Actively Recruiting
A Phase 1/1b Open-label, Multi-center Study of BMS-986506 in Participants With Advanced Clear Cell Renal Cell Carcinoma (ccRCC)
Led by Bristol-Myers Squibb · Updated on 2026-05-05
125
Participants Needed
9
Research Sites
47 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying BMS-986506 in people with advanced Clear Cell Renal Cell Carcinoma (ccRCC). This first-in-human Phase 1/1b study aims to see if BMS-986506 is safe and can be tolerated when taken alone by participants with ccRCC. The study is sponsored by Bristol-Myers Squibb and focuses on patients with locally advanced or metastatic ccRCC who have had previous treatments. Participants will receive specified doses of BMS-986506 on designated days across different parts of the study. The study is open-label and non-randomized, with all participants receiving the investigational drug. The trial includes multiple experimental parts to evaluate the drug's safety and effects over time. During the study, researchers will monitor participants for adverse events, serious adverse events, and any side effects leading to treatment changes or discontinuation for up to about two years. They will also measure drug levels in the blood and assess responses to treatment using standard tumor evaluation criteria for up to three years. Participants will undergo regular assessments and follow-ups to track safety, drug exposure, and cancer response throughout the study period.
CONDITIONS
Brief Title
A First-in-Human Study of BMS-986506 in Participants With Advanced Clear Cell Renal Cell Carcinoma (ccRCC)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must have histologically confirmed diagnosis of locally advanced or metastatic clear cell renal cell carcinoma (ccRCC).
- For part 1: Participants must have had at least two different prior treatment plans including immunotherapy and targeted therapy.
- For part 2: Participants must have had at least one standard treatment plan including both a PD-1/L1 inhibitor and a VEGF-TKI.
- Participants must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
- Participants must be 18 years of age or older.
You will not qualify if you...
- Participants unable to take oral medication without altering the dosage form (e.g., chewing, breaking, crushing).
- For Part 2A: Participants who have received more than 3 prior systemic treatments for locally advanced or metastatic ccRCC including prior HIF2a inhibitor treatment.
- Participants with hypoxia defined by pulse oximeter reading below 92% at rest or requiring supplemental oxygen.
- Participants who have received colony-stimulating factors (like G-CSF, GM-CSF, or recombinant EPO) within 28 days before first dose.
- Other protocol-defined inclusion and exclusion criteria apply.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 2 years from first dose
Participants receive specified doses of the study drug BMS-986506 on specified days to treat advanced clear cell renal cell carcinoma.
Visits scheduled according to dosing and safety monitoring over the treatment period
Duration - Up to approximately 3 years from first dose
Participants are monitored for safety and treatment outcomes after completing treatment with BMS-986506.
Periodic visits for response and safety assessments
Trial Site Locations
Total: 9 locations
1
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
2
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
3
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
Actively Recruiting
4
SCRI Oncology Partners
Nashville, Tennessee, United States, 37203
Actively Recruiting
5
START San Antonio
San Antonio, Texas, United States, 78229
Actively Recruiting
6
Arthur J.E. Child Comprehensive Cancer Centre
Calgary, Alberta, Canada, T2N 5G2
Actively Recruiting
7
Gustave Roussy
Villejuif, Val-de-Marne, France, 94800
Actively Recruiting
8
Hospital Universitario Reina Sofia
Córdoba, Andalusia, Spain, 14004
Actively Recruiting
9
Local Institution - 0018
Barcelona, Barcelona [Barcelona], Spain, 08035
Not Yet Recruiting
Research Team
B
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
F
First line of the email MUST contain NCT # and Site #.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
3
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