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

Active, not recruiting

• Conditions: Urothelial Cancer

• Registration Number: NCT07207928
• Lead Sponsor: Azienda Ospedaliera Universitaria Integrata Verona

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

Study Timeline

• Study Start: 2024-09-16
• Primary Completion: 2025-02-21
• Status Verified: 2025-09
• Study First Submitted: 2025-09-08
• Study First Submitted QC: 2025-09-26
• Last Update Submitted: 2025-09-26
• Study First Posted: 2025-10-06
• Last Update Posted: 2025-10-06
• Study Completion: 2026-09-16

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• At least 18 years of age
• ECOG PS 0-2
• Pathologically confirmed diagnosis of stage IV urothelial carcinoma, regardless of PDL-1 status
• Patients treated with first-line platinum-based chemotherapy (Cisplatin or Carboplatin) who have not shown disease progression after 4-6 cycles of chemotherapy
• Patients receiving immunotherapy with Avelumab in the first-line maintenance setting or with 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

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression-free survival	1 year	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.
Overall Survival	1 year	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.

Secondary Outcome Measures

Name	Time	Method
Duration of Subsequent Oncologic Treatments	1 year	Duration of Subsequent Oncologic Treatments in patients with advanced platinum-fit urothelial carcinoma who have no disease progression after 4-6 cycles of first-line platinum-based chemotherapy treated with Avelumab in first-line maintenance therapy compared to patients treated with Pembrolizumab in second-line therapy.
Adverse Events	1 year	Adverse Events of Any Grade Related to Treatment according to CTCAE 5.0, in patients with advanced platinum-fit urothelial carcinoma who have no disease progression after 4-6 cycles of first-line platinum-based chemotherapy treated with Avelumab in first-line maintenance therapy, compared to patients treated with Pembrolizumab in second-line therapy. Adverse events will be evaluated based on their severity and relationship to the treatment received.
Serious Adverse Events	1 year	Adverse Events of Grade 3 or Higher Related to Treatment according to CTCAE 5.0, 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, compared to patients treated with Pembrolizumab in second-line therapy. Adverse events of grade 3 or higher will be monitored and assessed for their relationship to the treatment received.
Overall Cost of Oncologic Therapy	1 year	Overall Cost of Oncologic Therapy in patients with advanced platinum-fit urothelial carcinoma who have no disease progression after 4-6 cycles of first-line platinum-based chemotherapy treated with Avelumab in first-line maintenance therapy, compared to patients treated with Pembrolizumab in second-line therapy. The cost will be evaluated for each treatment approach and compared between the two groups.

Trial Locations

Locations (1)

Azienda Ospedaliera Universitaria Integrata di Verona; 🇮🇹 Verona, verona, Italy