Clinical trial NCT05366725: A Study to Learn About the Study Medicine (Called Avelumab) in People With Advanced Urothelial Cancer After Chemotherapy
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Urothelial Cancer
Lead sponsor: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Sponsor class: INDUSTRY
First posted: 2022-05-09
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with a diagnosis of locally advanced or metastatic UC, either de novo or relapsed who are progression-free following completion of platinum-based chemotherapy.

Brief 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.

Detailed 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

Eligibility criteria: 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

Primary outcomes:
measure: Real world overall survival
timeFrame: September 2020 to June 2024
Secondary outcomes:
measure: Real world progression free survival
timeFrame: September 2020 to June 2024
measure: Adverse events explicitly attributed to avelumab
timeFrame: September 2020 to June 2024
measure: All-cause healthcare resource burden
timeFrame: September 2020 to June 2024
Other outcomes:
Locations:
city: Bristol
country: United Kingdom
facility: University Hospitals Bristol
city: Glasgow
country: United Kingdom
facility: Beatson West of Scotland Cancer Centre
city: Guildford
country: United Kingdom
facility: Royal Surrey County Hospital
city: London
country: United Kingdom
facility: University College London Hospital
city: London
country: United Kingdom
facility: Guy's and St Thomas' Hospital
city: Manchester
country: United Kingdom
facility: The Christie NHS Foundation Trust
city: Oxford
country: United Kingdom
facility: Churchill Hospital
city: Preston
country: United Kingdom
facility: Royal Preston Hospital
city: Stevenage
country: United Kingdom
facility: Lister Hospital
city: Wirral
country: United Kingdom
facility: Clatterbridge Hospital
Study officials:
affiliation: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
name: Medical Responsible
role: STUDY_DIRECTOR
References: