JAVEMACS: Japan AVElumab Maintenance And Continuous Treatment Study
NCT ID: NCT06412848
Last Updated: 2025-11-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
360 participants
OBSERVATIONAL
2024-05-09
2026-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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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).
Avelumab
This is an observational study, participants who received avelumab as first line maintenance therapy after a PBCT.
Interventions
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Avelumab
This is an observational study, participants who received avelumab as first line maintenance therapy after a PBCT.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Responsible
Role: STUDY_DIRECTOR
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Locations
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Hirosaki University Hospital
Hirosaki, Aomori, Japan
Ehime University Hospital
Tōon, Ehime, Japan
Kurume University Hospital
Kurume, Fukuoka, Japan
Hokkaido University Hospital
Sapporo, Hokkaido, Japan
Sapporo Medical University Hospital
Sapporo, Hokkaido, Japan
Kobe University Hospital
Kobe, Hyōgo, Japan
Iwate Medical University Hospital
Shiwa-gun, Iwate, Japan
Kagawa University Hospital
Kita-gun, Kagawa-ken, Japan
St. Marianna University Hospital
Kawasaki, Kanagawa, Japan
Kitasato University Hospital
Sagamihara, Kanagawa, Japan
Nara Medical University Hospital
Kashihara, Nara, Japan
Kindai University Hospital
Sayama, Osaka, Japan
Saitama Medical University International Medical Center
Hidaka, Saitama, Japan
Juntendo University Hospital
Bunkyō City, Tokya, Japan
Nippon Medical School Hospital
Bunkyo-ku, Tokyo, Japan
National Cancer Center Hospital
Chuo-ku, Tokyo, Japan
Teikyo University Hospital
Itabashi-ku, Tokyo, Japan
Akita University Hospital
Akita, , Japan
Kyushu Cancer Center
Fukuoka, , Japan
Kumamoto University Hospital
Kumamoto, , Japan
University Hospital Kyoto Prefectural University of Medicine
Kyoto, , Japan
Kyoto University Hospital
Kyoto, , Japan
Osaka International Cancer Institute
Osaka, , Japan
Tokushima University Hospital
Tokushima, , Japan
Toyama University Hospital
Toyama, , Japan
Yamagata University Hospital
Yamagata, , Japan
Countries
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Related Links
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Trial Awareness and Transparency Website
Medical Information Location Map - Med Info Contacts
Other Identifiers
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MS100070_0209
Identifier Type: -
Identifier Source: org_study_id
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