 Phase 2
RET fusion or mutation 1 2 Phase 3
ALK fusion 0 3 –
FLT3 mutation (ITD/TKD) 0 1 –
MET exon 14 skipping 0 1 –

Sponsors

Industry sponsors leading active biomarker-selected trials of ipilimumab.

  1. Vivace Therapeutics 1
  2. Orion Pharma 1
  3. Scancell 1
  4. Bristol Myers Squibb 1
  5. 7 Hills Pharma 1
  6. Sanofi 1
  7. MabQuest 1

Trials

34 of 62 trials shown

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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)

  6. A Phase II Study of Sintilimab Combined With Ipilimumab N01, Cetuximab and Dabrafenib in Patients With Microsatellite-Stable, BRAF V600E-Mutated Metastatic Colorectal Cancer

    Recruiting Phase 2 Tianjin Medical University Cancer Institute and Hospital Started 2026Primary completion 2027-12 NCT07506109

    ipilimumabsintilimabcetuximab FDA EUdabrafenib FDA EU

    Documented microsatellite stable (MSS) and BRAF V600E mutation by prior genomic testing.

    BRAF V600EBRAF V600E, Colorectal Cancer, Sintilimab, MSS (Microsatellite Stable)

  7. 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)

  8. 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 2026Primary completion 2028-10 NCT07878221

    ipilimumab FDA EUsintilimab

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

    MSI-H / dMMRGastric / Gastroesophageal Junction Adenocarcinoma

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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

  18. 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

  19. 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

  20. 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

  21. 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

  22. 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

  23. 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

  24. 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

  25. 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

  26. 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

  27. Personalized Vaccine Immunotherapy in Combination With Checkpoint Inhibitor for Treatment of Triple Negative Breast Cancer

    Recruiting Phase 1 Emory University Started 2025Primary completion 2026-12 NCT06324240

    ipilimumabpembrolizumabVaccine Therapy

    Patients who have a germline BRCA 1/2 mutation that meet the Food and Drug Administration (FDA) indication for use of adjuvant Olaparib …

    BRCA1/2 mutationAnatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8, Anatomic Stage IB Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8

  28. MAQ-001 in Patients With Advanced Solid Tumors

    Recruiting Phase 1 MabQuest Started 2024Primary completion 2026-06 NCT06514651

    MAQ-001ipilimumab FDA EU

    …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…

    MSI-H / dMMRStatus may be outdated, last updated 2024-07-23Advanced Solid Tumor

  29. CAR-DC Vaccine and ICIs in Local Advanced/Metastatic Solid Tumors

    Active, not recruiting Phase 1 Chinese PLA General Hospital Started 2023Primary completion 2026-06 NCT05631899

    KRAS-EphA-2-CAR-DCnab-paclitaxelcyclophosphamideAnti-PD-1 antibodyipilimumab

    …logy with documentation of tumor EphA2 positive (≥20%) and KRAS mutation (G12V or G12D or G12C) within 6 months prior to screening.

    KRAS G12CKRAS G12DSolid Tumor, Adult, EphA2 Overexpression, KRAS G12V, KRAS G12C

  30. 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

  31. 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

  32. Safety and Efficacy of Combination Osimertinib and Ipilimumab in Patients w EGFR Mutated NSCLC

    Active, not recruiting Phase 1 University of Utah Started 2020Primary completion 2024-01 NCT04141644

    ipilimumabosimertinib FDA EU

    Safety and Efficacy of Combination Osimertinib and Ipilimumab in Patients w EGFR Mutated NSCLC

    EGFR exon 19 deletion / L858RNon-Small Cell Lung Cancer With Mutation in Epidermal Growth Factor Receptor (Disorder)

  33. 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

  34. 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