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Avelumab and Radiation in Muscle-Invasive Bladder Cancer

Bladder Cancer Clinical Trial

Official title:
A Phase 2 Study of Avelumab in Combination With Bladder-Directed Radiation in Cisplatin-Ineligible Patients With Muscle-Invasive Urothelial Carcinoma of the Bladder

Clinical Trial Summary

This research study is studying the effects of adding a certain type of immunotherapy to standard bladder-directed radiation as a treatment for muscle-invasive urothelial carcinoma of the bladder. The drug in this study is: Avelumab (also known as BAVENCIO®)

Clinical Trial Description

This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific disease. "Investigational" means that the drug is being studied. The FDA (the U.S. Food and Drug Administration) has not approved the use of avelumab and bladder-directed radiation together for this specific disease but avelumab has been approved for other uses. While bladder-directed radiation is a standard treatment option for muscle-invasive urothelial carcinoma of the bladder, the use of avelumab in combination with bladder radiation in patients with urothelial carcinoma of the bladder is investigational. Radiation is used in the treatment of muscle-invasive bladder cancer, and avelumab has been approved by the FDA in patients with more advanced stages of this disease. Avelumab is a form of immunotherapy, which means it is designed to help the immune system fight cancer cells together with standard cancer treatments like radiation. Avelumab is currently approved by the FDA for the treatment of metastatic Merckel cell carcinoma (mMCC) and platinum-refractory metastatic urothelial carcinoma. The purpose of this study is to test whether the combination of immunotherapy and bladder directed radiation is effective in treating muscle-invasive bladder cancer. The study will also measure other outcomes such as participant's overall health and quality of life during and after treatment. In addition, the investigators will determine if certain biomarkers are correlated with outcomes following treatment with immunotherapy and radiation. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03747419
Study type Interventional
Source Dana-Farber Cancer Institute
Contact Kent Mouw, MD, PhD
Phone 617-525-7382
Email kent_mouw@dfci.harvard.edu
Status Recruiting
Phase Phase 2
Start date December 13, 2018
Completion date January 31, 2031
View Details
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