Comparing 3 vs 6 Cycles of Platinum-based Chemotherapy Prior to Maintenance Avelumab in Advanced Urothelial Cancer

This is an adaptive, open-label, randomised phase II trial that aims to evaluate the impact of 3 vs 6 cycles of first-line platinum-based chemotherapy followed by maintenance avelumab in the quality of life of patients with locally advanced or metastatic urothelial cancer. Initially, 224 eligible and evaluable patients (112 in each arm) will receive 3 cycles vs 6 cycles of 3-weekly gemcitabine plus cisplatin/carboplatin, followed by 2-weekly maintenance avelumab until disease progression or intolerable toxicities. Avelumab treatment will be given up to a maximum of 2 years from the end of chemotherapy.

NCT Number	NCT06892860
Lead Sponsor	Queen Mary University of London
Conditions	Urinary Bladder Neoplasms
Enrollment	320 participants
Start Date	2021-12-16
Primary Completion	2027-06-30 (estimated)
Study Completion	2027-12-22 (estimated)
Updated on ClinicalTrials.gov	2026-05-06