NCT07207928

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

Evaluation of Clinical Outcomes, Tolerability, and Costs of Avelumab as First-Line Maintenance Therapy and Pembrolizumab as Second-Line Therapy in Patients With Advanced Urothelial Cancer Without Disease Progression After First-Line Platinum-Based Chemotherapy: A Multicenter Retro-Prospective Observational Study in Real-World Clinical Practice

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 35 (actual)
• Sponsor: Azienda Ospedaliera Universitaria Integrata Verona · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Timeline

• Start date: 2024-09-16
• Primary completion: 2025-02-21
• Completion: 2025-12-22
• First posted: 2025-10-06
• Last updated: 2026-01-09

Locations

1 site across 1 country: Italy