Clinical Trial

A Study to Evaluate the Safety and Tolerability of Pumitamig Alone or In Combination With Ipilimumab in Participants With First-Line Advanced or Unresectable Hepatocellular Carcinoma (HCC) (ROSETTA HCC-206)

Recruiting Phase 1/2
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Summary
The purpose of this study is to evaluate the safety and tolerability of Pumitamig alone or in combination with Ipilimumab in participants with first-line advanced or unresectable Hepatocellular Carcinoma (HCC)
Protocol Amendment History 5 changes
notable Trial sites expanded: 59 -> 64 locations 2026-06-27
notable Enrollment increased: 129 -> 198 participants 2026-06-03
minor Trial arms changed: 6 -> 7 2026-06-03
notable Trial sites expanded: 50 -> 59 locations 2026-06-03
notable Trial sites expanded: 46 -> 50 locations 2026-05-09
Trial Details
NCT Number NCT07291076
Lead Sponsor Bristol-Myers Squibb
Collaborators: BioNTech SE
Conditions Hepatocellular Carcinoma (HCC)
Enrollment 198 participants
Start Date 2026-03-16
Primary Completion 2029-10-15 (estimated)
Study Completion 2031-10-14 (estimated)
Updated on ClinicalTrials.gov 2026-07-23