Status:
COMPLETED
Evaluation of Clinical Outcomes, Tolerability, and Costs of Avelumab Maintenance and Pembrolizumab Second-Line Therapy in Advanced Urothelial Cancer.
Lead Sponsor:
Azienda Ospedaliera Universitaria Integrata Verona
Collaborating Sponsors:
Ospedale Mater Salutis-Legnago(Verona), Italy
Casa di Cura Dott. Pederzoli
Conditions:
Urothelial Cancer
Eligibility:
All Genders
18+ years
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 patie...
Detailed Description
Retrospective-prospective study
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
September 16 2024
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 22 2025
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT07207928
Start Date
September 16 2024
End Date
December 22 2025
Last Update
January 9 2026
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Azienda Ospedaliera Universitaria Integrata di Verona
Verona, Verona, Italy, 37134