Home Forums Melanoma Diagnosis: Stage IV Update on trials: just in!

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  • #21534
    Catherine Poole
    Keymaster

    Here is the NRAS trial by Merck now recruiting *must be treatment naïve*

    http://www.clinicaltrials.gov/ct2/show/NCT01693068?term=200066&rank=4

    I also have updates on the Pd1 trials. NCT01866319 (MK-3475-006 / PN006) IPI naïve: MK3475 v MK3475 v IPI. This study is opening in a few weeks. Please email me with your geographic preferences. Some may start recruiting now and others in a month. Also, update on BMS Pd1/ipi trials for naïve

    .

    cpoole@melanomainternational.org

    #62271
    AndyT
    Participant

    Thank you Catherine for this updates! NCT01866319 (http://www.clinicaltrials.gov/ct2/show/NCT01866319?term=NCT01866319&rank=1) is indeed a very interesting PD-1 trial. Is is supposed to run in EU as well.

    For those fighters that are facing brain mets it would be really valuable if you could get more information regarding inclusion/exclusion criteria. Particularly regarding this (exclusion) one:

    “Known active central nervous system (CNS) metastases and/or carcinomatous meningitis; participants with previously treated brain metastases are eligible”

    Perhaps you could get more information form study authors on how “stable” your brain mets have to be (is it 4 weeks?) I am sure many mel fighters will have the same questions.

    Also the inclusion criteria, particularly:

    No prior systemic treatment (excluding adjuvant or neoadjuvant therapy) for melanoma (first line) or one prior systemic treatment (excluding adjuvant or neoadjuvant therapy) for melanoma (second line)

    For example, if one had zelboraf and chemo, are they still eligible?

    All the best,

    Andy

    #62272
    bettin
    Participant

    Thanks for that, Catherine.

    How encouraging that there is finally something for patients with NRAS mutations! The trial design however is somewhat disappointing- comparison should be to best available which would NOT be DTIC anymore!!!!

    Luckily it’s open-label and I will not be surprised that they will note high drop-out rates for patients on their dummy arm- I’ve heard industry people referring to DTIC as ‘toxic placebo’ in Melanoma which basically says it all.

    And it is is actually telling that the company itself offers patients on the DTIC arm cross-over to Pimasertib upon progression but even doesn’t mention the reverse option…..

    So good that there is something promising for NRAS positive patients, but what a disappointing trial design.

    #62273
    Catherine Poole
    Keymaster

    I often wonder why certain comparators are chosen. DTIC has 5% response rate? But it is cheap probably in comparison to the new approved therapies. Would that be why? Might as well go with a placebo.

    #62274
    JerryfromFauq
    Participant

    I think a 5% chance of response is still better than a placebo. In too many cases treatments are ruled out because of a low % of success. In the past 5% was a high response rate. I would prefer something more than DTIC, but as you said, it’s cheap! (and as a previous “standard of care” makes approval more likely for the newer treatment.

    #62275
    Catherine Poole
    Keymaster

    I guess you are right, but DTIC can have some nasty side effects which would offset the small chance of response. Glad to see you are well and active Jerry, knowing you have literally been through hell and high water! You might want to share your inspiring story here..

    #62276
    dkmc
    Participant

    Jerry- I would like to hear your story. I know I find great comfort in each story, each journey…and the hope they inspire. Thanks Catherine for encouraging him to share again, Karen

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