At a glance
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Phase II Multicentre, Randomized, Open-label Study to Evaluate the Safety and Efficacy of Avelumab With Gemcitabine/Carboplatin Versus Gemcitabine/Carboplatin Alone in Patients With Unresectable or Metastatic Urothelial Carcinoma (UC) Who Have Not Received Prior Systemic Therapy and Who Are Ineligible to Receive Cisplatin-based Therapy.
In Brief
A Phase 2 clinical trial evaluating avelumab 10mg/kg with carboplatin/gemcitabine and carboplatin/gemcitabine alone for Metastatic Urothelial Cancer. Completed, enrolled 85 participants across 15 sites.
Detailed Summary
Phase II Multicentre, randomized, open-label study to evaluate the safety and efficacy of avelumab with gemcitabine/carboplatin versus gemcitabine/carboplatin alone in patients with unresectable or metastatic urothelial carcinoma (UC) who have not received prior systemic therapy and who are ineligible to receive cisplatin-based therapy.
Study Details
Timeline
Interventions
Dosage and schedule: * Avelumab 10mg/kg will be administered over 60 minutes in the experimental arm as follows: * Intravenously every 2 weeks for two cycles. * During carboplatin-gemcitabine treatment, on day +15 (carboplatin will be administered on day 1; gemcitabine on days 1 and 8), for six cycles. Intravenously every 2 weeks until progressive disease o intolerance. * Intravenously every 2 weeks until progressive disease or intolerance. * Carboplatin-gemcitabine will be administered for six cycles, every three weeks, with the following posology, according to the SmPC * Carboplatin 5AUC day +1. * Gemcitabine 1000mg/m2 day +1 and +8.
•Carboplatin-gemcitabine will be administered for six cycles, every three weeks, with the following posology, according to the SmPC * Carboplatin 5AUC day +1. * Gemcitabine 1000mg/m2 day +1 and +8.