A Phase III, 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
Study Identifier:
TARA-002-301
CT.gov Identifier:
EudraCT Identifier:
N/A
EU Trial (CTIS) Number:
N/A
Study Contact Information:
Recruiting
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Study Summary
To evaluate the effect of TARA-002 in patients with BCG-naive NMIBC.
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.
Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
Unmapped
Unmapped
Bladder
Phase
The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
Phase III
Sex
Female & Male
Age
18+ years
Study Drug
Drug: Patients will receive TARA-002.
Study Status
Indicates the current recruitment status or the expanded access status
Recruiting
Requirements information
Inclusion criteria
- Male or female participants 18 years of age or older at the time of signing informed consentParticipants who have voluntarily given written informed consent after the nature of the study has been explained according to applicable requirements prior to study entryCentral histologic confirmation of high-grade non-muscle invasive CIS (± Ta/T1) with active diseaseParticipants 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 histologyConcomitant prostatic or upper tract urothelial involvement per Investigator's assessmentNodal 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
Clinical Study Information for Healthcare Providers
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Study Locations
Location
Investigator
Status
Condition(s) Treated at Site
Location
START Carolinas
Myrtle Beach, SC, United States, 29572
Investigator
Abhishek Srivastava
Status
Recruiting
Condition(s) Treated at Site
Unmapped
Unmapped
Bladder