First human testing of BMS-986506 in advanced clear cell kidney cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1, first-in-human interventional study gives escalating doses of the experimental agent BMS-986506 to adults with locally advanced or metastatic clear cell renal cell carcinoma to define safety and tolerability. The trial includes an initial dose-finding portion and a subsequent cohort-based expansion for participants with prior exposure to standard therapies such as PD-1/PD-L1 inhibitors and VEGF-targeted agents. Eligible participants must have histologically confirmed ccRCC and an ECOG performance status of 0–1, and some cohorts require specific prior treatment histories. Key exclusions include inability to take oral medication as formulated and significant hypoxia or excessive prior systemic regimens for certain cohorts.

Why it matters

Who can join: the full rules

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.

Where it's running

• Dana-Farber Cancer Institute
  Boston, Massachusetts, United States Recruiting
• Memorial Sloan Kettering Cancer Center
  New York, New York, United States Recruiting
• Fox Chase Cancer Center
  Philadelphia, Pennsylvania, United States Recruiting
• SCRI Oncology Partners
  Nashville, Tennessee, United States Recruiting
• START San Antonio
  San Antonio, Texas, United States Recruiting
• Arthur J.E. Child Comprehensive Cancer Centre
  Calgary, Alberta, Canada Recruiting

Study contacts

• Study coordinator: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
• Email: Clinical.Trials@bms.com
• Phone: 855-907-3286

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.