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
Qualifiers
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
Treatments tested in this trial
- Avelumab 10 mg/kg
- Screening
- Best Supportive Care (BSC)
- Follow-up plan
Treatment groups
48 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov