NCT07480356 · Protara Therapeutics
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
(ADVANCED-3)
What this study is about
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.
View original scientific description
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.
Interventions
DRUG
TARA-002
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.
DRUG
Investigator's Choice of Intravesical Chemotherapy
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 outcome measures
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)
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Queen Creek, Arizona
- Little Rock, Arkansas
- Bakersfield, California
- St Louis, Missouri
- Myrtle Beach, South Carolina
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 29, 2026 · Source of record for eligibility and locations