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BMS-986527

Phase 1

Clear Cell Renal Cell Carcinoma (ccRCC) | Small molecule | Oncology |Bristol-Myers Squibb Company|Last Updated: Sep 30, 2026

Development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Sep 2026

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment112

FDA Designations

No designations recorded

Clinical trial landscape

BMS-986527 · 1 trial · 1 indication

Phase 1 1
NCT07848295A Study to Assess the Safety and Tolerability of BMS-986527 in Participants With Clear Cell Renal Cell Carcinoma (ccRCC)Clear Cell Renal Cell Carcinoma (ccRCC)
NOT YET_RECRUITING112 Analytics
PHASE1NOT YET_RECRUITING
A Study to Assess the Safety and Tolerability of BMS-986527 in Participants With Clear Cell Renal Cell Carcinoma (ccRCC)
Clear Cell Renal Cell Carcinoma (ccRCC)Unlock trial analytics

Study Endpoints

Primary Endpoints

Incidence of adverse events (AEs)
Up to 2 years
Incidence of serious adverse events (SAEs)
Up to 2 years
Incidence of AEs meeting protocol-defined dose-limiting toxicity (DLT) criteria
Up to 2 years
Incidence of AEs leading to discontinuation
Up to 2 years
Number of deaths
Up to 2 years

Secondary Endpoints

Overall response rate (ORR)
Up to 2 years
Complete response rate (CRR)
Up to 2 years
Disease control rate (DCR)
Up to 2 years
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Cohort 1: BMS-986527 monotherapyEXPERIMENTAL -
Cohort 2: BMS-986527 with NivolumabEXPERIMENTAL -
Cohort 3: BMS-986527 with CabozantinibEXPERIMENTAL -

Interventions

NameTypeDescription
BMS-986527DRUGSpecified dose on specified days
NivolumabDRUGSpecified dose on specified days
CabozantinibDRUGSpecified dose on specified days
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites17

Inclusion Criteria * Participants must have a histologically confirmed diagnosis of a locally advanced and unresectable or metastatic renal cell carcinoma (RCC) with clear cell component. * Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Participa...

Countries:United StatesBelgiumFranceGermanyItalyNetherlandsSpain
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Recent Changes (Last 90 Days)

LOWSep 30, 2026NCT07848295NEW_TRIAL: changed
LOWSep 30, 2026NCT07848295NEW_TRIAL: changed

Frequently asked questions about BMS-986527

What is BMS-986527?

BMS-986527 is an investigational small molecule being developed by Bristol-Myers Squibb for the treatment of clear cell renal cell carcinoma (ccRCC), the most common form of kidney cancer. It is currently in Phase 1 clinical development and has not been approved by the FDA.

What is BMS-986527 used for in ccRCC?

BMS-986527 is being studied for use in clear cell renal cell carcinoma (ccRCC), a type of kidney cancer. It is an investigational therapy in Phase 1 testing, so its use is currently limited to clinical trial participants rather than routine clinical practice.

Who makes BMS-986527?

Bristol-Myers Squibb Company, which trades on the New York Stock Exchange under the ticker BMY, is the developer of BMS-986527. The company is sponsoring the clinical program evaluating the small molecule in clear cell renal cell carcinoma.

What phase is BMS-986527 in?

BMS-986527 is in Phase 1 clinical development. It is an investigational small molecule and has not received FDA approval. The Phase 1 program is designed to assess safety and tolerability in participants with clear cell renal cell carcinoma.

What clinical trials is BMS-986527 in?

BMS-986527 is being evaluated in one clinical trial, NCT07848295, titled A Study to Assess the Safety and Tolerability of BMS-986527 in Participants With Clear Cell Renal Cell Carcinoma (ccRCC). The Phase 1 study is not yet recruiting and plans to enroll 112 participants across the United States, Belgium, France, Germany, Italy, Netherlands, and Spain.

Who can enroll in the BMS-986527 trial?

The Phase 1 trial NCT07848295 enrolls adults 18 years and older of any sex who have clear cell renal cell carcinoma. It does not enroll healthy volunteers. The study is controlled, is not randomized, and is not double blinded, and it plans to enroll 112 participants across seven countries.