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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)

RecruitingPhase 1/2

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)

Who can join

Ages 18 and older · All sexes

Full eligibility 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.

About the study

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)

What is being tested

Sponsor: Bristol-Myers Squibb · Participants: 198 · Started: Mar 16, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT07291076

Locations in the U.S.

CaliforniaCity Of Hope, Duarte
Local Institution - 0070, Los Angeles (Not yet recruiting)
IllinoisLocal Institution - 0107, Chicago (Not yet recruiting)
MichiganLocal Institution - 0134, Detroit (Not yet recruiting)
New JerseyJohn Theurer Cancer Center at Hackensack University Medical Center, Hackensack
New YorkLocal Institution - 0100, Mineola (Not yet recruiting)
OregonProvidence Portland Medical Center, Portland
Providence St. Vincent Medical Center, Portland
TennesseeTennessee Oncology, Nashville
Vanderbilt University Medical Center, Nashville
WashingtonLocal Institution - 0083, Seattle (Not yet recruiting)

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.