

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 (NIAGARA).
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Treatment Agent: Durvalumab
Synopsis: AstraZeneca is doing this research to find out if the medication called Durvalumab combined with the standard of 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 (bladder cancer), for patients whose cancers progressed during or after platinum-based chemotherapy. 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.
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A Phase II Open Label, Study of IMMU-132 in Metastatic Urothelial Cancer After Failure of Platinum-Based Regimen or Anti-PD-1/PD-L1 Based Immunotherapy
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Treatment Agent: IMMU-132
Synopsis: You are being asked to take part in this research study because you have urothelial cancer that has progressed or returned. Your doctor is researching a potential new therapy product called sacituzumab govitecan. This is an experimental therapy, which means that sacituzumab govitecan is not approved by the FDA for use by the general public. Sacituzumab govitecan is composed of a drug attached to an antibody. The antibody in this study is a protein able to bind to the cells of your cancer and thereby facilitates the action of chemotherapy. This drug has been given to a small group of patients with your disease and this study is being conducted to further evaluate its effectiveness and how it is tolerated.
Sacituzumab govitecan is an investigational medication which means the FDA allows its use only in research.
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A Phase 2, Open-label, Single Agent, Multi-Center Study to Evaluate the Efficacy and Safety of INCB054828 in Subjects with Metastatic or Surgically Unresectable Urothelial Carcinoma Harboring FGF/FGFR Alterations
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Treatment Agent: INCB054828
Synopsis: The primary purpose of this research study is to assess how metastatic or surgically unresectable Urothelial Carcinoma with FGF/FGFR alterations responds to treatment with INCB054828. The other goals of the study are to determine how safe and well tolerated the study drug, INCB054828, is, and to obtain data to try and identify patients who would benefit most from INCB054828.
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Other protocol defined inclusion/exclusion criteria could apply
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