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
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 198 (estimated) |
| Sponsor | Bristol-Myers Squibb Industry-sponsored |
| Drugs / interventions | Ipilimumab |
| Locations | 67 sites (Duarte, California and 66 other locations) |
| Status | Recruiting |
| Started | March 16, 2026 |
| Main results expected | October 15, 2029 |
| Study ends | October 14, 2031 |
| Registry record updated | October 23, 2026 |
| Trial ID | NCT07291076 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
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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
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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
- Study coordinator: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
- Email: Clinical.Trials@bms.com
- Phone: 855-907-3286
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.