RecruitingPhase 1Phase 2NCT07291076

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)

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)

Sponsor

Bristol-Myers Squibb

Enrollment

129 participants

Start Date

Mar 31, 2026

Study Type

INTERVENTIONAL

Conditions

Hepatocellular Carcinoma (HCC)

Summary

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)

Eligibility

Min Age: 18 Years

Inclusion Criteria4

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 Criteria2

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.

Interventions

DRUGPumitamig

Specified dose on specified days

DRUGIpilimumab

Specified dose on specified days

DRUGAtezolizumab

Specified dose on specified days

DRUGBevacizumab

Specified dose on specified days

Locations(45)

Local Institution - 0070

Los Angeles, California, United States

Local Institution - 0107

Chicago, Illinois, United States

John Theurer Cancer Center at Hackensack University Medical Center

Hackensack, New Jersey, United States

Local Institution - 0100

Great Neck, New York, United States

Local Institution - 0080

Portland, Oregon, United States

Local Institution - 0022

Nashville, Tennessee, United States

Local Institution - 0102

Nashville, Tennessee, United States

Local Institution - 0083

Seattle, Washington, United States

Local Institution - 0024

Camperdown, New South Wales, Australia

Local Institution - 0033

Westmead, New South Wales, Australia

Local Institution - 0040

Birtinya, Queensland, Australia

Local Institution - 0096

Melbourne, Australia

Local Institution - 0064

Santiago, Santiago Metropolitan, Chile

Local Institution - 0106

Santiago Region Metropolitana, Santiago Metropolitan, Chile

Local Institution - 0075

Guangzhou, Guangdong, China

Local Institution - 0086

Xi'an, Shaanxi, China

Local Institution - 0078

Shanghai, Shanghai Municipality, China

Local Institution - 0056

Pessac, Aquitaine, France

Local Institution - 0004

Grenoble, Isère, France

Local Institution - 0018

Saint Priest En Jarez, Pays de la Loire Region, France

Local Institution - 0003

Bobigny, France

Local Institution - 0031

Cologne, North Rhine-Westphalia, Germany

Local Institution - 0028

Kiel, Schleswig-Holstein, Germany

Local Institution - 0030

Frankfurt, Germany

Local Institution - 0109

Pisa, Tuscany, Italy

Local Institution - 0088

Milan, Italy

Local Institution - 0016

Pisa, Italy

Local Institution - 0046

Rozzano (MI), Italy

Local Institution - 0021

Wroclaw, Lower Silesian Voivodeship, Poland

Local Institution - 0105

Warsaw, Masovian Voivodeship, Poland

Local Institution - 0020

Gdansk, Poland

Local Institution - 0009

Singapore, Singapore

Local Institution - 0012

Singapore, Singapore

Local Institution - 0027

Seongnam-si, Gyeonggi-do, South Korea

Local Institution - 0013

Seoul, Seoul Teugbyeolsi, South Korea

Local Institution - 0011

Seoul, Seoul-teukbyeolsi, South Korea

Local Institution - 0014

Pamplona, Navarre, Spain

Local Institution - 0060

Madrid, Spain

Local Institution - 0032

Taichung, Taiwan

Local Institution - 0055

Tainan, Taiana, Taiwan

Local Institution - 0006

Taipei, Taiwan

Local Institution - 0007

Taipei, Taiwan

Local Institution - 0073

London, London, City of, United Kingdom

Local Institution - 0051

Glasgow, South Western Scotland, United Kingdom

Local Institution - 0053

Metropolitan Borough of Wirral, United Kingdom

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