Phase II Trial of Durvalumab (MEDI4736) With/Without Tremelimumab for Advanced Hepatocellular Carcinoma After Palliative Hypofractionated Radiotherapy
Mary Feng, MD
Summary
This phase II trial studies how well standard of care hypofractionated radiation therapy followed by durvalumab with or without tremelimumab works in treating patients with hepatocellular cancer (liver cancer) that has spread to other places in the body (advanced) and that is growing, spreading, or getting worse (progressing). In some patients, cancer cells and immune cells start to express signals that stop the body's immune system from killing the cancer. New drugs being developed, such as durvalumab and tremelimumab, are designed to target and block these signals and may help increase the immune response to prevent or slow down cancer growth. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may help the immune system work even better. Giving durvalumab with or without tremelimumab after radiation therapy may work better than radiation therapy alone in treating patients with liver cancer.
Description
PRIMARY OBJECTIVE: I. Determine Objective Response Rate (ORR) (per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, excluding radiotherapy (RT)-treated lesions as targets) of Durvalumab (D), and D + Tremelimumab (T) after palliative RT in advanced Hepatocellular carcinoma (HCC) participants with or without progression on prior programmed death-ligand 1 (PD-L1) immune checkpoint inhibitor. SECONDARY OBJECTIVES: I. To determine the safety and tolerability of study interventions. II. Determine the efficacy of treatment interventions defined as progression-free survival (PFS)…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Histologically-diagnosed HCC with progression during or after prior PD-(L)1 checkpoint inhibitor immunotherapy (e.g., nivolumab and/or pembrolizumab or atezolizumab; prior durvalumab excluded), or without prior PD-(L)1 checkpoint inhibitor immunotherapy. a. For patients without prior histologic or cytologic diagnosis, radiographic diagnosis is allowed provided patients meet American Association for the Study of Liver Diseases (AASLD) criteria for radiographic diagnosis. 2. At least 1 Response Evaluation Criteria in Solid Tumors (RECIST) 1.1-measurable tumor present…
Interventions
- BiologicalDurvalumab
Given IV
- RadiationHypofractionated Radiation Therapy
Undergo hypofractionated RT
- BiologicalTremelimumab
Given IV
Location
- University of California, San FranciscoSan Francisco, California