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TARA-002 for High-Grade Non-Muscle Invasive Bladder Cancer

This study is looking into whether a treatment called TARA-002 is effective and safe for adults aged 18 and older who have high-grade non-muscle invasive bladder cancer (NMIBC) and have not yet received BCG treatment. Researchers want to see if TARA-002 can help people with this type of cancer and what its side effects might be. You would receive TARA-002 or a standard chemotherapy treatment, given directly into the bladder. The main goal is to see how many participants have a complete response (meaning the cancer is no longer detectable) after 6 months. To join, you must have a confirmed diagnosis of high-grade NMIBC.

Study design
This interventional study plans to enroll 284 participants. It compares TARA-002 to a doctor's choice of standard chemotherapy.
What's involved
Participants will receive 6 weekly treatments. If the treatment is successful at 12 weeks, you will receive additional treatments every 3 months up to Month 19, and then again at Month 25.
Compensation
Not stated in the trial record.
Follow-up
The study measures the main outcome at 6 months, and maintenance treatment continues up to Month 25.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07480356

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

Recruiting
PHASE3Ages 18+InterventionalTreatment
Protara Therapeutics
~284 participants
Updated 2026-08-21 on ClinicalTrials.gov
What's tested:TARA-002Investigator's Choice of Intravesical Chemotherapy

At a glance

Recruiting sites
10 of 10 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of high-grade complete response
Measured over Month 6

Conditions

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

Explore related trials

Non-Muscle Invasive Bladder Carcinoma

NCT07480356

Where you'd take part

This study runs at 10 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Arenia - Ivano-Frankivsk

    Ivano-Frankivsk, Ukraineno site contact published

    Recruiting

  • Arensia Kapitanivka - PPDS

    Kapitanivka, Ukraineno site contact published

    Recruiting

  • Arkansas Urology

    Little Rock, Arkansasno site contact published

    Recruiting

  • East Valley Urology Center of Arizona

    Queen Creek, Arizonano site contact published

    Recruiting

  • Houston Metro Urology

    Houston, Texasno site contact published

    Recruiting

  • Michael Oefelein Clinical Trials

    Bakersfield, Californiano site contact published

    Recruiting

  • Renown Regional Medical Center

    St Louis, Missourino site contact published

    Recruiting

  • START - Carolinas

    Myrtle Beach, South Carolinano site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Chief R&D Officer
[email protected]
16468440337
Email the study team

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Incidence of high-grade complete responseMonth 6

    Incidence of high-grade complete response of intravesical TARA-002 compared to Investigator's choice of intravesical chemotherapy determined by cystoscopy, urine cytology, and bladder biopsy (if applicable)