Tests pumitamig, with or without ipilimumab, in liver cancer
Tests pumitamig alone or with ipilimumab in adults with advanced liver cancer.
Key facts
- Who runs it
- Bristol-Myers Squibb
- Where
- Singapore, SingaporeSee the 2 sitesAlso in 13 other countries, 65 sites
- Trial code
- NCT07291076
- EU 2025-523602-33-00
- U1111-1327-4912
- Registry title
- 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)
- Status
- Recruiting
- Phase
- Phase 1/2
- People taking part
- 198 people, planned
- Started
- 16 Mar 2026
- Expected to end
- 14 Oct 2031
- Type of study
- Interventional, 7 groups
- Treatments tested
- Pumitamig
- Ipilimumab
- Record updated
- 23 October 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with liver cancer (hepatocellular carcinoma) that has spread locally or cannot be removed by surgery, and who have not yet had medicine for this stage.
- Age
- 18 years or older
- Sex
- Men and women can join.
- Disease stage
- Hepatocellular carcinoma confirmed under the microscope, locally advanced or not removable by surgery. The disease must be measurable (RECIST v1.1). ECOG performance status of 0 or 1.
- Earlier treatment
- No earlier systemic (whole-body) therapy for advanced or unresectable HCC.
Main reasons for not taking part
- Significant bleeding or blood clotting disorders, or clear signs of bleeding risk
- An organ transplant
- An autoimmune disease
The registry criteria, word for word
Show all 7 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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 in Singapore
Also in 13 other countries, 65 sites
- National Cancer Centre SingaporeSingapore, SingaporeContact: David Wai Meng Tai, Site 0012Taking people
- National University HospitalSingapore, SingaporeContact: Wei Peng Yong, Site 0009Taking people
About the trial
What the trial wants to find out
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)
The 7 groups in the trial
- Cohort 1ATreatment being tested
Treatment: Pumitamig and Ipilimumab
- Cohort 1BTreatment being tested
Treatment: Pumitamig and Ipilimumab
- Cohort 2ATreatment being tested
Treatment: Pumitamig and Ipilimumab
- Cohort 2BTreatment being tested
Treatment: Pumitamig and Ipilimumab
- Cohort 2CTreatment being tested
Treatment: Pumitamig
- Cohort 1A2Treatment being tested
Treatment: Pumitamig and Ipilimumab
- Cohort 1B2Treatment being tested
Treatment: Pumitamig and Ipilimumab
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
- 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)
- Plain-language title
- Tests pumitamig, with or without ipilimumab, in liver cancerGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 13 November 2026.
- Record updated
- 23 October 2026