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|Therapy Name||APX005M + Gemcitabine + Nab-paclitaxel + Nivolumab|
|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).|
|Gemcitabine||Gemzar||Difluorodeoxycytidine Hydrochlorothiazide|LY-188011||Chemotherapy - Antimetabolite 14||Gemzar (gemcitabine) is converted in cells to difluorodeoxycytidine di- and triphosphate (dFdCDP, dFdCTP), which act to inhibit ribonucleoside reductase and as a deoxynucleotide analog respectively, resulting in DNA strand termination and apoptosis (NCI Drug Dictionary).|
|Nab-paclitaxel||Abraxane||ABI-007|Paclitaxel Protein-bound||Chemotherapy - Taxane 2||Abraxane (nab-paclitaxel) is an albumin-stablized version of paclitaxel, which binds microtubules and prevents depolymerization, resulting in decreased cell motility and division (NCI Drug Dictionary).|
|Nivolumab||Opdivo||MDX-1106|BMS-936558||Immune Checkpoint Inhibitor 141 PD-L1/PD-1 antibody 83||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).|
|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|
|NCT03214250||Phase Ib/II||Gemcitabine + Nab-paclitaxel + Nivolumab APX005M + Gemcitabine + Nab-paclitaxel APX005M + Gemcitabine + Nab-paclitaxel + Nivolumab||Safety and Efficacy of APX005M With Gemcitabine and Nab-Paclitaxel With or Without Nivolumab in Patients With Previously Untreated Metastatic Pancreatic Adenocarcinoma||Active, not recruiting||USA||0|