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  • KEYNOTE -555

    Acronym: 

    MK-3475-555

    ACTRN/NCT /ethics: 

    NCT03665597

    Scientific title: 

    Relative Bioavailability Study of Subcutaneous Injection Versus Intravenous Infusion of Pembrolizumab (MK-3475) in Participants With Advanced Melanoma (MK-3475-555/KEYNOTE-555)

    Summary of trial and patient characteristics

    Cancer Type Melanoma & other skin
    Trial Type Treatment
    Phase Phase I Tumour Stream Melanoma
    Age Range 18 years and older Cancer Stage Locally Recurrent or Locally Advanced
    Sex Both Anticipated Start Date 2018-11-19
    Molecular Target Anticipated End Date
    Cancer Type Melanoma & other skin
    Trial Type Treatment
    Phase Phase I
    Age Range 18 years and older
    Sex Both
    Molecular Target
    Tumour Stream Melanoma
    Cancer Stage Locally Recurrent or Locally Advanced
    Anticipated Start Date 2018-11-19
    Anticipated End Date

    Trial Summary

    A phase-I randomized clinical study of Pembrolizumab (MK-3475) to evaluate the realtive bioavailability of subcutaneaous injection versus intravenous infusion in participants with advanced melanoma. Key inclusion criteria: unresectable stage III or IV; untreated for advanced or metastatic (BRAF v600 may have received SOC targeted therapy (BRAF/MEK inhibitor, ANti-PD not allowed)); have at least one measurable lesion.

    Lay Summary

    Relative Bioavailability Study of Subcutaneous Injection Versus Intravenous Infusion of Pembrolizumab (MK-3475) in Participants With Advanced Melanoma (MK-3475-555/KEYNOTE-555)

    Sponsor / Cooperative group

    Immunocore

    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