drugset / Trial / NCT03942328

Modified Immune Cells (Autologous Dendritic Cells) and a Vaccine (Prevnar) Combined With Immune Checkpoint Inhibition After High-Dose External Beam Radiation Therapy in Treating Patients With Unresectable Liver Cancer

NCT03942328

Phase 1/2 Recruiting 85 enrolled Mayo Clinic National Cancer Institute (NCI) · collab
Non-randomizedCrossoverOpen-labelTreatment

Summary

This early phase I trial studies the side effects of autologous dendritic cells and a vaccine called Prevnar in combination with immune checkpoint inhibition (with bevacizumab and atezolizumab or druvalumab) in treating patients liver cancer that cannot be removed by surgery (unresectable) after undergoing standard high-dose external beam radiotherapy. Autologous dendritic cells are immune cells generated from patients' own white blood cells that are grown in a special lab and trained to stimulate the immune system to destroy tumor cells. A pneumonia vaccine called Prevnar may also help stimulate the immune system. Bevacizumab is in a class of medications called antiangiogenic agents. It works by stopping the formation of blood vessels that bring oxygen and nutrients to tumor. This may slow the growth and spread of tumor. Immunotherapy with monoclonal antibodies, such as atezolizumab and durvalumab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Giving autologous dendritic cells and Prevnar in combination with immune checkpoint inhibition after radiotherapy may be safe, and tolerable and may stimulate the body's own immune system to fight against the tumor in patients with unresectable liver cancer.

Timeline

Start
2019-09-19
Primary completion
2030-05-31
Completion
2031-02-28

Drugs

EvaluationDrugModalityDoseRoute
Subject Prevnar 13 Vaccine Intramuscular
Subject therapeutic autologous dendritic cells Vaccine Other
Background Atezolizumab Monoclonal antibody Intravenous
Background Bevacizumab Monoclonal antibody Intravenous
Background Durvalumab Monoclonal antibody Intravenous