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

NCT07207928 | Completed

• 1 other identifier: 339CET
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Urothelial Cancer

Outcome Measures

Primary Outcomes (2)

• Progression-free survival

  Radiologic Progression-Free Survival (PFS) Evaluation in patients with advanced platinum-fit urothelial carcinoma who have no disease progression after 4-6 cycles of first-line platinum-based chemotherapy. These patients are treated with Avelumab in first-line maintenance therapy, or Pembrolizumab in second-line therapy. Radiologic progression is defined as the time from the start of first-line platinum-based chemotherapy to the date of radiologic progression (according to RECIST v1.1) after initiation of Avelumab maintenance therapy in the first-line or Pembrolizumab in the second-line, or death from any cause.

  1 year

• Overall Survival

  Overall Survival (OS) Evaluation in patients with advanced platinum-fit urothelial carcinoma who have no disease progression after 4-6 cycles of first-line platinum-based chemotherapy. These patients are treated with Avelumab in first-line maintenance therapy, or Pembrolizumab in second-line therapy.

  1 year

Secondary Outcomes (4)

• Duration of Subsequent Oncologic Treatments

  1 year

• Adverse Events

  1 year

• Serious Adverse Events

  1 year

• Overall Cost of Oncologic Therapy

  1 year

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with advanced urothelial cancer without disease progression after 4-6 cycles of first-line platinum-based chemotherapy

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Azienda Ospedaliera Universitaria Integrata Verona: lead
• Ospedale Mater Salutis-Legnago(Verona), Italy: collaborator
• Casa di Cura Dott. Pederzoli: collaborator

Study Sites (1)

Azienda Ospedaliera Universitaria Integrata di Verona

Verona, Verona, 37134, Italy

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2025
• First Posted: October 6, 2025
• Study Start: September 16, 2024
• Primary Completion: February 21, 2025
• Study Completion: December 22, 2025
• Last Updated: January 9, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)