Home Forums Melanoma Diagnosis: Stage IV IPI/PD1 Trial with Merck

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  • #21605
    Catherine Poole
    Keymaster

    This trial: http://clinicaltrials.gov/show/NCT01866319

    is comparing two different doses of PD1 vs. IPI. It has many trial locations globally, a few nationally. I have a list if you are interested. Please note you can have prior therapy, BUT no prior IPI.

    #62632
    Zapp
    Participant

    Jon is currently on his 2nd dose of Ipi. Thank you for the information. Darlene

    #62633
    MathewR
    Participant

    Catherine, generally I’ve been told that in order to get into an anti-PD-1 trial that I need to have “failed” at least one prior treatment. I’ve been on the GSK combo for about 8 weeks as an initial treatment (heavy tumor burden at the time of diagnosis). I’m getting great results, but am obviously concerned with the absence of an opportunity for a more durable solution. Are you aware of any anti-PD-1 trials where one need not “fail” the prior treatment (and may instead voluntarily stop the treatment in order to get into the trial)? (As an aside, my thought process is that, hopefully, I can come back to the GSK combo if needed, particularly since I haven’t been on it for very long.)

    Thanks, Mat

    #62634
    BNP68
    Participant

    Mat,

    I’m in NCT01783938 clinical trial. It’s an IPI/PD1 sequential trial. I know there’s no prior failure requirement with this trial. Unfortunately I know they’ve just about met their quota for patients but I heard they are still accepting patients at a few locations. Hope that helps.

    Brian

    #62635
    MathewR
    Participant

    Brian, thanks. My doctor is an investigator for your trial. Need to show disease progression since prior treatment (if you’ve had one), i.e., need to have failed. The inclusionary criteria for the trial Catherine posted uses different wording, so I’ve emailed one of the investigators.

    #62636
    Catherine Poole
    Keymaster

    It is complicated to say the least, so best to talk with the investigator/nurse. There are Pd1 trials where you need to have failed IPI and if BRAF positive, a braf drug. There are others where you can’t have had prior therapies (IPI naïve). The sequential and combination of IPI/Pd1 you must be IPI naïve, but you can have prior therapy such as IL2.

    #62637
    MathewR
    Participant

    Hi, I called the number on the clinical trial summary. The current domestic sites are (1) Chicago (Northwestern), (2) LA (Angeles, UCLA and Beverly Hills Cancer Ctr) and (3) Seattle (Seattle Cancer Alliance). However, after contacting Northwestern, I received an email indicating that their site was closing (somewhat surprising since the trial just opened in August?). I also spoke with a coordinator at SCCA who agreed that the wording of this trial may not require a “failure” of my current treatment. I’ll be looking into this trial further. For those more experienced than I, any thoughts on the absence of East Coast sites? I’d hate to be flying back and forth every 2 weeks only to learn that new sites open on the East Coast.

    #62638
    karlien
    Participant

    Catherine, I have a question regarding the trial NCT01866319 (MK-3475-006 AM1).

    My friend has melanoma diagnosis Stage IV. In 2012 he had chemotherapy. January 2013 he started Vemurafenib, but because of brain mets, he got WBRT in april 2013. After that he started Dabrafenib. After the PET-CT AND MR in july, the brain mets had decreased. After PET-CT and MR in september, the brain mets had decreased again.

    I know Dabrafenib will not work very much longer, and I’d like to know if he could be accepted for the MK-3475-006 AM1 trial. I don’t understand these inclusion criteria:

    1) 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)

    Is it a problem that he had chemotherapy, Vemurafenib, WBRT and Dabrafenib?

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

    Could he be accepted for the trial, now that his brain mets have decreased?

    Thanks in advance.

    #62639
    Catherine Poole
    Keymaster

    Because of the complicated language, I would call the site you want to participate in, talk to the study nurse and the get the info from the “horse’s mouth.” In other words, find out if there are indeed openings and then find out about eligibility. I am hoping to work with the parties who write up these trial descriptions to make them easier to understand. But it seems best to call the center for the best answers for now.

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