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

Merck KGaA (EMD Serono)

Status: Completed

Conditions: Urothelial Cancer

Treatments: Drug: Avelumab

Study type: Observational

Funder types: Industry

Identifiers

NCT05366725

B9991047

Details and patient eligibility

About

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.

Full 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

Enrollment: 106 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

106 participants in 1 patient group

Adult patients with locally advanced or metastatic urothelial cancer

Treatment:

Drug: Avelumab