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)
Recruiting now · Phase 1/Phase 2
Conditions studied: Hepatocellular Carcinoma (HCC)
In brief
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)
Key facts
- Study ID
- NCT07291076
- Run by
- Bristol-Myers Squibb
- People needed
- 198
- Starts
- 2026-03-16
- Expected to finish
- 2031-10-14
- Last updated by the study team
- 2026-07-23
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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 is running
- Taipei Veterans General Hospital — Taipei, Taiwan (enrolling)
- Hospital General Universitario Gregorio Marañon — Madrid, Spain (enrolling)
- Universitatsklinikum Schleswig-Holstein — Lübeck, Schleswig-Holstein, Germany (enrolling)
- National Taiwan University Hospital — Taipei, Taiwan (enrolling)
- Royal Prince Alfred Hospital — Camperdown, New South Wales, Australia (enrolling)
- Providence Portland Medical Center — Portland, Oregon, United States (enrolling)
- Providence St. Vincent Medical Center — Portland, Oregon, United States (enrolling)
- Centre Hospitalier Universitaire de Grenoble — La Tronche, Auvergne-Rhône-Alpes, France (enrolling)
- IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori" — Meldola, Emilia-Romagna, Italy (enrolling)
- National Cheng Kung University Hospital — Tainan, Taiwan (enrolling)
- Cancer Research UK - The Beatson Institute for Cancer Research (Cancer Research UK Beatson Laboratories) — Glasgow, South Western Scotland, United Kingdom (enrolling)
- Hammersmith Hospital — London, London, City of, United Kingdom (enrolling)
- Sunshine Coast University Hospital — Birtinya, Queensland, Australia (enrolling)
- The Royal Melbourne Hospital — Parkville, Victoria, Australia (enrolling)
- Bradfordhill — Santiago, Santiago Metropolitan, Chile (enrolling)
- Pontifica Universidad Catolica De Chile — Santiago Region Metropolitana, Santiago Metropolitan, Chile (enrolling)
- Tennessee Oncology — Nashville, Tennessee, United States (enrolling)
- CHU Bordeaux Haut-Leveque — Pessac, Aquitaine, France (enrolling)
- Vanderbilt University Medical Center — Nashville, Tennessee, United States (enrolling)
- Universitaetsklinikum Frankfurt — Frankfurt, Germany (enrolling)
- John Theurer Cancer Center at Hackensack University Medical Center — Hackensack, New Jersey, United States (enrolling)
- Local Institution - 0033 — Westmead, New South Wales, Australia
- Local Institution - 0123 — Nanchang, Jiangxi, China
- Local Institution - 0119 — Nanjing, Jiangsu, China
- Local Institution - 0100 — Mineola, New York, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.