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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 YorkLaura and Isaac Perlmutter Cancer Center at NYU Langone, Mineola
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 Nov 15, 2026. Each study sets its own eligibility; the study team decides who can join.