A Study of Intravesical Bacillus Calmette-Guerin (BCG) in combination with ALT-803 in Patients with Non-Muscle Invasive Bladder Cancer

Brief description of study

The purpose of this research study is to determine the safety and efficacy of the combination of ALT-803 plus BCG (Bacillus Calmette-Guerin) compared to BCG alone in non-muscle invasive bladder cancer patients with CIS disease (carcinoma in situ) and in patients with high grade papillary disease. The study is to assess if the combination with ALT-803 works for treating bladder cancer to show that there is no evidence of disease and free of signs and symptoms. The ALT-803 is an investigational drug that is designed to show powerful activity against human tumor cells. ALT-803 is an investigational drug in this study because it has not been approved by the U.S Food and Drug Administration (FDA), the health authority that gives approval for new medicines to be prescribed in the United States. BCG is an approved agent by the US Food and Drug Administration for bladder cancer.


Clinical Study Identifier: s18-00900
ClinicalTrials.gov Identifier: NCT02138734
Principal Investigator: Aaron Edward Katz.


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