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

Status: Recruiting
Diagnosis: Cutaneous Skin Cancer
NCT ID: NCT02083484 (View complete trial on
DFCI Protocol ID: 14-148


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 MK-3475 clinical trial.


Conducting Institutions:
Beth-Israel Deaconess Medical Center, Dana-Farber Cancer Institute, Brigham and Women's Hospital, Massachusetts General Hospital

Overall PI:
David McDermott, MD, Beth Israel Deaconess Medical Center

Site-responsible Investigators:
Frank Stephen Hodi, MD, Dana-Farber Cancer Institute
Donald Lawrence, MD, Massachusetts General Hospital

Dana-Farber Cancer Institute: Suzanne MacRae, 617-632-5906,
Beth-Israel Deaconess Medical Center: Cancer Trials Call Center, 617-667-3060
Massachusetts General Hospital: Cancer Trials Call Center, 877-789-6100

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 MK-3475 - 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 MK-3475 - Adequate organ function Exclusion criteria: - Eligible for an accessible MK-3475 clinical study or previously participated in a MK-3475 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 MK-3475 - 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 MK-3475 - Active infection requiring systemic therapy
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