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

Purpose

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.

Conditions

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

Eligibility

Eligible Ages
Over 18 Years
Eligible 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.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Participants receiving Investigator's choice of intravesical chemotherapy who are treatment failures and have CIS (±Ta) at any response assessment are eligible for crossover to TARA-002, provided they still meet all other study-specified eligibility requirements.
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

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

Recruiting Locations

East Valley Urology Center of Arizona
Queen Creek, Arizona 85140
Contact:
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Arkansas Urology
Little Rock, Arkansas 72211
Contact:
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Michael Oefelein Clinical Trials
Bakersfield, California 93301

Renown Regional Medical Center
St Louis, Missouri 63110
Contact:
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START - Carolinas
Myrtle Beach, South Carolina 29572
Contact:
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More Details

Status
Recruiting
Sponsor
Protara Therapeutics

Study Contact

Chief R&D Officer
16468440337
clinicaltrials@protaratx.com