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)
Sponsor: Bristol-Myers Squibb
Sponsor score: 60
ClinicalTrials ID:NCT07291076
This clinical trial assesses the safety and tolerability of Pumitamig, alone or with Ipilimumab, in advanced or unresectable HCC. Eligible participants are those with first-line HCC. Interventions include Pumitamig, Ipilimumab, Atezolizumab, and Bevacizumab, each administered at specified doses on designated days.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
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
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
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Local Institution - 0070 | 90064 | Los Angeles | California |
| Local Institution - 0107 | 60611 | Chicago | Illinois |
| John Theurer Cancer Center at Hackensack University Medical Center | 07601-2191 | Hackensack | New Jersey |
| Local Institution - 0100 | 11501 | Mineola | New York |
| Providence Portland Medical Center | 97213 | Portland | Oregon |
| Providence St. Vincent Medical Center | 97225 | Portland | Oregon |
| Tennessee Oncology | 37203 | Nashville | Tennessee |
| Vanderbilt University Medical Center | 37232 | Nashville | Tennessee |
| Local Institution - 0083 | 98109-1024 | Seattle | Washington |
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