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

NCT05568407 | Terminated

• 2 other identifiers: B9991050LATAM AVENUE
• Study Type: observational
• Target: 19
• Locations: 2 countries
• Sites: 7

Brief Summary

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.

Conditions

Bladder Cancer

Outcome Measures

Primary Outcomes (1)

• Overall Survival (OS)

  To evaluate OS rate at 12- and 24- months after the index date (date of the first Avelumab administration) in patients treated with Avelumab maintenance therapy.

  36 months

Secondary Outcomes (8)

• Progression-Free Survival

  36 months

• OS

  36 months

• Duration Of Treatment

  36 months

• Frequency and nature of all-cause adverse events (AEs)

  36 months

• Frequency of all-cause AEs leading to discontinuation or interruption of Avelumab maintenance therapy

  36 months

Study Arms (1)

Patients with Advanced or Metastatic Urothelial Cancer

Patients with Advanced or Metastatic Urothelial Cancer

Drug: Avelumab

Interventions

Avelumab DRUG

As used in real world practice

Patients with Advanced or Metastatic Urothelial Cancer

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

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)

You may qualify if:

• Adult patients, ≥18- years of age at the time of Avelumab treatment initiation
• 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)
• 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 \[CR\]).
• Patients who are receiving or have received at least one dose of Avelumab as the firstl ine maintenance therapy according to label indication
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (7)

Alexander Fleming S.A (Instituto Medico Especializado Alexander Fleming)

Ciudad Autonoma de Buenos Aires, Buenos Aires, 1426ANZ, Argentina

Location

Comite de Etica de la Investigacion del Hospital Italiano de La Plata

La Plata, Buenos Aires, B1900AXI, Argentina

Location

Sanatorio Privado de la Cañada

Córdoba, X5000BSQ, Argentina

Location

Hospital Moinhos de Vento

Porto Alegre, Rio Grande do Sul, 90035-001, Brazil

Location

Hospital Mãe de Deus/Aesc

Porto Alegre, Rio Grande do Sul, 90110-270, Brazil

Location

Hospital Alemão Oswaldo Cruz

São Paulo, São Paulo, Brazil

Location

Oncoclínicas Do Brasil Servicos Médicos S/A - Oncocentro

Rio de Janeiro, 22250-950, Brazil

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

avelumab

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: September 23, 2022
• First Posted: October 5, 2022
• Study Start: January 18, 2023
• Primary Completion: June 16, 2023
• Study Completion: June 16, 2023
• Last Updated: July 13, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

AR (3); BR (4)