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 |
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Health condition(s) or Problem(s) studied | |
Date of first enrollment | 28/09/2020 |
Target sample size | 600 |
Countries of recruitment | Japan,Asia except Japan,North America,South America,Europe,Oceania |
Study type | Interventional |
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 Outcome | efficacy confirmatory |
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Secondary Outcome | safety efficacy |
Key inclusion & exclusion criteria
Age minimum | >= 18age old |
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Age maximum | Not applicable |
Gender | Both |
Include criteria | |
Exclude criteria |
Related Information
Primary Sponsor | |
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Secondary Sponsor | |
Source(s) of Monetary Support | |
Secondary ID(s) | NCT04128696,JapicCTI-205354 |
Contact
Public contact | |
Name | |
Address | Akasaka Intercity AIR, 1-8-1 Akasaka, Minato-ku, Tokyo, Japan |
Telephone | +81-120-561-007 |
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 |
jp.gskjrct@gsk.com | |
Affiliation | GlaxoSmithKline K.K. |