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Therapy Name | NEO-PV-01 + Nivolumab + Poly ICLC + Sotigalimab |
Synonyms | |
Therapy Description | |
Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
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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 149 PD-L1/PD-1 antibody 121 | 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 (UC) , esophageal squamous cell carcinoma, resected esophageal or gastroesophageal junction (GEJ) cancer, as a monotherapy or in combination with Yervoy (ipilimumab) for melanoma, renal cell carcinoma (RCC), 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 for PD-L1-positive (>=1%) metastatic NSCLC without EGFR or ALK alterations, with Yervoy (ipilimumab) and platinum-based chemotherapy as first-line therapy for metastatic or recurrent NSCLC without EGFR or ALK alterations, with platinum doublet chemotherapy as neoadjuvant treatment for patients with resectable NSCLC, with Cabometyx (cabozantinib) for advanced RCC, with fluoropyrimidine- and platinum-containing chemotherapy for advanced or metastatic gastric cancer, GEJ cancer, and esophageal adenocarcinoma, and with cisplatin and gemcitabine as first-line treatment for unresectable or metastatic UC (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). | ||
Sotigalimab | APX005M|EPI-0050|APX-005M|APX 005M | CD40 Antibody 14 | Sotigalimab (APX005M) 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). |
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 |
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NCT03597282 | Phase I | Ipilimumab + Nivolumab Nivolumab + Sotigalimab Ipilimumab + NEO-PV-01 + Nivolumab + Poly ICLC NEO-PV-01 + Nivolumab + Poly ICLC + Sotigalimab 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 |