Home Forums Melanoma Diagnosis: Stage IV Expanded Access Program With Nivolumab for Subjects

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  • #21983
    LynnLuc
    Participant

    Expanded Access Program With Nivolumab for Subjects With Histologically Confirmed Stage III (Unresectable) or Stage IV Melanoma Progressing Post Prior Systemic Treatment Containing an Anti_CTLA-4 Monoclonal Antibody https://clinicaltrials.gov/ct2/show/NCT02142218

    #64429
    Catherine Poole
    Keymaster

    I’m getting the details on this shortly and will post here.

    #64430
    Catherine Poole
    Keymaster

    So this will require, like the Merck program, that you first must fail IPI and BRAF drugs is you are positive. It does not allow prior PD1 of any kind. It is rolling out with a conservative estimate of 14 days. Locations will likely be those that had prior trials. Stay tuned for more on global locations.

    #64431
    njreaders
    Participant

    Glad to see that this program is moving along but once again like the Merck 3475 early access it penalizes folks who have active brain mets and who are suffering physically because of them.

    peggy

    #64432
    Steven
    Participant

    Is it possible that the final FDA approval will also have the requirement about previous ipi use? Are there any other drugs in the world that require previous use of another drug?

    #64433
    Catherine Poole
    Keymaster

    Good question, but not what I have heard. The requirement will be for stage IV disease though. These requirements are based on clinical trials that they follow up and to meet unmet need, i.e. you must try the FDA approved drugs and run out of options.

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