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Cisplatin-Based Chemotherapy Followed by Maintenance Avelumab in UTUC

NCT07225374 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2025-11-06

No results posted yet for this study

Summary

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

Conditions

  • Upper Tract Urothelial Carcinoma

Interventions

DRUG

Avelumab 10 mg/kg

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.

PROCEDURE

Screening

Screening 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 Patients withdrawn from the study retain their screening number.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.

PROCEDURE

Best Supportive Care (BSC)

All 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.

OTHER

Follow-up plan

All 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.

Sponsors & Collaborators

  • Samsung Medical Center

    lead OTHER

Principal Investigators

  • SE HOON PARK, MD,PhD · SamsungMedicalCenter

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-16
Primary Completion
2026-07-01
Completion
2029-07-02
FDA Drug
Yes

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07225374 on ClinicalTrials.gov