Frequently Asked Questions about MK-3475 U.S. Expanded Access Program
Is this a clinical trial?
This is not a clinical trial; however similar to a clinical trial, the EAP has criteria for determining which patients are eligible to participate. Information on safety and efficacy will be collected, but far less information than is usually collected in a clinical trial that is conducted to support FDA approval of a drug.Does the program enroll like a clinical trial?
Yes, the program enrolls like a clinical trial in that patients must meet certain criteria in order to be eligible to participate, and that enrollment is on a first-come, first-in basis. However, the entry criteria for the MK-3475 EAP are broader than for the current or previous clinical trials.
How long will it take to enroll/receive MK-3475?
How long it might take to receive MK-3475 through the EAP will be different for every patient. The timing can be affected by a number of factors, including:
when a physician submits the information on behalf of the patient;
whether any follow up is required to review that application;
how many other patients are enrolling; and,
approval for the program by the local Institutional Review Board.
+Will there be an accelerated IRB approval for clinical trial sites?
That will be determined by each site, but we would expect many to seek accelerated IRB approval.Do participants have to be a U.S. citizen?
Nationality is not a criterion for the MK-3475 EAP. Patients cannot apply to the EAP on their own. Patients must work through their physicians to apply and physicians must be based in the U.S. to participate in the U.S. program.Where are the sites that participated in the MK-3475 clinical trials?
There are approximately 50 sites across the U.S. participating in the MK-3475 melanoma clinical trials (i.e., KEYNOTE 001, 002 and 006). The list of clinical trial sites is available through Idis, Merck’s partner vendor administering the program, and on www.clinicaltrials.gov
.How can I enroll?
Patients must work through their physicians to apply. Patients cannot apply for the EAP on their own.
• Physicians in the U.S. who are interested in enrolling a patient in the EAP should contact Idis at 1-855-478-4347 or via email at firstname.lastname@example.org
• The Expanded Access Program will expand to other countries in 2014. While we are not yet accepting applications on behalf of patients outside the U.S., Idis will be maintaining a list of inquiries so you can be contacted if the EAP becomes available in your country. The numbers for outside the U.S. are +44 (0)1932 824 123 or via e-mail at email@example.com
Which physicians will be eligible?
For approximately the first two months, the program will be available through physicians at MK-3475 clinical trial sites in the U.S. Following this initial phase, the program will be open to all physicians in
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the U.S. who have experience using systemic immunotherapy treatment for advanced melanoma patients.Are patients from the control arms of any MK-3475 studies eligible?
No, patients who were on the control arm of any MK-3475 studies are not eligible to participate in the expanded access program.Is this drug approved by the U.S. Food and Drug Administration?
Do eligible advanced melanoma patients have to pay for MK-3475 in the EAP?
Patients in the U.S. who receive MK-3475 through the EAP will not have to pay for the medicine for as long as they are receiving MK-3475 through the program. Merck is in the process of seeking approval for MK-3475 in the USA. If and when the drug is approved by FDA, Merck plans to provide MK-3475 through the program for a transition period after approval.Will there be a fee for office visits?
It is possible that there will be a fee for office visits. This is determined by the physician and his or her medical center/hospital. Whether insurance will cover office visit fees associated with participation in the program is a decision made by insurance companies directly.Under the inclusion criteria, which systemic therapies must patients with advanced melanoma have received previously to be eligible for the EAP?
Patients must have failed or progressed on standard of care systemic therapy (i.e., chemotherapy, immunotherapy). Also, patients must have failed or progressed after treatment with ipilimumab. If a patient is known to have a mutation in BRAF they must have been treated with either a BRAF inhibitor or MEK inhibitor; they do not need to have been treated with both.
Under the exclusion criteria, if you are not BRAF mutant, do you need to have previously received a systemic BRAF or MEK inhibitor?
No, only patients with a positive BR
AF mutation need to have received such treatment.
Under the exclusion criteria, who decides the exclusion criteria for adverse events? Does the physician make this decision?
Yes, the physician will grade the adverse event using the Common Terminology Criteria for Adverse Events (CTCAE).
Under the exclusion criteria, what does “treated brain metastases” mean?
Advanced melanoma patients with brain metastases who are clinically stable, post-surgical resection or radiation therapy are eligible. Patient with active CNS metastases and/or carcinomatous meningitis are ineligible.
What is an expanded access program?
An EAP is designed to provide a patient with access to a medicine before it is approved by a national health authority and outside of the clinical trial setting. For diseases that are immediately life-threatening and alternatives for treatment are either absent completely or have been exhausted, if one of our medicines has shown what appears to be a favorable benefit risk profile in an indication, Merck may create an EAP to help patients with the relevant condition and for whom access to a clinical trial is not possible. The type of program can vary by country, even for the same medicine.
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