TARA-002 Compared With Bladder Chemotherapy for Early-Stage High-Grade Bladder Cancer
Compares TARA-002 with chemotherapy in adults with high-grade non-muscle invasive bladder cancer.
Plain-language title generated from the registry record
Registry title: 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
Key facts
- Where
- Arlington, Atlanta, Austin, Bakersfield, Houston, Little Rock, Myrtle Beach, Queen Creek, and St Louis, United StatesSee the 9 sites
- Phase
- Phase 3
Where in United States
- Urology Partners of North TexasArlington, United StatesTaking people
- Urology of Greater Atlanta - Sandy SpringsAtlanta, United StatesTaking people
- Urology Austin, LLCAustin, United StatesTaking people
- Michael Oefelein Clinical TrialsBakersfield, United StatesTaking people
- Houston Metro UrologyHouston, United StatesTaking people
- Arkansas UrologyLittle Rock, United StatesTaking people
- START CarolinasMyrtle Beach, United StatesTaking people
- East Valley Urology Center of ArizonaQueen Creek, United StatesTaking people
- Renown Regional Medical CenterSt Louis, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Protara Therapeutics
- Trial code
- NCT07480356
- Record updated
- 6 October 2026
- Original 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.Read full original descriptionShow less
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
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.
Inclusion: 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: 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; Penicillin allergy (participants with a questionable history of allergy to penicillin will undergo penicillin blood allergy testing via central laboratory; Central confirmed variant histology.