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 range18 Years

SexALL

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)

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 range18 Years

SexALL

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)