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Recruiting Phase 1/2 NCT07291076

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)

Phase 1/2 – combined early trial
Conditions: Hepatocellular Carcinoma (HCC)

Sponsor: Bristol-Myers Squibb

trial.available_in: БГ
Overview
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)
Who can participate
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.
Locations 13
Australia (1)
Royal Prince Alfred Hospital
Camperdown , New South Wales
Simone Strasser, Site 0024
Chile (1)
Local Institution - 0064
Santiago , Santiago Metropolitan
NOT_YET_RECRUITING
China (1)
Local Institution - 0075
Guangzhou , Guangdong
NOT_YET_RECRUITING
France (1)
Local Institution - 0056
Pessac , Aquitaine
NOT_YET_RECRUITING
Germany (1)
Local Institution - 0031
Cologne , North Rhine-Westphalia
NOT_YET_RECRUITING
Italy (1)
Local Institution - 0109
Pisa , Tuscany
NOT_YET_RECRUITING
Poland (1)
Local Institution - 0021
Wroclaw , Lower Silesian Voivodeship
NOT_YET_RECRUITING
Singapore (1)
Local Institution - 0009
Singapore
NOT_YET_RECRUITING
South Korea (1)
Local Institution - 0027
Seongnam-si , Gyeonggi-do
NOT_YET_RECRUITING
Spain (1)
Local Institution - 0014
Pamplona , Navarre
NOT_YET_RECRUITING
Taiwan (1)
Local Institution - 0032
Taichung
NOT_YET_RECRUITING
United Kingdom (1)
Hammersmith Hospital
London , London, City of
David Pinato, Site 0073
United States (1)
Local Institution - 0070
Los Angeles , California
NOT_YET_RECRUITING
Technical details
Status
Recruiting
Phase
Phase 1/2
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
16.03.2026
Completion date
14.10.2031
Registry ID
NCT07291076
Source
anzctr
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