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QUILT-3.032: A Multicenter Clinical Trial of Intravesical Bacillus Calmette-Guerin (BCG) in Combination with ALT-803 in Patients with BCG Unresponsive High Grade Non-Muscle Invasive Bladder Cancer
This is a Phase II, open-label, single-arm, multicenter study of intravesical BCG plus ALT-803 in patients with BCG unresponsive high grade non-muscle invasive bladder cancer (NMIBC). All patients treated in the study will receive via a urinary catheter in the bladder, BCG plus ALT-803 weekly for 6 consecutive weeks (initial induction treatment period). After the first disease assessment, eligible patients will receive either a 3-week maintenance course or a 6-week re-induction course (second treatment period) at Month 3. Eligible patients will continue to receive maintenance treatment in the third treatment period at Months 6, 9, 12, and 18.
Primary: Cohort A: To assess the antitumor activity of intravesical BCG in combination with ALT-803 in patients with BCG unresponsive high-grade NMIBC as determined by complete response rate (for BCG-unresponsive carcinoma in situ (CIS) [with or without Ta/T1 papillary disease]) using cystoscopy, confirmatory bladder biopsy and urine cytology; Cohort B: To determine disease-free rate (for BCG-unresponsive high-grade Ta/T1 papillary disease) using cystoscopy and urine cytology Key Secondary Cohort A: To assess the duration of complete response (for BCG-unresponsive CIS [with or without Ta/T1 papillary disease]); Cohort B: To assess disease-free survival (for BCG-unresponsive high-grade Ta/T1 papillary disease)