Recruiting
Phase 1

BMS-986506

Sponsor:

Bristol-Myers Squibb

Code:

NCT07195682

Conditions

Renal Cell Carcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

BMS-986506

Pumitamig

Ipilimumab

Study Details

Brief 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.

Conditions

Renal Cell Carcinoma

Study ID

NCT07195682

Start date

Jan 15, 2026

Status verified date

Aug, 2026

Completion date

Apr 3, 2031

Anticipated

Primary completion date

May 3, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

281 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Part 1A BMS-986506 Monotherapy Escalation

experimental: Part 2A BMS-986506 Monotherapy Expansion

experimental: Part 2B BMS-986506 Monotherapy Expansion

experimental: Part 3A BMS-986506 + Pumitamig Combination Dose Escalation

experimental: Part 3B BMS-986506 + Pumitamig + Ipilimumab Combination Dose Escalation

experimental: Part 4A BMS-986506 + Pumitamig Combination Dose Expansion

experimental: Part 4B BMS-986506 + Pumitamig + Ipilimumab Combination Dose Expansion

Interventions

BMS-986506

Specified dose on specified days

Pumitamig

Specified dose on specified days

Ipilimumab

Specified dose on specified days

Primary outcome measure

  • Number of Participants With Adverse Events (AEs) [ Time Frame: Up to approximately 2 years from first dose of BMS-986506 ]
  • Number of Participants With Serious Adverse Events (SAEs) [ Time Frame: Up to approximately 2 years from first dose of BMS-986506 ]
  • Number of Participants With AEs Meeting Protocol Defined Dose-limiting Toxicity (DLT) Criteria [ Time Frame: Up to approximately Day 28 ]
  • Number of Participants With AEs Leading to Discontinuation [ Time Frame: 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 [ Time Frame: Up to approximately 2 years from first dose of BMS-986506 ]

Central Contacts and Locations

Central contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

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

Locations

Dana-Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Stephanie Berg, Site 0006

617-632-4932

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

Contacts

Martin Voss, Site 0029

646-888-4721

Fox Chase Cancer Center

Recruiting

Philadelphia, Pennsylvania, United States, 19111

Contacts

Elizabeth Plimack, Site 0002

215-728-3889

SCRI Oncology Partners

Recruiting

Nashville, Tennessee, United States, 37203

Contacts

Benjamin Garmezy, Site 0026

713-444-7804

START San Antonio

Recruiting

San Antonio, Texas, United States, 78229

Contacts

Amita Patnaik, Site 0001

210-593-5250

Arthur J.E. Child Comprehensive Cancer Centre

Recruiting

Calgary, Alberta, Canada, T2N 5G2

Contacts

Daniel Heng, Site 0021

4035213166

More Information

Sponsor

Bristol-Myers Squibb

Last update posted

Aug 11, 2026

Last verified

Aug, 2026

Keywords

  • Metastatic clear cell renal cell carcinoma
  • Advanced clear cell renal cell carcinoma
  • ccRCC
  • Kidney cancer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Bristol-Myers Squibb on 2026-08-11.