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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: TARA-002, Investigator's Choice of Intravesical Chemotherapy.
- Who it may be relevant to
- Registry conditions: Bladder (Urothelial, Transitional Cell) Cancer, Non-Muscle Invasive Bladder Carcinoma, Non-muscle Invasive Bladder Cancer With Carcinoma in Situ. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Ukraine
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official 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
Overview
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 maint - 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]
Secondary outcome measures (12)
- Duration of high-grade complete response [Time frame: Up to Month 60]
- Treatment emergent adverse events [Time frame: Up to Month 60]
- Treatment emergent serious adverse events [Time frame: Up to Month 60]
- 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 (CIS only) [Time frame: Month 6]
- Event-free survival [Time frame: Up to Month 60]
- Recurrence-free survival [Time frame: Up to Month 60]
- Progression-free survival [Time frame: Up to Month 60]
- Disease-specific progression-free survival [Time frame: Up ro Month 60]
- Overall survival [Time frame: Up to Month 60]
- Disease-specific survival [Time frame: Up to Month 60]
- Time to cystectomy [Time frame: Up to Month 60]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 5 centers
- East Valley Urology Center of Arizona — Queen Creek
- Arkansas Urology — Little Rock
- Michael Oefelein Clinical Trials — Bakersfield
- Renown Regional Medical Center — St Louis
- START - Carolinas — Myrtle Beach
Ukraine · 1 center
- Arensia Kapitanivka - PPDS — Kapitanivka
Identifiers
NCT: NCT07480356 · TARA-002-301