Cisplatin-Based Chemotherapy Followed by Maintenance Avelumab in UTUC
Trial Parameters
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Brief Summary
A Prospective Phase II Study of Adjuvant Cisplatin-Based Chemotherapy followed by Maintenance Avelumab in Upper Tract Urothelial Carcinoma
Eligibility Criteria
Inclusion Criteria: * Must be aged 19 years or more * Must have histologically or cytologically proven UTUC arising from renal pelvis and/or ureter. * Must have histological evidence of high-risk muscle-invasive disease (i.e., pT2\~ T4) and/or N+ disease. * Must have an ECOG performance status of 0 to 1 * Received at least 3 or 4 cycles of adjuvant cisplatin-based chemotherapy, and proved to have no evidence of disease recurrence with imaging studies, urine cytology and cystoscopy * At least 3 weeks since the last surgical procedures or chemotherapy prior to enrolment. Subjects must have recovered to \<Grade 2 from all acute toxicities or toxicity must be deemed irreversible by the investigator. * Adequate marrow function without growth factor support or transfusion dependency A. Neutrophil 1,500 cells/μL or more B. Platelet count 100,000/μL or more C. Hemoglobin 9.0 g/dL or more * Adequate renal function with serum creatinine 1.5 x ULN or a calculated creatinine clearance ≥ 50 mL/min