030-00: Expanded Access of MK-3475 in Metastatic Melanoma Patients with Limited to No Treatment Options

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030-00: Expanded Access of MK-3475 in Metastatic Melanoma Patients with Limited to No Treatment Options

This is an expanded access program (EAP), multi-site, worldwide treatment use protocol in patients with metastatic melanoma who have limited or no treatment options. Patients must have progressed after prior systemic therapy including standard of care agents which include ipilimumab and BRAF/MEK inhibitor when indicated. Patients cannot be eligible for an available MK-3475 clinical trial or have participated in a MK-3475 clinical trial. Patients will be treated until progression of disease or until the patient has received up to 2 years of treatment. The Expanded Access protocol will be closed to new patients if MK-3475 is submitted for approval but not approved by the regulatory agency in
the relevant country.
The EAP is anticipated to enroll approximately 4500 patients worldwide. Participation will begin with informed consent (and assent, if appropriate) followed by a baseline evaluation to assess the patients eligibility for treatment. Patients will be evaluated for safety at baseline
and before each cycle of MK-3475.

Protocol Number091403
Principal InvestigatorJanice Mehnert
ScopeNational
Applicable Disease SitesMelanoma, skin
Therapies InvolvedChemotherapy single agent systemic
Drugs InvolvedMK-3475
Participating InstitutionsRutgers Cancer Institute of New Jersey

For further information on this clinical trial, please contact us at 732-235-8675 or cinjclinicaltrials@umdnj.edu.