Home Forums Melanoma Diagnosis: Stage IV Phase III BMS PD1

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  • #20667
    Catherine Poole
    Keymaster

    Should be coming to trials soon. They skipped the phase II which is a good sign and will be going straight to III. Unfortunately, depending on what is chosen, this will be randomized to another agent as is required. Stay tuned to the details as soon I find out I will post them. This will be a global trial as well but not a huge amount of slots altogether. We can only hope it breezes through to approval.

    #56840
    pati
    Participant

    Catherine,

    I had heard a few months back it would be phase III; 2:1 randomized to chemo. Meaning 2 third of patients get anti-PD1 vs 1 third get chemo (oncologist’s best choice of chemo). In EU I had heard rumors about starting end of the year. I have not followed up on this but will do so.

    I REALLY hope that this has changed in the design…and above all that they allow for cross-over.

    Pati

    #56841
    Catherine Poole
    Keymaster

    The call I had with BMS didn’t allow any detail to be disclosed since they are in negotiation with the FDA right now. I could not find out anything further than what I posted but am promised details when they get ironed out. I did of course mention that it must be difficult to find something to randomize it with. There will be perhaps 80 slots globally.

    #56842
    hopeful
    Participant

    Hi Pati,

    I am thrilled to see your post. I occasionally visit the board and always look to see how you are doing. You helped me with some advice a few years ago which I have not forgotten how gratiful I was for your help.

    How are you doing? Your boys must be getting big now. Last post that I saw was that you were hoping to get into a PD1 trial. Did you get accepted into a PD1 trial?? I have read recently that Merck started a new arm to their PD1 trial which patients are randomized to either 10mg or 2 mg.

    I hope you are well. If you have time, please post how you are doing. My prayers are with you and your family.

    Hopeful

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