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
1 other identifier
observational
360
1 country
26
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2024
Typical duration for all trials
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 23, 2024
CompletedStudy Start
First participant enrolled
May 9, 2024
CompletedFirst Posted
Study publicly available on registry
May 14, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2026
May 28, 2026
May 1, 2026
2.1 years
April 23, 2024
May 27, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Baseline clinical and demographic characteristics
To describe the baseline clinical and demographic characteristics of participants.
Baseline
Characteristics of the first line PBCT just prior to avelumab maintenance
Up to 3 months
Secondary Outcomes (5)
Overall Survival (OS)
Up to 3 months
Progression-Free Survival (PFS)
Up to 3 months
Time to Treatment Failure (TTF)
Up to 3 months
Time to Next Treatment (TTNT)
Up to 3 months
Objective Response Rate (ORR)
Up to 3 months
Study Arms (1)
Urothelial Carcinoma Cohort
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).
Interventions
This is an observational study, participants who received avelumab as first line maintenance therapy after a PBCT.
Eligibility Criteria
Participants with locally advanced/metastatic Urothelial Carcinoma
You may qualify if:
- 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
You may not qualify if:
- Participant participated in a clinical trial in la/m UC during the study periods.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (26)
Hirosaki University Hospital
Hirosaki, Aomori, 036-8563, Japan
Ehime University Hospital
Tōon, Ehime, 791-0295, Japan
Kurume University Hospital
Kurume, Fukuoka, 830-0011, Japan
Hokkaido University Hospital
Sapporo, Hokkaido, 060-8648, Japan
Sapporo Medical University Hospital
Sapporo, Hokkaido, 060-8648, Japan
Kobe University Hospital
Kobe, Hyōgo, 650-0017, Japan
Iwate Medical University Hospital
Shiwa-gun, Iwate, 028-3695, Japan
Kagawa University Hospital
Kita-gun, Kagawa-ken, 761-0793, Japan
St. Marianna University Hospital
Kawasaki, Kanagawa, 216-8511, Japan
Kitasato University Hospital
Sagamihara, Kanagawa, 252-0374, Japan
Nara Medical University Hospital
Kashihara, Nara, 634-8522, Japan
Kindai University Hospital
Sayama, Osaka, 589-8511, Japan
Saitama Medical University International Medical Center
Hidaka, Saitama, 350-1298, Japan
Juntendo University Hospital
Bunkyō City, Tokya, 113-0033, Japan
Nippon Medical School Hospital
Bunkyo-ku, Tokyo, 113-8603, Japan
National Cancer Center Hospital
Chuo-ku, Tokyo, 104-0045, Japan
Teikyo University Hospital
Itabashi-ku, Tokyo, 173-8606, Japan
Akita University Hospital
Akita, 010-0041, Japan
Kyushu Cancer Center
Fukuoka, 811-1347, Japan
Kumamoto University Hospital
Kumamoto, 860-8556, Japan
University Hospital Kyoto Prefectural University of Medicine
Kyoto, 602-8566, Japan
Kyoto University Hospital
Kyoto, 606-8507, Japan
Osaka International Cancer Institute
Osaka, 540-0008, Japan
Tokushima University Hospital
Tokushima, 770-0042, Japan
Toyama University Hospital
Toyama, 930-0194, Japan
Yamagata University Hospital
Yamagata, 9902331, Japan
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Responsible
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 23, 2024
First Posted
May 14, 2024
Study Start
May 9, 2024
Primary Completion (Estimated)
June 30, 2026
Study Completion (Estimated)
June 30, 2026
Last Updated
May 28, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will not share