Home › Kidney Cancer (Renal Cell Carcinoma) › NCT07195682
A First-in-Human Study of BMS-986506 in Participants With Advanced Clear Cell Renal Cell Carcinoma (ccRCC)
RecruitingPhase 1
A Phase 1/1b Open-label, Multi-center Study of BMS-986506 in Participants With Advanced Clear Cell Renal Cell Carcinoma (ccRCC)
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
Inclusion Criteria * Participants must have histologically confirmed diagnosis of locally advanced or metastatic ccRCC. * For part 1: Participants must have already had at least two different treatment plans in the past, including immunotherapy and a targeted therapy. * For part 2: Participants must have had at least one standard treatment plan that included both a PD-1/L1 inhibitor and a VEGF-TKI (either together or one after the other). * Part 3: Participants must have had at least 1 standard treatment regimen (including a PD-1/L1 checkpoint inhibitor and/or a VEGF-TKI). * Part 4: Participants must not have received prior systemic therapy for metastatic RCC, but may have received prior adjuvant therapy for completely resected RCC with PD-1 inhibitor if recurrence occurred at least 6 months after the last dose of adjuvant or neoadjuvant therapy. * Eastern Cooperative Oncology Group performance status of 0 to 1. Exclusion Criteria * Inability to administer and/or tolerate oral medication without chewing, breaking, crushing, or otherwise altering the product dosage form. * Part 2A: Participants who have received more than 3 prior systemic regimens for locally advanced or metastatic ccRCC including prior treatment with HIF2a inhibitors. * Part 2A and Part 4: Participants who have received prior treatment with belzutifan (or another HIF2a inhibitor). * Part 3B and Part 4B: Participants who have received prior ipilimumab (or another anti-CTLA-4 containing antibody). * Participants who have hypoxia as defined by a pulse oximeter reading \< 92% at rest or requires intermittent or chronic supplemental oxygen. * Participants who have received colony-stimulating factors (eg, G-CSF, GM-CSF or recombinant EPO) within 28 days prior to the first dose of study intervention. * Part 3 and Part 4: Participants with a history of Grade ≥3 immune-mediated AEs leading to discontinuation of prior immunotherapy. * Other protocol-defined Inclusion/Exclusion criteria apply.
About the study
This is a first-in-human study of BMS-986506 in participants with advanced Clear Cell Renal Cell Carcinoma (ccRCC). The primary objective of this study is to find out if BMS-986506 is safe and can be tolerated when taken alone or in combination by participants with ccRCC.
What is being tested
- BMS-986506 (drug)
- Pumitamig (drug)
- Ipilimumab (drug)
Sponsor: Bristol-Myers Squibb · Participants: 281 · Started: Jan 15, 2026
Contact the study team
- BMS Clinical Trials Contact Center www.BMSClinicalTrials.com · Phone: 855-907-3286
Official record on ClinicalTrials.gov — NCT07195682
Locations in the U.S.
| Massachusetts | Dana-Farber Cancer Institute, Boston |
| New York | Memorial Sloan Kettering Cancer Center, New York |
| Pennsylvania | Fox Chase Cancer Center, Philadelphia |
| Tennessee | SCRI Oncology Partners, Nashville |
| Texas | START San Antonio, San Antonio |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.