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  • KEYPAD

    Acronym: 

    ANZUP1601

    ACTRN/NCT /ethics: 

    ACTRN12618000132246

    Scientific title: 

    Denosumab and Pembrolizumab in clear cell renal carcinoma

    Summary of trial and patient characteristics

    Cancer Type Kidney
    Trial Type Treatment
    Phase Phase II Tumour Stream Kidney
    Age Range 18 years and older Cancer Stage All stages
    Sex Both Anticipated Start Date 2017-12-12
    Molecular Target Anticipated End Date 2019-12-31
    Cancer Type Kidney
    Trial Type Treatment
    Phase Phase II
    Age Range 18 years and older
    Sex Both
    Molecular Target
    Tumour Stream Kidney
    Cancer Stage All stages
    Anticipated Start Date 2017-12-12
    Anticipated End Date 2019-12-31

    Trial Summary

    This study is designed to test the safety and potential benefit of adding an existing drug used for bone protection (denosumab) to a new immune stimulating drug (pembrolizumab). Who is it for? You may be eligible for this study if you have a confirmed unresectable or metastatic clear cell renal carcinoma, and you have adequate liver and bone function. Study details All participants will receive the two study drugs, along with vitamin D and calcium (mode of administration up to the discretion of the treating clinician). Treatment will continue until disease progression or toxicity. Patients will be monitored for tumour response and skeleton health. It is hoped this combination of medications will be as safe, and provide more benefit than the immune stimulating drug alone in treating kidney cancer.

    Lay Summary

    Denosumab and Pembrolizumab in clear cell renal carcinoma

    Sponsor / Cooperative group

    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