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Active, Not Recruiting

NCT Number: NCT06412848

JAVEMACS: Japan AVElumab Maintenance And Continuous Treatment Study

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Urothelial Carcinoma Carcinoma Carcinoma, Transitional Cell Neoplasms Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hirosaki University Hospital, Hirosaki, Aomori, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Avelumab

Drug

This is an observational study, participants who received avelumab as first line maintenance therapy after a PBCT.

Primary outcomes

  1. Baseline clinical and demographic characteristics

    Time frame: Baseline

    To describe the baseline clinical and demographic characteristics of participants.

  2. Characteristics of the first line PBCT just prior to avelumab maintenance

    Time frame: Up to 3 months

Secondary outcomes

  1. Overall Survival (OS)

    Time frame: Up to 3 months

  2. Progression-Free Survival (PFS)

    Time frame: Up to 3 months

  3. Time to Treatment Failure (TTF)

    Time frame: Up to 3 months

  4. Time to Next Treatment (TTNT)

    Time frame: Up to 3 months

  5. Objective Response Rate (ORR)

    Time frame: Up to 3 months

Sponsors and collaborators

Lead sponsor

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

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
May 14, 2024
Registry last updated
May 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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