NCT07480356
Not yet recruiting
Phase 3
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
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- Protara Therapeutics
- Enrollment
- 284
- Primary Endpoint
- Incidence of high-grade complete response
Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
TARA-002 (Arm A)
Experimental
Intervention: TARA-002 (Drug)
Investigator's choice of intravesical chemotherapy
Active Comparator
Intervention: Investigator's Choice of Intravesical Chemotherapy (Drug)
Outcomes
Primary Outcomes
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
- Overall survival(Up to Month 60)
- Duration of high-grade complete response(Up to Month 60)
- Treatment emergent adverse events(Up to Month 60)
- Treatment emergent serious adverse events(Up to Month 60)
- High-grade complete response rate(At Months 3, 9, 12, 15, 18, 21, 24, 27, 30, 36, 42, 48, 54, and 60)
- High-grade complete response rate (CIS only)(Month 6)
- Event-free survival(Up to Month 60)
- Recurrence-free survival(Up to Month 60)
- Progression-free survival(Up to Month 60)
- Disease-specific progression-free survival(Up ro Month 60)
- Disease-specific survival(Up to Month 60)
- Time to cystectomy(Up to Month 60)
- Time to recurrence delayed cystectomy(Up to Month 60)
- Time to progression(Up to Month 60)
- Time to disease worsening(Up to Month 60)
Investigators
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