A Prospective Phase II Study of Adjuvant Cisplatin-Based Chemotherapy followed by Maintenance Avelumab in Upper Tract Urothelial Carcinoma
Upper tract urothelial carcinoma (UTUC), including those that arise in the renal pelvis or in ureter, are relatively uncommon but highlyinvasive. Although radical surgery followed by adjuvant chemotherapy is considered a standard in the management of UTUC, a significant percentage of patients experience recurrence, leading to a poor prognosis. Nivolumab has been investigated for adjuvant treatment in the other trial, but unfortunately, a better DFS was not observed in patients with UTUC. Given the promising efficacy of the maintenance avelumab following first-line chemotherapy, the maintenance strategy looks promising in the adjuvant setting of curatively-resected UTUC.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
48
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 Patients withdrawn from the study retain their screening number.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.
Samsung Medical Center
Seoul, Gangnam, South Korea
RECRUITINGDisease-free survival (DFS)
Disease-free survival (DFS)
Time frame: In brief, CT scans (or MRIs) will be performed every 12 weeks during study treatment, through study completion, until progression of disease or 1 year starting from enrollment of study.
Progression free survival
Progression will be evaluated in this study using the RECIST 1.1 criteria.
Time frame: All subjects will be evaluated PFS as the time from the date of first study treatment to the date of disease progression or death, whichever comes first through the study, or 1 year starting from enrollment of study.
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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.