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Clinical Trial Summary

This phase II trial studies the side effects and how well nivolumab with or with ipilimumab works in treating patients with liver cancer that can be removed by surgery. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.


Clinical Trial Description

Primary Objective: --To evaluate the safety and tolerability of therapy with nivolumab alone or nivolumab + ipilimumab in resectable HCC in the context of presurgical therapy. Note: Note: As of January 8, 2020, 30 patients have been enrolled and 27 patients have been randomized. The PI decided to stop enrollment since the study has reached its target enrollment of 30 patients Secondary Objectives: --To assess the efficacy of presurgical nivolumab alone or nivolumab + ipilimumab therapy in HCC by estimating the objective response rate (ORR) and time to progression (TTP) per RECIST 1.1 progression-free survival (PFS). Exploratory Objectives: --To assess the immunological/biomarker changes in tumor tissues and peripheral blood in response to nivolumab alone or nivolumab + ipilimumab in HCC therapy (pre- vs post-treatment), and explore any potential association between these biomarker measures and antitumor response and immune-related response criteria (iRC) assessed by MD Anderson Department of Diagnostic Imaging. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03222076
Study type Interventional
Source M.D. Anderson Cancer Center
Contact
Status Completed
Phase Phase 2
Start date September 28, 2017
Completion date September 14, 2022

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