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BMS-986179

Phase 1

Malignant Solid Tumor | Monoclonal antibody | Oncology |Bristol-Myers Squibb Company|Last Updated: Apr 5, 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
CONTROLLED
Total Trials1
Total Enrollment235
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02754141An Investigational Immuno-therapy Study of Experimental Medication BMS-986179 Given Alone and in Combination With NivolumabPHASE1 COMPLETED 235 — — Jun 21, 2016Oct 12, 2021Apr 5, 202324 United States, Australia +5
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Study Endpoints
Primary Endpoints
Number of Participants With Drug Related AEs, SAEs, AEs Leading to Discontinuation and Deaths.
From first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months.

Number of participants with drug related adverse events (AE), drug related serious adverse events (SAE), drug related AEs Leading to discontinuation and drug related deaths

Secondary Endpoints
Number of Participants With a Best Overall Response (BOR) at Week 24
from initial treatment to week 24
Percentage of Participants With an Objective Response Rate (ORR) at Week 24
from initial treatment to week 24
Progression Free Survival Rate (PFSR) at Week 24
from initial treatment to week 24
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Arm A-MonotherapyEXPERIMENTALBMS-986179, dose as specified
Arm B- Combination TherapyEXPERIMENTALBMS-986179 + nivolumab, dose as specified
Arm C-Combination TherapyEXPERIMENTALBMS-986179 + rHuPH20, dose as specified
Interventions
NameTypeDescription
BMS-986179BIOLOGICALSpecified dose on specified days
NivolumabBIOLOGICALSpecified dose on specified days
rHuPH20BIOLOGICALSpecified dose on specified days
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites24

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: * Solid cancers that are advanced or have spread (for which alternative therapies were deemed not effective) * Eastern Cooperative Oncology Group (ECOG) 0-1 * ...

Countries:United StatesAustraliaCanadaFranceGermanyItalyNetherlands
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