drugset / Trial / NCT03617913

Avelumab in Combination With Fluorouracil and Mitomycin or Cisplatin and Radiation Therapy in Treating Participants With Muscle-Invasive Bladder Cancer

NCT03617913

NaSingle-groupOpen-labelTreatment

Summary

This phase II trial studies the side effects of avelumab and how well it works in combination with fluorouracil and mitomycin or cisplatin and radiation therapy in treating participants with muscle-invasive bladder cancer. Monoclonal antibodies, such as avelumab, may interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as fluorouracil, mitomycin, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy beams to kill tumor cells and shrink tumors. Giving avelumab with chemotherapy and radiotherapy may work better in treating participants with muscle-invasive bladder cancer.

Timeline

Start
2018-09-19
Primary completion
2019-11-14
Completion
2020-07-27

Drugs

EvaluationDrugModalityDoseRoute
Subject Avelumab Monoclonal antibody Intravenous
Subject Cisplatin Other / unclassified Intravenous
Subject Mitomycin C Other / unclassified Intravenous
Subject fluorouracil Small molecule Intravenous