Phase 1 Study of IMP321 (Eftilagimod Alpha) Adjuvant to Anti-PD-1 Therapy in Unresectable or Metastatic Melanoma

Exclusion Criteria

• •More than four prior lines of therapies for advanced or metastatic disease.
• •Prior PD-1/PDL-1 targeted therapy
• •Currently receiving treatment with another investigational drug, or less than 4 weeks since ending treatment on another investigational drug
• •Currently receiving systemic chemotherapy, targeted small molecule therapy, radiotherapy, or biological cancer therapy (other than pembrolizumab) or less than 4 weeks since completion of these therapies and first dose of study treatment
• •History of irAEs from ipilimumab of CTCAE Grade 4 requiring steroid treatment
• •Known cerebral or leptomeningeal metastases
• •Serious intercurrent infection within 4 weeks prior to first dose of study treatment
• •Active acute or chronic infection
• •History or evidence of interstitial lung disease or active non-infectious pneumonitis
• •Active auto-immune disease requiring immunosuppressive therapy
• •HIV positivity, active hepatitis B or hepatitis C
• •Continuous systemic treatment with either corticosteroids or other immunosuppressive medications within 4 weeks prior to first dose of study treatment