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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 1/2Sponsored by Bristol-Myers Squibb
Actively Recruiting
PhasePhase 1/2
SponsorBristol-Myers Squibb
Started2026-03-16
Est. completion2029-10-15
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations9 sites
View on ClinicalTrials.gov →
NCT07291076
Summary
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)
Eligibility
Age: 18 Years+Healthy volunteers accepted
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.
Conditions4
CancerHepatocellular Carcinoma (HCC)Liver CancerLiver Disease
Interventions4
Locations9 sites
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, 07601-2191
Martin Gutierrez, Site 0103551-996-5863
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Actively Recruiting
PhasePhase 1/2
SponsorBristol-Myers Squibb
Started2026-03-16
Est. completion2029-10-15
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations9 sites
View on ClinicalTrials.gov →
NCT07291076