drugset / Trial / NCT02794883

Tremelimumab and Durvalumab in Combination or Alone in Treating Patients With Recurrent Malignant Glioma

NCT02794883

RandomizedParallel-groupOpen-labelTreatment

Summary

The main purpose of this trial is to investigate the effects of a new class of drugs that help the patient's immune system attack their tumor (glioblastoma multiforme - GBM). These drugs have already shown benefit in some other cancer types and are now being explored in GBM. Both tremelimumab and durvalumab (MEDI4736) are "investigational" drugs, which means that the drugs are not approved by the Food and Drug Administration (FDA). Both drugs are antibodies (proteins used by the immune system to fight infections and cancers). Durvalumab attaches to a protein in tumors called PD-L1. It may prevent cancer growth by helping certain blood cells of the immune system get rid of the tumor. Tremelimumab stimulates (wakes up) the immune system to attack the tumor by inhibiting a protein molecule called CTLA-4 on immune cells. Combining the actions of these drugs may result in better treatment options for patients with glioblastoma.

Timeline

Start
2016-11-01
Primary completion
2018-05-09
Completion
2020-06-17

Drugs

EvaluationDrugModalityDoseRoute
Comparator Durvalumab Monoclonal antibody 750 mg Intravenous
Subject Tremelimumab Monoclonal antibody 75 mg Intravenous

Indications