Cisplatin-Based Chemotherapy Followed by Maintenance Avelumab in UTUC
ConditionUpper Tract Urothelial Carcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age20+
SponsorSamsung Medical Center
About this trial
A Prospective Phase II Study of Adjuvant Cisplatin-Based Chemotherapy followed by Maintenance Avelumab in Upper Tract Urothelial Carcinoma
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Must be aged 19 years or more
Must have histologically or cytologically proven UTUC arising from renal pelvis and/or ureter.
Must have histological evidence of high-risk muscle-invasive disease (i.e., pT2~ T4) and/or N+ disease.
Must have an ECOG performance status of 0 to 1
Disqualifiers
Ongoing treatment with an anticancer agent not contemplated in this protocol
Radiologic finding consistent with metastatic disease
Severe medical or psychological illness that preclude participation to study, including any history of clinically relevant coronary artery disease or myocardial infarction within the last 3 years, New York Heart Association (NYHA) grade III or greater congestive heart failure, cerebrovascular attack within the prior year, or current serious cardiac arrhythmia requiring medication except atrial fibrillation
Non-tolerable > Grade 2 neuropathy or evidence of unstable neurological symptoms within 4 weeks of Cycle 1 Day 1
Trial design
Design model
Single group
Treatments tested in this trial
Avelumab 10 mg/kg
DrugPatients 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
Procedure/SurgeryScreening 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 Patients withdrawn from the study retain their screening number.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.
Best Supportive Care (BSC)
Procedure/SurgeryAll 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.
Follow-up plan
Other interventionAll 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.
Treatment groups
48 Participants
are divided into 1 treatment groupGroup A: Single arm (Avelumab)Experimental treatment 4 interventions
Trial outcomes
Primary outcomes
1
Disease-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.Secondary outcomes
1
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.Sponsors and contacts
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Source ClinicalTrials.gov