Clinical trial · Observational
A Study to Learn About the Study Medicine (Avelumab) in Japanese Patients With Urothelial Carcinoma That Has Spread
Retrospective, Multicenter, Observational Study to Evaluate Current Treatment Patterns and Outcomes in Japanese Patients With Locally Advanced or Metastatic Urothelial Carcinoma Treated With First-line Avelumab Maintenance
- 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)
The purpose of this clinical trial is to learn about the current treatment patterns, safety, and effects of the study medicine (Avelumab) for the treatment of urothelial carcinoma. This study is seeking Japanese participants who: * have urothelial cancer that has spread * are treated with Avelumab for maintenance We will study the experiences of people receiving avelumab. This helps us learn the current treatment patterns, safety, and effects of avelumab. Participants will take part in this study up to 10 months. During this time, they will have no study visits.
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
- Japanese Patients With Locally Advanced or Metastatic Urothelial Carcinoma
- description
- Japanese Patients With Locally Advanced or Metastatic Urothelial Carcinoma who were treated with avelumab as first-line maintenance therapy
- interventionNames
- Drug: Avelumab
Primary outcomes (12)
- measure
- Age of Participants at Baseline
- timeFrame
- At baseline (at the initiation of avelumab maintenance therapy)
- description
- The age of participants at baseline was reported.
- measure
- Number of Participants With Advanced and Metastatic Urothelial Carcinoma by Sex
- timeFrame
- At baseline (at the initiation of avelumab maintenance therapy)
- description
- Number of Participants With Advanced and Metastatic UC by sex was reported.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 0 Years
Show eligibility criteria text
Inclusion Criteria: 1. Diagnosed with locally advanced or metastatic UC before receiving Avelumab 1L maintenance therapy. 2. Started treatment with avelumab for locally advanced or metastatic UC from 24 Feb 2021 (regulatory approval date) to 30 Nov 2021. 3. Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study. (1) Written consent is not required for patients who were transferred to a hospital, and registration with verbal consent is acceptable. (2) Opt-out enrollment is allowed for patients who have already died. 4)Deceased patients are also required to meet the inclusion criteria 1)-2). Exclusion Criteria: There are no exclusion criteria for this study.
References
Publications (1)
- DERIVEDKikuchi E, Hayakawa N, Nakayama M, Uno M, Nakatsu H, Kitagawa C, Miyake H, Yamada T, Fujita K, Shimoyama H, Nishihara K, Kobayashi M, Nakamura M, Fujimoto K, Sano T, Nishiyama N, Ito T, Kajita M, Kobayashi T, Kitamura H. J-AVENUE: A retrospective, real-world study evaluating patient characteristics and outcomes in patients with advanced urothelial carcinoma treated with avelumab first-line maintenance therapy in Japan. Int J Urol. 2024 Aug;31(8):859-867. doi: 10.1111/iju.15473. Epub 2024 May 9. PMID 38722221