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)
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.
Participants must not have significant bleeding or coagulation disorders or other obvious bleeding risk evidence.
Participants must not have an organ transplant or autoimmune disease.
Other protocol-defined Inclusion/Exclusion criteria apply.
Parallel
Pumitamig
DrugSpecified dose on specified days
Ipilimumab
DrugSpecified dose on specified days
7
Treatment groupsSee each treatment group below.
Number of participants with adverse events (AEs)
Phase 1
Number of participants with serious adverse events (SAEs) (as per Common Terminology Criteria for Adverse Events v5 (CTCAE v5))
Phase 1
Number of participants with AEs meeting protocol-defined dose-limiting toxicity (DLT) criteria
Phase 1
Number of participants with AEs leading to discontinuation
Phase 1
Number of participants with AEs
Phase 2
Number of participants with SAEs (as per CTCAE v5)
Phase 2
Number of participants with treatment-related adverse events (TRAEs)
Phase 2
Number of participants with AEs leading to discontinuation
Phase 2
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Bristol-Myers Squibb
Lead sponsor
BioNTech SE
Collaborator
