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Pumitamig alone or with ipilimumab for first-line advanced or unresectable liver cancer

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)

Phase1; Phase2 Interventional Bristol-Myers Squibb · NCT07291076

This trial will test whether pumitamig, alone or combined with ipilimumab, is safe and tolerable for people with advanced or unresectable hepatocellular carcinoma who have not had prior systemic therapy.

Quick facts

PhasePhase1; Phase2
Study typeInterventional
Enrollment129 (estimated)
Ages18 Years and up
SexAll
SponsorBristol-Myers Squibb Industry-sponsored
Drugs / interventionsIpilimumab
Locations50 sites (Los Angeles, California and 49 other locations)
Trial IDNCT07291076 on ClinicalTrials.gov

What this trial studies

This phase 1/2 interventional trial enrolls participants with histologically confirmed locally advanced or unresectable hepatocellular carcinoma and ECOG performance status 0–1. Participants receive pumitamig alone or pumitamig in combination with ipilimumab, with close monitoring for safety, tolerability, and tumour measurements by RECIST v1.1. The phase 1 portion follows dose-escalation principles to identify tolerable dosing, followed by phase 2 expansion to further characterize safety and preliminary activity. Key eligibility limits include no prior systemic therapy for advanced HCC and measurable disease.

Who should consider this trial

Good fit: Adults with histologically confirmed locally advanced or unresectable hepatocellular carcinoma, ECOG 0–1, measurable disease by RECIST v1.1, and no prior systemic therapy for advanced HCC are the intended participants.

Not a fit: Patients with significant bleeding or coagulation disorders, organ transplants, autoimmune disease, prior systemic therapy for advanced HCC, or poor performance status are unlikely to be eligible or to benefit from this trial.

Why it matters

Potential benefit: If successful, the regimen could provide a new first-line systemic option with a favorable safety profile for people with advanced or unresectable HCC.

How similar studies have performed: Combinations of immune checkpoint inhibitors (for example, PD-(L)1 plus CTLA-4 agents) and atezolizumab plus bevacizumab have shown activity in HCC, but pumitamig is a newer agent with limited prior clinical data in this setting.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Los Angeles, California and 49 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Hepatocellular CarcinomaFirst line HCCUnresectable HCCIpilimumabPumitamig
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.