A Study to Evaluate the Safety, Tolerability, and Efficacy of Pumitamig Alone or in Combination With Ipilimumab or Cabozantinib in Participants With Advanced Renal Cell Carcinoma (RCC) (ROSETTA RCC-208)

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorBristol-Myers Squibb

About this trial

The purpose of this study is to evaluate the safety, tolerability, and efficacy of Pumitamig alone or in combination with Ipilimumab or Cabozantinib in participants with advanced Renal Cell Carcinoma (RCC)

Eligibility criteria

Qualifiers

Participants must have a histologically confirmed diagnosis of locally advanced, unresectable (not amenable to curative surgery or radiation therapy) or metastatic Renal Cell Carcinoma (RCC).

Participants must have clear cell RCC (ccRCC) or non-clear cell RCC (nccRCC) may be enrolled in Part 1. Note: Part 2 may only enroll participants with ccRCC.

Participants may have favorable, intermediate or poor risk disease categories.

Disqualifiers

Participants must not have any untreated known CNS metastases.

Participants must not have a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of Cycle 1 Day1 (C1D1).

Participants must not have a history of interstitial lung disease or pneumonitis.

Participants must not have an uncontrolled pleural or pericardial effusion requiring recurrent therapeutic drainage procedures.

Trial design

Treatments tested in this trial

  • Pumitamig
  • Ipilimumab
  • Cabozantinib

Treatment groups

254 Participants
are divided into 9 treatment groups

9

Treatment groups

See each treatment group below.

Sponsors and collaborators

Bristol-Myers Squibb

Lead sponsor

BioNTech SE

Collaborator