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Brief Title: Phase II Trial of Lurbinectedin Combined With Avelumab as Switch Maintenance Firstline Therapy
Official Title: Phase II Trial of Lurbinectedin Combined With Avelumab as Switch Maintenance Firstline Therapy for Metastatic Urothelial Carcinoma With Stable or Responding Disease Following Platinum-based Chemotherapy
Study ID: NCT05574504
Brief Summary: A nonrandomized phase II trial is proposed combining avelumab (PD-L1 inhibitor immunotherapy) + lurbinectedin as switch maintenance therapy for mUC following stable or responding disease on 4-6 cycles of first line platinum-based chemotherapy
Detailed Description: The purpose of this research is to study benefit of the combination of lurbinectedin chemotherapy with maintenance avelumab immunotherapy in patients with advanced cancer of the urinary tract who have completed platinum-based chemotherapy. Avelumab alone is the usual approach and is already approved by the US FDA for the treatments of patients with this type of cancer. Lurbinectedin is approved for a type of lung cancer, but is not approved for urinary tract cancer.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
AdventHealth Cancer Institute, Orlando, Florida, United States