NCT05027425

Durvalumab (MEDI4736) and Tremelimumab for Hepatocellular Carcinoma in Patients Listed for a Liver Transplant

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Davendra Sohal · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Immunotherapy can safely downstage patients and achieve durable systemic disease control to improve clinical outcomes in HCC patients undergoing liver transplant.

Detailed description

ESR-20-21010 is a single-arm, open-label, Phase II, multicenter clinical trial designed to evaluate the safety and efficacy of durvalumab and tremelimumab for the treatment of hepatocellular carcinoma (HCC) patients who have cirrhosis or portal hypertension and are evaluated by institutional Liver Transplant team and deemed eligible for transplant. The key eligibility requirements include HCC, Child-Pugh score of up to 7, and ECOG PS of 0 or 1. Patients will be treated with the immunotherapy combination for up to 4 months. After a minimum 28 day washout, they will undergo locoregional therapy per institutional standards. Eventually, after a minimum 72-day washout from the end of immunotherapy, they will undergo liver transplant. The primary endpoint is proportion of patients experiencing post-transplant rejection (within 30 days of transplant). A total of 30 patients are to be enrolled, to allow at least 20 transplants for adequate primary endpoint analysis. An interim analysis after 10 patients will be performed to ensure safety. If there are untoward safety signals, study modification/discontinuation will be discussed.

Conditions

• Hepatocellular Carcinoma
• Cirrhosis
• Portal Hypertension

Interventions

Type	Name	Description
DRUG	Durvalumab	1500 mg IV, Q4W
DRUG	Tremelimumab	300 mg IV, 1 dose on day 1 of only the first cycle
PROCEDURE	Liver Transplant	minimum 72-day washout from the end of immunotherapy, patients will undergo liver transplant.

Timeline

• Start date: 2021-12-07
• Primary completion: 2025-12-07
• Completion: 2030-12-07
• First posted: 2021-08-30
• Last updated: 2024-11-22

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study