March 27, 2023: 

Results from a Big Ten CRC bladder cancer study of concurrent durvalumab and radiation therapy (DUART) followed by adjuvant durvalumab in patients with localized urothelial cancer of bladder were published in the Journal for ImmunoTherapy of Cancer. Sponsor-investigator Monika Joshi, MD, of Penn State Cancer Institute led this single-arm, multi-institutional phase II study.

The DUART study, also known as BTCRC-GU15-023, opened in 2016 was conducted in two phases. Phase Ib determined the maximum safe dose of durvalumab in combination with radiation therapy. Phase II helped researchers estimate progression free survival at one year and determine the disease control rate, which includes all complete responses, partial responses, and stable disease.

Sponsor-investigator Monika Joshi, MD of Penn State Cancer Institute led this single-arm, multi-institutional phase II study. Enrolled patients had pure or mixed urothelial bladder cancer with unresectable tumors and were unfit for surgery or cisplatin ineligible. Patients received durvalumab concurrently with radiation therapy for 7 weeks, followed by adjuvant durvalumab for 1 year.
The primary goal of this study was progression-free survival at 1 year and disease control rate post adjuvant durvalumab.

The study concluded that durvalumab with radiation therapy followed by adjuvant durvalumab was safe with promising efficacy in localized bladder patients with comorbidities, including node positive patients. Larger randomized studies are needed to evaluate the efficacy of combining immunotherapy and radiation therapy in bladder cancer.

Authors include Monika Joshi , Leonard Tuanquin, Junjia Zhu, Vonn Walter, Todd Schell, Matthew Kaag, Deepak Kilari, Jiangang Liao, Sheldon L Holder, Hamid Emamekhoo, Alexander Sankin, Suzzane Merrill, Hong Zheng, Joshua Warrick, Ralph Hauke, Benjamin Gartrel, Mark Stein, Joseph Drabick, David J Degraff, Yousef Zakharia.

Participating institutions include Holden Comprehensive Cancer Center, University of Iowa, Penn State Cancer Institute, University of Wisconsin Carbone Cancer Center, Froedtert and the Medical College of Wisconsin, Montefiore Medical Center, Methodist Hospital (Omaha, Neb.)

About the Big Ten Cancer Research Consortium: The Big Ten cancer centers have united 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 Big Ten Cancer Research Consortium creates a unique team-research culture to drive science rapidly from ideas to treatment-changing paradigms. 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 more than 9,800 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