Testing Anti-Cancer Drugs Erdafitinib with or without Atezolizumab in Patients with Localized Bladder Cancer Not Able to Receive Cisplatin Chemotherapy

UVA Tracking #
HSR220433
Principal Investigator
Michael Devitt
Contact
Contact Phone
Official Trial Title
An Open Label, Randomized Phase II Study Neoadjuvant Erdafitinib with or without Atezolizumab in Cisplatin-Ineligible Patients with Muscle Invasive Bladder Cancer (NERA)
Study Description

The University of Virginia Comprehensive Cancer Center seeks patients ages 18 and over with muscle invasive bladder cancer (MIBC) who are not candidates for standard of care chemotherapy for a research study. The purpose of this study is to compare erdafitinib alone to using the combination of erdafitinib and atezolizumab. Erdafitinib and atezolizumab are not approved for the treatment of MIBC, though erdafitinib is FDA approved to treat some metastatic bladder cancers. This study will help determine if the combination of erdafitinib and atezolizumab is better than erdafitinib alone.

The study involves receiving the investigational drugs, as well as coming in for study visits which include exams, laboratory tests, and procedures such as having your blood drawn, talking to the study doctor, and answering questionnaires. Participation includes a screening visit, 1-2 visits per cycle during treatment, local therapy, and a follow-up period via phone calls to keep track of how you are doing. There are 3 treatment cycles for this study lasting 21 days each.

The investigational drugs, erdafitinib and atezolizumab, as well as exams, tests, and procedures done for research purposes only will be provided at no cost to you.

uvacancertrials@hscmail.mcc.virginia.edu

Compensation

No Compensation