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

Conditions

Trial Phase

Trial Purpose and Description

Trial Purpose

This is an expanded access program (EAP) for participants who have progressed after prior systemic therapy including ipilimumab, and V-raf murine sarcoma viral oncogene homolog B1 (BRAF) inhibitor or mitogen-activated protein kinase (MEK) enzyme inhibitor when indicated. Participants cannot be eligible for or have participated in any pembrolizumab (MK-3475) clinical trial.


Participation Guidelines

Age:
Gender:
Both

Eligibility 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
Sponsor:
Merck Sharp & Dohme
Dates:
06/10/2014
Last Updated:
Study HIC#:
1404013699