# 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

Source: https://onco.cc/trials/nct07480356/  
OnCo record `nct07480356` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A phase 3 trial testing TARA-002 in bladder & urothelial cancer, now recruiting.

## Summary

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 is a phase 3 interventional study registered as NCT07480356, led by Protara Therapeutics, and recruiting on the registry. Official title: A Phase 3, Randomised Study to Evaluate the 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. Planned enrolment is 284 participants (estimated). The study started in 2026-05-29 and primary completion is expected in 2028-04. No results have been posted on ClinicalTrials.gov.

## Fields

- Kind: Trial
- Status: recruiting
- Last checked: 2026-09-11
- Tags: ctgov-ingest
- Registry id: NCT07480356
- Phase: 3
- Setting: A Phase 3, Randomized Study to Evaluate the 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
- Sponsor: Protara Therapeutics
- Enrolled: 284

## Sources

- ClinicalTrials.gov NCT07480356: https://clinicaltrials.gov/study/NCT07480356

## Connected records

- cancers: [Bladder & urothelial cancer](https://onco.cc/cancers/urothelial/), [Non-muscle-invasive bladder cancer](https://onco.cc/cancers/non-muscle-invasive-bladder-cancer/)
- drugs: [TARA-002](https://onco.cc/drugs/tara-002/)
- companies: [Protara Therapeutics](https://onco.cc/companies/protara-therapeutics/)

---
JSON: https://onco.cc/api/v1/entities/nct07480356.json