Hoosier Cancer Research Network urothelial cancer study was highlighted during the 2023 ASCO Genitourinary Cancers Symposium in San Francisco. In a poster and rapid abstract session presentation during the 2023 ASCO Genitourinary Cancers Symposium. Jason Brown, MD, PhD, of University Hospitals Seidman Cancer Center presented the results of HCRN GU14-188, a Phase Ib/II trial of neoadjuvant pembrolizumab and chemotherapy for T2-4aNOMO urothelial cancer.

This trial is a pre-surgical study involving subjects with muscle invasive bladder cancer, or urothelial cancer, who are candidates for neoadjuvant therapy. It is a two-part trial with a one-arm phase 1b portion followed by a two-arm phase II portion. The study treatment is stratified into two cohorts based on cisplatin eligibility.

The HCRN GU14-188 trial aimed to evaluate the efficacy and safety of immunotherapy plus chemotherapy in both cisplatin-eligible and cisplatin-ineligible patients with muscle-invasive bladder cancer.

Based on the results of the study, investigators concluded that the primary endpoint was met in both cohorts – providing excellent survival with sustainable response. Neoadjuvant chemo-immunotherapy demonstrated significant down staging in cisplatin eligible and cisplatin ineligible muscle-invasive urothelial cancer patients prior to definitive surgery, meeting the primary endpoint. Survival correlated with pathologic response The treatment was well tolerated. Ongoing studies will further evaluate chemoimmunotherapy in ineligible muscle-invasive urothelial cancer.

Participating institutions: 

• Community Health Network, Inc. Cancer Centers 
• Indiana University Melvin and Bren Simon Comprehensive Cancer Center 
• IU Health Central Indiana Cancer Centers 
• Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine 
• St. Vincent 
• Thomas Jefferson University / Sidney Kimmel Cancer Center 
• University Hospitals Seidman Cancer Center 
• University of New Mexico Comprehensive Cancer Center 
• Virginia Oncology Associates 

Authors: Jason Brown, Hristos Z. Kaimakliotis, William Kevin Kelly, Vikki Ammons, Joel Picus, Radhika Walling, Neda Hashemi-Sadraei, Pingfu Fu, Seunghee P Margevicius, Nabil Adra, Jorge A. Garcia, Rana R. McKay, Christopher J. Hoimes

About Hoosier Cancer Research Network:

Hoosier Cancer Research Network 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.