Home Forums Melanoma Diagnosis: Stage IV Good News: EAP opening for Nivo/IPI combo

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    Catherine Poole

    Of course for naive patients: NCT02186249 on clinicaltrials.gov or go to: http://clinicaltrials.gov/ct2/results?term=NCT02186249&Search=Search

    Locations aren’t posted yet, but will as soon as the centers get approvals, could be as long as 8 weeks.


    Catherine, any info on whether this means that BMS is seeking FDA approval for this combination (instead of nivo only after ipi failure)?


    This is really good news.

    Smart move by BMS and I’m sure they’re going for the combo to be a standard of care. Afterall why not sell two drugs instead of one.

    The trial data I saw was compelling. SAs were kinda rough though they appeared to be quite managable like those for IPI.


    Catherine Poole

    Matt: no idea, but I imagine they will ask for that combo to be allowed, but that is always top secret by both pharma and FDA as to what is going for approval. I did hear that with this combo the sides affects as Jeff mentioned were pretty pronounced and immediate. But hopefully they’ve learned from the trial and can mitigate.

    Catherine Poole
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