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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)

NCT07291076

RecruitingPhase 1, Phase 2

Sponsor: Bristol-Myers Squibb

Conditions: Hepatocellular Carcinoma (HCC)

Interventions: Pumitamig, Ipilimumab

Countries: United States, Australia, Chile, China, France, Germany, Italy, Japan

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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 (67)

Duarte, California, United States
Los Angeles, California, United States
Chicago, Illinois, United States
Detroit, Michigan, United States
Hackensack, New Jersey, United States
Mineola, New York, United States
Portland, Oregon, United States
Portland, Oregon, United States
Nashville, Tennessee, United States
Nashville, Tennessee, United States
Seattle, Washington, United States
Camperdown, New South Wales, Australia
Westmead, New South Wales, Australia
Birtinya, Queensland, Australia
Parkville, Victoria, Australia
Santiago, Santiago Metropolitan, Chile
Santiago Region Metropolitana, Santiago Metropolitan, Chile
Hefei, Anhui, China
Beijing, Beijing Municipality, China
Chongqing, Chongqing Municipality, China
Fuzhou, Fujian, China
Guangzhou, Guangdong, China
Nanning, Guangxi, China
Harbin, Heilongjiang, China
Nanyang, Henan, China
Nanjing, Jiangsu, China
Nanchang, Jiangxi, China
Xi'an, Shaanxi, China
Xi'an, Shaanxi, China
Jinan, Shandong, China
+ 37 more on CT.gov