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NCT Number: 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

The goal of this clinical trial is to learn if TARA-002 can treat high-grade non-muscle invasive bladder cancer (NMIBC) in BCG-naïve adults 18 years of age or older.

The main questions it aims to answer are:

* Can the study drug help participants with this type of cancer? * Is the study drug safe? * What are the side effects of the study drug?

Researchers will compare TARA-002 to chemotherapy to see if TARA-002 works to treat NMIBC.

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Key information

Conditions

Bladder (Urothelial, Transitional Cell) Cancer Carcinoma Carcinoma in Situ Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Non-Muscle Invasive Bladder Carcinoma Non-Muscle Invasive Bladder Neoplasms Non-muscle Invasive Bladder Cancer With Carcinoma in Situ Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Arensia Kapitanivka - PPDS, Kapitanivka, Ukraine

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

TARA-002

Drug

Participants will receive 6 weekly instillations of TARA-002. Participants confirmed to have a CR at Week 12 will enter the maintenance treatment period and will receive 3 additional weekly instillations of TARA-002 every 3 months up to Month 19, and then 3 weekly doses at Month 25. Participants who are eligible for reinduction at Week 12 will receive 6 additional weekly instillations of TARA-002. Participants who undergo reinduction and are confirmed to have a CR at Week 24 will enter the maintenance regimen treatment period and will receive 3 weekly instillations of TARA-002 every 3 months up to Month 19, and then 3 weekly doses at Month 25.

Investigator's Choice of Intravesical Chemotherapy

Drug

Participants will receive 6 weekly instillations of Investigator's choice of intravesical chemotherapy. Participants confirmed to have a CR at Week 12 will enter the maintenance regimen treatment period and will receive one intravesical instillation of Investigator's choice of intravesical chemotherapy every 1 month up to Month 25.

Primary outcomes

  1. Incidence of high-grade complete response

    Time frame: Month 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)

Secondary outcomes

  1. Duration of high-grade complete response

    Time frame: Up to Month 60

    Duration of high-grade complete response of intravesical TARA-002 compared to Investigator's choice of intravesical chemotherapy

  2. Treatment emergent adverse events

    Time frame: Up to Month 60

    Incidence and severity of treatment emergent adverse events (TEAEs) of intravesical TARA-002 compared to Investigator's choice of intravesical chemotherapy

  3. Treatment emergent serious adverse events

    Time frame: Up to Month 60

    Incidence and severity of treatment emergent serious adverse events (TESAEs) of intravesical TARA-002 compared to Investigator's choice of intravesical chemotherapy

  4. High-grade complete response rate

    Time frame: At Months 3, 9, 12, 15, 18, 21, 24, 27, 30, 36, 42, 48, 54, and 60

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

  5. High-grade complete response rate (CIS only)

    Time frame: Month 6

    High-grade complete response rate of intravesical TARA-002 compared to Investigator's choice of intravesical chemotherapy determined by cystoscopy, urine cytology, and bladder biopsy (if applicable) in sub-group of participants with CIS only

  6. Event-free survival

    Time frame: Up to Month 60

    Event-free survival (EFS) of intravesical TARA-002 compared to Investigator's choice of intravesical chemotherapy

  7. Recurrence-free survival

    Time frame: Up to Month 60

    Recurrence-free survival (RFS) of intravesical TARA-002 compared to Investigator's choice of intravesical chemotherapy

  8. Progression-free survival

    Time frame: Up to Month 60

    Progression-free survival (PFS) of intravesical TARA-002 compared to Investigator's choice of intravesical chemotherapy

  9. Disease-specific progression-free survival

    Time frame: Up ro Month 60

    Disease-specific progression-free survival (DSPFS) of intravesical TARA-002 compared to Investigator's choice of intravesical chemotherapy

  10. Overall survival

    Time frame: Up to Month 60

    Overall survival (OS) of intravesical TARA-002 compared to Investigator's choice of intravesical chemotherapy

  11. Disease-specific survival

    Time frame: Up to Month 60

    Disease-specific survival (DSS) of intravesical TARA-002 compared to Investigator's choice of intravesical chemotherapy

  12. Time to cystectomy

    Time frame: Up to Month 60

    Time to cystectomy of intravesical TARA-002 compared to Investigator's choice of intravesical chemotherapy

  13. Time to recurrence delayed cystectomy

    Time frame: Up to Month 60

    Time to recurrence delayed cystectomy of intravesical TARA-002 compared to Investigator's choice of intravesical chemotherapy

  14. Time to progression

    Time frame: Up to Month 60

    Time to progression of intravesical TARA-002 compared to Investigator's choice of intravesical chemotherapy

  15. Time to disease worsening

    Time frame: Up to Month 60

    Time to disease worsening of intravesical TARA-002 compared to Investigator's choice of intravesical chemotherapy

Study contacts

Contact information is provided by the study sponsor or research team.

Chief R&D Officer

CONTACT

[email protected]

16468440337

Sponsors and collaborators

Lead sponsor

Protara Therapeutics

Industry

Registry information

Official study title

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

Acronym: ADVANCED-3

Important dates

Study start
2026
Primary completion
2028
Study completion
2032
First posted
Mar 18, 2026
Registry last updated
Jun 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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