JAVEMACS: Japan AVElumab Maintenance And Continuous Treatment Study

NCT ID: NCT06412848

Last Updated: 2025-11-21

Study Results

Results pending

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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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

360 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-05-09

Study Completion Date

2026-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Urothelial Carcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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

Intervention Type DRUG

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.

Intervention Type DRUG

Eligibility Criteria

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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

Exclusion Criteria

* Participant participated in a clinical trial in la/m UC during the study periods.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Ehime University Hospital

Tōon, Ehime, Japan

Site Status

Kurume University Hospital

Kurume, Fukuoka, Japan

Site Status

Hokkaido University Hospital

Sapporo, Hokkaido, Japan

Site Status

Sapporo Medical University Hospital

Sapporo, Hokkaido, Japan

Site Status

Kobe University Hospital

Kobe, Hyōgo, Japan

Site Status

Iwate Medical University Hospital

Shiwa-gun, Iwate, Japan

Site Status

Kagawa University Hospital

Kita-gun, Kagawa-ken, Japan

Site Status

St. Marianna University Hospital

Kawasaki, Kanagawa, Japan

Site Status

Kitasato University Hospital

Sagamihara, Kanagawa, Japan

Site Status

Nara Medical University Hospital

Kashihara, Nara, Japan

Site Status

Kindai University Hospital

Sayama, Osaka, Japan

Site Status

Saitama Medical University International Medical Center

Hidaka, Saitama, Japan

Site Status

Juntendo University Hospital

Bunkyō City, Tokya, Japan

Site Status

Nippon Medical School Hospital

Bunkyo-ku, Tokyo, Japan

Site Status

National Cancer Center Hospital

Chuo-ku, Tokyo, Japan

Site Status

Teikyo University Hospital

Itabashi-ku, Tokyo, Japan

Site Status

Akita University Hospital

Akita, , Japan

Site Status

Kyushu Cancer Center

Fukuoka, , Japan

Site Status

Kumamoto University Hospital

Kumamoto, , Japan

Site Status

University Hospital Kyoto Prefectural University of Medicine

Kyoto, , Japan

Site Status

Kyoto University Hospital

Kyoto, , Japan

Site Status

Osaka International Cancer Institute

Osaka, , Japan

Site Status

Tokushima University Hospital

Tokushima, , Japan

Site Status

Toyama University Hospital

Toyama, , Japan

Site Status

Yamagata University Hospital

Yamagata, , Japan

Site Status

Countries

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Japan

Related Links

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Other Identifiers

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MS100070_0209

Identifier Type: -

Identifier Source: org_study_id

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