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

Exclusion Criteria:

Previous exposure to any immunomodulatory agents (e.g., anti- CD40, anti-PD-1/PD-L1, anti-CTLA-4, IDO inhibitors) except PD-1/PD-L1 targeting agents in the subsets of patients that must have previous treatment with anti-PD-1/PD-L1 therapy
Second malignancy (solid or hematologic) within the past 3 years except locally curable cancers that have been apparently cured
Active, known, clinically serious infections within the 14 days prior to first dose of investigational product
Use of systemic corticosteroids or other systemic immunosuppressive drugs
Active, known or suspected autoimmune disease
History of (non-infectious) pneumonitis that required corticosteroids or current pneumonitis
History of interstitial lung disease
History of life-threatening toxicity related to prior anti-PD-1/PD-L1 treatment for subjects with metastatic melanoma or NSCLC.