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BMS-986310

Phase 1

Advanced Cancer | Small molecule | Oncology |Bristol-Myers Squibb Company|Last Updated: Nov 8, 2021

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 Enrollment27
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03661632An Investigational Immunotherapy Study of BMS-986310 Administered Alone and in Combination With Nivolumab in Patients With Advanced Solid TumorsPHASE1 COMPLETED 27Sep 11, 2018Dec 29, 2020Nov 8, 20217 United States, Belgium +1
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Study Endpoints
Primary Endpoints
Incidence of Adverse Events (AE)
up to 3 years
Incidence of Serious Adverse Events (SAE)
up to 3 years
Incidence of AEs meeting protocol-defined dose-limiting toxicity (DLT) criteria
up to 3 years
Incidence of AEs leading to dose delays and discontinuation or delay in radical cystectomy (RC)
up to 3 years
Incidence of Laboratory abnormalities
up to 3 years
Incidence of death
up to 3 years
Secondary Endpoints
Objective response rate (ORR)
up to 3 years
Median duration of response (mDOR)
up to 3 years
Progression free survival rate (PFSR)
up to 24 months
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Dose EscalationEXPERIMENTALPart 1: BMS-986310 + Nivolumab Combination Dose Escalation Sub-Study A: A cohort of Cisplatin Ineligible Muscle Invasive Bladder Cancer patients will receive either monotherapy BMS-986310, or BMS-986310 + Nivolumab, or Nivolumab monotherapy. Sub-Study B: A cohort of PD\[L\]1 relapsed / refractory tumor cancer patients will be treated with monotherapy BMS-986310 followed by BMS-986310 + nivolumab
Cohort ExpansionEXPERIMENTALPart 2: Cohort Expansion will initiate upon consideration of the totality of data from Part 1. BMS-986310 + Nivolumab combination will be administered in specific patient populations.
Interventions
NameTypeDescription
BMS-986310DRUGSpecified dose on specified days
NivolumabBIOLOGICALSpecified dose on specified days
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites7

Inclusion Criteria: * Patients with measurable disease per RECIST v1.1 and have at least one lesion accessible for biopsy. * ECOG performance status less than or equal to 1 Part 1 and Sub-study B: i) Part 1 participants must have advanced or metastatic disease where no other standard of care trea...

Countries:United StatesBelgiumCanada
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