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Ipilimumab

Phase 3

Metastatic Colorectal Cancer | Monoclonal antibody | Oncology |Bristol-Myers Squibb Company|Last Updated: Oct 3, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedACTIVE_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment839
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04008030A 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)PHASE3 ACTIVE NOT_RECRUITING 839 — — Aug 5, 2019Jun 10, 2026Oct 3, 2025157 United States, Argentina +22
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Study Endpoints
Primary Endpoints
Progression-free Survival (PFS) by Blinded Independent Review Center (BICR) - Arm B vs. Arm A All Lines Centrally Confirmed MSI-H/dMMR
From date of randomization to the date of first objectively documented disease progression or death due to any cause, whichever occurs first (Up to approximately 60 months)

BICR-assessed Progression-free survival (PFS) is defined as the time from the randomization date to the date of first objectively documented disease progression per RECIST 1.1 (i.e, radiologic) or death due to any cause, whichever occurs first.

Progression-free Survival (PFS) by Blinded Independent Review Center (BICR) - Arm B vs. Arm C 1L Participants Centrally Confirmed MSI-H/dMMR
From date of randomization to the date of first objectively documented disease progression or death due to any cause, whichever occurs first (Up to approximately 32 months)

BICR-assessed Progression-free survival (PFS) is defined as the time from the randomization date to the date of first objectively documented disease progression per RECIST 1.1 (i.e, radiologic) or death due to any cause, whichever occurs first.

Secondary Endpoints
Progression-free Survival (PFS) by Blinded Independent Review Center (BICR) - 1L Participants
From date of randomization to the date of first objectively documented disease progression or death due to any cause, whichever occurs first
Progression-free Survival (PFS) by Blinded Independent Review Center (BICR) - Arm B vs. Arm A All Randomized Participants
From date of randomization to the date of first objectively documented disease progression or death due to any cause, whichever occurs first (Up to approximately 60 months)
Progression-free Survival (PFS) by Blinded Independent Review Center (BICR) - 1L Randomized Participants
From date of randomization to the date of first objectively documented disease progression or death due to any cause, whichever occurs first (Up to approximately 60 months)
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Arm A: Nivolumab MonotherapyEXPERIMENTAL -
Arm B: Nivolumab + Ipilimumab CombinationEXPERIMENTAL -
Arm C: Investigator's Choice ChemotherapyACTIVE_COMPARATORParticipants in Arm C would be allowed to receive Nivolumab + Ipilimumab if they progress
Interventions
NameTypeDescription
IpilimumabBIOLOGICALSpecified dose on specified days
OxaliplatinDRUGSpecified dose on specified days
LeucovorinDRUGSpecified dose on specified days
FluorouracilDRUGSpecified dose on specified days
IrinotecanDRUGSpecified dose on specified days
BevacizumabDRUGSpecified dose on specified days
CetuximabDRUGSpecified dose on specified days
NivolumabBIOLOGICALSpecified dose on specified days
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites157

Inclusion Criteria: * Histologically confirmed recurrent or metastatic colorectal cancer (CRC) irrespective of prior treatment history with chemotherapy and/or targeted agents not amenable to surgery (Applicable only during Part 1 enrollment of the study) * Histologically confirmed recurrent or met...

Countries:United StatesArgentinaAustraliaAustriaBelgiumBrazilCanadaChileChinaCzechiaDenmarkFranceGermanyGreeceIrelandItalyJapanNetherlandsNorwayPuerto RicoRomaniaSpainTurkey (Türkiye)United Kingdom
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Competitive Landscape -Colorectal Cancer 263 trials
CompanyTickerTrialsLead PhaseDrugs
AbbVie, Inc.ABBV8PHASE3Telisotuzumab Adizutecan, Telisotuzumab adizutecan, Bevacizumab, Trifluridine/Tipiracil, ABBV-400
Bristol-Myers Squibb CompanyBMY7PHASE3Ipilimumab, Oxaliplatin, Leucovorin, Fluorouracil, Irinotecan
Merck & Co., Inc.MRK6PHASE3Pembrolizumab, Oxaliplatin, Leucovorin, 5-fluorouracil, Irinotecan
Johnson & JohnsonJNJ5PHASE3Amivantamab, Cetuximab, 5-fluorouracil, Leucovorin calcium/Levoleucovorin, Oxaliplatin
Pfizer Inc.PFE12PHASE3PF-08634404, Bevacizumab, Chemotherapy, tucatinib, trastuzumab
GSK plc Sponsored ADRGSK6PHASE3Dostarlimab, CAPEOX, FOLFOX, GSK4418959, PD-1 inhibitor
Exelixis, Inc.EXEL5PHASE3XL092, Atezolizumab, Regorafenib, cabozantinib, atezolizumab
Summit Therapeutics IncSMMT3PHASE3Drug: Ivonescimab, Drug: Bevacizumab, AK112, AK117, Oxaliplatin
Natera, Inc.NTRA4PHASE3Capecitabine, Oxaliplatin, Folfirinox, FOLFOX regimen
Agenus Inc.AGEN4PHASE3Balstilimab, Botensilimab, CR6086, AGEN2034
Incyte CorporationINCY2PHASE3INCA33890, Bevacizumab, FOLFOX, Ruxolitinib, Capecitabine
Amgen Inc.AMGN1PHASE3FOLFIRI Regimen, Sotorasib, Panitumumab, Bevacizumab-awwb
Eli Lilly and CompanyLLY8PHASE2LY2157299, Capecitabine, Fluorouracil, LY4066434., Cetuximab
AstraZeneca PLCAZN8PHASE2Datopotamab deruxtecan, Capecitabine, 5-Fluorouracil, Volrustomig, Carboplatin
Takeda Pharmaceutical Co. Ltd. Sponsored ADRTAK5PHASE2fruquintinib, FOLFIRI, oxaliplatin , levofolinate calcium , 5-FU, panitumumab, mFOLFOX6 + panitumumab combination therapy
Novartis AG Sponsored ADRNVS7PHASE2Dabrafenib, Trametinib, JDQ443, TNO155, tislelizumab
BioNTech SE Sponsored ADRBNTX3PHASE2RO7198457, PM8002, Chemotherapy Regimen 1, BNT314, BNT327
Regeneron Pharmaceuticals, Inc.REGN2PHASE2Cemiplimab + Fianlimab, VV1, Cemiplimab
Revolution Medicines, Inc.RVMD7PHASE1RMC-6291, Elironrasib, Daraxonrasib, RMC-9805, RMC-6236
Veracyte, Inc.VCYT1PHASE3Tislelizumab
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT04008030primaryCompletionDate: changed
LOWMay 24, 2026NCT04008030studyFirstPostDate: changed