A Prospective Phase II Study of Adjuvant Cisplatin-Based Chemotherapy Followed by Maintenance Avelumab in Upper Tract Urothelial Carcinoma

Status: Recruiting
Location: See location...
Intervention Type: Procedure, Drug, Other
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

A Prospective Phase II Study of Adjuvant Cisplatin-Based Chemotherapy followed by Maintenance Avelumab in Upper Tract Urothelial Carcinoma

Eligibility
Participation Requirements
Sex: All
Minimum Age: 20
Healthy Volunteers: f
View:

⁃ 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

⁃ Received at least 3 or 4 cycles of adjuvant cisplatin-based chemotherapy, and proved to have no evidence of disease recurrence with imaging studies, urine cytology and cystoscopy

⁃ At least 3 weeks since the last surgical procedures or chemotherapy prior to enrolment. Subjects must have recovered to \<Grade 2 from all acute toxicities or toxicity must be deemed irreversible by the investigator.

⁃ Adequate marrow function without growth factor support or transfusion dependency A. Neutrophil 1,500 cells/μL or more B. Platelet count 100,000/μL or more C. Hemoglobin 9.0 g/dL or more

⁃ Adequate renal function with serum creatinine 1.5 x ULN or a calculated creatinine clearance ≥ 50 mL/min using the CockcroftGault or MDRD formulas

⁃ Adequate hepatic function A. Bilirubin 1.5 times upper limit of normal (x ULN) or less; does not apply to subjects with Gilbert's syndrome diagnosed as per institutional guidelines. B. AST (SGOT) and ALT (SGPT) 3 x ULN or less; if liver metastases are present, then 5 x ULN is allowed.

⁃ Women of childbearing potential must use effective contraception continuously for at least 30 days after the final dose of avelumab. At least one method classified as highly effective (failure rate \< 1%) must be employed (see Table 1).

⁃ Written and voluntary informed consent understood, signed and dated.

⁃ Negative serum or urine pregnancy test at screening for women of childbearing potential.

Locations
Other Locations
Republic of Korea
Samsung Medical Center
RECRUITING
Seoul
Contact Information
Primary
SE HOON Park, MD,PhD
hematoma@skku.edu
82-2-3410-3767
Time Frame
Start Date: 2025-09-16
Estimated Completion Date: 2029-07-02
Participants
Target number of participants: 48
Treatments
Experimental: Single arm (Avelumab)
It is a single arm study and in this arm 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.
Sponsors
Leads: Samsung Medical Center

This content was sourced from clinicaltrials.gov

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