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A Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients with Advanced Liver Cancers (Morpheus-Liver)
EU CTIS ID: 2023-506611-17-00
What this study is testing
To evaluate the efficacy of immunotherapy-based treatment combinations based on objective response rate (ORR) as determined by the investigator according to RECIST v1.1 and to evaluate the safety of immunotherapy-based treatment combinations
- Phase I and Phase II (Integrated)- Other
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- 1. Prior treatment with CD137 agonists or immune checkpoint blockade therapies or inhibitors targeting HIF2alpha
- 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
The study team makes the final eligibility decision.
Where it's taking place
- New Zealand
- Israel
- Korea, Republic of
- China
- Taiwan
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New Zealand; Israel; Korea, Republic of; China; Taiwan; United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.