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JAVEMACS: Japan AVElumab Maintenance And Continuous Treatment Study
JAVEMACS: Japan AVElumab Maintenance And Continuous Treatment Study

NCT06412848

CompletedN/A

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

Conditions: Urothelial Carcinoma

Interventions: Avelumab

Countries: Japan

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria
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.
Locations (26)
  • Hirosaki, Aomori, Japan
  • Tōon, Ehime, Japan
  • Kurume, Fukuoka, Japan
  • Sapporo, Hokkaido, Japan
  • Sapporo, Hokkaido, Japan
  • Kobe, Hyōgo, Japan
  • Shiwa-gun, Iwate, Japan
  • Kita-gun, Kagawa-ken, Japan
  • Kawasaki, Kanagawa, Japan
  • Sagamihara, Kanagawa, Japan
  • Kashihara, Nara, Japan
  • Sayama, Osaka, Japan
  • Hidaka, Saitama, Japan
  • Bunkyō City, Tokya, Japan
  • Bunkyo-ku, Tokyo, Japan
  • Chuo-ku, Tokyo, Japan
  • Itabashi-ku, Tokyo, Japan
  • Akita, Japan
  • Fukuoka, Japan
  • Kumamoto, Japan
  • Kyoto, Japan
  • Kyoto, Japan
  • Osaka, Japan
  • Tokushima, Japan
  • Toyama, Japan
  • Yamagata, Japan