Last updated 4 months ago
Safety and Efficacy Study of Intravesical Instillation of TARA-002 in Adults With High-grade Non-muscle Invasive Bladder Cancer
127 patients around the world
Available in United States, Argentina
Protara Therapeutics
1Research sites
127Patients around the world
This study is for people with
Bladder Cancer
Non-muscle-invasive bladder cancer
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- 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 (Cohort A).Participants with persistent or recurrent CIS (± Ta/T1) who are BCG unresponsive within 12 months of completion of adequate BCG therapy (Cohort B).
- Penicillin allergy (participants with a questionable history of allergy to penicillin will undergo penicillin blood allergy testing via central laboratory).Predominant (defined as > 50%) adenocarcinoma, squamous cell carcinoma, or histological variants including plasmacytoid, sarcomatoid, or squamous components according to central review.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.
Sites
Centro Argentino de Urología - CAU
Recruiting
StudyADVANCED-2
SponsorProtara Therapeutics
Conditions
Non-muscle-invasive bladder cancer
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT05951179
