Clinical trial · Observational
JAVEMACS: Japan AVElumab Maintenance And Continuous Treatment Study
A Multicenter, Retrospective, Observational Study of Avelumab Maintenance and Subsequent Therapies in Japanese Patients With Locally Advanced or Metastatic Urothelial Carcinoma
- 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)
This study is a multicenter, non-interventional, retrospective, medical chart review of locally advanced or metastatic (la/m) Urothelial Cancer UC participants who were prescribed avelumab as first line maintenance therapy after a platinum-based chemotherapy. This study aims to understand the index date (i.e., at the initiation of avelumab maintenance therapy) demographics and clinical characteristics of participants with locally advanced/metastatic Urothelial Carcinoma in Japan, and to describe their treatment patterns and outcomes.
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
- Urothelial Carcinoma Cohort
- description
- This is a single cohort study enrolling Participants with Urothelial Carcinoma (UC), who are prescribed treatment with avelumab as first line maintenance therapy after a platinum-based chemotherapy (PBCT).
- interventionNames
- Drug: Avelumab
Primary outcomes (2)
- measure
- Baseline clinical and demographic characteristics
- timeFrame
- Baseline
- description
- To describe the baseline clinical and demographic characteristics of participants.
- measure
- Characteristics of the first line PBCT just prior to avelumab maintenance
- timeFrame
- Up to 3 months
Secondary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Participants diagnosed with locally advanced/metastatic urothelial carcinoma (la/m UC) before receiving avelumab first line maintenance therapy * Participants with la/m UC (irrespective of tumor histology) whose disease has not progressed (ongoing stable disease, partial response, or complete response) following completion of first line PBCT and who has been treated with avelumab * Participants who has been started avelumab first line maintenance therapy for la/m UC from 24 Feb 2021 (date of approval for UC) to 6 months before the date of approval of implementation of this study at each site * Participants aged \>= 18 years old at index date * Other protocol defined inclusion criteria could apply Exclusion Criteria: * Participant participated in a clinical trial in la/m UC during the study periods.
References
Publications (1)
- DERIVEDEndo Y, Kitamura H, Shirotake S, Ikeda M, Yonemori K, Kawamura N, Fujihara A, Abe T, Shimizu F, Fujimoto K, Nakagawa T, Hatakeyama S, Nishihara K, Ikarashi D, Masumori N, Naito S, Fujita K, Hara T, Miura N, Negishi T, Yatsuda J, Kobayashi M, Taoka R, Furukawa J, Shono M, Kobayashi T, Kikuchi E. Avelumab maintenance therapy for advanced urothelial carcinoma: subgroup analyses by characteristics of first-line platinum-based chemotherapy from a real-world chart review study in Japan (JAVEMACS). BMC Cancer. 2026 Mar 26;26(1):575. doi: 10.1186/s12885-026-15781-1. PMID 41888732