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

NCT07480356 · ADVANCED-3 Phase 3Recruiting

Lead sponsor
Protara Therapeutics (Industry)
Enrollment
284 (estimated)
Start date
29 May 2026
Primary completion
Apr 2028 (estimated)
Study completion
1 Nov 2032
Last update posted
6 Oct 2026

Design

Study type
Interventional
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel
Masking
None
Arms
2

Interventions

  • TARA-002 Drug
  • Investigator's Choice of Intravesical Chemotherapy Drug

Conditions and primary outcome

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

Primary outcome

Incidence of high-grade complete response (Month 6)

Posted results on ClinicalTrials.gov

Results posted on ClinicalTrials.gov: No

Results from company and journal sources

No editor-confirmed results are on record for this study.

Publications

No PubMed citation lists NCT07480356.

CT-VCA trial quality

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Data integrity

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Source

Source: ClinicalTrials.gov, U.S. National Library of Medicine. Listing a study does not mean NLM has evaluated it.

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