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A study of Intravesical Bacillus Calmette-Guerin (BCG) in Combination with ALT-803 in Patients with Non-Muscle Invasive Bladder Cancer
The purposes of this research study are to find out the side effects of the study drug, ALT-803, plus BCG in Non-Muscle Invasive Bladder Cancer (NMIBC); find out how safe the study drug is and how well it is tolerated, and find out if the study drug plus Bacillus Calmette-Guerin (BCG) can stop the growth of the participant's tumor.
Primary Objectives: (1) Determination of MTD and designation of RD of ALT-803 in combination with BCG in patients who have non-muscle invasive bladder cancer (NMIBC). (2) Safety profile of BCG+ALT-803 in treated patients. (3) Disease response rate in treated patients. Secondary Objectives: (1) Immunogenicity and pharmacokinetic profiles of BCG+ALT-803 in treated patients. (2) Molecular alterations (e.g., assessed by immunohistochemistry and antibody-based immunoassays) in collected tissues (e.g., bladder tissue, blood and urine) will be noted during therapy and compared to prior therapy. (3) Recurrence-free survival, progression-free survival, overall survival, and duration of response of all treated patients.
ALT-803 (); BCG ()