Last updated on February 2020

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


Brief description of study

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.

Detailed Study Description

The FR-2 study is designed as a phase II, open label, single arm study in patients with microsatellite stable (MSS) stages II-IV rectal cancer, to assess the activity of PD-L1 inhibition with durvalumab (MEDI4736) monotherapy after standard chemo-radiotherapy (chemoRT). The study's primary aim is to determine the safety and efficacy of durvalumab immediately following chemoRT in patients undergoing subsequent surgery with stage II-IV rectal cancer.

One dose of durvalumab will be given every 2 weeks for four total doses beginning within 3-7 days of completing chemoRT. Surgery for all patients must occur within 812 weeks of the final dose of RT. Adjuvant chemotherapy after surgical recovery is at the discretion of the treating physician.

During a safety run-in, the first 6 patients will be closely followed for 30 days after last dose of durvalumab without further accrual of patients. Patients will receive durvalumab (750mg IV infusion once every 2 weeks) for 4 total doses. No other concurrent anti-neoplastic medications or treatments aside from standard supportive care will be allowed during the durvalumab treatment phase.

The safety run-in portion of the study will proceed to full enrollment at the proposed study therapy dose, (750 mg IV infusion every 2 weeks), if one or less dose-limiting toxicity (DLT) or significant safety concern attributable to durvalumab is identified during the observation period of the first 6 patients. If there are two or more DLTs, accrual to the study will stop with reassessment of the protocol.

A total of 47 patients will be enrolled in this study for a sample size of 41 surgically evaluable patients.

Required tissue and blood samples will be collected at specific time points and submitted for correlative science studies. Optional tumor and blood samples will be collected from consenting patients upon disease recurrence or progression.

Clinical Study Identifier: NCT03102047

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University of Florida

Gainesville, FL United States
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University of Michigan

Ann Arbor, MI United States
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Strecker Cancer Center

Belpre, OH United States
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Adena Regional Medical Center

Chillicothe, OH United States
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Columbus NCORP

Columbus, OH United States
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Grant Medical Center

Columbus, OH United States
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Doctors Hospital

Columbus, OH United States
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Marietta Memorial Hospital

Marietta, OH United States
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Marion General Hospital

Marion, OH United States
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Knox Community Hospital

Mount Vernon, OH United States
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Licking Memorial Hospital

Newark, OH United States
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Southern Ohio Medical Center

Port Clinton, OH United States
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Genesis Health Care Center

Zanesville, OH United States
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AHN Cancer Institute at Jefferson

Jefferson Hills, PA United States
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Forbes Regional Hospital

Monroeville, PA United States
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Allegheny General Hospital

Pittsburgh, PA United States
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WPAON/Medical Center Clinic

Pittsburgh, PA United States
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UPCI Hillman/Shadyside

Pittsburgh, PA United States
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UPMC Hillman Cancer Center

Pittsburgh, PA United States
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Wake Forest Medical Center

Winston-Salem, NC United States
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West Virginia University

Morgantown, WV United States
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Recruitment Status: Open


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