[Translation] A Phase III, randomized, open-label, multicenter study evaluating the efficacy and safety of TAR-200 compared with investigator’s choice of intravesical chemotherapy in subjects with high-risk non-muscle invasive bladder cancer (HR-NMIBC) who have relapsed after Bacillus Calmette-Guérin (BCG) therapy and are not candidates for or choose not to undergo radical cystectomy
主要目的是在BCG治疗末次给药后1年内出现单纯乳头状HR-NMIBC复发且拒绝或不适合接受根治性膀胱切除术(RC)的受试者中,比较接受TAR-200治疗与研究者选择的单药膀胱内化疗的无疾病生存期。
[Translation] The primary objective was to compare disease-free survival between patients treated with TAR-200 and investigator's choice of single-agent intravesical chemotherapy in subjects with recurrence of isolated papillary HR-NMIBC within 1 year after the last dose of BCG therapy who refused or were not candidates for radical cystectomy (RC).