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  • KEYNOTE-716

    Acronym: 

    MK-3475-716

    ACTRN/NCT /ethics: 

    NCT03553836

    Scientific title: 

    Safety and efficacy of pembrolizumab compared to placebo in resected high-risk stage II melanoma

    Summary of trial and patient characteristics

    Cancer Type Melanoma & other skin
    Trial Type Treatment
    Phase Phase III Tumour Stream Melanoma
    Age Range 12 years and older Cancer Stage All stages
    Sex Both Anticipated Start Date 2018-09-12
    Molecular Target Anticipated End Date 2033-10-21
    Cancer Type Melanoma & other skin
    Trial Type Treatment
    Phase Phase III
    Age Range 12 years and older
    Sex Both
    Molecular Target
    Tumour Stream Melanoma
    Cancer Stage All stages
    Anticipated Start Date 2018-09-12
    Anticipated End Date 2033-10-21

    Trial Summary

    This 2-part study will evaluate the safety and efficacy of pembrolizumab (MK-3475) compared to placebo in participants with surgically resected high-risk Stage II melanoma. Participants in Part 1 will receive either pembrolizumab or placebo in a double-blind design for up to 17 cycles. Participants who receive placebo or who stop treatment after receiving 17 cycles of pembrolizumab in Part 1, do not experience disease recurrence within 6 months of completing pembrolizumab in Part 1, and do not stop treatment with pembrolizumab for disease recurrence or intolerability, may be eligible to receive up to 35 additional cycles of pembrolizumab in Part 2 in an open-label design. The primary hypothesis of this study is that pembrolizumab increases recurrence-free survival (RFS) compared to placebo.

    Lay Summary

    Safety and efficacy of pembrolizumab compared to placebo in resected high-risk stage II melanoma

    Sponsor / Cooperative group

    Merck Sharp & Dohme Corp.

    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 Professor Michael Brown Recruiting