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Study of BMS-986506 for Advanced Clear Cell Kidney Cancer

This study is testing a new drug called BMS-986506 for people with advanced clear cell renal cell carcinoma (ccRCC), a type of kidney cancer. It's the first time this drug is being given to humans. The main goal is to see if BMS-986506 is safe and how well people can tolerate it when taken alone. You might be able to join if you have advanced ccRCC and have already received certain treatments, including immunotherapy and targeted therapy. The study will look at side effects and serious side effects for up to two years to understand the drug's safety. The study is currently recruiting about 125 participants.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll about 125 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for adverse events and serious adverse events for up to approximately 2 years from the first dose of BMS-986506.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07195682

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Bristol-Myers Squibb
~281 participants
Updated 2026-08-11 on ClinicalTrials.gov
What's tested:BMS-986506PumitamigIpilimumab

At a glance

Recruiting sites
9 of 11 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Participants With Adverse Events (AEs)
Measured over Up to approximately 2 years from first dose of BMS-986506
+4 more outcomes measured

Conditions

Renal Cell Carcinoma

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Clear Cell Renal Cell Carcinoma

NCT07195682

Where you'd take part

This study runs at 11 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Arthur J.E. Child Comprehensive Cancer Centre

    Calgary, Alberta, Canadastudy coordinator listed

    Recruiting

  • Dana-Farber Cancer Institute

    Boston, Massachusettsstudy coordinator listed

    Recruiting

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvaniastudy coordinator listed

    Recruiting

  • Gustave Roussy

    Villejuif, Val-de-Marne, Francestudy coordinator listed

    Recruiting

  • Hospital Universitari Vall d'Hebron

    Barcelona, Barcelona [Barcelona], Spainstudy coordinator listed

    Recruiting

  • Hospital Universitario Reina Sofia

    Córdoba, Andalusia, Spainstudy coordinator listed

    Recruiting

  • Memorial Sloan Kettering Cancer Center

    New York, New Yorkstudy coordinator listed

    Recruiting

  • SCRI Oncology Partners

    Nashville, Tennesseestudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Bristol-Myers Squibb · STUDY_DIRECTOR · Bristol-Myers Squibb

Who to contact

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
[email protected]
855-907-3286
Email the study team

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • 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) CriteriaUp to approximately Day 28
  • Number of Participants With AEs Leading to DiscontinuationUp 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 5.0Up to approximately 2 years from first dose of BMS-986506