Actively Recruiting
A Prospective Phase II Study of Adjuvant Cisplatin-Based Chemotherapy Followed by Maintenance Avelumab in Upper Tract Urothelial Carcinoma
Led by Samsung Medical Center · Updated on 2025-11-06
48
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to explore a treatment approach for upper tract urothelial carcinoma (UTUC), a rare but aggressive cancer affecting the renal pelvis or ureter. Despite standard radical surgery and chemotherapy, many patients face cancer recurrence and poor outcomes. Researchers are studying the use of maintenance avelumab after initial cisplatin-based chemotherapy to see if this strategy can help improve disease control in patients with high-risk, surgically treated UTUC. Participants will receive avelumab at a dose of 10 mg/kg through a one-hour infusion every two weeks. This treatment will continue on an outpatient basis for up to one year, or until the disease returns, unacceptable side effects occur, or the participant chooses to withdraw. This is a single-arm phase II study without a comparison group, focusing on the effects of maintenance avelumab following cisplatin chemotherapy. During the study, patients will have clinic visits every two weeks for treatment and monitoring. Tumor assessments using CT scans or MRIs will be performed approximately every 12 weeks to check for disease progression. Researchers will track disease-free survival as the primary outcome, along with progression-free survival as a secondary outcome. The study includes ongoing safety monitoring and will last up to one year from enrollment for each participant.
CONDITIONS
Brief Title
Cisplatin-Based Chemotherapy Followed by Maintenance Avelumab in UTUC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Must be aged 19 years or more
- Histologically or cytologically confirmed upper tract urothelial carcinoma from renal pelvis and/or ureter
- Evidence of high-risk muscle-invasive disease (pT2 to T4) and/or lymph node involvement
- ECOG performance status of 0 to 1
- Completed at least 3 or 4 cycles of adjuvant cisplatin-based chemotherapy with no disease recurrence by imaging, urine cytology, and cystoscopy
- At least 3 weeks since last surgery or chemotherapy with recovery to less than Grade 2 toxicity or irreversible toxicity
- Adequate marrow function: neutrophils ≥ 1500/µL, platelets ≥ 100,000/µL, hemoglobin ≥ 9.0 g/dL
- Adequate renal function: serum creatinine ≤ 1.5 times ULN or creatinine clearance ≥ 50 mL/min
- Adequate liver function: bilirubin ≤ 1.5 times ULN (except Gilbert's syndrome), AST and ALT ≤ 3 times ULN (or ≤ 5 times ULN if liver metastases present)
- Women of childbearing potential must use effective contraception during and 30 days after treatment
- Signed and dated informed consent
- Negative pregnancy test at screening for women of childbearing potential
You will not qualify if you...
- Receiving any anticancer treatment not described in this protocol
- Radiologic evidence of metastatic disease
- Severe medical or psychological illness preventing study participation, including recent heart attack, severe heart failure (NYHA grade III or above), recent stroke, or serious arrhythmia (except atrial fibrillation)
- Non-tolerable neuropathy above Grade 2 or unstable neurological symptoms within 4 weeks before starting treatment
- Major surgery (other than diagnostic or transurethral resection) within 4 weeks before treatment without full recovery
- Presence of second primary cancer or history of other cancers except cured cases approved by investigator
- Active, uncontrolled infections requiring systemic therapy
- History of allergic reactions to study treatment
- Any condition or disease that could interfere with study conduct or pose unacceptable risk
- Legal incapacity or significant cognitive impairment limiting consent or compliance
- Current use of immunosuppressive medication except low-dose steroids or local treatments
- Active autoimmune disease requiring systemic immunosuppressive therapy (controlled autoimmune diseases without such treatment allowed)
- Prior organ transplantation including stem cell transplantation
- Vaccination within 4 weeks before first dose except inactivated vaccines
- Persisting toxicity from prior therapy above Grade 1 (except alopecia, sensory neuropathy Grade ≤ 2, or other Grade ≤ 2 considered safe by investigator)
- Lactating women must stop 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 year
Participants receive avelumab 10 mg/kg as a 1-hour infusion every 2 weeks on an outpatient basis. Treatment continues until disease recurrence, unacceptable toxicity, consent withdrawal, or for a maximum of 1 year.
Biweekly visits for treatment infusion
Duration - Up to 1 year concurrent with treatment
Participants have tumor assessments approximately every 12 weeks during treatment and at treatment discontinuation if needed, along with clinic visits every 2 weeks during study treatment.
Clinic visits every 2 weeks; tumor assessments every 12 weeks
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
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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