Immune Therapy + Bevacizumab for Advanced Liver Cancer
Trial Summary
What is the purpose of this trial?
This is a multicenter, open-label, stratified, randomized study to evaluate the safety, tolerability, antitumor activity, pharmacokinetics, pharmacodynamics, and immunogenicity of durvalumab or tremelimumab monotherapy, or durvalumab in combination with tremelimumab or bevacizumab in advanced hepatocellular carcinoma.
Research Team
MedImmune, LLC MedImmune, LLC
Principal Investigator
MedImmune LLC
Eligibility Criteria
This trial is for adults with advanced liver cancer who have either not responded to, cannot tolerate, or chose not to use sorafenib or similar drugs. It's also open to those who haven't had any systemic therapy for their cancer. People can't join if they've had certain complications like ascites needing intervention, hepatic encephalopathy, major blood vessel thrombosis in the liver, active autoimmune diseases, recent immunosuppressive meds use, or gastrointestinal bleeding within the last year.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive various dosing regimens of durvalumab, tremelimumab, and bevacizumab based on the study part and cohort
Follow-up
Participants are monitored for safety and effectiveness after treatment
Survival Follow-up
All participants will be followed for survival until the end of study visit
Treatment Details
Interventions
- Bevacizumab
- Durvalumab
- Tremelimumab
Durvalumab is already approved in European Union, United States, Japan for the following indications:
- Locally advanced, unresectable non-small cell lung cancer (NSCLC)
- Extensive-stage small cell lung cancer (ES-SCLC)
- Limited-stage small cell lung cancer (LS-SCLC)
- Locally advanced or metastatic urothelial carcinoma
- Not specified in provided sources
Find a Clinic Near You
Who Is Running the Clinical Trial?
MedImmune LLC
Lead Sponsor
Dr. Reginald Seeto
MedImmune LLC
Chief Medical Officer since 2008
MD from University of Sydney, B.Sc. from University of Sydney
Peter Greenleaf
MedImmune LLC
Chief Executive Officer since 2006
MBA from St. Joseph’s University, B.S. from Western Connecticut State University