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Recruiting Phase 1

A First-in-Human Study of BMS-986506 in Participants With Advanced Clear Cell Renal Cell Carcinoma (ccRCC)

NCT07195682 · tracked via the Priya Life Science Italy tracker
Phase
Phase 1
Started
2026-01-15
Last updated
2026-08-11

Condition(s) studied

Renal Cell Carcinoma

Investigational drug(s) / intervention(s)

BMS-986506Pumitamig →Ipilimumab →

BMS-986506: Specified dose on specified days

Pumitamig: Specified dose on specified days

Ipilimumab: Specified dose on specified days

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Number of Participants With Adverse Events (AEs) — Up to approximately 2 years from first dose of BMS-986506
  • Number of Participants With Serious Adverse Events (SAEs) — Up to approximately 2 years from first dose of BMS-986506
  • Number of Participants With AEs Meeting Protocol Defined Dose-limiting Toxicity (DLT) Criteria — Up to approximately Day 28
  • Number of Participants With AEs Leading to Discontinuation — Up to approximately 2 years from first dose of BMS-986506
  • Number of Participants With AEs Leading to Deaths as Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v 5.0 — Up to approximately 2 years from first dose of BMS-986506

Trial sites (11)

FacilityCityRegionStatus
Dana-Farber Cancer Institute Boston Massachusetts Recruiting
Memorial Sloan Kettering Cancer Center New York New York Recruiting
Fox Chase Cancer Center Philadelphia Pennsylvania Recruiting
SCRI Oncology Partners Nashville Tennessee Recruiting
START San Antonio San Antonio Texas Recruiting
Arthur J.E. Child Comprehensive Cancer Centre Calgary Alberta Recruiting
Gustave Roussy Villejuif Val-de-Marne Recruiting
Local Institution - 0031 Roma Italy Not Yet Recruiting
Local Institution - 0033 Verona Italy Not Yet Recruiting
Hospital Universitario Reina Sofia Córdoba Andalusia Recruiting
Hospital Universitari Vall d'Hebron Barcelona Barcelona [Barcelona] Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07195682 on ClinicalTrials.gov ↗ ← All trials in Italy