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)
← catalyst calendarNCT07291076 · readout in 1,153 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
198estimated
Sites
67
Countries
Australia, Chile, China +11
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 | 2026-03-16 | actual | When the study began enrolling |
| Primary completion | 2029-10-15 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2031-10-14 | estimated | The whole study's end, after follow-up |
| First posted | 2025-12-18 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-08-18 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Hepatocellular Carcinoma (HCC)
Interventions
- Drug: Pumitamig — also filed as BMS-986545
- Drug: Ipilimumab — also filed as Yervoy
Primary outcomes
what the primary-completion date above is the date OFNumber of participants with adverse events (AEs)
measured Up to approximately 25 weeks
Number of participants with serious adverse events (SAEs) (as per Common Terminology Criteria for Adverse Events v5 (CTCAE v5))
measured Up to approximately 25 weeks
Number of participants with AEs meeting protocol-defined dose-limiting toxicity (DLT) criteria
measured Up to day 21
Number of participants with AEs leading to discontinuation
measured Up to approximately 25 weeks
Number of participants with AEs leading to death
measured Up to approximately 25 weeks
Objective response (OR) (confirmed complete response (CR) or partial response (PR)) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 per investigator assessment
measured Up to week 48
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