Tice BCG (live attenuated bacillus Calmette-Guerin)

P3, N=516, Active, not recruiting, UNICANCER | Trial completion date: Feb 2028 --> Oct 2028 | Trial primary completion date: Apr 2024 --> Oct 2024

P1, N=9, Completed, Northwestern University | Active, not recruiting --> Completed

P2, N=29, Completed, Johns Hopkins University | Recruiting --> Completed | N=180 --> 29

P3, N=516, Active, not recruiting, UNICANCER | Recruiting --> Active, not recruiting

P3, N=501, Active, not recruiting, University of Sydney | Recruiting --> Active, not recruiting

We established the preclinical safety and efficacy of live-attenuated Salmonella enterica Typhi strain ZH9 as a novel immunotherapy for NMIBC.Material and MethodsZH9 efficacy and mechanism of action (MOA) were tested in the murine orthotopic, syngeneic MB49 tumor model, compared to OncoTICE®BCG...Systemic priming further enhances immune responses and may therefore result in greater efficacy. This suggests that ZH9 immunotherapy may improve outcomes for patients with NMIBC, allowing less aggressive treatment and more reliable manufacturing method than the current SOC.

P2/3, N=0, Withdrawn, Carman Giacomantonio | N=100 --> 0 | Trial completion date: Dec 2031 --> Sep 2022 | Not yet recruiting --> Withdrawn | Trial primary completion date: Dec 2031 --> Sep 2022

P2/3, N=100, Not yet recruiting, Carman Giacomantonio | Trial completion date: Jul 2031 --> Dec 2031 | Trial primary completion date: Jul 2031 --> Dec 2031

These data support clinical investigation of dBCG-Tokyo as a treatment for patients with BCG-intolerant NMIBC.

P3, N=516, Recruiting, UNICANCER | Trial primary completion date: Apr 2022 --> Apr 2024

P2/3, N=100, Not yet recruiting, Carman Giacomantonio | Trial completion date: Apr 2026 --> Jul 2031 | Trial primary completion date: Apr 2026 --> Jul 2031

P2/3, N=100, Not yet recruiting, Carman Giacomantonio | Trial completion date: Sep 2030 --> Apr 2026 | Trial primary completion date: Sep 2025 --> Apr 2026

TICE BCG 50 mg was administered intravesically weekly x 6 weeks with maintenance therapy per the treating urologist’s discretion. Durvalumab in combination with intravesical BCG therapy or EBRT can be safely administered to NMIBC patients. Complete response rates in the treated BCG-unresponsive NMIBC population are promising with no unexpected adverse events observed. Longer-term follow up to assess the true frequency of durable responses at 12-months and beyond as well as validation of predictive biomarkers associated with durable responses is warranted.

P2/3, N=100, Not yet recruiting, Carman Giacomantonio | N=40 --> 100 | Trial completion date: Jan 2030 --> Sep 2030 | Trial primary completion date: Jan 2025 --> Sep 2025

P3; Not yet recruiting --> Recruiting

P3; N=614; Not yet recruiting; Sponsor:UNICANCER