Urinary Bladder NeoplasmsNCT05699135
A Study to Learn About the Effect of Avelumab First-Line Maintenance in Canadian People With Advanced Bladder Cancer
An observational study of Urinary Bladder Neoplasms and Bladder Cancer, run by Pfizer at 1 site in Canada.
Trial summary
The purpose of this study is to learn about the safety and effects of the study medicine (called avelumab) for the treatment of advanced bladder cancer. This study is including participants who: Participated in the Canadian avelumab patient support program Have been diagnosed with advanced bladder cancer Have been… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urinary Bladder Neoplasms, Bladder Cancer, Bladder Tumors
- What is being tested?
- Avelumab first-line maintenance
- Type of treatment
- Injection or infusion
- How many people
- 150 participants
- Where
- 1 siteCanada
- Study dates
- 9 Mar 2023to 30 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: Canadian patients histologically diagnosed with stage IV LA/mUC and having participated in the avelumab patient-support program (PSP).
Who may be able to join
- Enrolled in the Canadian avelumab1LM Patient support program (PSP)
- Histologically confirmed diagnosis of stage IV LA/mUC
- No evidence of disease progression following first-line platinum-based chemotherapy
- Receipt of avelumab1LM following 1L platinum-based chemotherapy
- Received the last dose of chemotherapy no more than 10 weeks before entering the PSP
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- ≥6 months of follow-up from initiation of AVE 1LM therapy until study end date, unless the patient has died, with known date of death.
Who cannot join
- Diagnosed with LA/mUC and enrolled in the PSP, but did not receive avelumab
- Pregnancy at index date
- Participation in an interventional clinical trial at any point during the study period
- The index date will be considered as the initiation of index therapy. The index therapy will be considered as the avelumab 1LM treatment after 1L platinum-based chemotherapy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment Effectiveness of Avelumab First-Line Maintenance Among Canadian Patients With Advanced Urothelial Carcinoma (TRAVELER)
The purpose of this study is to learn about the safety and effects of the study medicine (called avelumab) for the treatment of advanced bladder cancer.
This study is including participants who:
Read more
- Participated in the Canadian avelumab patient support program
- Have been diagnosed with advanced bladder cancer
- Have been treated with platinum-based chemotherapy without their disease progressing All participants in this study have previously received avelumab first-line maintenance for the treatment of their advanced bladder cancer.
Pfizer will examine the experiences of people receiving the study medicine. This will help determine the efficacy and safety of the study medicine for the treatment of bladder cancer.
Read the detailed description
Avelumab was approved by Health Canada in December 2020 for the maintenance treatment of patients with locally advanced/metastatic urothelial carcinoma (LA/mUC) whose disease has not progressed following first-line (1L) platinum-based chemotherapy. As the urothelial carcinoma treatment landscape evolves with novel indications for previously existing medicines and novel agents entering the market, additional insights are needed to assist in guiding treatment decision making. No observational studies of treatment patterns and outcomes for patients in Canada treated with avelumab first-line maintenance (1LM) have been conducted. The purpose of the current study is to conduct an analysis of patient and disease characteristics and treatment patterns to further elucidate the clinical effectiveness and impact of avelumab 1LM therapy for patients with LA/mUC in Canada.
The primary research objective is to assess effectiveness outcomes in a clinical setting for Canadian patients with LA/mUC treated with avelumab 1LM therapy, specifically overall survival (OS) from the date of avelumab 1LM initiation to the date of death from any cause and progression-free survival (PFS) from the date of avelumab 1LM initiation to the date of progression or death from any cause. Selected secondary objectives include describing treatment patterns, describe AEs explicitly attributed to avelumab among patients with LA/mUC treated with avelumab 1LM and response rates from date of avelumab 1LM initiation, and separately, from the date of chemotherapy initiation, and duration of response (DOR) from date of best overall response in each line of therapy.
- Being tested
- Avelumab first-line maintenance
- Keywords
- Bladder Cancer, Bladder Neoplasms, Bladder Tumors, Cancer of Bladder, Cancer of the Bladder, Malignant Tumor of Urinary Bladder, Neoplasms, Bladder, Urinary Bladder Cancer, Metastatic bladder cancer, Locally advanced bladder cancer, Urothelial carcinoma, Locally advanced urothelial carcinoma, Metastatic urothelial carcinoma, avelumab, avelumab maintenance, Canada bladder cancer, Non-interventional study
- Medical subject headings
- Urinary Bladder Neoplasms, Carcinoma, Transitional Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Avelumab first-line maintenanceDrug
Patients with LA/mUC who following 4-6 cycles platinum chemotherapy and have not progressed, received avelumab, recommended dose of 10mg/kg body weight, intravenously administered over 60 minutes every 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| Canadian Patients with Advanced Urothelial Carcinoma | Patients with LA/mUC who following 4-6 cycles of platinum chemotherapy and have not progressed, received avelumab, recommended dose of 10mg/kg body weight intravenously administered over 60 minutes every 2 weeks Receives: Drug: Avelumab first-line maintenance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
OS from the date of avelumab initiation to the date of death from any cause
Measured: 12 months
Progression-free survival
Progression-free survival from the date of avelumab first-line maintenance initiation to the date of progression or death from any cause
Measured: 12 months
Secondary outcomes (12)
Adverse events explicitly attributed to avelumab
Description of AEs explicitly attributed to avelumab among patients with LA/mUC treated with AVE 1LM
Measured: 12 months
Response rate
Response rate from date of AVE 1LM initiation, and separately, from the date of chemotherapy initiation, and DOR from date of best overall response in each line of therapy
Measured: 12 months
Description of patient characteristics
Measured: 12 months
Overall survival from the date of chemotherapy initiation to the date of death from any cause
OS from the date of chemotherapy initiation (prior to AVE 1LM) to the date of death from any cause
Measured: 12 months
Progression-free survival from the date of chemotherapy initiation to the date of progression or death from any cause
PFS from the date of chemotherapy initiation (prior to AVE 1LM) to the date of progression or death from any cause
Measured: 12 months
First-Line therapy description
First-line therapy type, dose, number of cycles, switching and discontinuations
Measured: 12 months
Time to post-diagnostic imaging
Time to post-diagnostic imaging
Measured: 12 months
Time to treatment discontinuation
Time to treatment discontinuation
Measured: 12 months
Time to initiation of AVE 1LM following last dose of chemotherapy
Time to initiation of AVE 1LM following last dose of chemotherapy
Measured: 12 months
Treatment duration of AVE 1LM
Treatment duration of AVE 1LM
Measured: 12 months
Time to next treatment
Time to next treatment
Measured: 12 months
Reasons for treatment discontinuation
Reasons for treatment discontinuation
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2023
- Study start9 Mar 2023
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Why it stopped: The trial was terminated for strategic reasons. 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 Urinary Bladder NeoplasmsStudies 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 150 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
- NCT05699135
- Sponsor's protocol ID
- B9991053
- Other IDs
- TRAVELER
- Status last verified
- Apr 2024
- First submitted
- 15 Dec 2022
- Last updated
- 24 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- 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 24 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Effectiveness of Avelumab First-Line Maintenance Among Canadian Patients With Advanced Urothelial Carcinoma (TRAVELER)
- ClinicalTrials.gov ID
- NCT05699135
- Acronym / sponsor ID
- B9991053
- Keywords
- Bladder Cancer, Bladder Neoplasms, Bladder Tumors, Cancer of Bladder, Cancer of the Bladder, Malignant Tumor of Urinary Bladder, Neoplasms, Bladder, Urinary Bladder Cancer
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The trial was terminated for strategic reasons. The decision was not based on any safety and/or efficacy concerns.
- Enrolment
- 150 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 9 Mar 2023 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 26 Jan 2023 (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.
The purpose of this study is to learn about the safety and effects of the study medicine (called avelumab) for the treatment of advanced bladder cancer.
This study is including participants who:
- Participated in the Canadian avelumab patient support program
- Have been diagnosed with advanced bladder cancer
- Have been treated with platinum-based chemotherapy without their disease progressing All participants in this study have previously received avelumab first-line maintenance for the treatment of their advanced bladder cancer.
Pfizer will examine the experiences of people receiving the study medicine. This will help determine the efficacy and safety of the study medicine for the treatment of bladder cancer.
Detailed description
Avelumab was approved by Health Canada in December 2020 for the maintenance treatment of patients with locally advanced/metastatic urothelial carcinoma (LA/mUC) whose disease has not progressed following first-line (1L) platinum-based chemotherapy. As the urothelial carcinoma treatment landscape evolves with novel indications for previously existing medicines and novel agents entering the market, additional insights are needed to assist in guiding treatment decision making. No observational studies of treatment patterns and outcomes for patients in Canada treated with avelumab first-line maintenance (1LM) have been conducted. The purpose of the current study is to conduct an analysis of patient and disease characteristics and treatment patterns to further elucidate the clinical effectiveness and impact of avelumab 1LM therapy for patients with LA/mUC in Canada.
The primary research objective is to assess effectiveness outcomes in a clinical setting for Canadian patients with LA/mUC treated with avelumab 1LM therapy, specifically overall survival (OS) from the date of avelumab 1LM initiation to the date of death from any cause and progression-free survival (PFS) from the date of avelumab 1LM initiation to the date of progression or death from any cause. Selected secondary objectives include describing treatment patterns, describe AEs explicitly attributed to avelumab among patients with LA/mUC treated with avelumab 1LM and response rates from date of avelumab 1LM initiation, and separately, from the date of chemotherapy initiation, and duration of response (DOR) from date of best overall response in each line of therapy.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Canadian Patients with Advanced Urothelial Carcinoma | – | Drug: Avelumab first-line maintenancePatients with LA/mUC who following 4-6 cycles of platinum chemotherapy and have not progressed, received avelumab, recommended dose of 10mg/kg body weight intravenously administered over 60 minutes every 2 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Canadian patients histologically diagnosed with stage IV LA/mUC and having participated in the avelumab patient-support program (PSP).
Key inclusion criteria (7 listed)
- Enrolled in the Canadian avelumab1LM Patient support program (PSP)
- Histologically confirmed diagnosis of stage IV LA/mUC
- No evidence of disease progression following first-line platinum-based chemotherapy
- Receipt of avelumab1LM following 1L platinum-based chemotherapy
- Received the last dose of chemotherapy no more than 10 weeks before entering the PSP
Key exclusion criteria (4 listed)
- Diagnosed with LA/mUC and enrolled in the PSP, but did not receive avelumab
- Pregnancy at index date
- Participation in an interventional clinical trial at any point during the study period
- The index date will be considered as the initiation of index therapy. The index therapy will be considered as the avelumab 1LM treatment after 1L platinum-based chemotherapy.
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 |
|---|---|---|
| Avelumab first-line maintenancePatients with LA/mUC who following 4-6 cycles platinum chemotherapy and have not progressed, received avelumab, recommended dose of 10mg/kg body weight, intravenously administered over 60 minutes every 2 weeks | Drug | Canadian Patients with Advanced Urothelial Carcinoma |
Primary outcome
Overall survival
Time frame: 12 months
OS from the date of avelumab initiation to the date of death from any cause
Progression-free survival
Time frame: 12 months
Progression-free survival from the date of avelumab first-line maintenance initiation to the date of progression or death from any cause
12 secondary outcomes
Adverse events explicitly attributed to avelumab
Time frame: 12 months
Response rate
Time frame: 12 months
Description of patient characteristics
Time frame: 12 months
Overall survival from the date of chemotherapy initiation to the date of death from any cause
Time frame: 12 months
Progression-free survival from the date of chemotherapy initiation to the date of progression or death from any cause
Time frame: 12 months
First-Line therapy description
Time frame: 12 months
Time to post-diagnostic imaging
Time frame: 12 months
Time to treatment discontinuation
Time frame: 12 months
Time to initiation of AVE 1LM following last dose of chemotherapy
Time frame: 12 months
Treatment duration of AVE 1LM
Time frame: 12 months
Time to next treatment
Time frame: 12 months
Reasons for treatment discontinuation
Time frame: 12 months
Results and safety
The study was stopped early (reason given: The trial was terminated for strategic reasons. 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 24 Apr 2024.
- 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.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Bladder Neoplasms and Bladder Cancer, run by Pfizer at 1 site in Canada.
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 7 inclusion and 4 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 24 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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 was terminated for strategic reasons. 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 (time frame: 12 months). The study lists 2 primary outcomes in all. 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 24 Apr 2024; AzTrials last refreshed its copy on 26 Oct 2026.