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)
Bristol-Myers Squibb
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)
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria * Participants must have a histologically confirmed diagnosis of locally advanced or unresectable Hepatocellular Carcinoma (HCC). * Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Participants must have no prior systemic therapy for advanced/ unresectable HCC. * Participants must have measurable disease as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Exclusion Criteria * Participants must not have significant bleeding or coagulation disorders or other obvious bleeding risk evidence. * Participants must…
Interventions
- DrugPumitamig
Specified dose on specified days
- DrugIpilimumab
Specified dose on specified days
- DrugAtezolizumab
Specified dose on specified days
- DrugBevacizumab
Specified dose on specified days
Locations (50)
- Local Institution - 0070Los Angeles, California
- Local Institution - 0107Chicago, Illinois
- John Theurer Cancer Center at Hackensack University Medical CenterHackensack, New Jersey
- Local Institution - 0100Mineola, New York
- Providence Portland Medical CenterPortland, Oregon
- Providence St. Vincent Medical CenterPortland, Oregon