Therapy Detail

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Therapy Name APX005M + NEO-PV-01 + Nivolumab + Poly ICLC
Synonyms
Therapy Description

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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 153 PD-L1/PD-1 antibody 100 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 (NSCLC) progressed on prior therapies, 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 NSCLC without EGFR or ALK alterations, in combination with Yervoy (ipilimumab) and platinum-based chemotherapy as first-line therapy in patients with metastatic or recurrent NSCLC without EGFR or ALK alterations, in combination with platinum doublet chemotherapy as neoadjuvant treatment for patients with resectable NSCLC, 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).

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References

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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


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