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

Completed

• Conditions: Urothelial Carcinoma
• Interventions: Drug: Avelumab

• Registration Number: NCT04822350
• Lead Sponsor: Pfizer

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-03-22
• Study First Submitted QC: 2021-03-26
• Study First Posted: 2021-03-30
• Study Start: 2021-07-13
• Primary Completion: 2024-04-25
• Study Completion: 2024-04-25
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-22
• Last Update Posted: 2025-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 599

Inclusion Criteria

1. Patient ≥ 18 years of age

2. 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.

   • For a patient alive at the moment of the inclusion in the study : the patient must be informed of the study, he/she must be given an information letter signed by the investigator and must not be opposed to the collection of his/her data
   • For a patient who died before the inclusion in the study : the patient (during his life time) must not be opposed in writing to the collection of his data.

3. Patient benefiting from a social security scheme according to local regulations

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Locally advanced or metastatic urothelial carcinoma patients treated with avelumab	Avelumab	-

Primary Outcome Measures

Name	Time	Method
overall survival	Avelumab initiation up to 4 years	time between the first injection of avelumab and the date of death from any cause

Secondary Outcome Measures

Name	Time	Method
Overall response rate on subsequent treatments	Discontinuation of avelumab up to 4 years	Complete Response or Partial Response as a best response during the subsequent treatments
Overall survival on subsequent treatments	Discontinuation of avelumab up to 4 years	time between the first dose of subsequent treatment and the date of death from any cause
overall Survival from the start of the chemotherapy used in 1st line	1st line Chemotherapy start up to 4 years	time between the first injection of the chemotherapy used in 1st line and the date of death from any cause.
Progression free survival 1	Avelumab initiation up to 4 years	time between the first injection of avelumab and the date of progression or death from any cause.
duration of treatment	Avelumab initiation up to 4 years	time between the first and last dose of avelumab.
Patient reported outcome	Initiation of avelumab, 6 weeks, 3 months, and every three months for up to 2 years	Evolution of PROs NCCN/FACT FBlSI-18 and EQ-5D-5L scores during avelumab treatment.
Duration of subsequent treatments	Discontinuation of avelumab up to 4 years	time between the first and last dose of subsequent treatment
Progression free survival 2	Avelumab initiation up to 4 years	time between the first injection of avelumab and the date of progression or death from any cause during the 2nd line of treatment post-avelumab.
duration of response	Beginning of response up to 4 years	time between the beginning of the response and progression or death from any cause.
Patterns of progression under avelumab	Avelumab initiation up to 4 years	Metastatic sites and type of progression (new lesion(s)/progression of known lesion(s)).
Adverse events (AEs) reporting	Avelumab initiation up to 4 years	Adverse events (AEs) of any type, grade 3-4 AEs, AEs leading to interruption or discontinuation, AEs leading to death.
Premedications (acetaminophen and antihistamine)	Avelumab initiation up to 4 years	Proportion of patients who received a premedication at each injection of avelumab. Median number of cycles with premedication.
overall response rate	Avelumab initiation up to 4 years	Complete Response or Partial Response as a best response during the avelumab treatment.
Progression free survival on subsequent treatments	Discontinuation of avelumab up to 4 years	time between the first dose of subsequent treatment and the date of progression or death from any cause

Trial Locations

Locations (81)

CHU Charles Nicolle; 🇫🇷 Rouen, Haute-normandie, France

CHU Nantes; 🇫🇷 Nantes, PAYS DE LA Loire, France

Centre Hospitalier du Pays d AIX; 🇫🇷 Aix-en-provence, France

CHU Amiens-Picardie; 🇫🇷 Amiens Cedex 1, France

Centre Hospitalier Victor Dupouy; 🇫🇷 Argenteuil Cedex, France

Centre Hospitalier Auxerre; 🇫🇷 Auxerre, France

Institut Sainte Catherine; 🇫🇷 Avignon, France

Centre Hospitalier de la cote Basque; 🇫🇷 Bayonne, France

Chru Besancon; 🇫🇷 Besancon Cedex, France

CHU de Bordeaux - Hopital Saint Andre; 🇫🇷 Bordeaux cedex, France

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