A Study of Pumitamig and Ipilimumab for Advanced Liver Cancer
This study is looking at the safety of two drugs, Pumitamig and Ipilimumab, when given alone or together to people with advanced or unresectable hepatocellular carcinoma (HCC), which is a type of liver cancer. You might be able to join if you are 18 or older, have been diagnosed with advanced or unresectable HCC, and haven't had other systemic treatments for it. The study will measure how many participants experience side effects or serious side effects to understand the safety of these treatments. The study plans to enroll about 198 participants, but its current recruitment status is unclear.
- Study design
- This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll about 198 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study measures side effects for up to approximately 25 weeks, and dose-limiting toxicities for up to 21 days.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
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)
At a glance
Conditions
NCT07291076
Where you'd take part
This study runs at 67 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Asan Medical Center
Seoul, Seoul-teukbyeolsi [Seoul], South Koreastudy coordinator listed
Recruiting
Azienda Ospedaliero Universitaria Pisana
Pisa, Tuscany, Italystudy coordinator listed
Recruiting
Bradfordhill
Santiago, Santiago Metropolitan, Chilestudy coordinator listed
Recruiting
Cancer Research UK - The Beatson Institute for Cancer Research (Cancer Research UK Beatson Laboratories)
Glasgow, South Western Scotland, United Kingdomstudy coordinator listed
Recruiting
Centre Hospitalier Universitaire de Grenoble
La Tronche, Auvergne-Rhône-Alpes, Francestudy coordinator listed
Recruiting
Centre Hospitalier Universitaire de Saint Étienne - Hôpital Nord
Saint Priest En Jarez, Pays de la Loire Region, Francestudy coordinator listed
Recruiting
Cha Bundang Medical Center, Cha University
Seongnam-si, Kyǒnggi-do, South Koreastudy coordinator listed
Recruiting
China Medical University Hospital
Taichung, Taiwanstudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Bristol-Myers Squibb · STUDY_DIRECTOR · Bristol-Myers Squibb
Who to contact
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Inclusion
Exclusion
What this trial measures
- Number of participants with adverse events (AEs)Up to approximately 25 weeks
Phase 1
- Number of participants with serious adverse events (SAEs) (as per Common Terminology Criteria for Adverse Events v5 (CTCAE v5))Up to approximately 25 weeks
Phase 1
- Number of participants with AEs meeting protocol-defined dose-limiting toxicity (DLT) criteriaUp to day 21
Phase 1
- Number of participants with AEs leading to discontinuationUp to approximately 25 weeks
Phase 1
- Number of participants with AEs leading to deathUp to approximately 25 weeks
Phase 1
- Objective response (OR) (confirmed complete response (CR) or partial response (PR)) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 per investigator assessmentUp to week 48
Phase 2