Vanderbilt Clinical Trials

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)

Purpose

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)

Condition

Hepatocellular Carcinoma (HCC)

Eligibility

Eligible Ages: Over 18 Years
Eligible Sex: All
Accepts Healthy Volunteers: No

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.

Study Design

Phase: Phase 1/Phase 2
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Masking: None (Open Label)

Arm Groups

Arm	Description	Assigned Intervention
Experimental Cohort 1A		Drug: Pumitamig Specified dose on specified days Other names: BMS-986545 Drug: Ipilimumab Specified dose on specified days Other names: Yervoy
Experimental Cohort 1B		Drug: Pumitamig Specified dose on specified days Other names: BMS-986545 Drug: Ipilimumab Specified dose on specified days Other names: Yervoy
Experimental Cohort 2A		Drug: Pumitamig Specified dose on specified days Other names: BMS-986545 Drug: Ipilimumab Specified dose on specified days Other names: Yervoy
Experimental Cohort 2B		Drug: Pumitamig Specified dose on specified days Other names: BMS-986545 Drug: Ipilimumab Specified dose on specified days Other names: Yervoy
Other Cohort 2C		Drug: Atezolizumab Specified dose on specified days Drug: Bevacizumab Specified dose on specified days
Experimental Cohort 2D		Drug: Pumitamig Specified dose on specified days Other names: BMS-986545

Recruiting Locations

Vanderbilt University Medical Center
Nashville, Tennessee 37232

Contact:
Thatcher Heumann, Site 0102
615-875-6814

More Details

Status: Recruiting
Sponsor: Bristol-Myers Squibb

Study Contact

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
855-907-3286
Clinical.Trials@bms.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.