A Phase 3, Randomized, Open-label, Multi-center Study Evaluating the Efficacy and Safety of TAR-200 Versus Investigator’s Choice of Intravesical Chemotherapy in Participants Who Received Bacillus Calmette-Guérin (BCG) and Recurred with High-risk Non-Muscle-Invasive Bladder Cancer (HR-NMIBC) and Who Are Ineligible for or Elected Not to Undergo Radical Cystectomy

Phase 1

Recruiting

• Conditions: High-Risk Non-muscle-invasive Bladder Cancer; MedDRA version: 20.0Level: PTClassification code: 10005003Term: Bladder cancer Class: 100000004864; Therapeutic area: Diseases [C] - Neoplasms [C04]

• Registration Number: CTIS2023-507685-10-00
• Lead Sponsor: Janssen Cilag International

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-01-23
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 248

Inclusion Criteria

Histologically confirmed diagnosis by local pathology (within 90 days of documented informed consent) of recurrent, papillary-only HR-NMIBC (defined as HG Ta or any T1, no CIS)., Participants with variant histologic subtypes are allowed if tumor(s) demonstrate urothelial (transitional cell histology) predominance. However, neuroendocrine, and small cell variants will be excluded., All visible tumor completely resected prior to randomization. Urine cytology must not be positive or suspicious for HG UC before randomization. For participants with lamina propria invasion (T1) on the Screening biopsy/TURBT, muscularis propria must be present to rule out MIBC., Participants must have received at least 5 of 6 induction doses of BCG (adequate induction) with or without maintenance therapy., Diagnosis of recurrent, papillary-only HR-NMIBC (defined as HG Ta or any T1, no CIS) must be within 12 months of the last dose of BCG therapy., Participants must be ineligible for or have elected not to undergo RC.

Exclusion Criteria

Presence of CIS at any point from time of diagnosis of papillary-only HR-NMIBC recurrence to randomization. Additionally, presence or history of histologically confirmed, muscle-invasive, locally advanced, nonresectable, or metastatic UC (ie, T2, T3, T4, N+, and/or M+)., Must not currently have UC or histological variant at any site outside of the urinary bladder. UC of the upper urinary tract (including renal pelvis and ureter) is allowable if treated with complete nephroureterectomy more than 24 months prior to randomization with no evidence of recurrence., N+ and/or M+ per BICR of CT/MR Urography., Received serial intravesical therapy or systemic therapy from the time of histologic diagnosis of recurrent HR-NMIBC to date of randomization. Immediate post-TURBT single-dose per-operative intravesical chemotherapy is allowed in accordance with institutional guidelines.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified