NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCT2080225258

Registered date:01/07/2020

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

Basic Information

Recruitment status completed
Health condition(s) or Problem(s) studied
Date of first enrollment28/09/2020
Target sample size600
Countries of recruitmentJapan,Asia except Japan,North America,South America,Europe,Oceania
Study typeInterventional
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 :

Outcome(s)

Primary Outcomeefficacy confirmatory
Secondary Outcomesafety efficacy

Key inclusion & exclusion criteria

Age minimum>= 18age old
Age maximumNot applicable
GenderBoth
Include criteria
Exclude criteria

Related Information

Contact

Public contact
Name
Address Akasaka Intercity AIR, 1-8-1 Akasaka, Minato-ku, Tokyo, Japan
Telephone +81-120-561-007
E-mail jp.gskjrct@gsk.com
Affiliation GlaxoSmithKline K.K.
Scientific contact
Name
Address Akasaka Intercity AIR, 1-8-1 Akasaka, Minato-ku, Tokyo, Japan
Telephone +81-120-561-007
E-mail jp.gskjrct@gsk.com
Affiliation GlaxoSmithKline K.K.