臨床研究等提出・公開システム

Japanese

Date of registration	May. 28, 2024
Last modified on	Jan. 30, 2025
Trial ID	jRCT1031240122

Scientific Title	Evaluation of avelumab maintenance therapy and subsequent treatment status in Japanese patients with locally advanced or metastatic urothelial carcinoma using a large-scale database in Japan. (JAVEMACS-D: Japan AVElumab Maintenance And Continuous treatment Study- Database study)
Public Title	Evaluation of avelumab maintenance therapy and subsequent treatment status in Japanese patients with locally advanced or metastatic urothelial carcinoma using a large-scale database in Japan. (JAVEMACS-D: Japan AVElumab Maintenance And Continuous treatment Study- Database study)

Contact for Scientific Queries	Name	Ito Takayuki
	Affiliation	Merck Biopharma Co., Ltd.
	Address	Meguro-ku Shimomeguro 1-8-1 Alco Tower 4F
	Telephone	+81-3-6756-0800
	E-mail	takayuki.ito@merckgroup.com
Contact for Public Queries	Name	Shono Michihiro
	Affiliation	Merck Biopharma Co., Ltd.
	Address	Meguro-ku Shimomeguro 1-8-1 Alco Tower 4F
	Telephone	+81-3-6756-0800
	E-mail	michihiro.shono@merckgroup.com

Recruitment status	Complete

Anticipated date of first enrollment		May. 28, 2024
Actual date of first enrollment
Target sample size		900
Study Type		Observational
Study Design	allocation
	masking
	control
	assignment
	purpose
Key inclusion & exclusion criteria	Inclusion Criteria	Individuals can be included in the study only if they meet all the following criteria: 1.Confirmed diagnosis of UC in either the renal pelvis, ureter, bladder, or other and unspecified urinary organs based on ICD-10 code (C65-68) before the index date 2.Patient who was prescribed a first dose of avelumab between 24th February 2021 and 30th April 2023 3.Patient aged 18 years old or older at the index date
	Exclusion Criteria	Individuals are excluded from the study if they meet any of the following criteria: 1.Patient with no prescribed history of platinum-based combination chemotherapy (PBCT) prior to the start of avelumab prescription 2.Patient who are considered to have received any combination therapy of avelumab and anti-cancer agents 3.Considered to have participated in a clinical trial in la/m UC at any time during the study period
	Age Minimum	18age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Locally advanced or metastatic urothelial carcinoma (la/mUC)
Intervention(s)
Health Condition(s) Keyword		urothelial carcinoma
Intervention(s) Keyword
Health Condition(s) Code		D001749
Intervention(s) Code
Primary Outcome(s)		1.Describe the baseline demographics and clinical characteristics of patients received avelumab maintenance with la/m UC 2.Describe the characteristics of first PBCT prior to avelumab maintenance 3.Describe number and proportion of patients who transitioned to subsequent treatments (second, third and fourth) after avelumab maintenance
Secondary Outcome(s)		1.Time to Treatment Failure (TTF), TTF2 2.Time to Next Treatment (TTNT), TTNT2 3.Overall Survival (OS)

Primary Sponsor	Merck Biopharma Co., Ltd.

Source of Monetary Support / Secondary Sponsor	Merck Biopharma Co., Ltd.
Secondary Sponsor	Not applicable

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	Non-Profit Organization MINS Research Ethics Committee
Address	5-20-9-401 Mita, Minato-ku, Tokyo, Tokyo
Telephone	+81-3-6416-1868
E-Mail	npo-mins@j-irb.com
Approval Status	Approval
Date of approval	May. 09, 2024

Plan to share IPD	No
Plan description

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
2	Jan. 30, 2025	(this page)	Changes
1	May. 28, 2024	Detail

List of change history