JAVEMACS: Japan AVElumab Maintenance And Continuous Treatment Study

Last updated: February 18, 2025
Sponsor: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Carcinoma

Urothelial Carcinoma

Treatment

Avelumab

Clinical Study ID

NCT06412848
MS100070_0209
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participants diagnosed with locally advanced/metastatic urothelial carcinoma (la/mUC) before receiving avelumab first line maintenance therapy

  • Participants with la/m UC (irrespective of tumor histology) whose disease has notprogressed (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/mUC from 24 Feb 2021 (date of approval for UC) to 6 months before the date ofapproval of implementation of this study at each site

  • Participants aged >= 18 years old at index date

  • Other protocol defined inclusion criteria could apply

Exclusion

Exclusion Criteria:

  • Participant participated in a clinical trial in la/m UC during the study periods.

Study Design

Total Participants: 360
Treatment Group(s): 1
Primary Treatment: Avelumab
Phase:
Study Start date:
May 09, 2024
Estimated Completion Date:
June 30, 2026

Connect with a study center

  • Hirosaki University Hospital

    Hirosaki, Aomori 036-8563
    Japan

    Site Not Available

  • Ehime University Hospital

    Toon, Ehime 791-0295
    Japan

    Site Not Available

  • Kurume University Hospital

    Kurume, Fukuoka 830-0011
    Japan

    Site Not Available

  • Hokkaido University Hospital

    Sapporo, Hokkaido 060-8648
    Japan

    Site Not Available

  • Sapporo Medical University Hospital

    Sapporo, Hokkaido 060-8648
    Japan

    Site Not Available

  • Kobe University Hospital

    Kobe, Hyogo 650-0017
    Japan

    Site Not Available

  • Iwate Medical University Hospital

    Shiwa-gun, Iwate 028-3695
    Japan

    Site Not Available

  • Kagawa University Hospital

    Kita-gun, Kagawa 761-0793
    Japan

    Site Not Available

  • St. Marianna University Hospital

    Kawasaki, Kanagawa 216-8511
    Japan

    Site Not Available

  • Kitasato University Hospital

    Sagamihara, Kanagawa 252-0374
    Japan

    Site Not Available

  • Nara Medical University Hospital

    Kashihara, Nara 634-8522
    Japan

    Site Not Available

  • Kindai University Hospital

    Osakasayama, Osaka 589-8511
    Japan

    Site Not Available

  • Saitama Medical University International Medical Center

    Hidaka, Saitama 350-1298
    Japan

    Site Not Available

  • Juntendo University Hospital

    Bunkyo-ku, Tokya 113-0033
    Japan

    Site Not Available

  • Nippon Medical School Hospital

    Bunkyo-ku, Tokyo 113-8603
    Japan

    Site Not Available

  • National Cancer Center Hospital

    Chuo-ku, Tokyo 104-0045
    Japan

    Site Not Available

  • Teikyo University Hospital

    Itabashi-ku, Tokyo 173-8606
    Japan

    Site Not Available

  • Akita University Hospital

    Akita, 010-0041
    Japan

    Site Not Available

  • Kyushu Cancer Center

    Fukuoka, 811-1347
    Japan

    Site Not Available

  • Kumamoto University Hospital

    Kumamoto, 860-8556
    Japan

    Site Not Available

  • Kyoto University Hospital

    Kyoto, 606-8507
    Japan

    Site Not Available

  • University Hospital Kyoto Prefectural University of Medicine

    Kyoto, 602-8566
    Japan

    Site Not Available

  • Osaka International Cancer Institute

    Osaka, 540-0008
    Japan

    Site Not Available

  • Tokushima University Hospital

    Tokushima, 770-0042
    Japan

    Site Not Available

  • Toyama University Hospital

    Toyama, 930-0194
    Japan

    Site Not Available

  • Yamagata University Hospital

    Yamagata, 9902331
    Japan

    Site Not Available

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