A Study to Learn About the Study Medicine (Called Avelumab) in People With Advanced Urothelial Cancer After Chemotherapy

Urothelial Cancer Clinical Trial

Official title:

A MULTI-CENTRE NON-INTERVENTIONAL STUDY TO DESCRIBE THE EARLY CLINICAL EXPERIENCE OF AVELUMAB USED AS MONOTHERAPY FOR THE FIRST-LINE MAINTENANCE TREATMENT OF ADULT PATIENTS WITH LOCALLY ADVANCED OR METASTATIC UROTHELIAL CARCINOMA WHO ARE PROGRESSION-FREE FOLLOWING PLATINUM-BASED CHEMOTHERAPY

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05366725
• Other study ID #: B9991047
• Status: Active, not recruiting
• Start date: June 29, 2022
• Est. completion date: November 30, 2024

Study information

• Verified date: June 2024
• Source: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this clinical trial is to learn about the safety and effects of the study medicine (called Avelumab) in people with advanced urothelial (bladder) cancer (UC) whose disease hasn't worsened after receiving chemotherapy.

This study is seeking participants who:

1. Have UC that cannot be operated on or has spread to other parts of the body

2. Received 1st line platinum-based chemotherapy and had stable disease, partial response, or complete response to this treatment

3. Received Avelumab as indicated as the only therapy for the first-line maintenance who are progression-free following platinum-based chemotherapy

4. Are 18 years or older on the date that they start taking Avelumab

All participants in this study will receive Avelumab, a standard treatment for urothelial carcinoma. Participants will take part in this study for about 4 years. During this time, they will take Avelumab as instructed in the real-world setting. We will study the experiences of people receiving the study medicine. This will help us decide if the study medicine is safe and effective.

Description:

The primary objective of this study is to estimate real-world overall survival (rwOS) in a real-world cohort of patients treated with avelumab monotherapy for the first-line maintenance treatment of adult patients with locally advanced or metastatic UC who are progression-free following platinum-based chemotherapy.

The secondary objectives are:

1. To describe the clinical and demographic characteristics of the study population

2. To estimate real-world progression-free survival (rwPFS)

3. To describe treatment characteristics of 1L anti-cancer therapies received prior to the initiation of avelumab as 1Lmaintenance therapy

4. To describe treatment patterns after initiation of avelumab as 1L maintenance therapy

5. To describe the adverse events (AEs) explicitly attributed to avelumab in a real-world population

6. To describe real-world all-cause associated healthcare resource burden associated with avelumab therapy

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 106
• Est. completion date: November 30, 2024
• Est. primary completion date: June 27, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patients with a diagnosis of locally advanced or metastatic UC, either de novo or relapsed

2. Patients received 1L platinum-based chemotherapy and had stable disease, partial response, or complete response to this treatment

3. Patients received avelumab as indicated as a monotherapy for the first-line maintenance treatment of adult patients with locally advanced or metastatic UC who are progression-free following platinum-based chemotherapy

4. Patients aged =18 years on the date that they commenced avelumab -

Exclusion Criteria:

1. Patients whose hospital records are not available for review

2. Patients who are receiving an investigational medicinal product as part of a clinical trial at the time of maintenance therapy with avelumab

Related Conditions & MeSH terms

• Urothelial Cancer

Intervention

Drug:
• Avelumab
As provided in real world practice

Locations

Country	Name	City	State
United Kingdom	University Hospitals Bristol	Bristol
United Kingdom	Beatson West of Scotland Cancer Centre	Glasgow
United Kingdom	Royal Surrey County Hospital	Guildford
United Kingdom	Guy's and St Thomas' Hospital	London
United Kingdom	University College London Hospital	London
United Kingdom	The Christie NHS Foundation Trust	Manchester
United Kingdom	Churchill Hospital	Oxford
United Kingdom	Royal Preston Hospital	Preston
United Kingdom	Lister Hospital	Stevenage
United Kingdom	Clatterbridge Hospital	Wirral

Sponsors (1)

Lead Sponsor	Collaborator
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Real world overall survival	Time between avelumab initiation until date of death from any cause or end of follow-up	September 2020 to June 2024
Secondary	Real world progression free survival	Time between avelumab initiation until earliest of: Date of first progression; Date of death from any cause	September 2020 to June 2024
Secondary	Adverse events explicitly attributed to avelumab	Any AE with explicit attribution to avelumab as noted in the clinical records. Explicit attribution is not inferred by a temporal relationship between drug administration and an AE butmust be based on a definite statement of causality by a healthcare provider linking drug administration to the AE.; AE diagnosis; Outcome of AE; Classification as either serious or non-serious AE; Results in hospitalisation or prolongation of hospitalisation; Is life threatening; Resulted in death; Persistent or significant incapacity; Congenital anomaly/birth defect in any offspring; Other important medical event that may require medical or surgical intervention to avoid any of the above criteria; AEs discontinuation of avelumab; AEs leading to systemic steroid treatment	September 2020 to June 2024
Secondary	All-cause healthcare resource burden	Mean and median number, per patient, of the following: Accident and emergency visits; Hospitalisations; Duration of hospitalisation (days)	September 2020 to June 2024

External Links

•   Trial Awareness and Transparency website