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A Study of Avelumab in Real-World Treatment for Patients With Advanced or Metastatic Urothelial Cancer

TerminatedN/A

Sponsor: Pfizer

Conditions: Bladder Cancer

Interventions: Avelumab

Countries: Argentina, Brazil

This ambispective (both retrospective and prospective) NIS will evaluate the effectiveness and safety of Avelumab as a maintenance therapy administered after completion of first-line platinum-based chemotherapy in patients with locally advanced or metastatic urothelial cancer under routine conditions of daily clinical practice in Argentina and Brazil in line with the approved Avelumab label indication. Primary objective: • To evaluate overall survival (OS) rate at 12 and 24- months after the index date (date of the first Avelumab administration) in patients treated with Avelumab maintenance therapy. Secondary objectives: • To assess OS in patients treated with Avelumab maintenance therapy. To assess progression-free survival (PFS) of patients treated with Avelumab maintenance therapy. • To evaluate safety and tolerability of Avelumab maintenance therapy. • To assess duration of treatment (DOT) between the first and last dose of avelumab. • To describe the clinical and demographics characteristics of Argentinean and Brazilian patients treated with Avelumab maintenance therapy. Other objectives: • To evaluate anti-tumor effectiveness of Avelumab maintenance therapy.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

Inclusion Criteria:

1. Adult patients, ≥18- years of age at the time of Avelumab treatment initiation
2. Patients with locally advanced or metastatic urothelial cancer with any histology (histologically confirmed, unresectable locally advanced or metastatic urothelial carcinoma and/or documented Stage IV disease (per American Joint Committee on Cancer/International Union for Cancer Control TNM system1 19-21) at the start of first-line chemotherapy)
3. Patients who have completed first-line platinum-based chemotherapy with no evidence of disease progression according to medical chart (ie, with a SD, PRor complete response \[CR\]).
4. Patients who are receiving or have received at least one dose of Avelumab as the firstl ine maintenance therapy according to label indication
5. Patients with ongoing treatment with Avelumab who provided written informed consent allowing the data collection. For decease patients and those who are lost to follow-up, an approved ICF waiver is allowed.

Exclusion Criteria:

* Patients who have participated in any interventional clinical trial of a drug or device within 28- days prior to the start of Avelumab maintenance therapy.

Locations (7)

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
La Plata, Buenos Aires, Argentina
Córdoba, Argentina
Porto Alegre, Rio Grande do Sul, Brazil
Porto Alegre, Rio Grande do Sul, Brazil
São Paulo, São Paulo, Brazil
Rio de Janeiro, Brazil