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-naive High-Grade Non-Muscle Invasive Bladder Cancer (ADVANCED-3)

未提供0 个研究点目标入组 28 人开始时间: 待定

适应症

试验速览

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•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 (with or without 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 less than or equal to 2 doses of BCG within the 24 months prior to the most recent CIS diagnosis

•Penicillin allergy (participants with a questionable history of allergy to penicillin will undergo penicillin blood allergy testing via central laboratory
•Participants with central confirmed variant histology, including adenocarcinoma or squamous cell carcinoma
•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 or higher bladder cancer that existed at any point in time in the participant's history.

发起方

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