CA266-0006: ROSETTA HCC-206
Research type
Research Study
Full title
ROSETTA HCC-206: An Open-Label, Multi-Center, Randomized Phase 1/2 Study of Pumitamig Alone or In Combination with Ipilimumab in Participants with First-Line Advanced or Unresectable Hepatocellular Carcinoma (HCC)
IRAS ID
1013161
Contact name
GSM-CT Representative
Contact email
Sponsor organisation
Bristol-Myers Squibb Services Unlimited Company
Eudract number
2025-523602-33
Research summary
This study is testing a new medicine called pumitamig, for people with advanced liver cancer (hepatocellular carcinoma, HCC) who have not had previous treatment for their advanced disease. Pumitamig is an antibody designed to block two pathways that help cancer grow and hide from the body's immune system. Sometimes it is given along with another immune therapy called ipilimumab. The study also compares pumitamig (with ipilimumab or alone) against two approved cancer drugs: atezolizumab and bevacizumab.
The clinical trial is taking place at several hospitals and is an “open label” study, meaning both doctors and patients know what treatment is being given. There are two main phases:
• Phase 1: The focus is on checking safety—how the body responds to the medicine, what side effects appear, and finding the best dose. Around 24 people will join this phase.
• Phase 2: This part looks at how well pumitamig works (alone or with ipilimumab) by comparing it to the standard combination of atezolizumab and bevacizumab. About 105 participants will be involved here.
In total, around 129 participants will be enrolled in the study. To be included, participants must be adults (18 and older) with advanced or unresectable HCC confirmed by medical tests, and must not have received past treatments for advanced HCC. Other medical requirements, such as liver function, are also checked to ensure safety.
The main goal is to find out if pumitamig, especially with ipilimumab, can improve responses to treatment and help people live longer or healthier lives. Researchers will also closely monitor side effects and look for biological markers that might help predict which patients benefit most.
Sponsored by Bristol-Myers Squibb, the ultimate aim is to develop new, more effective and longer-lasting treatments for advanced liver cancer, where current options are still limited.REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
26/NW/0004
Date of REC Opinion
13 Feb 2026
REC opinion
Further Information Favourable Opinion