Phase II Randomized Study of 3 Versus 6 Cycles of Platinum-based Chemotherapy Followed by Maintenance Avelumab in Advanced Urothelial Cancer

What this Trial Is About

This trial investigates the impact on quality of life of giving 3 versus 6 cycles of first-line platinum-based chemotherapy followed by maintenance treatment with avelumab in patients with locally advanced or metastatic urothelial cancer. It is an adaptive, open-label, randomized phase II study involving patients with bladder or related urothelial cancers. The study aims to understand how the number of chemotherapy cycles before immunotherapy affects patient-reported outcomes and clinical measures. Participants will be randomly assigned to receive either 3 or 6 cycles of chemotherapy consisting of gemcitabine plus cisplatin or carboplatin given every 3 weeks. Gemcitabine is administered on day 1 and day 8 of each 21-day cycle. After chemotherapy, patients will start maintenance treatment with avelumab every 2 weeks, continuing for up to 2 years or until disease progression or intolerable side effects occur. The study compares these two chemotherapy durations followed by the same maintenance immunotherapy. Throughout the study, participants will complete patient-reported outcome questionnaires to assess quality of life and undergo clinical evaluations to monitor safety, tolerability, and disease response. The main outcome is the effect on quality of life after the treatment cycles, with secondary measures including additional patient and clinician-reported outcomes, safety, and treatment efficacy. The total duration on avelumab maintenance can last up to 2 years following chemotherapy. The study began in December 2021 and will continue until December 2027.

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