Bladder CancerNCT05568407
A Study of Avelumab in Real-World Treatment for Patients With Advanced or Metastatic Urothelial Cancer
An observational study of Bladder Cancer, run by Pfizer at 7 sites in 2 countries.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- Avelumab
- How many people
- 19 participants
- Where
- 7 sitesin 2 countries
- Study dates
- 18 Jan 2023to 16 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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)
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
Brazil4 sites
Hospital Moinhos de Vento
Porto Alegre, Rio Grande do Sul, 90035-001
Hospital Mãe de Deus/Aesc
Porto Alegre, Rio Grande do Sul, 90110-270
Oncoclínicas Do Brasil Servicos Médicos S/A - Oncocentro
Rio de Janeiro, 22250-950
Hospital Alemão Oswaldo Cruz
São Paulo, São Paulo
Argentina3 sites
Alexander Fleming S.A (Instituto Medico Especializado Alexander Fleming)
Ciudad Autonoma de Buenos Aires, Buenos Aires, 1426ANZ
Sanatorio Privado de la Cañada
Córdoba, X5000BSQ
Comite de Etica de la Investigacion del Hospital Italiano de La Plata
La Plata, Buenos Aires, B1900AXI
About this study
Official title: A NIS of Avelumab in Real-World Treatment for Patients With Advanced or Metastatic Urothelial Cancer in Argentina and Brazil -LATAM AVENUE
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.
Read the 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
- Conditions
- Bladder Cancer
- Being tested
- Avelumab
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AvelumabDrug
As used in real world practice
| Study group | Role | What they receive |
|---|---|---|
| Patients with Advanced or Metastatic Urothelial Cancer | Patients with Advanced or Metastatic Urothelial Cancer Receives: Drug: Avelumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 36 months
Secondary outcomes (8)
Progression-Free Survival
Patients treated with Avelumab maintenance therapy
Measured: 36 months
OS
In patients treated with Avelumab maintenance therapy
Measured: 36 months
Duration Of Treatment
Between the first and last dose of Avelumab
Measured: 36 months
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
Measured: 36 months
Frequency of all-cause AEs leading to discontinuation or interruption of Avelumab maintenance therapy
Progression disease; Toxicity; Patient Decision
Measured: 36 months
Duration of Avelumab maintenance therapy among the patients who discontinued the study drug due to all-cause AEs
Disease progression; Toxicity; Patient Decision
Measured: 36 months
Frequency of potential signs and symptoms of immune-related AEs
Dyspnea; Fatigue; Rush; Glottis Edema; Cardiological Abnormalities; Cough; Pneumonitis
Measured: 36 months
Frequency of patients with Avelumab dosing change due to any AE related to this drug
Dosage decrease for toxicity
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2022
- Study start18 Jan 2023
- Primary completion16 Jun 2023
- Study completion16 Jun 2023
Why it stopped: The trial terminated due to the inability to recruit the planned number of subjects. The decision was not based on any safety and/or efficacy concerns.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05568407
- Sponsor's protocol ID
- B9991050
- Other IDs
- LATAM AVENUE
- Status last verified
- Jul 2023
- First submitted
- 23 Sep 2022
- Last updated
- 13 Jul 2023
- Results posted
- No
- Individual data sharing
- No: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A NIS of Avelumab in Real-World Treatment for Patients With Advanced or Metastatic Urothelial Cancer in Argentina and Brazil -LATAM AVENUE
- ClinicalTrials.gov ID
- NCT05568407
- Acronym / sponsor ID
- B9991050
- Conditions
- Bladder Cancer
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The trial terminated due to the inability to recruit the planned number of subjects. The decision was not based on any safety and/or efficacy concerns.
- Enrolment
- 19 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 18 Jan 2023 (actual)
- Primary completion
- 16 Jun 2023 (actual)
- Study completion
- 16 Jun 2023 (actual)
- First posted
- 5 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Advanced or Metastatic Urothelial Cancer | – | Drug: AvelumabPatients with Advanced or Metastatic Urothelial Cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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)
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AvelumabAs used in real world practice | Drug | Patients with Advanced or Metastatic Urothelial Cancer |
Primary outcome
Overall Survival (OS)
Time frame: 36 months
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.
8 secondary outcomes
Progression-Free Survival
Time frame: 36 months
OS
Time frame: 36 months
Duration Of Treatment
Time frame: 36 months
Frequency and nature of all-cause adverse events (AEs)
Time frame: 36 months
Frequency of all-cause AEs leading to discontinuation or interruption of Avelumab maintenance therapy
Time frame: 36 months
Duration of Avelumab maintenance therapy among the patients who discontinued the study drug due to all-cause AEs
Time frame: 36 months
Frequency of potential signs and symptoms of immune-related AEs
Time frame: 36 months
Frequency of patients with Avelumab dosing change due to any AE related to this drug
Time frame: 36 months
Results and safety
The study was stopped early (reason given: The trial terminated due to the inability to recruit the planned number of subjects. The decision was not based on any safety and/or efficacy concerns.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2023.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: No. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
Related trials for Bladder Cancer
RecruitingPhase 2/3
Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma
RecruitingPhase 3
A Clinical Trial of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) and Pembrolizumab (MK-3475A) in Participants With Bladder Cancer (MK-2870-055)
Bladder Cancer
Active, not recruitingPhase 2/3
A Study of CTX-009 in Combination With Paclitaxel in Adult Patients With Unresectable Advanced, Metastatic or Recurrent Biliary Tract Cancers (COMPANION-002)
Biliary Tract Cancer, Cholangiocarcinoma
Recruiting
Effect of Cyclic Sighing Breathing Exercise on CRBD, Pain, and Sleep Quality in Patients Undergoing TUR
Transurethral Resection of Bladder Tumor, Transurethral Resection of the Prostate (TURP)
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bladder Cancer, run by Pfizer at 7 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Brazil, Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The trial terminated due to the inability to recruit the planned number of subjects. The decision was not based on any safety and/or efficacy concerns.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (OS) (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2023.