This is an open-label, phase 2, randomized study of intravesical N-803 plus BCG (experimental arm A) and intravesical N-803 plus gemcitabine (experimental arm B) in participants who have intermediate-risk Ta/T1 papillary disease. The primary objective of this study is to evaluate the efficacy of these experimental therapies without the need for surgical intervention by CR rate at month 3 or month 6 (for re-inducted participants).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Combination therapy N-803 plus BCG
Combination therapy N-803 plus Gemcitabine
Efficacy of Arms A and B at Month 3 and Month 6
Evaluate efficacy of experimental therapies with a) intravesical N-803 plus BCG or b) intravesical N-803 plus gemcitabine by CR rate at month 3 or month 6 (for re-inducted participants) in participants with intermediate-risk NMIBC.
Time frame: At Month 3 and Month 6
Efficacy of Arms A and B at by CR rate at each response assessment
Evaluate efficacy of experimental therapy by CR rate at each response assessment.
Time frame: At Month 3 through Month 36
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.