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JAVEMACS: Japan AVElumab Maintenance And Continuous Treatment Study - Trial NCT06412848

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.

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NCT06412848
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Trial Details
ClinicalTrials.gov โ€ข NCT06412848
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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

Study Focus

Urothelial Carcinoma

Avelumab

Observational

drug

Sponsor & Location

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

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

N/A

May 09, 2024

Jul 31, 2024

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 organs
Malignant neoplasm of ureter
Malignant neoplasms of urinary tract
Malignant neoplasm: Overlapping lesion of urinary organs
Malignant neoplasm: Urethra

Data Source

ClinicalTrials.gov

NCT06412848

Non-Device Trial