CA266-0003: ROSETTA CRC-203
Research type
Research Study
Full title
ROSETTA CRC-203: A Blinded, Randomized Phase 2/3 Study of Pumitamig in Combination with Chemotherapy Versus Bevacizumab in Combination with Chemotherapy in Participants with Previously Untreated, Unresectable, or Metastatic Colorectal Cancer
IRAS ID
1013201
Contact name
GSM-CT Representative
Contact email
Sponsor organisation
Bristol-Myers Squibb Services Unlimited Company
Eudract number
2025-523224-45
Clinicaltrials.gov Identifier
Research summary
The purpose of this study is to see whether the drug pumitamig works to treat untreated, unresectable, metastatic colorectal cancer (mCRC). Patients with this type of cancer may be eligible to take part. Experts are still researching pumitamig, to understand side effects and how well it works. Study involvement may help mCRC patients, but there are no guarantees. It may help mCRC patients in the future. A company that makes medicines called Bristol-Myers Squibb is paying for this study.
This study will have 2 periods, Phase 2 then Phase 3. Phase 2 will determine which of 2 pumitamig doses has a better balance of safety and efficacy. This selected dose is assessed in Phase 3. Phase 3 will determine whether the selected dose is more effective than standard of care (chemotherapy) in treating mCRC. In Phase 3, the length of time patients can go without their cancer getting worse on pumitamig will be compared to the length of time on chemotherapy.
About 90 patients will be in Phase 2 and 900 patients in Phase 3. In total, there will be about 990 people in this study around the world, including in the UK. UK patients will be recruited and treated at specialist hospitals. From start to finish patients can expect to be in this study for up to 8.5 years (Phase 2) or 6.5 years (Phase 3). Patients’ suitability for the study is assessed across 2-3 hospital visits over 4 weeks. On treatment, patients will visit once every 2-3 weeks. The number of visits depends on how long treatments are taken for, patients’ disease development, and whether treatment side effects are experienced. Two safety checks are performed 30 and 90 days after the last treatment dose, then 12-weekly telephone health checks are performed until study end.REC name
London - Chelsea Research Ethics Committee
REC reference
25/LO/0832
Date of REC Opinion
6 Jan 2026
REC opinion
Further Information Favourable Opinion