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 16, 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

Plain Language Summary

Simplified for easier understanding

This early-phase study tests the safety and tolerability of a new drug called pumitamig — alone or in combination with other therapies — in people with locally advanced or unresectable liver cancer (hepatocellular carcinoma, or HCC) who have not yet received systemic (whole-body) treatment. **You may be eligible if...** - You have been diagnosed with locally advanced or unresectable liver cancer (HCC), confirmed by biopsy - You have not received any prior systemic therapy for advanced HCC - You have at least one measurable tumor - You are in good general health (ECOG 0–1) **You may NOT be eligible if...** - You have significant bleeding disorders or blood clotting problems - You have had an organ transplant or have an autoimmune disease - Other protocol-specific health conditions apply Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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(46)

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

Mineola, New York, United States

Local Institution - 0080

Portland, Oregon, United States

Local Institution - 0111

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

Royal Prince Alfred Hospital

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

National Cheng Kung University Hospital

Tainan, Taiwan

Local Institution - 0006

Taipei, Taiwan

Taipei Veterans General Hospital

Taipei, Taiwan

Hammersmith Hospital

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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NCT07291076

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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)

Conditions

Summary

Eligibility

Plain Language Summary

Interventions

Locations(46)

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