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BMS-986156

Phase 1

Solid Tumors | Small molecule | Oncology |Bristol-Myers Squibb Company|Last Updated: Mar 6, 2023

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 Enrollment295
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02598960An Investigational Immuno-therapy Study of Experimental Medication BMS-986156, Given by Itself or in Combination With Nivolumab in Patients With Solid Cancers or Cancers That Have Spread.PHASE1 COMPLETED 295 — — Oct 14, 2015Dec 16, 2019Mar 6, 202327 United States, Australia +8
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Study Endpoints
Primary Endpoints
Number of Participants With All Cause Adverse Events (AEs), Serious Adverse Events, AEs Leading to Discontinuation and Deaths
From first treatment to 100 days post last dose. Approximately 29 months

Number of participants with all cause adverse events (AEs), serious adverse events (SAEs), adverse events leading to discontinuation, and number of participant deaths. AEs and laboratory values will be graded according to the NCI CTCAE version 4.03.

Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests
From first treatment to 100 days post last dose. Approximately 29 months

Number of Participants with laboratory abnormalities in specific thyroid tests. TSH = Thyroid stimulating hormone ULN = Upper limit number LLN = Lower limit number

Number of Participants With Laboratory Abnormalities in Specific Liver Tests
From first treatment to 100 days post last dose. Approximately 29 months

Number of Participants with laboratory abnormalities in specific liver tests. ALT = alanine aminotransferase AST = aspartate aminotransferase ALP = alkaline phosphatase

Secondary Endpoints
Best Overall Response
From first dose to a response or progressive disease (Approximately 50 Months)
Overall Response Rate
From first dose to CR and PR (Approximately 50 Months)
Progression Free Survival (PFS)
From first dose to disease progression (Approximately 50 Months)
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
BMS-986156: Dose EscalationEXPERIMENTAL -
BMS-986156 + nivolumab (nivo): Dose EscalationEXPERIMENTAL -
BMS-986156: Dose ExpansionEXPERIMENTAL -
BMS-986156 + nivolumab (nivo): Dose ExpansionEXPERIMENTAL -
BMS986156 + Nivo: Cohort ExpansionEXPERIMENTAL -
Interventions
NameTypeDescription
BMS-986156DRUG -
NivolumabDRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites27

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: * For Dose Escalation: * Subjects with any previously treated advanced (metastatic or refractory) solid tumor * For Cohort Expansion: * Subjects must have a previously tr...

Countries:United StatesAustraliaBelgiumCanadaFranceGermanyItalyNetherlandsSpainSwitzerland
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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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