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Nivolumab and rHuPH20

Phase 3

Clear Cell Renal Cell Carcinoma | Monoclonal antibody | Oncology |Bristol-Myers Squibb Company|Last Updated: Oct 9, 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
RandomizedDouble-BlindACTIVE_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment681
FDA Designations
BREAKTHROUGH_THERAPYPRIORITY_REVIEW
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04810078A Study of Subcutaneous Nivolumab Versus Intravenous Nivolumab in Participants With Previously Treated Clear Cell Renal Cell Carcinoma That is Advanced or Has SpreadPHASE3 ACTIVE NOT_RECRUITING 681 — — May 21, 2021May 10, 2027Oct 9, 202589 United States, Argentina +15
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Study Endpoints
Primary Endpoints
Time-averaged serum concentration over 28 days (Cavgd28)
Up to 28 days
Trough serum concentration at steady-state (Cminss)
Up to 4 months
Secondary Endpoints
Objective response rate (ORR) by Blinded Independent Central Review (BICR) with a minimum of 6 months follow-up
Up to 2 years 6 months
Trough serum concentration at day 28 (Cmind28)
At 28 days
Maximum serum concentration after the first dose (Cmax1)
Up to 7 days
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Arm AEXPERIMENTAL -
Arm BACTIVE_COMPARATOR -
Arm CEXPERIMENTAL -
Arm DEXPERIMENTAL -
Interventions
NameTypeDescription
Nivolumab and rHuPH20BIOLOGICALSpecified dose on specified days
NivolumabBIOLOGICALSpecified dose on specified days
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites89

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: * Histological confirmation of renal cell carcinoma (RCC) with a clear cell component, including participants who may also have sarcomatoid features * Advanced...

Countries:United StatesArgentinaBrazilChileCzechiaFinlandFranceIrelandItalyMexicoNew ZealandPolandPortugalRomaniaRussiaSpainTurkey (Türkiye)
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT04810078primaryCompletionDate: changed
LOWMay 24, 2026NCT04810078studyFirstPostDate: changed