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Clinical Trial VICCMEL1434

Title

Expanded Access of MK-3475 in Metastatic Melanoma Patients with Limited to No Treatment Options

Principal Investigator(s)

Igor Puzanov

Details

  • Protocol No. VICCMEL1434
  • Open Date: 07/03/2014
  • Staging: N/A
  • Age Group: Adults
  • Scope: National
  • Objective: This program is designed to provide expanded access to MK-3475 prior to the product's approval.
  • Disease Sites: Melanoma
  • Therapies: Molecular Targeted Agents / Immunotherapy / Biologics
  • Drugs: MK-3475; Pembrolizumab
  • Participating Institutions: Vanderbilt University
  • National Clinical Trial ID: NCT02083484
  • Secondary Protocol No: Not Specified

Description

Patients are being asked to take part in this research studyEAP because they have metastatic melanoma. MK-3475 is an experimental treatment. MK-3475 is being studied as a possible cancer treatment. Experimental means that MK-3475 has not yet been approved by any governmental health authority. Merck Sharp & Dohme Corp., (a subsidiary of Merck & Co. Inc.) the company that is investigating MK-3475 has developed a set of conditions to make MK-3475 available to your doctor through an Expanded Access Program referred to also as EAP. The patient's doctor will also need to comply with other government rules in providing the MK-3475 to the patient before it has been approved for use in the United States. About This Expanded Access Program (EAP) There may be reasons why patients are not allowed to receive MK-3475 under the EAP. Some of these reasons include: - Patient is eligible for an accessible MK-3475 clinical study. - Patient has previously participated in a MK-3475 clinical study. - Patient is eligible for treatment with certain marketed products (such as ipilimumab). - Patient has untreated brain metastases or active central nervous system metastases. - Patient is less than 12 years of age. - Patient has not recovered from prior surgery and are less than 4 weeks from undergoing major surgery. - Patient is pregnant or breastfeeding or expect to become pregnant during the treatment period or within 120 days of completing treatment. - Patient is a male who is expecting to father a child during the treatment period. - Patient has a history of pneumonitis (inflammation of the lung tissue). - Patient has a condition that may interfere with treatment compliance or compromise their safety. - Patient has an active infection requiring therapy. - Patient requires steroid treatment for treatment of immune-related adverse events experienced on another immunotherapy. - Patient has received a live virus vaccine within 30 days of planned start of therapy. Patient has a history of clinically severe autoimmune disease (an illness that occurs when their tissues are wrongly attacked by their own immune system). The doctor or staff will discuss these and any other reasons why the patient may not be allowed to receive MK-3475 under the EAP. About MK-3475 What is known about MK-3475- MK-3475 is being studied by Merck to see if it has any effect in treating cancer. MK-3475 has been given to men and women with cancer to see what side effects would occur. About 479 men and women with cancer were treated for up to approximately 1.5 years. Multiple doses up to 10 mg/kg were given every two or three weeks.

Eligibility

Ages Eligible for Study:12 Years and older
Genders Eligible for Study:Both

Criteria

Inclusion Criteria:
• Unresectable (Stage III) or metastatic melanoma
• Failed or progressed on standard of care systemic therapy including ipilimumab
• Willing to sign Informed Consent
• Eastern Cooperative Oncology Group Performance status of 0 or 1
• Female participants of childbearing potential must be willing to use adequate contraception or be surgically sterile, or abstain from heterosexual activity starting with the first dose of treatment through at least 120 days after the last dose of pembrolizumab
• Male participants must agree to use an adequate method of contraception starting with the first dose of treatment through 120 days after the last dose of pembrolizumab
• Adequate organ function
Exclusion Criteria:
• Eligible for an accessible pembrolizumab clinical study or previously participated in a pembrolizumab clinical study
• Eligible for treatment with a marketed BRAF inhibitor or MEK inhibitor
• Not recovered to Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 or better due to prior chemotherapy, radioactive, or biological cancer therapy (including monoclonal antibodies)
• Not recovered from minor or major surgery and less than 4 weeks from major surgery
• History of life-threatening or severe immune-related adverse events on treatment with another immunotherapy
• Expected to require any other form of systemic antineoplastic therapy while receiving pembrolizumab
• History of clinically severe autoimmune disease (e.g., requires chronic immunosuppressive therapy)
• History of pneumonitis, organ transplant, human immunodeficiency virus (HIV), active hepatitis B or hepatitis C
• Active central nervous system metastases, carcinomatous meningitis, untreated brain metastases
• Pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of treatment with pembrolizumab
• Active infection requiring systemic therapy