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

Bladder Cancer Clinical Trial

Official title:

A NIS of Avelumab in Real-World Treatment for Patients With Advanced or Metastatic Urothelial Cancer in Argentina and Brazil -LATAM AVENUE

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05568407
• Other study ID #: B9991050
• Secondary ID: LATAM AVENUE
• Status: Terminated
• Start date: January 18, 2023
• Est. completion date: June 16, 2023

Study information

• Verified date: July 2023
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Urothelial carcinoma are tumors originating from the urothelial cells that line the bladder, renal pelvis, ureter, and urethra. Each year, bladder cancer (BC) accounts for 3.0% of global cancer diagnoses, with more than 570,000 new cases diagnosed and 2.1% of new deaths, with more than 210,000 deaths worldwide. In Latin America, BC placed the 10th and 9th positions in the incidence of cancer in Argentina and Brazil, respectively, and both countries have BC as the 5th most frequent cancers among males excluding non-melanoma skin cancer. 2-4 Among men, BC is the 6th most common cancer and the 9th leading cause of cancer death. Incidence and mortality in males are approximately four times higher compared to women with BC globally. In 2020, Argentina and Brazil reported over 3,700 and 15,800 new cases of BC, respectively. The 5-year prevalence at all ages of 11,401 (25 per 100,000) in Argentina and 43,545 (20 per 100,000) in Brazil. Besides male population, other risk factors for BC include prevalence of tobacco smoking, infection with Schistosoma haematobium, occupational exposures to organic solvents, and arsenic contamination in drinking water. 2,5 First-line standard of care for patients with advanced or metastatic urothelial cancer is a platinum-based chemotherapy regimen; however, the median OS in patients treated with Cisplatin-based chemotherapy is only 12-14 months, approximately. Besides, most patients with advanced or metastatic urothelial cancer commonly experience disease progression within 9 months after initiation of treatment

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 19
• Est. completion date: June 16, 2023
• Est. primary completion date: June 16, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

Drug:
• Avelumab
As used in real world practice

Locations

Country	Name	City	State
Argentina	Alexander Fleming S.A (Instituto Medico Especializado Alexander Fleming)	Ciudad Autonoma de Buenos Aires	Buenos Aires
Argentina	Sanatorio Privado de la Cañada	Cordoba
Argentina	Comite de Etica de la Investigacion del Hospital Italiano de La Plata	La Plata	Buenos Aires
Brazil	Hospital Mãe de Deus/Aesc	Porto Alegre	RIO Grande DO SUL
Brazil	Hospital Moinhos de Vento	Porto Alegre	RIO Grande DO SUL
Brazil	Oncoclínicas Do Brasil Servicos Médicos S/A - Oncocentro	Rio de Janeiro
Brazil	Hospital Alemão Oswaldo Cruz	Sao Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

Argentina,  Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Progression-Free Survival	Patients treated with Avelumab maintenance therapy	36 months
Secondary	OS	In patients treated with Avelumab maintenance therapy	36 months
Secondary	Duration Of Treatment	Between the first and last dose of Avelumab	36 months
Secondary	Frequency and nature of all-cause adverse events (AEs)	Toxicity; Dosage change (frequency and dosses approved); Progression disease; Cardiological Abnormalities; Dyspnea; Cough; Pneumonitis; Lab Abnormalities	36 months
Secondary	Frequency of all-cause AEs leading to discontinuation or interruption of Avelumab maintenance therapy	Progression disease; Toxicity; Patient Decision	36 months
Secondary	Duration of Avelumab maintenance therapy among the patients who discontinued the study drug due to all-cause AEs	Disease progression; Toxicity; Patient Decision	36 months
Secondary	Frequency of potential signs and symptoms of immune-related AEs	Dyspnea; Fatigue; Rush; Glottis Edema; Cardiological Abnormalities; Cough; Pneumonitis	36 months
Secondary	Frequency of patients with Avelumab dosing change due to any AE related to this drug	Dosage decrease for toxicity	36 months

External Links

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