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NCT06412848

JAVEMACS: Japan AVElumab Maintenance And Continuous Treatment Study

A Multicenter, Retrospective, Observational Study of Avelumab Maintenance and Subsequent Therapies in Japanese Patients With Locally Advanced or Metastatic Urothelial Carcinoma
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany·ClinicalTrials.gov·drugRecruiting
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Study focus
Disease/Condition
Urothelial Carcinoma
Drug/Device/Intervention
Avelumab
Study type
Observational
Intervention type
drug
Sponsor & location
Primary sponsor
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Location
Hirosaki,Toon,Kurume,Sapporo,Sapporo,Kobe,Shiwa-gun,Kita-gun,Kawasaki,Sagamihara,Kashihara,Osakasayama,Hidaka,Bunkyo-ku,Bunkyo-ku,Chuo-ku,Itabashi-ku,Akita,Fukuoka,Kumamoto,Kyoto,Kyoto,Osaka,Tokushima, Japan
Timeline & enrollment
Phase
N/A
Start date
May 09, 2024
End date
Jul 31, 2024
Enrollment
300 participants
Primary outcome

Baseline clinical and demographic characteristics,Characteristics of the first line PBCT just prior to avelumab maintenance

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.

ICD-10 classifications
Carcinoma in situ: Other and unspecified urinary organsMalignant neoplasm of ureterMalignant neoplasms of urinary tractMalignant neoplasm: Overlapping lesion of urinary organsMalignant neoplasm: Urethra
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06412848
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06412848 through Pure Global AI's free database. This phase not specified trial is sponsored by Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany and is currently Recruiting. The study focuses on Urothelial Carcinoma. Target enrollment is 300 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.