CA266-0008 ROSETTA-RCC-208
Research type
Research Study
Full title
Rosetta-RCC-208 : A Phase I / II open-label, multi-center, randomized study of Pumitamig alone or in combination with Ipilimumab or Cabozantinib in participants with advanced renal cell carcinoma (RCC).
IRAS ID
1013346
Contact name
GSM-CT Representative
Contact email
Sponsor organisation
Bristol-Myers Squibb Services Unlimited Company
Eudract number
2025-523637-26
Research summary
ROSETTA RCC-208 is a global phase 1/2 clinical trial testing the safety, tolerability and effectiveness of pumitamig alone or in combination with either ipilimumab or cabozantinib, compared to current standard treatments, in adults with previously untreated, advanced or metastatic kidney cancer (renal cell carcinoma or RCC). The study aims to find out whether pumitamig, which targets two cancer pathways (PD-L1 and VEGF-A), works better than existing therapies, and to determine the best dose for future use. Approximately, up to 264 participants will take part in the study globally, including the UK.
The study has three parts (screening, treatment and follow-up) and two stages (phase 1 and phase 2). Phase 1 tests the safety of pumitamig combined with either ipilimumab or cabozantinib at different dose levels to find the safest and best dose. Phase 2 compares pumitamig (alone or in combination) to standard treatments (nivolumab plus ipilimumab, or nivolumab plus cabozantinib) and will measure how well pumitamig (alone or in combination) shrinks tumors compared to standard treatments. Both phases will also monitor side effects, time without cancer worsening and overall survival. Participants are randomly assigned to different treatment groups.
Participants (18 years or older) will receive treatment for up to 2 years or until the cancer progresses or side effects become too severe. After stopping treatment, participants will be monitored in-person for side effects for about 90 days and then contacted remotely about every 12 weeks for long-term follow-up. Total study duration is expected to be Approximately. 4 years.REC name
London - Chelsea Research Ethics Committee
REC reference
26/LO/0047
Date of REC Opinion
6 Feb 2026
REC opinion
Further Information Favourable Opinion