Expanded Access Program for MK-3475 Opens TODAY!

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Expanded Access Program for MK-3475 Opens TODAY!

Postby Catherine Poole » Mon Mar 10, 2014 3:43 pm

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."
Catherine M. Poole, President/Founder
Melanoma International Foundation
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Re: Expanded Access Program for MK-3475anc Opens TODAY!

Postby Catherine Poole » Mon Mar 10, 2014 5:04 pm

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!
Catherine M. Poole, President/Founder
Melanoma International Foundation
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Re: Expanded Access Program for MK-3475 Opens TODAY!

Postby MariaS » Mon Mar 10, 2014 8:17 pm

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.
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Re: Expanded Access Program for MK-3475 Opens TODAY!

Postby MathewR » Mon Mar 10, 2014 9:19 pm

Thanks for the wonderful news Catherine!
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Re: Expanded Access Program for MK-3475 Opens TODAY!

Postby Jonathan » Tue Mar 11, 2014 8:04 am

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.
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Re: Expanded Access Program for MK-3475 Opens TODAY!

Postby Catherine Poole » Tue Mar 11, 2014 9:13 am

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.
Catherine M. Poole, President/Founder
Melanoma International Foundation
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Re: Expanded Access Program for MK-3475 Opens TODAY!

Postby NYKaren » Tue Mar 11, 2014 9:24 am

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
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Re: Expanded Access Program for MK-3475 Opens TODAY!

Postby erinmay22 » Tue Mar 11, 2014 10:14 am

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
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Re: Expanded Access Program for MK-3475 Opens TODAY!

Postby LynnLuc » Tue Mar 11, 2014 12:56 pm

Awesome news!!! March 26 will be NED's 4 birthday and June will be 5 years DX'ed Stage IV! I did Nivolumab!
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Re: Expanded Access Program for MK-3475 Opens TODAY!

Postby buffcody » Thu Mar 13, 2014 5:22 am

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?
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