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|Therapy Name||APX005M + NEO-PV-01 + Nivolumab + Poly ICLC|
|Drug Name||Trade Name||Synonyms||Drug Classes||Drug Description|
|APX005M||EPI-0050|APX-005M|APX 005M|Sotigalimab||CD40 Antibody 13||APX005M (Sotigalimab) is a monoclonal antibody to TNFRSF5 (CD40), which mimics the binding of the ligand, CD40LG (CD40L), to stimulate proliferation of T-cells and enhance an anti-tumor response (PMID: 31275618).|
|NEO-PV-01||NEO PV 01|NEO-PV 01||NEO-PV-01 is a personalized neoantigen vaccine that may stimulate anti-tumor immunity (Journal of Clinical Oncology 36, no. 15_suppl).|
|Nivolumab||Opdivo||MDX-1106|BMS-936558||Immune Checkpoint Inhibitor 135 PD-L1/PD-1 antibody 79||Opdivo (nivolumab) is an antibody that targets PD-1 (PDCD1), which results in increased T-cell activation and enhanced anti-tumor immune response (PMID: 28891423). Opdivo (nivolumab) is FDA approved for use as a monotherapy in patients with non-small cell lung cancer, small cell lung cancer, Hodgkin's lymphoma, head and neck squamous cell carcinoma, urothelial carcinoma, esophageal squamous cell carcinoma, resected esophageal or gastroesophageal junction (GEJ) cancer, as a monotherapy or in combination with Yervoy (ipilimumab) in patients with melanoma, renal cell carcinoma, microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (including patients 12 years or older), and hepatocellular carcinoma, in combination with Yervoy (ipilimumab) as first-line therapy in patients with PD-L1-positive (>=1%) metastatic non-small cell lung cancer without EGFR or ALK alterations, in combination with Yervoy (ipilimumab) and platinum-based chemotherapy as first-line therapy in patients with metastatic or recurrent non-small cell lung cancer without EGFR or ALK alterations, in combination with Cabometyx (cabozantinib) in patients with advanced renal cell carcinoma, and in combination with fluoropyrimidine- and platinum-containing chemotherapy in patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma (FDA.gov).|
|Poly ICLC||Hiltonol||Hiltonol (poly ICLC) is a synthetic double stranded RNA complex, which induces interferon production and stimulates anti-tumor immune response (PMID: 22126373).|
|Molecular Profile||Indication/Tumor Type||Response Type||Therapy Name||Approval Status||Evidence Type||Efficacy Evidence||References|
|Clinical Trial||Phase||Therapies||Title||Recruitment Status||Covered Countries||Other Countries|
|NCT03597282||Phase I||Ipilimumab + Nivolumab APX005M + Nivolumab Ipilimumab + NEO-PV-01 + Nivolumab + Poly ICLC APX005M + NEO-PV-01 + Nivolumab + Poly ICLC Nivolumab + Poly ICLC NEO-PV-01 + Nivolumab + Poly ICLC||A Personal Cancer Vaccine (NEO-PV-01) and APX005M or Ipilimumab With Nivolumab in Patients With Advanced Melanoma||Terminated||USA||0|