A Study to Assess the Safety and Tolerability of BMS-986527 in Participants With Clear Cell Renal Cell Carcinoma (ccRCC)

NCT07848295 | Not Yet Recruiting Phase 1 FDA Drug

• 4 other identifiers: CA259-00012025-522761-29U1111-1324-21072025
• Study Type: interventional
• Target: 112
• Locations: 7 countries
• Sites: 17

Brief Summary

The purpose of this study is to assess the safety and tolerability of BMS-986527 in participants with Clear Cell Renal Cell Carcinoma (ccRCC)

Conditions

Clear Cell Renal Cell Carcinoma (ccRCC)

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (11)

• Overall response rate (ORR)

  Up to 2 years

• Complete response rate (CRR)

  Up to 2 years

• Disease control rate (DCR)

  Up to 2 years

• Duration of response (DOR)

  Up to 2 years

• Progression-free survival (PFS)

  Up to 2 years

Study Arms (3)

Cohort 1: BMS-986527 monotherapy

EXPERIMENTAL

Drug: BMS-986527

Cohort 2: BMS-986527 with Nivolumab

EXPERIMENTAL

Drug: BMS-986527; Drug: Nivolumab

Cohort 3: BMS-986527 with Cabozantinib

EXPERIMENTAL

Drug: BMS-986527; Drug: Cabozantinib

Interventions

BMS-986527 DRUG

Specified dose on specified days

Cohort 1: BMS-986527 monotherapy; Cohort 2: BMS-986527 with Nivolumab; Cohort 3: BMS-986527 with Cabozantinib

Nivolumab DRUG

Specified dose on specified days

Also known as: Opdivo

Cohort 2: BMS-986527 with Nivolumab

Cabozantinib DRUG

Specified dose on specified days

Also known as: CABOMETYX

Cohort 3: BMS-986527 with Cabozantinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Participants must have measurable disease as assessed by the Investigator using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).
• For Cohorts 1 and 2, participants should have previously received, be refractory to, ineligible for, or intolerant of standard of care (SoC) immunotherapy (IO) and/or tyrosine kinase inhibitors (TKIs). Participants in Cohort 3 should have previously received, be refractory to, ineligible for, or intolerant of SoC IO, but those who have not been previously exposed to SoC TKI agents are permitted.

You may not qualify if:

• Participants must not have prior history of malignancies (other than clear cell renal cell carcinoma (ccRCC)) or lymphoproliferative disease, unless the participant has been free of the disease for ≥ 2 years.
• For Cohort 2 only: has relapsed or is refractory within 12 months of the most recent IO therapy.
• For Cohort 3 only: use of strong inhibitor and inducers of CYP3A4, and P-glycoprotein (P-gp) substrates within 14 days or 5 half-lives (whichever is longer) of start of TKI.

Sponsors & Collaborators

• Juno Therapeutics, Inc., a Bristol-Myers Squibb Company: lead
• Bristol-Myers Squibb: collaborator

Study Sites (17)

Local Institution - 0018

New Haven, Connecticut, 06510, United States

Location

Local Institution - 0022

Basking Ridge, New Jersey, 07920, United States

Location

Local Institution - 0024

New York, New York, 10027, United States

Location

Local Institution - 0017

Cleveland, Ohio, 44195, United States

Location

Local Institution - 0019

Houston, Texas, 77030, United States

Location

Local Institution - 0026

Seattle, Washington, 98109-1024, United States

Location

Local Institution - 0004

Ghent, Oost-Vlaanderen, 9000, Belgium

Location

Local Institution - 0003

Leuven, 3000, Belgium

Location

Local Institution - 0007

Villejuif, Val-de-Marne, 94800, France

Location

Local Institution - 0014

Marseille, 13273, France

Location

Local Institution - 0005

Essen, North Rhine-Westphalia, 45122, Germany

Location

Local Institution - 0012

Jena, Thuringia, 07747, Germany

Location

Local Institution - 0010

Rozzano, Milano, 20089, Italy

Location

Local Institution - 0011

Roma, 00168, Italy

Location

Local Institution - 0008

Amsterdam, 1066 CX, Netherlands

Location

Local Institution - 0020

Madrid, 28040, Spain

Location

Local Institution - 0002

Madrid, 28041, Spain

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

Nivolumab; cabozantinib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Central Study Contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

855-907-3286; Clinical.Trials@bms.com

First line of the email MUST contain NCT # and Site #.

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2026
• First Posted: September 30, 2026
• Study Start (Estimated): December 31, 2026
• Primary Completion (Estimated): October 18, 2030
• Study Completion (Estimated): April 17, 2031
• Last Updated: September 30, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: See Plan Description
• Access Criteria: See Plan Description

Locations

FR (2); NL (1); ES (2); US (6); IT (2); DE (2); BE (2)