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Expanded Access Program

Frequently Asked Questions about MK-3475 U.S. Expanded Access Program

 
On March 10, 2014, Merck initiated an Expanded Access Program (EAP) in the U.S. for MK-3475, the company’s investigational anti-PD-1 immunotherapy, for patients with advanced melanoma who have been previously treated with ipilimumab and, if indicated, a BRAF inhibitor.
Below are answers to the top questions Merck has received from U.S. patient advocacy organizations about the MK-3475 EAP in advanced melanoma:

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.

What about patients who are not eligible for this EAP?

At this time, we are providing MK-3475 through many clinical trials and through the MK-3475 EAP for patients with advanced melanoma.
Merck has established this EAP for eligible people with advanced melanoma as this is the only group where we believe we have enough data on safety and efficacy at this time.

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.

Can patients enroll themselves?

Patients cannot apply to the EAP on their own. Patients must work through their physicians to apply.

Which physicians will be eligible?

In the U.S., the program is open to all physicians who have experience using systemic immunotherapy treatment for advanced melanoma patients. Outside the U.S., the criteria may vary by country.

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?

No.

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 ipilimumab. If a patient is known to have a BRAF mutation, they must have been treated with either a BRAF inhibitor or MEK inhibitor.
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 BRAF 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.

Expanded Access Program for MK-3475 in Advanced Melanoma

An expanded access program is now available 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 on www.clinicaltrials.gov.
The program is limited to patients with advanced melanoma because that is the only patient group where we believe we have enough data on safety and efficacy.
The MK-3475 Expanded Access Program for advanced melanoma will be administered by a partner company, Idis.
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.
Only physicians can enroll patients in the EAP. Patients should work through their physician to determine if they are eligible to enroll in the EAP.

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