QUILT-205: Long-Term Follow-Up of Subjects in QUILT-2.005 Phase 1b Trial of Intravesical N-803 Plus BCG in BCG-Naive Non-Muscle Invasive Bladder Cancer (NMIBC)

N803 plus Bacillus Calmette-Guerin (BCG)

QUILT-2.005 phase 1b (NCT02138734) was an open-label, dose-escalation, multicenter study of intravesical Bacillus Calmette-Guerin (BCG) plus N-803 in BCG-naïve non muscle invasive bladder cancer (NMIBC). A modified 3 + 3 design was used. Three subjects were enrolled at each dose level starting at 100 μg/instillation of N-803 and subsequently increasing to 200 μg/instillation and 400 μg/instillation. A standard dose of BCG, 50 mg, was employed. The primary endpoints of the study were: determination of the maximum tolerated dose (MTD) and designation of the recommended dose (RD) of N-803 in combination with BCG in subjects who have BCG-naïve NMIBC; safety profile of N-803 plus BCG in treated subjects; and disease response rate in treated subjects. A total of 9 subjects with high-risk, high-grade, BCG-naïve, NMIBC were enrolled into 3 cohorts and treated by intravesical administration of N-803 plus BCG.

Obtain Long Term Follow-Up data to be summarized using descriptive statistics

assessed up to 60 months

Assess the Complete response yearly

assessed up to 60 months

Asses Disease-free Survival

assessed up to 60 months