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RecruitingInterventionalPhase 1/Phase 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)

NCT ID: NCT07291076Sponsor: Bristol-Myers SquibbLast updated: 2026-06-02

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)

Arms & interventions

  • DrugPumitamig

    Specified dose on specified days

  • DrugIpilimumab

    Specified dose on specified days

Outcome measures

Primary

  • Number of participants with adverse events (AEs)

    Phase 1

    Time frame: Up to approximately 25 weeks

  • Number of participants with serious adverse events (SAEs) (as per Common Terminology Criteria for Adverse Events v5 (CTCAE v5))

    Phase 1

    Time frame: Up to approximately 25 weeks

  • Number of participants with AEs meeting protocol-defined dose-limiting toxicity (DLT) criteria

    Phase 1

    Time frame: Up to day 21

  • Number of participants with AEs leading to discontinuation

    Phase 1

    Time frame: Up to approximately 25 weeks

  • Number of participants with AEs leading to death

    Phase 1

    Time frame: Up to approximately 25 weeks

  • Objective response (OR) (confirmed complete response (CR) or partial response (PR)) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 per investigator assessment

    Phase 2

    Time frame: Up to week 48

Secondary

  • Number of participants with AEs

    Time frame: Up to approximately 25 weeks

  • Number of participants with SAEs (as per CTCAE v5)

    Time frame: Up to approximately 25 weeks

  • Number of participants with treatment-related adverse events (TRAEs)

    Time frame: Up to approximately 25 weeks

  • Number of participants with AEs leading to discontinuation

    Time frame: Up to approximately 25 weeks

  • Number of participants with AEs leading to death

    Time frame: Up to approximately 25 weeks

  • End of infusion concentration of Pumitamig

    Time frame: Up to day 21

  • End of trough concentration of Pumitamig

    Time frame: Up to day 21

  • Trough concentration of Ipilimumab

    Time frame: Up to day 21

  • Incidence of anti-drug antibodies against Pumitamig

    Time frame: Up to 5 years

  • Incidence of anti-drug antibodies against Ipilimumab

    Time frame: Up to 5 years

  • Progression-free survival (PFS) by RECIST v1.1 per investigator assessment

    Time frame: Up to 4 years

  • Duration of response (DOR) (confirmed by PR or CR) by RECIST v1.1 per investigator assessment

    Time frame: Up to 4 years

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
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.

Study locations (9)

Local Institution - 0070

Los Angeles, California, 90064

Not Yet Recruiting
Site 0070 · Contact

Local Institution - 0107

Chicago, Illinois, 60611

Not Yet Recruiting
Site 0107 · Contact

John Theurer Cancer Center at Hackensack University Medical Center

Hackensack, New Jersey, 07601-2191

Recruiting
Martin Gutierrez, Site 0103 · Contact
551-996-5863

Local Institution - 0100

Mineola, New York, 11501

Not Yet Recruiting
Site 0100 · Contact

Providence Portland Medical Center

Portland, Oregon, 97213

Recruiting
Binbin Zheng, Site 0080 · Contact
503-215-3878

Providence St. Vincent Medical Center

Portland, Oregon, 97225

Recruiting
Binbin Zheng, Site 0111 · Contact
503-215-3878

Tennessee Oncology

Nashville, Tennessee, 37203

Recruiting
Jeffery Russell, Site 0022 · Contact
615-986-0857

Vanderbilt University Medical Center

Nashville, Tennessee, 37232

Recruiting
Laura Goff, Site 0102 · Contact
615-322-4967

Local Institution - 0083

Seattle, Washington, 98109-1024

Not Yet Recruiting
Site 0083 · Contact