Home Forums Melanoma Diagnosis: Stage IV Expanded Access Program for MK-3475 Opens TODAY!

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  • #21865
    Catherine Poole
    Keymaster

    Here’s the announcement from Merck: “An expanded access program is now available in the U.S. for MK-3475, Merck’s investigational anti-PD-1 immunotherapy, for eligible patients with advanced melanoma who have been previously treated with ipilimumab and, if indicated, a BRAF inhibitor. The U.S. Food and Drug Administration has agreed to the initiation of this program. The study is available onwww.clinicaltrials.gov (#NCT02083484).

    The MK-3475 Expanded Access Program for advanced melanoma will be administered by a partner company, Idis. Physicians in the U.S. can reach Idis at 1-855-478-4347 or atmk3475us@idispharma.com. For approximately the first two months, the program will be available through physicians at MK-3475 melanoma clinical trial sites in the U.S. Following this initial phase, the program will be open to all physicians in the U.S. who have experience using systemic treatment for melanoma.

    Merck intends to expand the program to other countries in 2014. While applications outside the U.S. are not yet being accepted, Idis will be maintaining a list of physician inquiries so they can be contacted if the expanded access program becomes available in their country. Outside the U.S., physicians may contact Idis at +44 (0)1932 824 123 or mk3475row@idispharma.com.

    MK-3475 is an investigational therapy and is not approved for use by any regulatory agency. An expanded access program is for patients who have serious or immediately life-threatening illnesses for which no comparable or satisfactory alternate therapies are available.”

    #63783
    Catherine Poole
    Keymaster

    Here’s the scoop: you must have failed either or both, IPI and BRAF therapy, any kind, other PD1 or PDL. Brain mets must be stable but they will be pretty loose on this. It will be in Europe/Australia etc in 3 months or less. When it posts on clinicaltrials.gov we will list it and then there will be locations. Happy Day!

    #63784
    MariaS
    Participant

    Happy Day indeed! What would be a safe assumption for access to treatment in Canada? Two months? Three months? Another question would be how would they select the patients, since I’m pretty sure the demand will probably be way bigger than the supply at this point in time.

    #63785
    MathewR
    Participant

    Thanks for the wonderful news Catherine!

    #63786
    Jonathan
    Participant

    no question it won’t be available anywhere immediately, and may take a good couple of months to be up and running, from what I understand. So this means “it’s on the way.” Chosing patients is a whole other issue, and I’d imagine very much a local decision. Still, great news.

    #63787
    Catherine Poole
    Keymaster

    Don’t have an answer on Canada, but because of the regulatory agencies there, may be a little longer down the road. The individual physician needs to contact the agency listed above. The clinicaltrials.gov number is: NCT02083484). It is not yet posted however.

    #63788
    NYKaren
    Participant

    I am seeing my doc at 8:30 tomorrow morning. I just figured out that it’s smart to have blood drawn the day before (today) since my labs don’t always show up the same day.

    I know that NYU has a Merck PD1 clinical trial, so I’ll let you know what she says. (once it went to phase 2 trial, we were too afraid of chemo arm, and I’ve been dealing w/brain mets, for me to be without medicine, so I’ve been on tafilnar for 7 months and combo for 3) Tafinlar was a very dramatic improvement, MEK not so much, but seems to be holding me steady.

    fingers crossed,

    Karen

    #63789
    erinmay22
    Participant

    Yes this is great news to hear! Hopefully one step closer to approval but I know there are lots of folks that would like a chance to try this! I get my next scans March 17th and results and dose #21 on March 20th. So far tumors left have shrunk or remained stable with nothing new! and very few side effects…

    Erin

    #63790
    LynnLuc
    Participant

    Awesome news!!! March 26 will be NED’s 4 birthday and June will be 5 years DX’ed Stage IV! I did Nivolumab!

    #63791
    buffcody
    Participant

    For the purposes of this access, what does failing ipi mean? The two mets I had when I began ipi were radiated. One definite met since then. Surgically resected. Two suspicious areas on PET scan now not definitely diagnosed yet 16 months after ipi completed. My oncologist feels that the ipi was successful. But now? So did I fail ipi?

    #63792
    marta010
    Participant

    Just curious how the drugs are paid for under the Expanded Access Program? Are you technically enrolled in the trial and the drug is provided or if prescribed by your doctor, does the patient pay? Thanks.

    #63793
    MariaS
    Participant

    My understanding is that the EA is set up like a phase IV trial, I don’t think a doctor can prescribe it, you still have to be enrolled in the program. It may be paid by the drug company, not sure.

    #63794
    njreaders
    Participant

    Catherine,

    Would you please expand on what you know regarding how Merck will view brain mets for the 3475 early access? My husband is 4 weeks post Yervoy and the MRI shows some tumors shrank, some are stable, and some ‘grew’. Maybe the growth is the Yervoy ‘pseudo-progession’?? How will Merck view this type of patient?

    thanks!

    #63795
    Catherine Poole
    Keymaster

    I am supposed to be getting further clarification next week on the program. It was my understanding that they would be pretty loose about brain mets. It isn’t a clinical trial, so no need to worry about skewing the data which is why I assume they preclude that. But I’ve had many questions myself and hope to get some answers soon. In the meantime, the individual center may have the criteria, but I don’t know where they are yet. I would try the centers who have had the trial previously. More soon I hope!

    #63796
    Catherine Poole
    Keymaster

    I don’t think it will be that strict. Could you do IPI again? I doubt it. So it is more like they are looking for folks who have run out of the traditional options, i.e. IPI and the BRAF drugs.

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