CD40 Agonistic Antibody APX005M (Sotigalimab) in Combination With Nivolumab

Inclusion Criteria

• •Histologically or cytologically confirmed, immunotherapy naïve or PD-1/PD-L1 pre-treated, metastatic or locally advanced non-small cell lung cancer not amenable to curative treatment. Subjects may be treatment naive or could have received one prior platinum based chemotherapy for non-small cell lung cancer and subjects with a documented activating mutation (e.g., EGFR, ALK, ROS) must also have received the appropriate therapy and progressed
• •Histologically or cytologically confirmed unresectable or metastatic melanoma that progressed during treatment with an anti-PD-1/PD-L1 therapy and had confirmation of PD\>=4 weeks later. Subjects with BRAF activating mutation could have also received a BRAF inhibitor and/or MEK inhibitor regimen prior to anti-PD-1/PD-L1 therapy.
• •Measurable disease by RECIST 1.1
• •ECOG performance status of 0 or 1
• •Adequate bone marrow, liver and kidney function
• •Negative pregnancy test for women of child bearing potential
• •Agreement to use effective methods of contraception per the protocol requirements