A Phase II Study to Evaluate the Efficacy and Safety of Y-90, Durvalumab, Tremelimumab, and Zanzalintinib in Patients With Unresectable and Locally-Advanced Hepatocellular Carcinoma
OHSU Knight Cancer Institute
Summary
This phase II trial tests how well giving Y-90 radioembolization, durvalumab, tremelimumab and zanzalintinib works for the treatment of hepatocellular carcinoma that cannot be removed by surgery (unresectable) and that has spread to nearby tissue or lymph nodes (locally advanced). Y-90 radioembolization is a therapy that injects radioactive particles directly into an artery that feeds liver tumors to cut off their blood supply. Immunotherapy with monoclonal antibodies, such as durvalumab and tremelimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Zanzalintinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving Y-90 radioembolization, durvalumab, tremelimumab and zanzalintinib may be effective for treating unresectable and locally-advanced hepatocellular carcinoma.
Description
PRIMARY OBJECTIVE: I. To assess proportion of participants that are progression-free at 6 months. SECONDARY OBJECTIVES: I. To assess safety of study intervention. II. To estimate objective response rate (ORR) for study intervention. III. To estimate disease control rate (DCR) for study intervention. IV. To estimate time to disease progression (TTP) for study intervention. V. To estimate progression-free survival. VI. To estimate overall survival (OS) for study intervention. EXPLORATORY OBJECTIVE: I. To evaluate therapy induced changes in the tumor and tumor immune microenvironments. OUTL…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Participant must provide written informed consent before any study-specific procedures or interventions are performed * Participants aged ≥ 18 years * Body weight \> 30 kg * Patients must have radiologically, or histologically or cytologically confirmed hepatocellular cancer that is not amenable to transplant or resection: * Barcelona Clinic Liver Cancer Stage B or C * Cirrhosis grade of Child-Pugh (CP) A or CP-B7 (excluding albumin-bilirubin \[ALBI\] grade 3) * Fibrolamellar and mixed hepatocellular/cholangiocarcinoma subtypes are not eligible * Disease must not…
Interventions
- ProcedureAngiogram
Undergo angiogram
- ProcedureBiopsy Procedure
Undergo tumor biopsy
- ProcedureBiospecimen Collection
Undergo blood and urine sample collection
- ProcedureComputed Tomography
Undergo CT scan
- BiologicalDurvalumab
Given IV
- ProcedureMagnetic Resonance Imaging
Undergo MRI
- ProcedureSingle Photon Emission Computed Tomography
Location
- OHSU Knight Cancer InstitutePortland, Oregon