Noah M. Hahn, MD, deputy director of Johns Hopkins Greenberg Bladder Cancer Institute and sponsor-investigator of the multi-site Hoosier Cancer Research Network ADAPT-BLADDER study, GU16-243, highlighted the Phase I findings during a poster session at the Society of Urologic Oncology’s 2020 Annual Meeting in December.

The phase I portion of the clinical trial was open to adults with non-muscle invasive bladder cancer (NMIBC) who were previously treated with the Bacillus Calmette-Guerin (BCG) vaccine. The study tested the immunotherapeutic agent durvalumab combined with BCG, or durvalumab combined with radiation therapy. The primary objective of the phase I study was to determine the recommended Phase II dose for each combination regimen.

Among the 28 patients enrolled, the median age was 74 years, with a majority of male subjects.

Results of the phase I study demonstrated the combination with intravesical BCG therapy or EBRT can be safely administered to NMIBC patients. Additionally, complete response rates in the treated BCG-unresponsive NMIBC population show promise, with no unexpected adverse events observed.

HCRN member sites participating in the study include: BCG Oncology, P.C.; Columbia University Irving Medical Center; Dana-Farber Cancer Institute; Fox Chase Cancer Center; Indiana University Melvin and Bren Simon Comprehensive Cancer Center; Rush University Medical Center; Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins; Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine; Stanford University; University of Iowa Holden Comprehensive Cancer Center; and University of North Carolina Lineberger Comprehensive Cancer Center.

Funding support for the study was provided by AstraZeneca/MedImmune.

Authors included Noah M. Hahn, Michael A. O’Donnell, Jason A. Efstathiou, Marianna Zahurak, Gary Rosner, Jeff Smith, Max R. Kates, Trinity J. Bivalacqua, Phuoc T. Tran, Daniel Y. Song, Alex S. Baras, Andres Matoso, Woonyoung Choi, Kellie N. Smith, Drew M. Pardoll, Luigi Marchionni, Bridget McGuire, Burles Johnson, Tanya O’Neal, David J. McConkey, Tracy L. Rose, Marc Bjurlin, Emerson A. Lim, Charles G. Drake, Christopher B. Anderson, Donald L. Lamm, Daniel M. Geynisman, Mark A. Hallman, Eric M. Horwitz, Essel Al-Saleem, David YT Chen, Alexander Kutikov, Gordon Guo, Timothy A. Masterson, Nabil Adra, and Hristos Z. Kaimakliotis.

See abstract.

About Hoosier Cancer Research Network:

Hoosier Cancer Research Network (formerly known as Hoosier Oncology Group) conducts innovative cancer research in collaboration with academic and community physicians and scientists across the United States. The organization provides comprehensive clinical trial management and support, from conception through publication. Created in 1984 as a program of the Walther Cancer Institute, Hoosier Cancer Research Network became an independent nonprofit clinical research organization in 2007. Since its founding, Hoosier Cancer Research Network has conducted more than 230 trials in a variety of cancer types and supportive care, resulting in more than 350 publications. More than 9,000 subjects have participated in Hoosier Cancer Research Network clinical trials.