A Trial Evaluating the Safety & Efficacy of Intra-Tumoral Ipilimumab in Combination With Intra-venous Nivolumab in Patients With Metastatic Melanoma

Inclusion Criteria

• •1. Men and women \>/= 18 years of age
• •2. Signed and dated written informed consent prior any study related procedure
• •3. Histologically confirmed and clinically or radiologically progressing unresectable Stage III or Stage IV melanoma, as per AJCC staging system
• •4. Patients with at least two lesions:
• •* At least one injectable tumor lesion (≥1cm3)
• •* At least one target lesion (measurable lesion as per RECIST 1.1)
• •5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• •6. Treatment naïve subjects or patients relapsing after prior local or systemic anticancer therapy. Note that systemic anticancer therapy is permitted if it was completed at least 28 days or 5 times its half life (whichever is shorter) prior to the first study dose, and all related adverse events have either returned to baseline or stabilized.
• •7. Measurable disease by CT or MRI per RECIST 1.1 criteria.
• •8. Recent (less than 3 month) tumor tissue must be provided for patient stratification and biomarker analyses. In order to be equally randomized, a subject must be classified as PDL1 positive, PD-L1 negative, or PD-L1 indeterminate. If an insufficient amount of tumor tissue is available prior to the start of the screening phase, subjects must consent to allow the acquisition of additional tumor tissue for performance of biomarker analyses.
• +27 more criteria