Home Forums Melanoma Diagnosis: Stage IV New Phase III openings for IPI/PD1 trial

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  • #21377
    Catherine Poole
    Keymaster

    A little more info: http://clinicaltrials.gov/ct2/show/NCT01844505

    Overall survival is the endpoint. Just starting to recruit. Here are the exclusion criteria:

    •Active brain metastases or leptomeningeal metastases

    •Ocular melanoma

    •Subjects with active, known or suspected autoimmune disease

    •Subjects with a condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of treatment

    •Prior treatment with an anti-Programmed Death receptor-1 (PD-1), anti-Programmed Death-1 ligand-1 (PD-L1), anti-PD-L2, or anti-cytotoxic T lymphocyte associated antigen-4 (anti-CTLA-4) antibody

    Here are the locations: Omid Hamid – The Angeles Clinic – Los Angeles, CA

    Jeff Infante – Sarah Cannon Research Institute – Tennessee Oncology – Nashville, TN

    Frederick Aronson – Maine Center for Cancer Medicine

    Three arms: Pd1, IPI, and Pd1/IPI combined…will get full description

    #61358
    Anonymous
    Guest

    So moving quickly to a LARGE (900+) phase III IPI/PD1 combo trial with placebo arms tells me where BMS might be headed. Like perhaps getting the IPI/PD1 combo approved at the same time as PD1 itself or at least providing a basis to allow the oncs to percsribe both if PD1 approval pops out first.

    Too bad (and annoying to me) that you have to have no prior PD1 or, especially, IPI history. That leaves early explorers like Jonathan out in the cold, but maybe as the trial progresses, other arms might pop up allowing prior use.

    A wonderful, hopeful development though!

    Thanks Catherine!

    #61359
    Catherine Poole
    Keymaster

    Yes, and if the results are as promising as predicted at ASCO, approval will happen and that will bring folks like Jonathan back into the fold of getting it. GSK also did this dual approval with the BRaf and Mek. In the meantime, Jonathan has the happy news of being accepted into a very interesting trial starting soon. I’ll let him tell all though.

    #61360
    Sandalwood36
    Participant

    Any predictions on when PD1 might be approved? Bob needs it now and will likely be excluded from trials due to poor physical status (ie mostly bedridden, but getting PT and working on it).

    #61361
    Sandalwood36
    Participant

    Can someone explain to me why the sickest people, the ones that need a new drug the most, are excluded from trials for poor activity rating? Many of these warriors will die without having the chance to try a promising drug. What do they have to lose by offering them a trial drug. I can’t believe that anyone would sue if there loved one passed from a trial drug. I just don’t get it. It’s like dangling a carrot in front of your face saying ‘we have a drug that might help you, but you can’t have it’. Seems cruel and unacceptable to me.

    #61362
    Catherine Poole
    Keymaster

    I guess their theory is that if their performance level is low they may not benefit and skew the results of the trial. I’m really not sure of the logic. You might press for compassionate use at Merck or BMS but I know this is hard to get. I agree with you that the sickest need it now rather than later. I wish I could personally do something about that!

    #61363
    Sandalwood36
    Participant

    Thanks Catherine.

    #61364
    Jonathan
    Participant

    I’m sorry to hear about your husband’s exclusion from that trial – it is very hard to accept that the pharmas simply run the clinical trials on the strict basis of trial design, without regard to compassion (until the very last stage, when FDA approval is in the bag and it’s good PR). This is a very clear case from the early studies that anti-PD1 (in combo with Ipi or not) is a major improvement over “standard therapy.” So it really becomes an ethical issue of witholding clearly improved therapy (not just promising) from patients with no other recourse – and I know a number of oncologists are upset about this, but can’t do anything about it.

    Anyway, concerning my situation, since it was mentioned, it’s true that a) I’m still quite angry about being excluded from a decent anti-PD1 trial because I did the CT-011 version, which doesn’t work on melanoma patients, and b) I’m also very optimistic about the trial of this ADC drug (targeted chemotherapy) from Genentech that’s another phase I. I’ll be starting it in about 10 days, and another patient (ocular, with a very good response) confirms no side-effects. I’ll keep you informed.

    I wrote about it before on this forum, and Celeste has more on her blog about it. It’s hard not to be very optimistic because the oncologists and nurses involved are so upbeat themselves. Only time (about a month) will tell.

    On the CT-011 business (for those still interested), they apparently are going into a phase II version, but not recruiting melanoma patients (can’t imagine why…or why Teva has severed their cooperative agreement with CureTech after reviewing their phase I clinical data). Since they’re not obliged to make public the phase I results, and they can claim some ‘activity” in some other patients, apparently, this remains a valid scientific (but hardly ethical) reason for the other pharmas (BMS and Merck) to continue to exclude former CT-011 patients from their trials.

    Best,

    Jonathan

    #61365
    dhdoyle68
    Participant

    Catherine Poole wrote:

    A little more info: http://clinicaltrials.gov/ct2/show/NCT01844505

    Overall survival is the endpoint. Just starting to recruit. Here are the exclusion criteria:

    •Active brain metastases or leptomeningeal metastases

    •Ocular melanoma

    •Subjects with active, known or suspected autoimmune disease

    •Subjects with a condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of treatment

    •Prior treatment with an anti-Programmed Death receptor-1 (PD-1), anti-Programmed Death-1 ligand-1 (PD-L1), anti-PD-L2, or anti-cytotoxic T lymphocyte associated antigen-4 (anti-CTLA-4) antibody

    Here are the locations: Omid Hamid – The Angeles Clinic – Los Angeles, CA

    Jeff Infante – Sarah Cannon Research Institute – Tennessee Oncology – Nashville, TN

    Frederick Aronson – Maine Center for Cancer Medicine

    Three arms: Pd1, IPI, and Pd1/IPI combined…will get full description

    :? That’s weird, Dr. Fred Aronson is my wifes Onocologist and he never mentioned it. It has been April since she’s seen him. We’ve been dealing with Beth-Israel Deaconess Medical Center since early May. She starts her Merck PD-1 trial this Friday at BIDMC. He originally wanted her to do IL-2.

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