Phase II Study of Cisplatin Chemotherapy Followed by Maintenance Avelumab for Upper Tract Urothelial Carcinoma

What this Trial Is About

This research aims to explore a treatment approach for upper tract urothelial carcinoma UTUC, a rare but aggressive cancer affecting the renal pelvis or ureter. Despite standard radical surgery and chemotherapy, many patients face cancer recurrence and poor outcomes. Researchers are studying the use of maintenance avelumab after initial cisplatin-based chemotherapy to see if this strategy can help improve disease control in patients with high-risk, surgically treated UTUC. Participants will receive avelumab at a dose of 10 mgkg through a one-hour infusion every two weeks. This treatment will continue on an outpatient basis for up to one year, or until the disease returns, unacceptable side effects occur, or the participant chooses to withdraw. This is a single-arm phase II study without a comparison group, focusing on the effects of maintenance avelumab following cisplatin chemotherapy. During the study, patients will have clinic visits every two weeks for treatment and monitoring. Tumor assessments using CT scans or MRIs will be performed approximately every 12 weeks to check for disease progression. Researchers will track disease-free survival as the primary outcome, along with progression-free survival as a secondary outcome. The study includes ongoing safety monitoring and will last up to one year from enrollment for each participant.

Cisplatin-Based Chemotherapy Followed by Maintenance Avelumab in UTUC