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  • KEYNOTE-826

    Acronym: 

    KEYNOTE-826

    ACTRN/NCT /ethics: 

    NCT03635567

    Scientific title: 

    Efficacy and Safety Study of First-line Treatment With Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy in Women With Persistent, Recurrent, or Metastatic Cervical Cancer (MK-3475-826/KEYNOTE-826)

    Summary of trial and patient characteristics

    Cancer Type Gynaecological
    Trial Type Treatment
    Phase Phase III Tumour Stream Cervical Cancer
    Age Range 18 years and older Cancer Stage Metastatic or Widespread, Locally Recurrent or Locally Advanced
    Sex Female Anticipated Start Date 2018-10-25
    Molecular Target Anticipated End Date 2022-11-23
    Cancer Type Gynaecological
    Trial Type Treatment
    Phase Phase III
    Age Range 18 years and older
    Sex Female
    Molecular Target
    Tumour Stream Cervical Cancer
    Cancer Stage Metastatic or Widespread, Locally Recurrent or Locally Advanced
    Anticipated Start Date 2018-10-25
    Anticipated End Date 2022-11-23

    Trial Summary

    The purpose of this study is to assess the efficacy and safety of pembrolizumab (MK-3475) plus one of four platinum-based chemotherapy regimens compared to the efficacy and safety of placebo plus one of four platinum-based chemotherapy regimens in the treatment of adult women with persistent, recurrent, or metastatic cervical cancer. Possible chemotherapy regimens include: paclitaxel plus cisplatin with or without bevacizumab and paclitaxel plus carboplatin with or without bevacizumab. The primary study hypotheses are that the combination of pembrolizumab plus chemotherapy is superior to placebo plus chemotherapy with respect to: 1) Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) as assessed by blinded independent central review (BICR), or, 2) Overall Survival (OS).

    Lay Summary

    Efficacy and Safety Study of First-line Treatment With Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy in Women With Persistent, Recurrent, or Metastatic Cervical Cancer (MK-3475-826/KEYNOTE-826)

    Sponsor / Cooperative group

    Merck Sharp & Dohme Corp.

    Participating Hospitals

    Hospital Clinical Trial Coordinator Email Phone Principal Investigator Recruitment Status
    Flinders Medical Centre Alex Scott-Hoy alex.scott-hoy@sa.gov.au 08 8204 4830 Ganessan Kichenadasse Recruiting