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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) | Clinical Trials | Clareo Health

RECRUITINGPHASE1/PHASE2

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)

NCT07291076•Bristol-Myers Squibb

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.

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

Key Dates

Start Date

March 31, 2026

Primary Completion Date

October 15, 2029

Completion Date

October 14, 2031

Last Updated

March 4, 2026

Enrollment

129

ESTIMATED participants

Conditions

Hepatocellular Carcinoma (HCC)

Interventions

Pumitamig

DRUG

Ipilimumab

DRUG

Atezolizumab

DRUG

Bevacizumab

DRUG

Contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

855-907-3286 Clinical.Trials@bms.com

First line of the email MUST contain NCT # and Site #.

CONTACT

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RECRUITINGPHASE4

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 4, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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)

Inclusion Criteria

Exclusion Criteria

NIS on the Benefits of TIPS in Patients With HCC Receiving Atezo+Bev in 1st-Line Therapy

The Treatment of Liver Injury After Liver Resection With Polyene Phosphatidylcholine

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