Intravesical BCG + ALT-803 (N-803) in Patients With NMIBC
Research type
Research Study
Full title
A Study of Intravesical Bacillus Calmette-Guerin (BCG) in Combination With ALT-803 (N-803) in Patients With Non-Muscle Invasive Bladder Cancer.
IRAS ID
1012219
Contact name
Charles Garlisi
Contact email
Sponsor organisation
ImmunityBio, Inc
Eudract number
2025-521223-78
Clinicaltrials.gov Identifier
Research summary
Summary of the Study:
This is a phase 2b, randomized, two-cohort, open-label, multicenter study of intravesical N-803 plus BCG versus BCG alone, in BCG naïve patients with high-grade NMIBC. Patients will be enrolled into one of two study cohorts and randomized into two arms to be treated with either N-803 plus BCG or BCG alone. Cohort A will initially enroll 366 patients who have histologically confirmed presence of CIS (with or without Ta/T1 papillary disease). Cohort B will initially enroll 230 patients who have histologically confirmed high-grade Ta/T1 papillary disease only. Cohorts A and B are 2 independent study cohorts and will be evaluated separately for efficacy.
Objectives of the Study:
Cohort A: To determine the efficacy of the combination of N-803 plus BCG compared to BCG alone in patients with CIS disease (with or without Ta/T1) in terms of complete response (CR) rate at 6 months using cystoscopy, confirmatory bladder biopsy (if required), and urine cytology;
Cohort B: To determine the efficacy of the combination of N-803 plus BCG compared to BCG alone in patients with high-grade papillary disease (Ta/T1 only) in terms of disease-free survival(DFS) using cystoscopy, confirmatory bladder biopsy (if required), and urine cytology.REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
25/NE/0096
Date of REC Opinion
15 Jul 2025
REC opinion
Further Information Favourable Opinion