臨床研究等提出・公開システム

Date of registration	April. 05, 2017
Last modified on	April. 13, 2022
Trial ID	jRCT2080223502

Scientific Title	-
Public Title	-

Completion Date or Terminated date	Feb. 21, 2022
Actual Enrolled Number
Baseline Characteristics
Participant flow
Adverse events
Primary Outcome Measures
Secondary Outcome Measures
Brief summary
Posting of journal publication
Date of the first journal publication of results	July. 05, 2019
URL hyperlink(s) related to results and publications	https://link.springer.com/article/10.1007/s11523-021-00810-9#article-info

Plan to share IPD	No
Plan description	-
URL link to protocol file(s)
Version of protocol file(s)	version: date:

Contact for Scientific Queries	Name
	Contact Name for Scientific Queries	Merck Biopharma Co., Ltd
	Address	1-8-1 Shimomeguro, Meguro-ku, Tokyo 153-8926, Japan
	Phone Number	+81-120-870-088
	E-mail Address	-

Contact for Public Queries	Name
	Contact Name for Public Queries	Merck Biopharma Co., Ltd
	Address	1-8-1 Shimomeguro, Meguro-ku, Tokyo 153-8926, Japan
	Phone Number	+81-120-870-088
	E-mail Address	-

Recruitment Status	completed

Date of First Enrolment		Mar. 11, 2016
Target Sample Size		117
Study Type		Interventional
Study Design	Study Design	-
Study Design	Objective	treatment purpose
Phase		1
Key inclusion & exclusion criteria	Inclusion Criteria	-
	Exclusion Criteria	-
	Minimum Age	20age old over
	Maximum Age	No limit
	Gender	Both
Health Condition or Problem Studied		-
Intervention(s)		investigational material(s) Generic name etc : - INN of investigational material : Bintrafusp Alfa (Genetical Recombination) Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : - control material(s) Generic name etc : - INN of investigational material : - Therapeutic category code : Dosage and Administration for Investigational material : -
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		safety -
Secondary Outcome		efficacy pharmacokinetics -

Primary Sponsor	Merck Biopharma Co., Ltd
Secondary Sponsor	-

Name of Funding Organization	-
Name of Research Funding	-

Name of IRB	-
Address of IRB	-
Phone Number of IRB	-
E-mail Address of IRB	-
Status of IRB Review	approved
Date of Approval by IRB	Feb. 17, 2016

Name of IRB	-
Address of IRB	-
Phone Number of IRB	-
E-mail Address of IRB	-
Status of IRB Review	approved
Date of Approval by IRB	Feb. 17, 2016

Name of IRB	-
Address of IRB	-
Phone Number of IRB	-
E-mail Address of IRB	-
Status of IRB Review	approved
Date of Approval by IRB	Feb. 17, 2016

Secondary ID No.	NCT02699515
Name of Other Registries	ClinicalTrials.gov

Secondary ID No.	JapicCTI-173557
Name of Other Registries

Countries / Regions of Recruitment	Japan/Asia except Japan

History of Changes

No	Publication date
4	April. 13, 2022	(this page)	Changes
3	May. 12, 2021	Detail	Changes
2	Oct. 09, 2018	Detail	Changes
1	April. 05, 2017	Detail

List of change history