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  • MK3475-412 Keynote-412

    Acronym: 

    Keynote 412

    ACTRN/NCT /ethics: 

    NCT03040999

    Scientific title: 

    A Randomized Phase III Study of Pembrolizumab Given Concomitantly With Chemoradiation and as Maintenance Therapy Versus Chemoradiation Alone in Subjects With Locally Advanced Head and Neck Squamous Cell Carcinoma (KEYNOTE-412)

    Summary of trial and patient characteristics

    Cancer Type Head and Neck
    Trial Type Treatment
    Phase Phase III Tumour Stream Head and Neck
    Age Range 18 years and older Cancer Stage Locally Recurrent or Locally Advanced
    Sex Both Anticipated Start Date 2017-05-05
    Molecular Target Anticipated End Date 2021-05-16
    Cancer Type Head and Neck
    Trial Type Treatment
    Phase Phase III
    Age Range 18 years and older
    Sex Both
    Molecular Target
    Tumour Stream Head and Neck
    Cancer Stage Locally Recurrent or Locally Advanced
    Anticipated Start Date 2017-05-05
    Anticipated End Date 2021-05-16

    Trial Summary

    The purpose of this study is to determine the efficacy and safety of pembrolizumab given concomitantly with chemoradiation (CRT) and as maintenance therapy versus placebo plus CRT in participants with locally advanced head and neck squamous cell carcinoma (LA HNSCC). The primary hypothesis is that pembrolizumab in combination with CRT is superior to placebo in combination with CRT with respect to event-free survival (EFS) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by blinded independent central review (BICR).

    Lay Summary

    A Randomized Phase III Study of Pembrolizumab Given Concomitantly With Chemoradiation and as Maintenance Therapy Versus Chemoradiation Alone in Subjects With Locally Advanced Head and Neck Squamous Cell Carcinoma (KEYNOTE-412)

    Sponsor / Cooperative group

    Merck

    Participating Hospitals

    Hospital Clinical Trial Coordinator Email Phone Principal Investigator Recruitment Status
    Royal Adelaide Hospital Anne Milton anne.milton@sa.gov.au 08 7074 2342 Nimit Singhal Recruiting