This is a Phase Ib/IIb, randomized, two-cohort, open-label, multicenter study of intravesical
N-803 plus BCG versus BCG alone, in BCG naïve patients with high-grade NMIBC.
The study includes a dose escalation phase (phase Ib) and an expansion phase (phase IIb).
In the phase Ib, patients will be treated with intravesical N-803 in combination with BCG.
The purpose of the phase Ib portion of the study is to evaluate the safety, identify the
Maximum Tolerated Dose (MTD) of N-803 and determine the Recommended Dose (RD) level of N-803
in combination with BCG for the phase IIb expansion.
In the phase IIb expansion, patients will be randomized to receive either intravesical N-803
in combination with BCG or BCG alone. Patients will be enrolled into one of two study cohorts
(Cohort A and Cohort B). These will be two independent study cohorts, evaluated separately
for treatment efficacy.
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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