Phase 1 Biomarker Study of Anti-PDL-1 in Advanced Melanoma

Inclusion Criteria

• •Men and women ≥ 18 years
• •Eastern Cooperative Oncology Group (ECOG) status = 0 to 1
• •Subjects with unresectable Stage III or IV Melanoma who are either refractory or intolerant to, or have refused standard therapy for treatment of metastatic Melanoma
• •Subject must have histologic or cytologic confirmation of advanced Melanoma
• •Subjects must have at least one measurable lesion at baseline by computed tomography (CT) or magnetic resonance imaging (MRI) as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria
• •Subjects must have at least 1 tumor site that can be biopsied at acceptable clinical risk and must consent to pre- and post-treatment biopsies