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 email@example.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 firstname.lastname@example.org
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."