CompletedNot Applicable

A NON-INTERVENTIONAL STUDY ON AVELUMAB USE IN PATIENTS WITH ADVANCED OR METASTATIC UROTHELIAL CARCINOMA

France596 participantsStarted 2021-07-13

Plain-language summary

A multicenter ambispective (retrospective and prospective) non-interventional study of patients with locally advanced or metastatic urothelial carcinoma (adv/mUC) treated with avelumab in France, not impacting the treatment decision made by the treating physician and the medical management of treated patients.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Patient ≥ 18 years of age
. Patient with locally advanced or metastatic urothelial carcinoma (irrespective of tumor histology) whose disease has not progressed (ongoing stable disease, partial response or complete response) following completion of first-line platinum-based chemotherapy and who has been (retrospective), is (retrospective and prospective), will be (prospective) treated with avelumab.
. Patient benefiting from a social security scheme according to local regulations

Exclusion criteria

. For a patient alive at the moment of the inclusion in the study: patient without liberty, under tutelage, or unable to give oral consent.
. Patient enrolled in a prospective interventional clinical trial assessing an investigational product.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Overall Survival (OS): Overall

Timeframe: From first injection of avelumab to the date of death due to any cause or censoring date, whichever occurred first (for a maximum of 62.3 months follow-up)

OS: by Histology Group

Timeframe: From first injection of avelumab to the date of death due to any cause or censoring date, whichever occurred first (for a maximum of 62.3 months follow-up)

Trial details

NCT IDNCT04822350

SponsorPfizer

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2024-04-25

Results submitted2025-12-22

View on ClinicalTrials.gov More Urothelial Carcinoma trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Patient ≥ 18 years of age
. Patient with locally advanced or metastatic urothelial carcinoma (irrespective of tumor histology) whose disease has not progressed (ongoing stable disease, partial response or complete response) following completion of first-line platinum-based chemotherapy and who has been (retrospective), is (retrospective and prospective), will be (prospective) treated with avelumab.
. Patient benefiting from a social security scheme according to local regulations

Exclusion criteria

. For a patient alive at the moment of the inclusion in the study: patient without liberty, under tutelage, or unable to give oral consent.
. Patient enrolled in a prospective interventional clinical trial assessing an investigational product.

What they're measuring

Overall Survival (OS): Overall

Timeframe: From first injection of avelumab to the date of death due to any cause or censoring date, whichever occurred first (for a maximum of 62.3 months follow-up)

OS: by Histology Group

Timeframe: From first injection of avelumab to the date of death due to any cause or censoring date, whichever occurred first (for a maximum of 62.3 months follow-up)