drugset / Trial / NCT03102047

Study of Durvalumab (MEDI4736) After Chemo-Radiation for Microsatellite Stable Stage II-IV Rectal Cancer

NCT03102047 ↗

Phase 2 Completed 45 enrolled NSABP Foundation Inc
NaSingle-groupOpen-labelTreatment

Summary

This study is being done to look at the safety and response to the investigational drug durvalumab (MEDI4736) following chemo-radiation therapy for patients with MSS stage II to IV rectal cancer. Durvalumab recognizes specific proteins on the surface of cancer cells and triggers the immune system to destroy the cancer cells. The chemoRT portion of the treatment will be completed just before the course of durvalumab is initiated. In order to learn more about certain characteristics of rectal cancer tumors, this study includes special research tests using samples from diagnostic tumors, a tissue sample from tumors removed during surgery, fresh tumor samples from an area where the cancer has recurred, and blood samples.

Timeline

Start
2018-05-14
Primary completion
2021-02-22
Completion
2021-12-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Durvalumab Monoclonal antibody 750 mg Intravenous

Indications