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  • MK3475-564 Keynote 564

    Acronym: 

    Keynote 564

    ACTRN/NCT /ethics: 

    NCT03142334

    Scientific title: 

    A Phase III, Randomized, Double-Blind, Placebo-Controlled Clinical Trial of Pembrolizumab (MK-3475) as Monotherapy in the Adjuvant Treatment of Renal Cell Carcinoma Post Nephrectomy (KEYNOTE-564)

    Summary of trial and patient characteristics

    Cancer Type Kidney
    Trial Type Treatment
    Phase Phase III Tumour Stream Kidney
    Age Range 18 years and older Cancer Stage All stages
    Sex Both Anticipated Start Date 2017-06-09
    Molecular Target Anticipated End Date 2022-11-12
    Cancer Type Kidney
    Trial Type Treatment
    Phase Phase III
    Age Range 18 years and older
    Sex Both
    Molecular Target
    Tumour Stream Kidney
    Cancer Stage All stages
    Anticipated Start Date 2017-06-09
    Anticipated End Date 2022-11-12

    Trial Summary

    The purpose of this study is to evaluate the safety and efficacy of pembrolizumab (MK-3475) in the adjuvant treatment of adult participants who have undergone nephrectomy and have intermediate-high risk, high risk, or M1 no evidence of disease (M1 NED) renal cell carcinoma (RCC) with clear cell component. The primary study hypothesis is that pembrolizumab is superior to placebo with respect to Disease-free Survival (DFS) as assessed by the Investigator in male and female participants with intermediate-high risk, high risk and M1 NED RCC.

    Lay Summary

    A Phase III, Randomized, Double-Blind, Placebo-Controlled Clinical Trial of Pembrolizumab (MK-3475) as Monotherapy in the Adjuvant Treatment of Renal Cell Carcinoma Post Nephrectomy (KEYNOTE-564)

    Sponsor / Cooperative group

    Merck Sharp & Dohme Corp

    Participating Hospitals

    Hospital Clinical Trial Coordinator Email Phone Principal Investigator Recruitment Status
    Ashford Cancer Centre Research Helen Daykin hdaykin@adelaidecancercentre.com.au 08 8292 2240 Recruiting