Evaluation of Clinical Outcomes, Tolerability, and Costs of Avelumab Maintenance and Pembrolizumab Second-Line Therapy in Advanced Urothelial Cancer.

NCT ID: NCT07207928

Last Updated: 2026-01-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 35 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-09-16
• Study Completion Date: 2025-12-22

Brief Summary

The goal of this observational study is to evaluate the clinical outcomes, side effects, and costs of Avelumab maintenance therapy in first-line and Pembrolizumab in second-line for platinum-fit patients with advanced urothelial cancer who have not shown disease progression after 4-6 cycles of platinum-based first-line chemotherapy.

Researchers will compare the effects of Avelumab (used as maintenance in first-line) and Pembrolizumab (used in second-line) to see if there are differences in clinical outcomes, toxicity profiles, and costs.

Participants will:

Receive Avelumab as maintenance therapy in the first-line or Pembrolizumab in the second-line as per standard clinical practice.

Be monitored for clinical outcomes, side effects, and costs over a period of up to 12 months prospectively and 10 years retrospectively.

Detailed Description

Retrospective-prospective study

Conditions

Urothelial Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Eligibility Criteria

Inclusion Criteria

• At least 18 years of age
• ECOG PS 0-2
• Diagnosis of pathologically confirmed stage IV urothelial cancer, regardless of PD-L1 status
• Patients treated with platinum-based chemotherapy (Cisplatin or Carboplatin) in the first-line setting who have not shown disease progression after 4-6 cycles of chemotherapy
• Patients receiving Avelumab as maintenance therapy in the first-line setting or Pembrolizumab in the second-line setting
• Availability of hospital and/or outpatient medical records for clinical data collection
• Ability to understand and willingness to provide informed consent, or deceased patients at the time of enrollment, in compliance with Article 110 of the Privacy Code and the safeguards established by the Data Protection Authority in Provision No. 298 of May 9, 2024.

Exclusion Criteria

• History of another malignancy or concurrent malignancy (except for cured non-melanoma skin cancer, low-risk prostate cancer, T1/T2 glottic cancer, stage 0 or I breast cancer, non-invasive bladder cancer, or in situ cervical cancer).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ospedale Mater Salutis-Legnago(Verona), Italy

UNKNOWN

Sponsor Role: collaborator

Casa di Cura Dott. Pederzoli

OTHER

Sponsor Role: collaborator

Azienda Ospedaliera Universitaria Integrata Verona

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Azienda Ospedaliera Universitaria Integrata di Verona

Verona, Verona, Italy

Countries

Italy

Other Identifiers

339CET

Identifier Type: -

Identifier Source: org_study_id