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Trial ID CA266-0006  |   NCT07291076

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)

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Summary

  • Phase 1/Phase 2
  • Male and Female Gender icon
  • 18+
    Age Range
  • 31
    Locations
  • BMS Not Yet Recruiting Study icon
    Not Yet Recruiting

Overview

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)

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Key Eligibility Criteria

Inclusion Criteria

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  • Participants must have a histologically confirmed diagnosis of locally advanced or unresectable Hepatocellular Carcinoma (HCC).
    1. Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
      1. Participants must have no prior systemic therapy for advanced/ unresectable HCC.
        1. Participants must have measurable disease as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

          Exclusion Criteria

          Exclusion Criteria Icon
          • Participants must not have significant bleeding or coagulation disorders or other obvious bleeding risk evidence.
            1. Participants must not have an organ transplant or autoimmune disease.
              Additional Information *
              • Other protocol-defined Inclusion/Exclusion criteria apply.

                Treatment Options

                Study Arms

                ASSIGNED INTERVENTION

                Study Arms

                Experimental: Cohort 1A

                ASSIGNED INTERVENTION
                • Drug: Pumitamig, Ipilimumab

                Study Arms

                Experimental: Cohort 1B

                ASSIGNED INTERVENTION
                • Drug: Pumitamig, Ipilimumab

                Study Arms

                Experimental: Cohort 2A

                ASSIGNED INTERVENTION
                • Drug: Pumitamig, Ipilimumab

                Study Arms

                Experimental: Cohort 2B

                ASSIGNED INTERVENTION
                • Drug: Pumitamig, Ipilimumab

                Study Arms

                Other: Cohort 2C

                ASSIGNED INTERVENTION
                • Drug: Atezolizumab, Bevacizumab

                Study Arms

                Experimental: Cohort 2D

                ASSIGNED INTERVENTION
                • Drug: Pumitamig
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