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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorBristol-Myers Squibb

About this trial

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

Qualifiers

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).

Disqualifiers

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).

Trial design

Treatments tested in this trial

  • BMS-986506
  • Pumitamig
  • Ipilimumab

Treatment groups

281 Participants
are divided into 7 treatment groups

7

Treatment groups

See each treatment group below.

Sponsors and collaborators