Recent Updates
Recently added Catalysts

Nivolumab

Phase 3

Various Advanced Cancer | Monoclonal antibody | Oncology |Bristol-Myers Squibb Company|Last Updated: Feb 17, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials5
Total Enrollment2,693
FDA Designations
BREAKTHROUGH_THERAPYPRIORITY_REVIEW
Clinical Trials (5)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03143153A Study to Evaluate Efficacy in Subjects With Esophageal Cancer Treated With Nivolumab and Ipilimumab or Nivolumab Combined With Fluorouracil Plus Cisplatin Versus Fluorouracil Plus CisplatinPHASE3 COMPLETED 970Jun 29, 2017Jan 13, 2025Feb 17, 2026190 United States, Argentina +25
NCT02632409An Investigational Immuno-therapy Study of Nivolumab, Compared to Placebo, in Patients With Bladder or Upper Urinary Tract Cancer, Following Surgery to Remove the CancerPHASE3 ACTIVE NOT_RECRUITING 709Mar 22, 2016May 27, 2027Oct 16, 2025188 United States, Argentina +28
NCT03130959A Study to Evaluate the Safety and Efficacy of Nivolumab Monotherapy and Nivolumab in Combination With Ipilimumab in Pediatric Participants With High Grade Primary Central Nervous System (CNS) MalignanciesPHASE2 COMPLETED 166Jun 12, 2017Jan 17, 2022Aug 9, 202254 United States, Australia +13
NCT02387996A Study of Nivolumab in Participants With Metastatic or Unresectable Bladder CancerPHASE2 COMPLETED 270Mar 9, 2015Nov 12, 2021Nov 1, 202267 United States, Australia +9
NCT02488759An Investigational Immuno-therapy Study to Investigate the Safety and Effectiveness of Nivolumab, and Nivolumab Combination Therapy in Virus-associated TumorsPHASE1 COMPLETED 578Oct 13, 2015Oct 24, 2022Nov 13, 202340 United States, Belgium +9
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Overall Survival (OS) in Participants With Tumor Cell PD-L1
From the date of randomization to up to the date of death (up to approximately 20 months)

Overall Survival (OS) is defined as the time between the date of randomization and the date of death. For participants without documentation of death, OS will be censored on the last date the subject was known to be alive.

Progression-free Survival (PFS) as Assessed by BICR in Participants With Tumor Cell PD-L1
From the date of randomization to up to the date of the first documented disease progression or death (up to approximately 9 months)

Progression-free survival (PFS) is defined as the time from randomization to the date of the first documented progressive disease (PD) per Blinded Independent Central Review (BICR) or death due to any cause. Participants who die without a reported prior PD per BICR (and die without start of subsequent therapy) will be considered to have progressed on the date of death. Participants who did not have documented PD per BICR per RECIST1.1 criteria and who did not die, will be censored at the date of the last evaluable tumor assessment on or prior to initiation of the subsequent anti-cancer therapy. Participants who did not have any on-study tumor assessments and did not die (or died after initiation of the subsequent anti-cancer therapy) will be censored at the randomization date. Participants who started any subsequent anti-cancer therapy without a prior reported PD per BICR will be censored at the last tumor assessment on or prior to initiation of the subsequent anti-cancer therapy.

Disease Free Survival (DFS)
approximately up to 48 months

The time between the date of randomization and the date of first documented recurrence (local urothelial tract, local non-urothelial tract or distant), or death due to any cause, whichever occurs first.

Disease Free Survival (DFS) in PD-L1 Expression ≥ 1% Population
approximately up to 48 months

The time between the date of randomization and the date of first documented recurrence (local urothelial tract, local non-urothelial tract or distant), or death due to any cause, whichever occurs first.

Number of Safety Lead-In Participants With Dose Limiting Toxicities (DLTs)
up to 6 weeks post-dosing

A dose-limiting toxicity (DLT) is defined as a drug-related AE occurring in the first 6 weeks of study treatment. A participant was considered evaluable for a DLT if study treatment was delayed \> 2 weeks or was discontinued due to a related Adverse Event (AE), or if planned study treatment (3 doses of nivolumab in Module A, 2 doses of nivolumab plus ipilimumab in Module B) was administered and safety evaluation after 6 weeks on study is available to the study steering committee (SSC).

Number of Safety Lead-In Participants With Serious Adverse Events (SAEs)
up to 6 weeks post-dosing

The number of Safety Lead-In Participants who experienced a Serious Adverse Event (SAE) during the course of the study.

Number of Safety Lead-In Participants With Adverse Events (AEs) Leading to Discontinuation
From first dose to 30 days post-last dose (up to approximately 6 weeks)

The number of Safety Lead-In Participants who experienced an Adverse Event (AE) during the course of the study that lead to discontinuation of study therapy.

Overall Survival (OS), Cohort 1 Only
up to approximately 42 months

Overall survival (OS) is defined as the time between the date of diagnosis and the date of death in Cohort 1.

Progression-Free Survival (PFS), Cohorts 2-4
up to approximately 42 months

Progression-free survival (PFS) is defined as the time from first dose to the date of the first documented tumor progression or death due to any cause.

Progression-Free Survival (PFS), Cohort 5 Only
up to approximately 42 months

Progression-free survival (PFS) is defined as the time from first dose to the date of the first documented tumor progression or death due to any cause.

Objective Response Rate Per BIRC Assessment
From the date of first dose to the date of objectively documented progression or the date of subsequent therapy, whichever occurs first (assessed up to 14 months)

Objective Response Rate (ORR) was defined as the number of participants with a best overall response of confirmed Complete Response (CR) or Partial Response (PR) (per RECIST 1.1 criteria) divided by the number of all treated participants. RECIST 1.1 = Response Evaluation Criteria in Solid Tumors. CR= Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. PR= At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. BIRC= blinded independent review committee

ORR Per BIRC Assessment by PD-L1 Expression Level
From the date of first dose to the date of objectively documented progression or the date of subsequent therapy, whichever occurs first (assessed up to 14 months)

Objective Response Rate (ORR) was defined as the number of participants with a best overall response of confirmed Complete Response (CR) or Partial Response (PR) (per RECIST 1.1 criteria) divided by the number of all treated participants. RECIST 1.1 = Response Evaluation Criteria in Solid Tumors. CR= Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. PR= At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. BIRC= blinded independent review committee PD-L1 expression level= membranous staining in greater than or equal to 5% and greater than or equal to 1% tumor cells. n = Number of participants in each category

Time to Response (TTR)
From first dosing date to the date of the first confirmed response (up to approximately 14 months)

TTR is defined as the time from first dosing date to the date of the first confirmed complete response (CR) or partial response (PR), as assessed by the Blinded Independent Review Committee (BIRC). Complete response is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. Partial response is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

Duration of Response (DOR)
From the first confirmed response to the date of the first documented tumor progression or death due to any cause, whichever occurs first (up to approximately 14 months)

DOR is defined as the time from first confirmed response, complete response (CR) or partial response (PR) to the date of the first documented tumor progression as determined using RECIST 1.1 criteria or death due to any cause, whichever occurs first. Participants who start subsequent therapy without a prior reported progression will be censored at the last evaluable tumor assessments prior to initiation of the subsequent anticancer therapy. Participants who die without a reported prior progression will be considered to have progressed on the date of their death. Participants who neither progress nor die will be censored on the date of their last evaluable tumor assessment.

Neoadjuvant: Number of Participants With Drug-Related Select Adverse Events (AEs)
From first dose to 30 days post last dose (Up to 2 months)

Number of participants with any grade of drug-related select adverse events (AEs) including endocrine, gastrointestinal, hepatic, pulmonary, renal, skin, and hypersensitivity AEs in Neoadjuvant cohort

Neoadjuvant: Number of Participants With Drug-Related Serious Adverse Events (SAEs)
From first dose to 30 days post last dose (Up to 2 months)

Number of participants with any grade of drug-related serious adverse events (SAEs) in Neoadjuvant cohort

Neoadjuvant: Rate of Surgery Delay
Day 29

Rate of surgery delay is defined as the percentage of participants in the neoadjuvant cohort with surgery delayed \> 4 weeks from the planned surgery date or planned start date for chemoradiation due to a drug-related adverse event. Participants with the following diseases will be assessed: 1. HPV positive squamous cell carcinoma of the Head and Neck (SCCHN); 2. HPV negative SCCHN; 3. Cervical Carcinoma; 4. Vaginal/Vulvar Carcinoma; 5. Merkel Cell Carcinoma

Metastatic: Investigator-Assessed Objective Response Rate (ORR)
From the date of first dose to the date of the initial objectively documented tumor progression or the date of the last tumor assessment prior to subsequent therapy (Up to 65 months)

Objective response rate (ORR) is defined as the percentage of participants with a best overall response (BOR) of confirmed complete response (CR) or partial response (PR) using RECIST 1.1 criteria. An ORR in excess of 10% will be considered of clinical interest, and an ORR of 25% or greater will be considered of strong clinical interest. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Participants with the following diseases will be assessed: 1. EBV positive related gastric cancer; 2. HPV positive SCCHN; 3. Other anogenital HPV associated cancers; 4. GYN (Cervical, Vaginal, Vulvar) carcinoma; 5. Merkel cell carcinoma (MCC); 6. Nasopharyngeal carcinoma (NPC)

Secondary Endpoints
Overall Survival (OS) in All Randomized Participants
From the date of randomization to up to the date of death (up to approximately 88 months)
Progression-free Survival (PFS) in All Randomized Participants as Assessed by BICR
From the date of randomization to up to the date of the first documented disease progression or death (up to approximately 88 months)
Objective Response Rate (ORR) as Assessed by BICR
From the date of randomization to up to the date of objectively documented progression or the date of subsequent anti-cancer therapy, whichever occurs first (up to 88 months)
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Nivolumab + IpilimumabEXPERIMENTAL -
Nivolumab + Cisplatin + FluorouacilEXPERIMENTAL -
Cisplatin + FluorouracilACTIVE_COMPARATOR -
NivolumabEXPERIMENTALNivolumab dose as specified
PlaceboPLACEBO_COMPARATORPlacebo dose as specified
Module AEXPERIMENTAL -
Module BEXPERIMENTAL -
Neoadjuvant CohortEXPERIMENTALNivolumab intravenous infusion as specified \*\*Not participating: Japan, Korea, and Taiwan
Metastatic Monotherapy CohortEXPERIMENTALNivolumab intravenous infusion as specified
Nivolumab plus Ipilimumab CohortEXPERIMENTALNivolumab intravenous infusion as specified with Ipilimumab intravenous infusion as specified \*\*Not participating: Belgium, France and Germany Cohort expansion participating countries: Spain, US, UK, Netherlands, Japan and Mexico \*\*Not participating in cohort expansion: France, Germany, Korea and Taiwan
Nivolumab plus Relatlimab CohortEXPERIMENTALNivolumab intravenous infusion as specified with Relatlimab intravenous infusion as specified \*\* Not Participating: Belgium, Germany, France, Japan, Korea, Taiwan, UK, and Netherlands Enrollment is closed for this cohort
Nivolumab plus Daratumumab CohortEXPERIMENTALNivolumab intravenous infusion as specified with Daratumumab intravenous infusion as specified \*\*Not Participating: Belgium, Germany, France, Japan, Korea, Taiwan, UK, and Netherlands Enrollment is closed for this cohort
Interventions
NameTypeDescription
NivolumabBIOLOGICALSpecified dose on specified days
IpilimumabBIOLOGICALSpecified dose on specified days
CisplatinDRUGSpecified dose on specified days
FluorouracilDRUGSpecified dose on specified days
PlaceboOTHER -
RelatlimabDRUG -
DaratumumabDRUG -
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites190

Inclusion Criteria: * Must have histologically confirmed squamous cell carcinoma or adenosquamous cell carcinoma of esophagus * Male or Female at least 18 years of age * Must have esophageal cancer that cannot be operated on, or treated with definitive chemoradiation with curative intent, that is a...

Countries:United StatesArgentinaAustraliaAustriaBrazilCanadaChileChinaColombiaCzechiaDenmarkFranceHong KongItalyJapanMexicoPeruPolandPortugalRomaniaRussiaSingaporeSouth KoreaSpainTaiwanTurkey (Türkiye)United KingdomBelgiumGermanyGreeceIrelandIsraelNetherlandsSwedenSwitzerlandNorwayFinland
Unlock Eligibility Criteria
Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT02632409primaryCompletionDate: changed
LOWMay 24, 2026NCT02632409studyFirstPostDate: changed