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 |
|---|---|---|
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Experimental Cohort 1A |
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Experimental Cohort 1B |
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Experimental Cohort 2A |
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Experimental Cohort 2B |
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Other Cohort 2C |
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Experimental Cohort 2D |
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Recruiting Locations
Vanderbilt University Medical Center
Nashville, Tennessee 37232
Nashville, Tennessee 37232
Contact:
Thatcher Heumann, Site 0102
615-875-6814
Thatcher Heumann, Site 0102
615-875-6814
More Details
- Status
- Recruiting
- Sponsor
- Bristol-Myers Squibb
Study Contact
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com855-907-3286
Clinical.Trials@bms.com