Study of Tremelimumab and Durvalumab for Advanced Liver Cancer
This study is looking at the safety of two drugs, tremelimumab and durvalumab, in people with advanced liver cancer (hepatocellular carcinoma or HCC) and a specific type of liver scarring (Child-Pugh-B cirrhosis). You would receive a single dose of tremelimumab through an IV, followed by regular IV doses of durvalumab every four weeks. The main goal is to see how many people experience serious side effects. This study is for people aged 18 and older with advanced HCC who have not yet received treatment for it. The study aims to enroll 32 participants and is currently recruiting.
- Study design
- This is a single-arm, phase II study, meaning all 32 participants will receive the same treatment. It is not specified if the study is blinded.
- What's involved
- You will receive an IV dose of tremelimumab once, and then IV doses of durvalumab every four weeks. You will have CT or MRI scans before treatment and at least every 8 weeks, along with blood tests every cycle, until your disease progresses or side effects become too severe.
- Compensation
- Not stated in the trial record.
- Follow-up
- You will be followed for survival for up to one year after starting treatment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Study of Tremelimumab and Durvalumab (MEDI4736) (T300+D) in Advanced Hepatocellular Carcinomas With Child-Pugh-B Cirrhosis
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Sukeshi Arora, MD · PRINCIPAL_INVESTIGATOR · The University of Texas Health Science Center at San Antonio
Who to contact
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What this trial measures
- Grade 3 or Higher Treatment Related Treatment Emergent-Adverse Events (TRTE-AEs)Baseline up to 1 year
The number and grade 1-5 of all adverse events will be documented according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0; measured at baseline, each cycle, and up to 90 days after treatment discontinued. Grade 3 and higher TRTE-AEs will be reported for this outcome.