A Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients with Advanced Liver Cancers (Morpheus-Liver)
- Conditions
- Advanced liver cancersMedDRA version: 21.1Level: LLTClassification code: 10049010Term: Carcinoma hepatocellular Class: 10029104Therapeutic area: Diseases [C] - Neoplasms [C04]
- Registration Number
- CTIS2023-506611-17-00
- Lead Sponsor
- F. Hoffmann-La Roche AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 275
1. Age = 18 years, with an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 within 7 days prior to randomization, 2. Locally advanced or metastatic and/or unresectable hepatocellular carcinoma (HCC) with diagnosis confirmed by histology/cytology or clinically by American Association for the Study of Liver Diseases criteria in cirrhotic patients, 3. Child-Pugh class A within 7 days prior to randomization, 4. Disease that is not amenable to curative surgical and/or locoregional therapies, 5. No prior systemic treatment (including systemic investigational agents) for HCC, 6. Life expectancy = 3 months, as determined by the investigator and availability of a representative tumor specimen that is suitable for determination of PD-L1 and/or additional biomarker status via central testing
1. Prior treatment with CD137 agonists or immune checkpoint blockade therapies, 2. Treatment with investigational therapy within 28 days prior to initiation of study, 3. Treatment with locoregional therapy to liver within 28 days prior to initiation of study, or non-recovery from side effects of any such procedure, 4. Untreated or incompletely treated esophageal and/or gastric varices with bleeding or at high risk for bleeding, 5. A prior bleeding event due to esophageal and/or gastric varices within 6 months prior to initiation of study, 6. AEs from prior anti-cancer therapy that have not resolved to Grade 1 or better, with the exception of alopecia of any grade
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method