Nov. 21, 2016:

Patients with locally advanced bladder cancer often find themselves at a fork in the road when it comes to treatment decisions. The determining factor for many patients is whether or not they are candidates for surgery.

For those who can have cisplatin based chemotherapy and can undergo surgery, the standard approach is often well defined; but for those who cannot, the road ahead is not so clear. A new Big Ten Cancer Research Consortium study, led by Monika Joshi, MD, MRCP, of Penn State Cancer Institute, may help to open new options for these patients.

The Phase Ib/II study of concurrent durvalumab and radiation therapy (DUART) followed by adjuvant durvalumab in patients with urothelial cancer of the bladder is open to accrual at Penn State Cancer Institute. Additional member sites within the Big Ten Cancer Research Consortium are expected to open the study in the near future.

“This trial will offer a novel non-chemotherapy based therapeutic approach for bladder cancer patients who are unfit for surgery and have locally advanced disease,” Dr. Joshi said. “These patients are at a high risk of recurrence either in the bladder, lymph nodes, or even distant sites, and they currently do not have a standard option that works best.”

The DUART study, also known as BTCRC-GU15-023, will be conducted in two phases. Phase Ib will determine the maximum safe dose of durvalumab in combination with radiation therapy. Phase Ib will enroll six subjects. Phase II will help researchers estimate progression free survival at one year and determine the disease control rate, which includes all complete responses, partial responses, and stable disease. Phase II will enroll about 36 subjects.

How the Intervention Works

T cells work to fight infections and diseases throughout the human body. Cancer cells often interrupt this normal function of T cells by taking control of a molecular pathway called PD-1 (programmed death-1). By controlling this pathway, cancer cells avoid an attack from T cells.

Durvalumab is an investigational monoclonal antibody, a type of immunotherapy, that blocks PD-L1 (programmed death-ligand 1) on the surface of cancer cells. This allows the T cells to remain active and attack cancer cells.

Radiation therapy uses high-energy rays to damage or kill cancer cells by stopping them from growing and dividing. Radiation therapy is usually paired with chemotherapy as a standard treatment for bladder cancer. However radiation therapy can also modulate the immune system to increase the effectiveness of immunotherapy treatment.

The use of durvalumab in combination with radiation therapy is investigational. This means that the U.S. Food and Drug Administration has not approved this combination to treat patients with advanced bladder cancer.

Patients with locally advanced urothelial cancer of the bladder (T2-4, N0-2, M0) may be eligible to enroll in this study.

More information about this clinical trial, including full eligibility criteria, is available at www.clinicaltrials.gov, using trial #NCT02891161.

This trial is supported by MedImmune, LLC, a wholly owned subsidiary of AstraZeneca PLC.

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 www.bigten.org.