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
9
Treatment groupsSee each treatment group below.
Sponsors and collaborators
Bristol-Myers Squibb
Lead sponsor
BioNTech SE
Collaborator