Clinical trial Recruiting at 38 sites Phase1; Phase2 Interventional Ages 18 and up

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

Official 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)

Run by Bristol-Myers Squibb · NCT07291076 · Data updated 2026-11-12

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
Ages18 Years and up
SexAll
Enrollment198 (estimated)
SponsorBristol-Myers Squibb
Industry-sponsored
Drugs / interventionsIpilimumab
Locations67 sites (Duarte, California and 66 other locations)
StatusRecruiting
StartedMarch 16, 2026
Main results expectedOctober 15, 2029
Study endsOctober 14, 2031
Registry record updatedOctober 23, 2026
Trial IDNCT07291076 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

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 it's running

  • City Of Hope
    Duarte, California, United States
    Recruiting
  • John Theurer Cancer Center at Hackensack University Medical Center
    Hackensack, New Jersey, United States
    Recruiting
  • Laura and Isaac Perlmutter Cancer Center at NYU Langone
    Mineola, New York, United States
    Recruiting
  • Providence Portland Medical Center
    Portland, Oregon, United States
    Recruiting
  • Providence St. Vincent Medical Center
    Portland, Oregon, United States
    Recruiting
  • Tennessee Oncology
    Nashville, Tennessee, United States
    Recruiting
Show 44 more locations
  • Vanderbilt University Medical Center
    Nashville, Tennessee, United States
    Recruiting
  • Royal Prince Alfred Hospital
    Camperdown, New South Wales, Australia
    Recruiting
  • Sunshine Coast University Hospital
    Birtinya, Queensland, Australia
    Recruiting
  • The Royal Melbourne Hospital
    Parkville, Victoria, Australia
    Recruiting
  • Bradfordhill
    Santiago, Santiago Metropolitan, Chile
    Recruiting
  • Pontifica Universidad Catolica De Chile
    Santiago Region Metropolitana, Santiago Metropolitan, Chile
    Recruiting
  • CHU Bordeaux Haut-Leveque
    Pessac, Aquitaine, France
    Recruiting
  • Centre Hospitalier Universitaire de Grenoble
    La Tronche, Auvergne-Rhône-Alpes, France
    Recruiting
  • Chu Saint Eloi
    Montpellier, Languedoc-Roussillon, France
    Recruiting
  • Centre Hospitalier Universitaire de Saint Étienne - Hôpital Nord
    Saint Priest En Jarez, Pays de la Loire Region, France
    Recruiting
  • Hôpital Avicenne
    Bobigny, France
    Recruiting
  • Uniklinik Koeln
    Cologne, North Rhine-Westphalia, Germany
    Recruiting
  • Universitatsklinikum Schleswig-Holstein
    Lübeck, Schleswig-Holstein, Germany
    Recruiting
  • Universitaetsklinikum Frankfurt
    Frankfurt, Germany
    Recruiting
  • Universitaetsmedizin Mainz
    Mainz, Germany
    Recruiting
  • IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"
    Meldola, Emilia-Romagna, Italy
    Recruiting
  • Azienda Ospedaliero Universitaria Pisana
    Pisa, Tuscany, Italy
    Recruiting
  • Uniwersyteckie Centrum Kliniczne
    Gdansk, Poland
    Recruiting
  • National University Hospital
    Singapore, Singapore
    Recruiting
  • National Cancer Centre Singapore
    Singapore, Singapore
    Recruiting
  • Cha Bundang Medical Center, Cha University
    Seongnam-si, Kyǒnggi-do, South Korea
    Recruiting
  • Asan Medical Center
    Seoul, Seoul-teukbyeolsi [Seoul], South Korea
    Recruiting
  • Samsung Medical Center
    Seoul, Seoul-teukbyeolsi [Seoul], South Korea
    Recruiting
  • Clinica Universidad de Navarra
    Pamplona, Navarre, Spain
    Recruiting
  • Hospital General Universitario Gregorio Marañon
    Madrid, Spain
    Recruiting
  • China Medical University Hospital
    Taichung, Taiwan
    Recruiting
  • National Cheng Kung University Hospital
    Tainan, Taiwan
    Recruiting
  • National Taiwan University Hospital
    Taipei, Taiwan
    Recruiting
  • Taipei Veterans General Hospital
    Taipei, Taiwan
    Recruiting
  • Hammersmith Hospital
    London, London, City of, United Kingdom
    Recruiting
  • Cancer Research UK - The Beatson Institute for Cancer Research (Cancer Research UK Beatson Laboratories)
    Glasgow, South Western Scotland, United Kingdom
    Recruiting
  • The Clatterbridge Cancer Centre
    Metropolitan Borough of Wirral, United Kingdom
    Recruiting
  • Local Institution - 0070
    Los Angeles, California, United States
    Not yet recruiting
  • Local Institution - 0107
    Chicago, Illinois, United States
    Not yet recruiting
  • Local Institution - 0134
    Detroit, Michigan, United States
    Not yet recruiting
  • Local Institution - 0083
    Seattle, Washington, United States
    Not yet recruiting
  • Local Institution - 0033
    Westmead, New South Wales, Australia
    Not yet recruiting
  • Local Institution - 0122
    Hefei, Anhui, China
    Not yet recruiting
  • Local Institution - 0114
    Beijing, Beijing Municipality, China
    Not yet recruiting
  • Local Institution - 0125
    Chongqing, Chongqing Municipality, China
    Not yet recruiting
  • Local Institution - 0116
    Fuzhou, Fujian, China
    Not yet recruiting
  • Local Institution - 0075
    Guangzhou, Guangdong, China
    Not yet recruiting
  • Local Institution - 0129
    Nanning, Guangxi, China
    Not yet recruiting
  • Local Institution - 0130
    Harbin, Heilongjiang, China
    Not yet recruiting

+17 more sites. See ClinicalTrials.gov for the full list.

Study contacts

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 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.