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RecruitingLast updated: 21 May 2026

ROSETTA HCC-206: Testing immunotherapy treatments for people with advanced or inoperable liver cancer (HCC)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)

Trial purpose

Medical clipboardCancer treatment

Tumor type

Upper gastrointestinal tract Cancers Upper gastrointestinal tract

Age

People18+

Trial acronym

ROSETTA HCC-206

Clinical summary

Summary

This clinical trial is testing new immunotherapy treatments for people with advanced liver cancer, also called hepatocellular carcinoma (HCC).

The main aims of the study are to find out:

  • How safe the study treatments are
  • What side effects may occur
  • How well the treatments can control or shrink the cancer

Who can take part?
You may be able to join this study if you:

  • Are aged 18 years or older
  • Have advanced or inoperable liver cancer (HCC) that cannot be removed with surgery
  • Have not had systemic treatment for advanced HCC before

The study team and your doctor can carefully check if the trial is suitable for you.

Study details
This is a Phase 1/2 clinical trial, Phase 1 looks closely at safety and side effects. Phase 2 explores how well the treatment works compared to other treatments.

Within each phase, there are multiple treatment groups. Eligible participants will be randomly allocated (by chance) to one of the treatment groups. These may include receiving:

  • pumitamig immunotherapy with ipilimumab immunotherapy, or
  • atezolizumab immunotherapy with bevacizumab targeted therapy, or
  • pumitamig immunotherapy on its own

 

Conditions

This trial is treating people with advanced or unresectable liver cancer who have not had prior treatment for their advanced disease

Eligibility

Inclusion

  • 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

  • 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.

Inclusion

  • Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
  • Your cancer has not spread to other parts of the body, but it is not possible to perform surgery to remove it (unresectable).

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

Recruiting hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov, EU Clinical Trials Register *. View further details about this trial on the registry via the links below:

  • NCT07291076 *
  • 2025-523602-33 *
  • CA266-0006; U1111-1327-4912

Trial sponsor

Bristol-Myers Squibb

Scientific Title

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)

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