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  • FLIGHT

    Acronym: 

    FLIGHT

    ACTRN/NCT /ethics: 

    ACTRN12617001621303

    Scientific title: 

    Novel Triple Combination Immunotherapy for Patients with Metastatic Melanoma

    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 Metastatic or Widespread
    Sex Both Anticipated Start Date 2018-02-04
    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 Metastatic or Widespread
    Anticipated Start Date 2018-02-04
    Anticipated End Date

    Trial Summary

    The aim of this project is to investigate the effects of CDX-301 on the safety, clinical activity, and immune priming of glembatumumab vedotin combined with pembrolizumab or nivolumab in adult patients with locally advanced or metastatic melanoma. Who is it for? You may be eligible to join this study if you are aged 18 years or over and have unresectable, histologically confirmed Stage 3 or 4 melanoma not responding to pembrolizumab or nivolumab treatment. Study details: All participants will receive CDX-301 and glembatumumab vedotin in combination with either pembrolizumab or nivolumab. CDX-301 is administered by subcutaneous injection, whereas glembatumumab vedotin, pembrolizumab and nivolumab are administered intravenously, i.e. directly into the vein. CDX-301 will be given on Days -6 to -2 of a 3-weekly study cycle, for a total of two cycles. Glembatumumab Vedotin will be given on day 1 of each 3-weekly study cycle. In addition patients will receive either Pembrolizumab on day 1 of each cycle every 3 weeks OR Nivolumab every 2 weeks. Participants continue with Glembatumumab Vedotin, Pembrolizumab or Nivolumab, unless there is protocol-defined progression of disease or intolerance of one or more of these drugs We will collect blood samples from your vein before you receive the study treatments and between each of the study treatments. These blood samples will be analysed in the laboratory for the presence and character of specialised white blood cells, which may have been mobilised into the blood by the CDX-301 and glembatumumab vedotin treatment. A sample of your original melanoma biopsy tissue may be compared with additional (optional) melanoma tissue biopsies taken during the course of the study. These melanoma samples will be examined in the laboratory for evidence of any new immune reaction that may be caused by the action of CDX-301 and glembatumumab vedotin. This study will help in determining whether CDX-301 is safe to administer in combination with glembatumumab vedotin and with either pembrolizumab or nivolumab.

    Lay Summary

    Novel Triple Combination Immunotherapy for Patients with Metastatic Melanoma

    Sponsor / Cooperative group

    Celldex

    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 Recruitment on Hold