Clinical trial NCT05568407: A Study of Avelumab in Real-World Treatment for Patients With Advanced or Metastatic Urothelial Cancer
Official title: A NIS of Avelumab in Real-World Treatment for Patients With Advanced or Metastatic Urothelial Cancer in Argentina and Brazil -LATAM AVENUE
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Bladder Cancer
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2022-10-05
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
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)

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.

Detailed 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

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.

Primary outcomes:
measure: Overall Survival (OS)
timeFrame: 36 months
Secondary outcomes:
measure: Progression-Free Survival
timeFrame: 36 months
measure: OS
timeFrame: 36 months
measure: Duration Of Treatment
timeFrame: 36 months
measure: Frequency and nature of all-cause adverse events (AEs)
timeFrame: 36 months
measure: Frequency of all-cause AEs leading to discontinuation or interruption of Avelumab maintenance therapy
timeFrame: 36 months
measure: Duration of Avelumab maintenance therapy among the patients who discontinued the study drug due to all-cause AEs
timeFrame: 36 months
measure: Frequency of potential signs and symptoms of immune-related AEs
timeFrame: 36 months
measure: Frequency of patients with Avelumab dosing change due to any AE related to this drug
timeFrame: 36 months
Other outcomes:
Locations:
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Alexander Fleming S.A (Instituto Medico Especializado Alexander Fleming)
state: Buenos Aires
city: La Plata
country: Argentina
facility: Comite de Etica de la Investigacion del Hospital Italiano de La Plata
state: Buenos Aires
city: Cordoba
country: Argentina
facility: Sanatorio Privado de la Cañada
city: Porto Alegre
country: Brazil
facility: Hospital Moinhos de Vento
state: RIO Grande DO SUL
city: Porto Alegre
country: Brazil
facility: Hospital Mãe de Deus/Aesc
state: RIO Grande DO SUL
city: Sao Paulo
country: Brazil
facility: Hospital Alemão Oswaldo Cruz
state: SP
city: Rio de Janeiro
country: Brazil
facility: Oncoclínicas Do Brasil Servicos Médicos S/A - Oncocentro
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: