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

Part of paid clinical trials in Queen Creek, Arizona.

Sponsor
Protara Therapeutics
Study ID
NCT07480356
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
May 29, 2026
Status verified
Jun 2026
Primary completion
Apr 30, 2028
Completion
Nov 30, 2032

Study Design

Enrollment
284 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: TARA-002 (Arm A)
  • Active Comparator: Investigator's choice of intravesical chemotherapy

Primary Outcome Measure

Incidence of high-grade complete response [ Time Frame: Month 6 ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
East Valley Urology Center of ArizonaQueen CreekArizona85140
Use Central Contact
Arkansas UrologyLittle RockArkansas72211
Use Central Contact
Michael Oefelein Clinical TrialsBakersfieldCalifornia93301-
Renown Regional Medical CenterSt LouisMissouri63110
Use Central Contact
START - CarolinasMyrtle BeachSouth Carolina29572
Use Central Contact

Find similar trials in Queen Creek, AZ

By research site
East Valley Urology Center of Arizona· Queen Creek, AZArkansas Urology· Little Rock, ARMichael Oefelein Clinical Trials· Bakersfield, CARenown Regional Medical Center· St Louis, MOSTART - Carolinas· Myrtle Beach, SC

Related Studies