May 26, 2017:

A Big Ten Cancer Research Consortium study is evaluating the safety and efficacy of durvalumab (MEDI4736) following multi-modality therapy in esophageal cancer.

The phase II study, known as BTCRC-ESO14-012, is currently open for accrual at the Indiana University Melvin and Bren Simon Cancer Center, the University of Illinois Cancer Center, the Holden Comprehensive Cancer Center at the University of Iowa, Michigan State University Breslin Cancer Center, and the University of Michigan Comprehensive Cancer Center.

Treatment for esophageal cancer usually involves chemotherapy plus radiation, followed by surgery to remove part of the esophagus. Patients are then followed to make sure the cancer does not return. The likelihood of recurrence is greater when residual cancer cells are found in the surgical sample.

“Unfortunately, the majority of people who have cancer at the time of surgery will relapse,” said Shadia Jalal, MD, a researcher at the IU Simon Cancer Center and the sponsor-investigator of the study. “Even though we took all the cancer out, if the surgical sample had evidence of esophageal cancer after chemotherapy and radiation, the chance of it coming back is very high.”

Dr. Jalal calls these recurrent cancers “smart” and difficult to treat. Part of the difficulty in treating these cancers may be related to the ability of cancer cells to produce proteins called PD-L1 (programmed death-ligand 1), which bind to a protein on the surface of immune cells called PD-1 (programmed death-1). When this binding occurs, cancer cells are able to “hide” from the immune system.

In recent years, researchers working in cooperation with pharmaceutical companies have developed a new class of drugs that inhibit the PD-1/PD-L1 interaction. These drugs, which include durvalumab, bind to PD-L1 on the surface of cancer cells, which allows the immune cells to recognize and attack the cancer cells.

The BTCRC-ESO14-012 clinical trial will allow researchers to study if giving durvalumab after chemoradiation and surgery will help the body’s immune system keep the cancer from relapsing or recurring. This will allow researchers to know whether adding durvalumab is better, the same, or worse than the usual approach.

The use of durvalumab following chemoradiation and surgery is investigational. This means the U.S. Food and Drug Administration has not approved durvalumab to treat this type of cancer.

The study is open to subjects with locally advanced esophageal cancer who have had chemotherapy and radiation prior to surgery, and whose surgical sample contained residual cancer cells. Additional eligibility requirements must be met to enroll in the study.

Funding support for BTCRC-ESO14-012 is provided by MedImmune, LLC, a wholly owned subsidiary of AstraZeneca PLC.

More information about this clinical trial, including full eligibility criteria, is available at, using trial #02639065.

About the Big Ten Cancer Research Consortium: The Big Ten Cancer Research Consortium was created in 2013 to transform the conduct of cancer research through collaborative, hypothesis-driven, highly translational oncology trials that leverage the scientific and clinical expertise of Big Ten universities. The goal of the Big Ten Cancer Research Consortium is to create a unique team-research culture to drive science rapidly from ideas to new approaches to cancer treatment. Within this innovative environment, today’s research leaders collaborate with and mentor the research leaders of tomorrow with the unified goal of improving the lives of all patients with cancer.

About the Big Ten Conference: The Big Ten Conference is an association of world-class universities whose member institutions share a common mission of research, graduate, professional and undergraduate teaching and public service. Founded in 1896, the Big Ten has sustained a comprehensive set of shared practices and policies that enforce the priority of academics in the lives of students competing in intercollegiate athletics and emphasize the values of integrity, fairness and competitiveness. The broad-based programs of the 14 Big Ten institutions will provide over $200 million in direct financial support to almost 9,500 students for more than 11,000 participation opportunities on 350 teams in 42 different sports. The Big Ten sponsors 28 official conference sports, 14 for men and 14 for women, including the addition of men’s ice hockey and men’s and women’s lacrosse since 2013. For more information, visit