A Phase III, Randomized, Open-Label, Multi-Center, Global Study to Determine the Efficacy and Safety of Durvalumab in Combination With Gemcitabine+Cisplatin for Neoadjuvant Treatment Followed by Durvalumab Alone for Adjuvant Treatment in Patients With Muscle-Invasive Bladder Cancer

Protocol No
AZ-D933RC00001-NIAGARA
Principal Investigator
Deepak Kilari
Phase
III
Summary
AstraZeneca is doing this research to find out if the medication called Durvalumab combined with the standard of care treatment will work and be safe for the treatment of Muscle Invasive Bladder Cancer. Durvalumab has been approved by the FDA as therapy for the treatment of locally advanced or metastatic urothelial carcinoma, for patients whose cancers progressed during or after platinum-based chemotherapy. Durvalumab has also been approved by the FDA and the European Medicines Agency (EMA) for the treatment of patients with locally advanced non-small cell lung cancer after chemoradiation therapy. Durvalumab is still in the development stage for the treatment of Muscle Invasive Bladder Cancer and is not approved for treatment of Muscle Invasive Bladder Cancer except for use in research studies like this. In this study, Durvalumab is being used in combination with two standard of care chemotherapy drugs, Gemcitabine and Cisplatin. Both drugs are approved by the FDA for the treatment of bladder cancer. We don't know if this study will help you. Your condition may get better, but it could stay the same or even get worse. We hope the information from this study will help us develop a better treatment for Muscle Invasive Bladder Cancer in the future.
Description
Durvalumab+ Gemcitabine/Cisplatin (Neoadjuvant) & Durvalumab (Adjuvant) for MIBC (NIAGARA)
Participating Institutions
Froedtert Hospital
Status
OPEN TO ACCRUAL
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