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)

Bristol-Myers Squibb (BMS)

Status and phase: Begins enrollment this month; Phase 2; Phase 1

Conditions: Hepatocellular Carcinoma (HCC)

Treatments: Drug: Atezolizumab; Drug: Bevacizumab; Drug: Pumitamig; Drug: Ipilimumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT07291076

2025-523602-33 (Other Identifier)

CA266-0006

U1111-1327-4912 (Other Identifier)

Details and patient eligibility

About

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)

Enrollment: 129 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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 not have an organ transplant or autoimmune disease.
• Other protocol-defined Inclusion/Exclusion criteria apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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129 participants in 6 patient groups

Cohort 1A

Experimental group

Treatment:

Drug: Ipilimumab

Drug: Pumitamig

Cohort 1B

Experimental group

Treatment:

Drug: Ipilimumab

Drug: Pumitamig

Cohort 2A

Experimental group

Treatment:

Drug: Ipilimumab

Drug: Pumitamig

Cohort 2B

Experimental group

Treatment:

Drug: Ipilimumab

Drug: Pumitamig

Cohort 2C

Other group

Treatment:

Drug: Bevacizumab

Drug: Atezolizumab

Cohort 2D

Experimental group

Treatment:

Drug: Pumitamig