NCT07195682PHASE1Recruiting
A First-in-Human Study of BMS-986506 in Participants With Advanced Clear Cell Renal Cell Carcinoma (ccRCC)
Bristol-Myers Squibb
Start Date
1/15/2026
Completion Date
4/3/2031
Summary
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.
Eligibility Criteria
Age Range: 18 years to No maximum
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.
Interventions
DRUG
BMS-986506
DRUG
Pumitamig
DRUG
Ipilimumab
Conditions
Renal Cell Carcinoma
Locations
Dana-Farber Cancer Institute
Boston, Massachusetts 02215
United States
Memorial Sloan Kettering Cancer Center
New York, New York 10065
United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania 19111
United States
SCRI Oncology Partners
Nashville, Tennessee 37203
United States
START San Antonio
San Antonio, Texas 78229
United States
Arthur J.E. Child Comprehensive Cancer Centre
Calgary, Alberta T2N 5G2
Canada
Gustave Roussy
Villejuif, Val-de-Marne 94800
France
Local Institution - 0031
Roma, 00168
Italy
Local Institution - 0033
Verona, 37134
Italy
Hospital Universitario Reina Sofia
Córdoba, Andalusia 14004
Spain
Hospital Universitari Vall d'Hebron
Barcelona, Barcelona [Barcelona] 08035
Spain