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

Part of paid clinical trials in St Louis, Missouri.

Sponsor
University of Cincinnati
Study ID
NCT05027425
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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

Key Dates

Start date
Dec 7, 2021
Status verified
Apr 2026
Primary completion
Nov 7, 2024
Completion
Nov 7, 2024

Study Design

Enrollment
8 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Durvalumab + Tremelimumab + Liver Transplant
    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.

Primary Outcome Measure

Cellular Rejection Rates [ Time Frame: Up to 30 days post transplant. The average time from consent to transplant was 11.88 months. ]

Locations (3)

FacilityCityStateZIPSite coordinators
Washington University School of MedicineSt LouisMissouri63130-
University of CincinnatiCincinnatiOhio45267-
Simmons Comprehensive Cancer Center UT Southwestern Medical CenterDallasTexas75235-

Find similar trials in St Louis, MO

By condition
Liver cancer
By specialty
OncologyGI oncologyHepatology
By research site
Washington University School of Medicine· St Louis, MOUniversity of Cincinnati· Cincinnati, OHSimmons Comprehensive Cancer Center UT Southwestern Medical Center· Dallas, TX

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