Home Forums Melanoma Diagnosis: Stage IV Anti PD1 Exclusion Criteria

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  • #20793
    dianam
    Guest

    My husband has presented a severe colitis with the first dose of Ipi, which has forced him to be admitted for a month in the hospital, and left him out of the clinical trial.

    I wonder if anyone knows if this is an exclusion criteria, for entry into a study with Anti PD1.

    Thank you very much.

    #57744
    Anonymous
    Guest

    It really depends on the trial but typically, there would be exclusions for chronic and/or active colitis (or other auto-immune disfunction), chronic steroid use beyond about the equivalent of 5mg of Predisone per day (which is about what the body normally makes) and there will probably be a “wash out” period (as much as a few months but hubby only had one IPI infusion) needed to make sure the IPI is reasonnably out of his system. Best to talk to the PD-1 trial centers though.

    Hope this helps.

    Jeff

    #57745
    Anonymous
    Guest

    Thanks for the reply.

    My husband is 45 years old and was diagnosed with stage IV, 3 years ago, when our children were 5 and 9 years.

    The toxicity to Ipi was in Julio/12 and colitis has been a side effect of medication, not a chronic and / or active colitis (auto-immune) and since then is not medicated with corticosteroids.

    The colitis was severe and required parenteral nutrition for almost a month and 2 doses of Remicade to be controlled.

      Now has started a clinical trial of Zelboraf and I hope with all my heart that works for a long time.

    I’ll go a step further and looking alterntivas, but we live in Spain and not a lot of available clinical trial and I have fear that the antecedent of toxicity leave it out of the possibilities that we have.

    Thanks again!

    #57746
    Catherine Poole
    Keymaster

    This shouldn’t be an exlcusion criteria. I agree, it is only if he is actively on steroids will he not be allowed into the trial. We can only hope that the therapy will be approved in the near future and this wouldn’t be an issue. I hope all goes well on the Zelboraf for him!! Please let us know. We also have a lot of experts here (patients) who have been on Zelboraf and can help with feedback on side affects.

    #57747
    NYKaren
    Participant

    As of about 3 months ago, prior Remicade use is not an exclusion for the Merck trials, but it is for BMS.

    All the best,

    Karen

    #57748
    Anonymous
    Guest

    Thanks for everything.

    Diana.

    #57749
    Gilly
    Participant

    Hi Diana

    My husband is also 45 and we have 4 kids 12-17 – we live in central France – we have been treated at IGR in Paris under Caroline Robert and Christine Mateus – I know that Pati was having Anti Pd1 in Paris – is there any chance your husband could travel if you cant find the treatments in Spain ? My husband – also stage 4 – is hoping to start the Combi V trial – either Zelboraf or the GSK Braf/Mek inhibitors – we are hoping for the latter because the side effects seem better – All the best for your husband and for the rest of you also – If you want to come to Paris and you need a stop half way – you are welcome !

    #57750
    Anonymous
    Guest

    Thanks Gilly, you are very kind.

    Now we are with this clinical trial, which began six weeks ago and next week, will make the thoraco abdominal CT and brain MRI, to see the first responses.

    He has fairly well tolerated, treatment with Zelboraf, much rash in the first few weeks, and joint pain that improves with paracetamol or ibuprofen.

    Now the rash has decreased.

    He always kept his work and sports activities, as well as taking care of our children, because the two always work long hours.

    Thanks for your offer. I hope not to need it and to have these resources here in Spain.

    He is treated at the Hospital Clinic of Barcelona, which has its own unit of clinical trial, but if necessary, would be willing to travel where treatments had.

    I hope your husband tolerates the medication as well as mine and we can meet one day to celebrate how well they are both.

    #57751
    Gilly
    Participant

    Thats great Diane – I think you are in good hands in Barcelona – I hope the Zelboraf works for your husband ! Good luck for the scans next week – the results for Zelboraf working seem to be spectacular sometimes ! Look after yourselves.

    #57752
    jmmm
    Participant

    A question…would steroid use for radiation induced necrosis (necrosis from gamma knife) be a disqualifier for the PD-1 trials, too? My husband is on 2 Mg of decahedron a day to reduce the necrosis swelling.

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