Home Forums Melanoma Diagnosis: Stage IV BMS Pd1 Nivo Expanded Access opening

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  • #22053
    Catherine Poole
    Keymaster

    There will be an update on the clinical trials.gov site shortly of sites. Here’s the url: http://clinicaltrials.gov/ct2/show/NCT02142218?term=NCT02142218.&rank=1

    #64777
    tcell
    Participant

    Hi Catherine,

    Seems it is on me this time to ask THE QUESTION:

    Any good news about rest of the world for Nivo EAP? Or does Bms intend to open the EAP for e.g. Europe at the same time as the US?

    Thanks,

    Chris

    #64778
    Catherine Poole
    Keymaster

    Locations are supposed to listed soon, but it is rolling out slowly in the U.S. I will ask. You will have better luck finding the Merck EAP for now.

    #64779
    rick1981
    Participant

    So far only two locations (both in the US) for Nivo:

    http://clinicaltrials.gov/ct2/show/NCT02142218?term=nivolumab&rank=38

    Does somebody have the EAS info for Merck PD-1 in Europe?

    Thanks, Rick

    #64780
    Catherine Poole
    Keymaster

    They are not releasing these locations to the public, you have to ask your doctor to contact them. I know Germany has one, (Essen) and probably Paris.. Check our global list and contact those near you. I wish I could get the definitive locations!

    #64781
    rick1981
    Participant
    #64782
    Catherine Poole
    Keymaster

    That is so odd since Japan has one of the lowest incidences of melanoma in the world. But I guess if you wanted to get the drug, you could travel there?

    #64783
    Celeste Morris
    Participant

    That’s great! Thanks for pointing that out, Rick. Approval of Nivo first in Japan is not really that surprising when you remember ONO Pharmaceutical developed the anti-PD1 monoclonal antibody ONO4538 in collaboration with Medarex, who called the product MDX1106. In 2009 BMS gained the right to develop the drug they called BMS936558 in North America. In 2011, BMS further gained the rights to the product in the rest of the world…EXCEPT in Japan, Korea, and Taiwan….where ONO retained exclusive development rights and had ongoing Phase II studies in place for non small cell lung cancer and melanoma patients as well as Phase III studies in renal cell carcinoma. (Results of those studies are hard to find.) Every step forward is a good one in drug availability!

    #64784
    Catherine Poole
    Keymaster

    I realized a Japanese company was involved, but Japan has one of the lowest melanoma rates so releasing it where there is no demand puzzled me. But if the release is for lung cancer then that would make sense. Does anyone know the medical system of Japan? I believe it is not socialized but similar to ours.

    #64785
    cheris
    Participant

    I’ve been on a get away with my husband and purposely did not read anything on melanoma. I was hoping to obtain some peace of mind, but that didn’t happen as much as I had hoped. There were spots of time that I didn’t think about being Stage IV; however, there were times that I felt that I couldn’t believe that I had this diagnosis.

    I had an appointment at Sara Cannon, but cancelled because my onc wants to do scans, and discuss treatment. I didn’t feel comfortable postponing the tests.

    That’s good news about Nivo. Do you need Ipi first, and can you be NED?

    Thank you.

    Cheris

    #64786
    Catherine Poole
    Keymaster

    Yes, you need Yervoy first and I don’t know if they would prescribe of NED. I will try to find out, but it is doubtful.

    #64787
    rick1981
    Participant

    Hello,

    I received news that Compassionate Use of Pembro (after Ipi) is coming to Europe, with 5 locations in Belgium opening soon.

    Also, I heard that Expanded Access of Nivo plus Ipi is expanding in the US, with Yale an option shortly. Any news on this program for Europe?

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