Cisplatin-Based Chemotherapy Followed by Maintenance Avelumab in UTUC

Patients who meet all of the inclusion criteria and none of the exclusion criteria will receive avelumab 10 mg/kg as a 1-h infusion every 2 weeks. Avelumab will repeat every 2 weeks on an outpatient basis and continued until disease recurrence, unacceptable toxicity, consent withdrawal, or for a maximum of 1 year.

Screening numbers are endowed to all patients who sign the informed consent forms. These screening numbers are used as 'Subject Identification Code" along with patient initials. Patients withdrawn from the study retain their screening number. New patients must always be allotted with a new screening number.

All study subjects will be also eligible to receive best supportive care (BSC) defined as any standard supportive measures that are not considered a primary treatment of the disease under study, including the use of growth factors (i.e. G-CSF) for myelosuppression, analgesics and transfusion of blood products. BSC will be provided at the discretion of the investigators.

All patients are to have a clinic visit every 2 weeks (+3 days) during during study treatment. Tumor assessments will be performed at screening and approximately every 12 weeks, or sooner if deemed necessary by the investigator. A tumor assessment will be performed upon treatment discontinuation (End of Treatment visit) if the reason for discontinuation is other than disease progression and no tumor assessment was performed in the prior 12 weeks, or a tumor assessment is required for the confirmation of DFS.