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NCT07291076PHASE1, PHASE2Recruiting

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)

Bristol-Myers Squibb

Start Date

3/16/2026

Completion Date

10/14/2031

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 Criteria

Age Range: 18 years to No maximum

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.

Interventions

DRUG

Pumitamig

DRUG

Ipilimumab

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Conditions

Hepatocellular Carcinoma (HCC)

Locations

Local Institution - 0137

Duarte, California 91010

United States

Local Institution - 0070

Los Angeles, California 90064

United States

Local Institution - 0107

Chicago, Illinois 60611

United States

Local Institution - 0134

Detroit, Michigan 48202

United States

John Theurer Cancer Center at Hackensack University Medical Center

Hackensack, New Jersey 07601-2191

United States

Local Institution - 0100

Mineola, New York 11501

United States

Providence Portland Medical Center

Portland, Oregon 97213

United States

Providence St. Vincent Medical Center

Portland, Oregon 97225

United States

Tennessee Oncology

Nashville, Tennessee 37203

United States

Vanderbilt University Medical Center

Nashville, Tennessee 37232

United States

Local Institution - 0083

Seattle, Washington 98109-1024

United States

Royal Prince Alfred Hospital

Camperdown, New South Wales 2050

Australia

Local Institution - 0033

Westmead, New South Wales 2145

Australia

Sunshine Coast University Hospital

Birtinya, Queensland 4575

Australia

The Royal Melbourne Hospital

Parkville, Victoria 3052

Australia

Bradfordhill

Santiago, Santiago Metropolitan 8420383

Chile

Pontifica Universidad Catolica De Chile

Santiago Region Metropolitana, Santiago Metropolitan 8330034

Chile

Local Institution - 0114

Beijing, Beijing Municipality 100036

China

Local Institution - 0125

Chongqing, Chongqing Municipality 400016

China

Local Institution - 0116

Fuzhou, Fujian 350028

China

Local Institution - 0075

Guangzhou, Guangdong 510515

China

Local Institution - 0130

Harbin, Heilongjiang 150001

China

Local Institution - 0128

Nanyang, Henan 473000

China

Local Institution - 0119

Nanjing, Jiangsu 210008

China

Local Institution - 0123

Nanchang, Jiangxi 330006

China

Local Institution - 0115

Xi'an, Shaanxi 710038

China

Local Institution - 0086

Xi'an, Shaanxi 710126

China

Local Institution - 0118

Jinan, Shandong 250117

China

Local Institution - 0078

Shanghai, Shanghai Municipality 200032

China

Local Institution - 0126

Hangzhou, Zhejiang 310022

China

CHU Bordeaux Haut-Leveque

Pessac, Aquitaine 33600

France

Centre Hospitalier Universitaire de Grenoble

La Tronche, Auvergne-Rhône-Alpes 38700

France

Local Institution - 0001

Montpellier, Languedoc-Roussillon 34295

France

Local Institution - 0018

Saint Priest En Jarez, Pays de la Loire Region 42270

France

Local Institution - 0003

Bobigny, 93000

France

Local Institution - 0031

Cologne, North Rhine-Westphalia 50937

Germany

Universitatsklinikum Schleswig-Holstein

Lübeck, Schleswig-Holstein 23538

Germany

Universitaetsklinikum Frankfurt

Frankfurt, D-60590

Germany

Local Institution - 0026

Mainz, 55101

Germany

IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"

Meldola, Emilia-Romagna 47014

Italy

Local Institution - 0109

Pisa, Tuscany 56126

Italy

Local Institution - 0089

Milan, 20132

Italy

Local Institution - 0016

Pisa, 56126

Italy

Local Institution - 0017

Osakasayama-shi, Osaka 5898511

Japan

Local Institution - 0008

Kashiwa, 277-8577

Japan

Local Institution - 0021

Wroclaw, Lower Silesian Voivodeship 53-439

Poland

Local Institution - 0105

Warsaw, Masovian Voivodeship 02-106

Poland

Local Institution - 0020

Gdansk, 80-952

Poland

Local Institution - 0009

Singapore, 119074

Singapore

Local Institution - 0012

Singapore, 169610

Singapore

Local Institution - 0027

Seongnam-si, Gyeonggi-do 13496

South Korea

Local Institution - 0013

Seoul, Seoul Teugbyeolsi 06351

South Korea

Local Institution - 0011

Seoul, Seoul-teukbyeolsi 05505

South Korea

Local Institution - 0014

Pamplona, Navarre 31008

Spain

Local Institution - 0015

Barcelona, 8036

Spain

Hospital General Universitario Gregorio Marañon

Madrid, 28007

Spain

Local Institution - 0095

Madrid, 28050

Spain

Local Institution - 0032

Taichung, 404332

Taiwan

National Cheng Kung University Hospital

Tainan, 704

Taiwan

National Taiwan University Hospital

Taipei, 10002

Taiwan

Taipei Veterans General Hospital

Taipei, 11217

Taiwan

Hammersmith Hospital

London, London, City of W12 0HS

United Kingdom

Cancer Research UK - The Beatson Institute for Cancer Research (Cancer Research UK Beatson Laboratories)

Glasgow, South Western Scotland G611BD

United Kingdom

Local Institution - 0053

Metropolitan Borough of Wirral, CH63 4JY

United Kingdom