ROSETTA RCC-208: A Phase 1/2 Open-label, Multi-center, Randomized Study of Pumitamig Alone or in Combination With Ipilimumab or Cabozantinib in Participants With Advanced Renal Cell Carcinoma (RCC)
Bristol-Myers Squibb
Summary
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
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria * 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. * Participants must not have received prior systemic therapy for metastatic RCC, with the following exceptions: i) One prior adjuvant or neoad…
Interventions
- DrugPumitamig
Specified dose on specified days
- DrugIpilimumab
Specified dose on specified days
- DrugCabozantinib
Specified dose on specified days
- DrugNivolumab
Specified dose on specified days
Locations (72)
- Local Institution - 0117New Haven, Connecticut
- Sibley Memorial HospitalWashington D.C., District of Columbia
- Local Institution - 0126Orlando, Florida
- Local Institution - 0124Iowa City, Iowa
- Johns Hopkins HospitalBaltimore, Maryland
- Washington University School of MedicineSt Louis, Missouri