A Randomized Open-Label Phase III Study of Sacituzumab Govitecan Versus Treatment of Physician's Choice in Subjects With Metastatic or Locally Advanced Unresectable Urothelial Cancer

You may be able to join if

• Subjects meeting all of the following inclusion criteria at Screening/Baseline will be eligible for participation in the study: Female or male subjects, ≥18 years of age, able to understand and give written informed consent.
• Male subjects and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception as described in Appendix 6 of the protocol
• Subjects with histologically documented UC that is metastatic or locally advanced unresectable defined as Tumor (T) 4b, any node (N) or Any T, N 2-3
• Tumors of upper and lower urinary tract are permitted. Mixed histologic types are allowed if urothelial is the predominant histology.
• ECOG performance status (PS) score of 0 or 1.
• Subjects with progression or recurrence following receipt of platinum-containing regimen and anti-PD-1/PD-L1 therapy for metastatic or locally advanced unresectable disease will be enrolled. a) Subjects with recurrence or progression ≤12 months following completion of cisplatincontaining chemotherapy given in the neo-adjuvant/adjuvant setting may utilize that line of therapy to be eligible for the study. The 12-month period is counted from completion of surgical intervention or cisplatin therapy, respectively. These subjects must receive anti-PD-1/PD L1 therapy in the metastatic or locally advanced unresectable setting to be eligible. b) Subjects who received either carboplatin or anti-PD-1/PD-L1 therapy in the neoadjuvant/ adjuvant setting will not be able to count that line of therapy towards eligibility for the study. c) Cisplatin-ineligible subjects who meet one of the below criteria and who were treated with carboplatin in the metastatic or locally advanced unresectable settings may count that line of therapy towards eligibility. They must then have received anti-PD-1/PD-L1 therapy in metastatic or locally advanced unresectable setting to be eligible for the study. Cisplatin ineligibility is defined as meeting one of the following criteria: i) Creatinine Clearance <60 mL/min ii) Grade ≥2 Audiometric Hearing Loss iii) Grade ≥2 Peripheral Neuropathy iv) New York Heart Association (NYHA) Class III heart failure v) ECOG PS ≥2 d) Anti-PD-1/PD-L1 therapy administered as part of maintenance therapy may be counted towards eligibility for the study e) Subjects who have progressed after receiving enfortumab vedotin in prior lines of therapy, and subjects who are either ineligible or unable to tolerate enfortumab vedotin therapy, are eligible to enroll in the study. f) Subjects who received only concurrent chemoradiation for bladder preservation without further systemic therapy are not eligible to enroll in the study. The substitution of carboplatin for cisplatin does not constitute a new regimen provided no new chemotherapeutic agents were added to the regimen and no progression was noted prior to the change in platinum.