Actively Recruiting
Cisplatin-Based Chemotherapy Followed by Maintenance Avelumab in UTUC
Led by Samsung Medical Center · Updated on 2025-11-06
48
Participants Needed
1
Research Sites
197 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A Prospective Phase II Study of Adjuvant Cisplatin-Based Chemotherapy followed by Maintenance Avelumab in Upper Tract Urothelial Carcinoma
CONDITIONS
Official Title
Cisplatin-Based Chemotherapy Followed by Maintenance Avelumab in UTUC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 19 years or older
- Histologically or cytologically confirmed upper tract urothelial carcinoma from renal pelvis and/or ureter
- Histological evidence of high-risk muscle-invasive disease (pT2 to T4) and/or N+ disease
- ECOG performance status of 0 to 1
- Completed at least 3 or 4 cycles of adjuvant cisplatin-based chemotherapy with no evidence of disease recurrence by imaging, urine cytology, and cystoscopy
- At least 3 weeks since last surgery or chemotherapy with recovery to less than Grade 2 acute toxicities or irreversible toxicity
- Adequate bone marrow function without growth factor or transfusion dependence: neutrophils >= 1500/µL, platelets >= 100,000/µL, hemoglobin >= 9.0 g/dL
- Adequate renal function: serum creatinine <= 1.5 times upper limit of normal or creatinine clearance >= 50 mL/min
- Adequate liver function: bilirubin <= 1.5 times upper limit of normal (except Gilbert's syndrome), AST and ALT <= 3 times upper limit of normal (or <= 5 times if liver metastases present)
- Women of childbearing potential must use highly effective contraception during treatment and for at least 30 days after final dose
- Signed informed consent
- Negative pregnancy test for women of childbearing potential at screening
You will not qualify if you...
- Receiving anticancer treatments not described in this study
- Evidence of metastatic disease on imaging
- Severe medical or psychological illnesses preventing participation, including recent coronary artery disease, heart attack within 3 years, severe heart failure, recent stroke, or serious arrhythmias except atrial fibrillation
- Neuropathy greater than Grade 2 or unstable neurological symptoms within 4 weeks before treatment start
- Major surgery other than diagnostic or transurethral resection within 4 weeks before treatment without full recovery
- Second primary cancer or history of other malignancies except cured cases as judged by investigator
- Active uncontrolled infections requiring systemic therapy
- History of allergic reactions to study treatments
- Conditions that could interfere with study conduct or pose unacceptable risk
- Legal incapacity or dementia limiting informed consent or compliance
- Current immunosuppressive medication use except for specified low-dose or local steroids
- Active autoimmune disease requiring systemic immunosuppressive treatment (controlled autoimmune diseases not requiring such treatment allowed)
- Prior organ transplantation including stem-cell transplantation
- Vaccination within 4 weeks before first dose except inactivated vaccines
- Persisting toxicities from prior therapies greater than Grade 1 except alopecia or stable neuropathy Grade 2
- Lactating women who do not discontinue breastfeeding during treatment and for 30 days after last dose
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Samsung Medical Center
Seoul, Gangnam, South Korea, 06351
Actively Recruiting
Research Team
S
SE HOON Park, MD,PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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