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  • CHARLI

    Acronym: 

    CHARLI

    ACTRN/NCT /ethics: 

    NCT03161756

    Scientific title: 

    Evaluation of Denosumab in combination with immune checkpoint inhibitors in patietns with unresectable or metastatic melanoma (CHARLI)

    Summary of trial and patient characteristics

    Cancer Type Melanoma & other skin
    Trial Type Treatment
    Phase Phase I, Phase II Tumour Stream Melanoma
    Age Range 18 years and older Cancer Stage Locally Recurrent or Locally Advanced
    Sex Both Anticipated Start Date 2017-12-07
    Molecular Target Anticipated End Date 2023-06-01
    Cancer Type Melanoma & other skin
    Trial Type Treatment
    Phase Phase I, Phase II
    Age Range 18 years and older
    Sex Both
    Molecular Target
    Tumour Stream Melanoma
    Cancer Stage Locally Recurrent or Locally Advanced
    Anticipated Start Date 2017-12-07
    Anticipated End Date 2023-06-01

    Trial Summary

    The purpose of this project is to test the addition of a new treatment called denosumab to standard immunotherapies for patients with metastatic melanoma. Denosumab has been used for many years to help treat cancers such as prostate cancer and breast cancer, but it is not currently used in melanoma. We hope the addition of denosumab to current melanoma therapies will make these treatments work better without adding to the side effects. Who is it for? You may be eligible to join this study if you are aged 18 years or over and have been diagnosed with metastatic melanoma (melanoma that has spread). Study details: Nivolumab and ipilimumab are approved treatments for advanced melanoma in Australia and overseas. Patients with metastatic melanoma, who are not enrolled in a study, are commonly prescribed nivolumab alone or the combination of nivolumab and ipilimumab as standard care. However, there is limited information on the effectiveness and safety of these treatments in combination with denosumab. Recent melanoma research in animal models has shown that denosumab can make immunotherapies such as ipilimumab and nivolumab work better. Because denosumab has been used in patients with breast and prostate cancer for a long time and is safe, we now want to test the benefits and safety of adding denosumab to immunotherapies in this study.

    Lay Summary

    Evaluation of Denosumab in combination with immune checkpoint inhibitors in patietns with unresectable or metastatic melanoma (CHARLI)

    Sponsor / Cooperative group

    Australia and New Zealand Melanoma Trials 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 Amitesh Roy Not Yet Recruiting