A Phase Ib/II, Open-Label, Multicenter, Randomized Umbrella Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients With Advanced Liver Cancers (Morpheus-Liver)
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Health Professionals
What is the purpose of this trial?
This is a Phase Ib/II, open-label, multicenter, randomized umbrella study in participants with advanced liver cancers. The study is designed with the flexibility to open new treatment arms as new treatments become available, close existing treatment arms that demonstrate minimal clinical activity or unacceptable toxicity, modify the participant population, or introduce additional cohorts of participants with other types of advanced primary liver cancer.
Cohort 1 will enroll participants with locally advanced or metastatic hepatocellular carcinoma (HCC) who have not received prior systemic therapy for their disease. Eligible participants will initially be randomly assigned to one of several treatment arms (Stage 1). Participants who experience loss of clinical benefit or unacceptable toxicity during Stage 1 may be eligible to receive treatment with a different treatment combination (Stage 2). When a Stage 2 treatment combination is available, this will be introduced by amending the protocol.
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Principal Investigator
Sub-Investigators
- Agatha Hecht
- Alison Johnson
- Armand Russo, MD
- Clarice Grens
- Harold Tara Jr, MD
- Jeremy Kortmansky, MD
- Jill Lacy, MD
- Jose Morales-Marin
- Justin Persico, MD
- Kristen Hoxie
- Larisa Fleysher
- Laura Sabourin
- Laura Van Metre Baum, MD, MPH
- Madeline Santiago
- Melissa Gambaccini, APRN, AOCNP, FNPC
- Michael Cecchini, MD
- Michael Cohenuram, MD
- Neal Fischbach, MD
- Osarugue Otasowie
- Pawan Karanam, MD
- Sara Anastasio, RN
- Teresa White
- Thejal Srikumar, MD, MPH
- Vanna Dest
- Vidya Kesavan
- Virginia Syombathy
- Zia Rahman, MD
- Last Updated02/13/2025
- Study HIC#2000030007