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BMS-986416

Phase 1

Advanced Solid Tumors | Small molecule | Oncology |Bristol-Myers Squibb Company|Last Updated: Apr 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
CONTROLLEDBiomarker
Total Trials1
Total Enrollment67
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04943900A Study of BMS-986416 With and Without Nivolumab in Select Solid TumorsPHASE1 COMPLETED 67 — — Aug 9, 2021Feb 27, 2025Apr 9, 202519 United States, Argentina +5
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Study Endpoints
Primary Endpoints
Incidence of Adverse Events (AEs)
Up to 100 days after the last treatment of study intervention(s)
Incidence of Serious Adverse Events (SAEs)
Up to 100 days after the last treatment of study intervention(s)
Incidence of AEs meeting protocol-defined dose-limiting toxicity (DLT) criteria
Up to 100 days after the last treatment of study intervention(s)
Incidence of AEs leading to discontinuation
Up to 100 days after the last treatment of study intervention(s)
Incidence of AEs leading to death
Up to 100 days after the last treatment of study intervention(s)
Protocol-defined maximum tolerated dose (MTD) or maximum administered dose (MAAD)
Up to 100 days after the last treatment of study intervention(s)
Secondary Endpoints
Maximum observed serum concentration (Cmax) of BMS-986416
Up to 100 days after the last treatment of study intervention(s)
Time of maximum observed serum concentration (Tmax) of BMS-986416
Up to 100 days after the last treatment of study intervention(s)
Trough observed serum concentration (Ctrough) of BMS-986416
Up to 100 days after the last treatment of study intervention(s)
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Part 1A: Monotherapy (BMS-986416)EXPERIMENTAL -
Part 1B: Combination Therapy (BMS-986416 + Nivolumab)EXPERIMENTAL -
Interventions
NameTypeDescription
BMS-986416DRUGSpecified dose on specified days
NivolumabDRUGSpecified dose on specified days
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites19

Inclusion Criteria: * Participants with histologically or cytologically confirmed locally advanced unresectable, metastatic, or recurrent select solid tumor * Eligible tumor types Non-small cell lung cancer (NSCLC), Urothelial carcinoma (UC), Squamous cell carcinoma of the head and neck (SCCHN), He...

Countries:United StatesArgentinaBelgiumCanadaChileJapanNetherlands
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Competitive Landscape -Other Solid Tumors 9 trials
CompanyTickerTrialsLead PhaseDrugs
Merck & Co., Inc.MRK2PHASE2pembrolizumab, V503, GARDASIL
Incyte CorporationINCY1PHASE2Chemotherapy, Retifanlimab
Novartis AG Sponsored ADRNVS1PHASE1KFA115, pembrolizumab
Iovance Biotherapeutics IncIOVA2PHASE2E7 TCR-T cells, Aldesleukin
AstraZeneca PLCAZN1 — Trastuzumab deruxtecan
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