Study of Adding Durvalumab to Chemotherapy Before Surgery for High-Grade Upper Urinary Tract Urothelial Cancer

What this Trial Is About

Researchers are evaluating the effect of adding durvalumab, an immunotherapy drug, to chemotherapy before surgery in patients with high-grade upper urinary tract urothelial cancer. This phase IIIII clinical trial aims to compare outcomes between patients receiving chemotherapy alone and those receiving chemotherapy combined with durvalumab. The study focuses on improving event-free survival and pathologic complete response rates before surgery. Participants are assigned to one of three groups based on eligibility for cisplatin chemotherapy. Cisplatin-eligible patients are randomized to receive either durvalumab with accelerated methotrexate, vinblastine, doxorubicin, and cisplatin aMVAC chemotherapy, or aMVAC chemotherapy alone. Cisplatin-ineligible patients receive durvalumab combined with gemcitabine. Treatments are given intravenously in cycles every 14 or 21 days for up to four cycles. Surgery is scheduled within 21 to 60 days following treatment completion for patients without metastatic or unresectable disease. During the study, participants undergo tissue biopsies, blood sample collection, and imaging scans such as CT or MRI to monitor their cancer. After treatment and surgery, follow-up visits occur within 30 days and then every 3 to 6 months for up to five years. Researchers measure event-free survival, pathologic complete response, overall survival, disease-free survival, cancer-specific survival, kidney function, and safety outcomes throughout the trial.

Testing the Addition of MEDI4736 (Durvalumab) to Chemotherapy Before Surgery for Patients With High-Grade Upper Urinary Tract Cancer