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| Name | Class |
|---|---|
| Ospedale Mater Salutis-Legnago(Verona), Italy | UNKNOWN |
| Casa di Cura Dott. Pederzoli | OTHER |
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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.
Retrospective-prospective study
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Subsequent Oncologic Treatments | 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. | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with advanced urothelial cancer without disease progression after 4-6 cycles of first-line platinum-based chemotherapy
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Azienda Ospedaliera Universitaria Integrata di Verona | Verona | Verona | 37134 | Italy |
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| Adverse Events | 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. | 1 year |
| Serious Adverse Events | 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. | 1 year |
| Overall Cost of Oncologic Therapy | 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. | 1 year |