Program for Pembrolizumab (MK-3475) in Participants With Metastatic Melanoma Who Have Failed Standard of Care Therapy Including Ipilimumab (MK-3475-030)

Expanded access is currently available for this treatment.
Verified April 2015 by Merck Sharp & Dohme Corp.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT02083484
First received: March 7, 2014
Last updated: April 20, 2015
Last verified: April 2015
  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 with the exception of a participant enrolled in the pembrolizumab protocol MK-3475-006 who received treatment on the ipilimumab treatment arm and progressed; such participants will be eligible to participate in the EAP, regardless of prior treatment with a BRAF/MEK inhibitor, as long as all other eligibility criteria for MK-3475-030 are met.


Condition Intervention
Melanoma
Biological: Pembrolizumab

Study Type: Expanded Access     What is Expanded Access?
Official Title: Expanded Access of MK-3475 in Metastatic Melanoma Patients With Limited to No Treatment Options

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Intervention Details:
    Biological: Pembrolizumab
    Each participant will receive pembrolizumab every 3 weeks for up to 2 years or until confirmed radiographic disease progression, unacceptable toxicity, confirmed positive pregnancy test, withdrawal of consent, or pembrolizumab approval in the participant's country.
Detailed Description:

Pembrolizumab has been approved by the U.S. Food and Drug Administration for the treatment of patients with unresectable metastatic melanoma and disease progression following ipilimumab and if BRAF V600 mutation positive, a BRAF inhibitor. The Expanded Access Program (EAP) for this medicine in the U.S. is closed. The EAP will continue outside the U.S.

  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 (with the exception of a participant with progressive disease while on the ipilimumab arm of MK-3475-006, regardless of prior treatment with a BRAF/MEK inhibitor, as long as all other eligibility criteria for this study are met)
  • 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 (with the exception of a participant with progressive disease while on the ipilimumab arm of MK-3475-006)
  • Eligible for treatment with a marketed BRAF inhibitor or MEK inhibitor (with the exception of a participant with progressive disease while on the ipilimumab arm of MK-3475-006, regardless of prior treatment with a BRAF/MEK inhibitor, as long as all other eligibility criteria for this study are met)
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02083484

Contacts
Contact: Idis 1-855-478-4347 mk3475us@idispharma.com

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Director Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT02083484     History of Changes
Other Study ID Numbers: 3475-030
Study First Received: March 7, 2014
Last Updated: April 20, 2015
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Melanoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Neuroectodermal Tumors
Neuroendocrine Tumors
Nevi and Melanomas

ClinicalTrials.gov processed this record on May 28, 2015