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JAVEMACS: Japan AVElumab Maintenance And Continuous Treatment Study

Recruiting
18 years of age
Both
Phase N/A

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Overview

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

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 details

Urothelial Carcinoma

NCT06412848

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

1 June 2024

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