Clinical trial · Observational
A NON-INTERVENTIONAL STUDY ON AVELUMAB USE IN PATIENTS WITH ADVANCED OR METASTATIC UROTHELIAL CARCINOMA
AVENANCE - A Non-interventional Study to Provide Real-world Data on the Use of Avelumab as a Maintenance Treatment for Patients With Advanced or Metastatic Urothelial Carcinoma
NCT04822350CI-TRIAL-00107164AVENANCEcompletedResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Urothelial Carcinoma | Urothelial Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Avelumab | Drug | Avelumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- Locally advanced or metastatic urothelial carcinoma patients treated with avelumab
- interventionNames
- Drug: Avelumab
Primary outcomes (2)
- measure
- 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)
- description
- OS was defined as the time from the date of first injection of avelumab to the date of death due to any cause. Participants last known to be alive or lost to follow-up were censored at date of last contact. Analysis was performed using Kaplan-Meier method.
- measure
- 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)
- description
- OS was defined as the time from the date of first injection of avelumab to the date of death due to any cause. Participants last known to be alive or lost to follow-up were censored at date of last contact. OS according to histology group: pure urothelial carcinoma, pure variant and urothelial carcinoma variant were reported in this outcome measure. Analysis was performed using Kaplan-Meier method.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.