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NCT Number: 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)

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 information

Conditions

Hepatocellular Carcinoma (HCC) Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pumitamig

Drug

Specified dose on specified days

Other names: BMS-986545

Ipilimumab

Drug

Specified dose on specified days

Other names: Yervoy

Primary outcomes

  1. Number of participants with adverse events (AEs)

    Time frame: Up to approximately 25 weeks

    Phase 1

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

    Time frame: Up to approximately 25 weeks

    Phase 1

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

    Time frame: Up to day 21

    Phase 1

  4. Number of participants with AEs leading to discontinuation

    Time frame: Up to approximately 25 weeks

    Phase 1

  5. Number of participants with AEs leading to death

    Time frame: Up to approximately 25 weeks

    Phase 1

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

    Time frame: Up to week 48

    Phase 2

Secondary outcomes

  1. Number of participants with AEs

    Time frame: Up to approximately 25 weeks

    Phase 2

  2. Number of participants with SAEs (as per CTCAE v5)

    Time frame: Up to approximately 25 weeks

    Phase 2

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

    Time frame: Up to approximately 25 weeks

    Phase 2

  4. Number of participants with AEs leading to discontinuation

    Time frame: Up to approximately 25 weeks

    Phase 2

  5. Number of participants with AEs leading to death

    Time frame: Up to approximately 25 weeks

    Phase 2

  6. End of infusion concentration of Pumitamig

    Time frame: Up to day 21

    Phase 2

  7. End of trough concentration of Pumitamig

    Time frame: Up to day 21

    Phase 2

  8. Trough concentration of Ipilimumab

    Time frame: Up to day 21

    Phase 2

  9. Incidence of anti-drug antibodies against Pumitamig

    Time frame: Up to 5 years

    Phase 2

  10. Incidence of anti-drug antibodies against Ipilimumab

    Time frame: Up to 5 years

    Phase 2

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

    Time frame: Up to 4 years

    Phase 2

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

    Time frame: Up to 4 years

    Phase 2

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Collaborators

  • BioNTech SE

Registry information

Official study title

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)

Important dates

Study start
2026
Primary completion
2029
Study completion
2031
First posted
Dec 18, 2025
Registry last updated
Sep 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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