A Phase II/III trial of Durvalumab and Chemotherapy for Patients with High Grade Upper Tract Urothelial Cancer Prior to Nephroureterectomy EA8192
Objective
Primary Objectives: The primary objective of the cisplatin eligible cohort (N=220) is to compare event-free survival (EFS) between patients with UTUC randomized to neoadjuvant aMVAC alone or in combination with Durvalumab.
The primary objective of the cisplatin ineligible cohort (N=29) is evaluation of pathologic complete response at radical nephroureterectomy (RNU) (pCR, pT0N0/ Nx).
Secondary Objectives: To assess pathologic complete response (pCR) at surgery. (Cisplatin eligible cohort) Event-free survival (EFS) will be evaluated for the cisplatin ineligible cohort as a secondary endpoint. (Cisplatin ineligible cohort) Overall survival in all, and by post chemotherapy response (ypCR, yp =< T1N0, yp >= T2Nany). (All patients) To evaluate disease-free survival (DFS) in each arm of the trial separately. (All patients) To evaluate cancer-specific survival of patients in each arm of the trial separately. (All patients) To evaluate renal function outcomes following systemic treatment and following surgery ([RNU) in each arm of the trial separately. (All patients) To evaluate safety and tolerability of neoadjuvant aMVAC alone or in combination with durvalumab prior to RNU. (All patients)
