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BMS-986310

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment27

FDA Designations

No designations recorded

Clinical trial landscape

BMS-986310 · 1 trial · 1 indication

Phase 1 1
NCT03661632An Investigational Immunotherapy Study of BMS-986310 Administered Alone and in Combination With Nivolumab in Patients With Advanced Solid TumorsAdvanced Cancer
COMPLETED27 Analytics
PHASE1COMPLETED
An Investigational Immunotherapy Study of BMS-986310 Administered Alone and in Combination With Nivolumab in Patients With Advanced Solid Tumors
Advanced CancerUnlock trial analytics

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 to 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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Competitive Landscape -Cancer 5 trials (matched to "Advanced Cancer")

Frequently asked questions about BMS-986310

What is BMS-986310 used for?

BMS-986310 is an investigational small molecule being studied for the treatment of advanced cancer, specifically advanced solid tumors. It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.

Who makes BMS-986310?

BMS-986310 is being developed by Bristol-Myers Squibb Company, a biopharmaceutical company listed on the New York Stock Exchange under the ticker symbol BMY.

What phase is BMS-986310 in?

BMS-986310 is in Phase 1 clinical development. It is an investigational drug and has not been approved for any use. A Phase 1 study of the drug has been completed.

What clinical trials is BMS-986310 in?

BMS-986310 has one completed Phase 1 clinical trial, identified as NCT03661632. This study evaluated the drug administered alone and in combination with nivolumab in patients with advanced solid tumors, enrolling 27 participants in the United States, Belgium, and Canada.

How does BMS-986310 work?

BMS-986310 is a small molecule being investigated as an immunotherapy for advanced cancer. The specific molecular target of BMS-986310 has not been disclosed in available information.