Pumitamig & IpilimumabA 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)

Arms

Interventions

Primary outcome measure

• Number of participants with adverse events (AEs) [ Time Frame: Up to approximately 25 weeks ]
• Number of participants with serious adverse events (SAEs) (as per Common Terminology Criteria for Adverse Events v5 (CTCAE v5)) [ Time Frame: Up to approximately 25 weeks ]
• Number of participants with AEs meeting protocol-defined dose-limiting toxicity (DLT) criteria [ Time Frame: Up to day 21 ]
• Number of participants with AEs leading to discontinuation [ Time Frame: Up to approximately 25 weeks ]
• Number of participants with AEs leading to death [ Time Frame: 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 [ Time Frame: Up to week 48 ]