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)
← catalyst calendarNCT07293351 · readout in 1,197 d
Sponsored by Bristol-Myers Squibb (industry) · BMY — their whole pipeline →. With BioNTech SE.
Phase
Phase 1/2
Status
Recruiting
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
254estimated
Sites
91
Countries
Argentina, Australia, Brazil +18
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2026-03-26 | actual | When the study began enrolling |
| Primary completion | 2029-11-28 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2031-11-26 | estimated | The whole study's end, after follow-up |
| First posted | 2025-12-19 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-07-30 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Advanced Renal Cell Carcinoma (RCC)
Interventions
- Drug: Pumitamig — also filed as BMS-986545, BNT327, PM8002
- Drug: Ipilimumab — also filed as Yervoy, BMS-734016
- Drug: Cabozantinib
Primary outcomes
what the primary-completion date above is the date OFNumber of participants with adverse events (AEs)
measured Up to approximately 2 years from end of treatment
Number of participants with serious adverse events (SAEs) (as per Common Terminology Criteria for Adverse Events v5 (CTCAE v5))
measured Up to approximately 2 years from end of treatment
Number of participants with AEs meeting protocol-defined dose-limiting toxicity (DLT) criteria
measured Up to day 21 from first dose
Number of participants with AEs leading to discontinuation
measured Up to approximately 2 years from end of treatment
Number of participants with AEs leading to death
measured Up to approximately 2 years from end of treatment
Objective response rate (ORR) (confirmed complete response (CR) or partial response (PR)) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 per investigator assessment
measured Up to approximately 2 years from end of treatment
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