N/A
N=106
A Study to Learn About the Study Medicine (Called Avelumab) in People With Advanced Urothelial Cancer After Chemotherapy
Urothelial Cancer
Bottom Line
View on ClinicalTrials.gov: NCT05366725 ↗Enrolled (actual)
106
Serious AEs
32.1%
Results posted
Dec 2025
Primary outcome: Primary: Real-World Overall Survival — 16.8 months
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Avelumab (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
- Primary completion
- Jun 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Real-World Overall Survival |
21.8 | — |
| SECONDARY Clinical Characteristics: Time From First Diagnosis to Locally Advanced or Metastatic Diagnosis |
67.4 | — |
| SECONDARY Clinical Characteristics: Participant's Age at Locally Advanced or Metastatic Diagnosis |
68.5 | — |
| SECONDARY Clinical Characteristics: Participant's Stage of UC at Locally Advanced or Metastatic Diagnosis |
13; 8; 20; 55; 10 | — |
| SECONDARY Clinical Characteristics: Participant's Histology at Locally Advanced or Metastatic Diagnosis |
86; 11; 9 | — |
| SECONDARY Clinical Characteristics: Number of Participants With De Novo Disease or Newly Relapsed at Locally Advanced or Metastatic Diagnosis |
59; 46; 1 | — |
| SECONDARY Clinical Characteristics: Participant's Programmed Death-Ligand 1 (PD-L1) Tumour Assessment Immune Cell (IC) Test Result at Locally Advanced or Metastatic Diagnosis |
2.0 | — |
| SECONDARY Clinical Characteristics: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Score of 0, 1 and 2, 3 or 4 |
35; 36; 5; 30 | — |
| SECONDARY Clinical Characteristics: Participants Site of Metastases |
64; 21; 32; 18; 19 | — |
| SECONDARY Clinical Characteristics: Number of Participants With Prior Radical Treatment of Primary UC at Locally Advanced or Metastatic Diagnosis |
47; 57; 2 | — |
| SECONDARY Clinical Characteristics: Number of Participants With Prior Adjuvant or Neoadjuvant System Therapy at Locally Advanced or Metastatic Diagnosis |
35; 69; 2 | — |
| SECONDARY Age of Participants at Avelumab Initiation |
69.3 | — |
| SECONDARY Real-World Progression-Free Survival (Rw-PFS) |
8.7 | — |
| SECONDARY Treatment Characteristics: Type of First Systemic Anticancer Treatment (SACT) Regimen Received Before Avelumab Start Date |
49; 55; 2 | — |
| SECONDARY Treatment Characteristics: Number of First- Line Systematic Anti-Cancer Therapy (SACT) Cycles Received |
5.3 | — |
| SECONDARY Treatment Characteristics: Number of Participants Switching Between Different Platinum-Based Chemotherapies |
7; 99 | — |
| SECONDARY Treatment Characteristics: Time From Completion of First Line Systematic Anti-Cancer Therapy (SACT) to Start of Avelumab |
8.5 | — |
| SECONDARY Treatment Characteristics: Response to First Line Therapy |
9; 54; 42; 1 | — |
| SECONDARY Treatment Characteristics: Response to First-Line Therapy Based on Computed Tomography (CT) Scan Evidence |
101; 5 | — |
| SECONDARY Treatment Patterns: Duration of Treatment With Avelumab |
34.2 | — |
| SECONDARY Treatment Patterns: Number of Participants Who Received Second-Line Therapy as Per eCRF |
15 | — |
| SECONDARY Treatment Patterns: Time Interval Between Start of Avelumab and Start of Second-Line Therapy |
38.7 | — |
| SECONDARY Treatment Patterns: Systematic Anti-Cancer Therapy Regimen Received as Second Line Therapy |
5 | — |
| SECONDARY Treatment Patterns: High Dose Systemic Steroid Use |
24; 80; 2 | — |
| SECONDARY Number of Participants With Adverse Events (AEs) Explicitly Attributed to Avelumab in a Real-World Population |
80 | — |
| SECONDARY Healthcare Resource Burden Associated With Avelumab Therapy: Accident and Emergency Visits |
1.9 | — |
| SECONDARY Healthcare Resource Burden Associated With Avelumab Therapy: Hospitalizations |
2.7 | — |
| SECONDARY Healthcare Resource Burden Associated With Avelumab Therapy: Participants Duration of Hospitalisation |
14.5 | — |
| SECONDARY Real-World Overall Survival |
21.8 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Patients with a diagnosis of locally advanced or metastatic UC, either de novo or relapsed
- Patients received 1L platinum-based chemotherapy and had stable disease, partial response, or complete response to this treatment
- 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
- Patients aged ≥18 years on the date that they commenced avelumab -
Exclusion Criteria
- Patients whose hospital records are not available for review
- Patients who are receiving an investigational medicinal product as part of a clinical trial at the time of maintenance therapy with avelumab
Data sourced from ClinicalTrials.gov (NCT05366725). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.