臨床研究等提出・公開システム

Date of registration	July. 01, 2020
Last modified on	Nov. 28, 2022
Trial ID	jRCT2080225258

Scientific Title	A Randomized, Double-blind, Adaptive, Phase II/III Study of GSK3359609 or Placebo in Combination with Pembrolizumab for First-Line Treatment of PD-L1 Positive Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma
Public Title	A Phase II/III study of GSK3359609 in combination with pembrolizumab compared with pembrolizumab plus placebo in participants with PD-L1 positive recurrent or metastatic HNSCC

Contact for Scientific Queries	Name
	Contact Name for Scientific Queries	GlaxoSmithKline K.K.
	Address	Akasaka Intercity AIR, 1-8-1 Akasaka, Minato-ku, Tokyo, Japan
	Phone Number	+81-120-561-007
	E-mail Address	jp.gskjrct@gsk.com

Contact for Public Queries	Name
	Contact Name for Public Queries	GlaxoSmithKline K.K.
	Address	Akasaka Intercity AIR, 1-8-1 Akasaka, Minato-ku, Tokyo, Japan
	Phone Number	+81-120-561-007
	E-mail Address	jp.gskjrct@gsk.com

Recruitment Status	completed

Date of First Enrolment		Sept. 28, 2020
Target Sample Size		600
Study Type		Interventional
Study Design	Study Design
Study Design	Objective	treatment purpose
Phase		2-3
Key inclusion & exclusion criteria	Inclusion Criteria
	Exclusion Criteria
	Minimum Age	18age 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 : - Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : Generic name etc : INN of investigational material : - 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 : --- Other Dosage and Administration for Investigational material :
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		efficacy confirmatory
Secondary Outcome		safety efficacy

Primary Sponsor
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	July. 21, 2020

Secondary ID No.	NCT04128696
Name of Other Registries	ClinicalTrials.gov

Secondary ID No.	JapicCTI-205354
Name of Other Registries

Countries / Regions of Recruitment	Japan/Asia except Japan/North America/South America/Europe/Oceania

History of Changes

No	Publication date
6	Nov. 28, 2022	(this page)	Changes
5	Nov. 24, 2022	Detail	Changes
4	May. 18, 2021	Detail	Changes
3	April. 20, 2021	Detail	Changes
2	Oct. 06, 2020	Detail	Changes
1	July. 01, 2020	Detail

List of change history