Brief Title: Efficacy and Safety of Intravesical TARA-002 Compared With Investigator’s Choice of Intravesical Chemotherapy in Participants With BCG-naïve High-grade Non-muscle Invasive Bladder Cancer

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Incidence of high-grade complete response

Primary Outcome 1 - Timeframe: Month 6

CONDITION

• Bladder (Urothelial
• Transitional Cell) Cancer
• Non-Muscle Invasive Bladder Carcinoma
• Non-muscle Invasive Bladder Cancer With Carcinoma in Situ

ELIGIBILITY

Inclusion Criteria:
* Male or female participants 18 years of age or older at the time of signing informed consent

- * Participants who have voluntarily given written informed consent after the nature of the study has been explained according to applicable requirements prior to study entry

- * Central histologic confirmation of high-grade non-muscle invasive CIS (± Ta/T1) with active disease

- * Participants who are BCG naive, or participants who are BCG exposed and have not received intravesical BCG for at least 24 months prior to the most recent CIS diagnosis, or participants who received ≤2 doses of BCG within the 24 months prior to the most recent CIS diagnosis
Exclusion Criteria:
* Penicillin allergy (participants with a questionable history of allergy to penicillin will undergo penicillin blood allergy testing via central laboratory

- * Central confirmed variant histology

- * Concomitant prostatic or upper tract urothelial involvement per Investigator's assessment

- * Nodal and metastatic disease are excluded if they existed at any time (whether present or in the past)

- * Any history of ≥ T2 bladder cancer that existed at any point in time in the participant's history
For more information on eligibility criteria, please contact the Sponsor.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: N/A

Role: N/A

Affiliation: N/A

Overall Contact

Name: Chief R&D Officer

Phone: 16468440337

Email: [email protected]

LOCATION