JAVEMACS: Japan AVElumab Maintenance And Continuous Treatment Study

May 23, 2024 updated by: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

A Multicenter, Retrospective, Observational Study of Avelumab Maintenance and Subsequent Therapies in Japanese Patients With Locally Advanced or Metastatic Urothelial Carcinoma

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Japan
      • Akita, Japan, 010-0041
        • Not yet recruiting
        • Akita University Hospital
      • Fukuoka, Japan, 811-1347
        • Recruiting
        • Kyushu Cancer Center
      • Kumamoto, Japan, 860-8556
        • Not yet recruiting
        • Kumamoto University Hospital
      • Kyoto, Japan, 606-8507
        • Not yet recruiting
        • Kyoto University Hospital
      • Kyoto, Japan, 602-8566
        • Not yet recruiting
        • University Hospital Kyoto Prefectural University of Medicine
      • Osaka, Japan, 540-0008
        • Recruiting
        • Osaka International Cancer Institute
      • Tokushima, Japan, 770-0042
        • Not yet recruiting
        • Tokushima University Hospital
      • Toyama, Japan, 930-0194
        • Not yet recruiting
        • Toyama University Hospital
      • Yamagata, Japan, 9902331
        • Recruiting
        • Yamagata University Hospital
    • Aomori
      • Hirosaki, Aomori, Japan, 036-8563
        • Not yet recruiting
        • Hirosaki University Hospital
    • Ehime
      • Toon, Ehime, Japan, 791-0295
        • Not yet recruiting
        • Ehime University Hospital
    • Fukuoka
      • Kurume, Fukuoka, Japan, 830-0011
        • Not yet recruiting
        • Kurume University Hospital
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 060-8648
        • Not yet recruiting
        • Hokkaido University Hospital
      • Sapporo, Hokkaido, Japan, 060-8648
        • Not yet recruiting
        • Sapporo Medical University Hospital
    • Hyogo
      • Kobe, Hyogo, Japan, 650-0017
        • Recruiting
        • Kobe University Hospital
    • Iwate
      • Shiwa-gun, Iwate, Japan, 028-3695
        • Not yet recruiting
        • Iwate Medical University Hospital
    • Kagawa
      • Kita-gun, Kagawa, Japan, 761-0793
        • Recruiting
        • Kagawa University Hospital
    • Kanagawa
      • Kawasaki, Kanagawa, Japan, 216-8511
        • Not yet recruiting
        • St. Marianna University Hospital
      • Sagamihara, Kanagawa, Japan, 252-0374
        • Not yet recruiting
        • Kitasato University Hospital
    • Nara
      • Kashihara, Nara, Japan, 634-8522
        • Recruiting
        • Nara Medical University Hospital
    • Osaka
      • Osakasayama, Osaka, Japan, 589-8511
        • Not yet recruiting
        • Kindai University Hospital
    • Saitama
      • Hidaka, Saitama, Japan, 350-1298
        • Not yet recruiting
        • Saitama Medical University International Medical Center
    • Tokya
      • Bunkyo-ku, Tokya, Japan, 113-0033
        • Not yet recruiting
        • Juntendo University Hospital
    • Tokyo
      • Bunkyo-ku, Tokyo, Japan, 113-8603
        • Not yet recruiting
        • Nippon Medical School Hospital
      • Chuo-ku, Tokyo, Japan, 104-0045
        • Not yet recruiting
        • National Cancer Center Hospital
      • Itabashi-ku, Tokyo, Japan, 173-8606
        • Not yet recruiting
        • Teikyo University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Participants with locally advanced/metastatic Urothelial Carcinoma

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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).
Drug: Avelumab
This is an observational study, participants who received avelumab as first line maintenance therapy after a PBCT.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Baseline clinical and demographic characteristics
Time Frame: Baseline
To describe the baseline clinical and demographic characteristics of participants.
Baseline
Characteristics of the first line PBCT just prior to avelumab maintenance
Time Frame: Up to 3 months
Up to 3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall Survival (OS)
Time Frame: Up to 3 months
Up to 3 months
Progression-Free Survival (PFS)
Time Frame: Up to 3 months
Up to 3 months
Time to Treatment Failure (TTF)
Time Frame: Up to 3 months
Up to 3 months
Time to Next Treatment (TTNT)
Time Frame: Up to 3 months
Up to 3 months
Objective Response Rate (ORR)
Time Frame: Up to 3 months
Up to 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Investigators

  • Study Director: Medical Responsible, Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 9, 2024

Primary Completion (Estimated)

July 31, 2024

Study Completion (Estimated)

July 31, 2024

Study Registration Dates

First Submitted

April 23, 2024

First Submitted That Met QC Criteria

May 10, 2024

First Posted (Actual)

May 14, 2024

Study Record Updates

Last Update Posted (Actual)

May 24, 2024

Last Update Submitted That Met QC Criteria

May 23, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MS100070_0209

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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