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Therapy Name Gemcitabine + Nab-paclitaxel + Nivolumab + Sotigalimab
Synonyms
Therapy Description

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Drug Name Trade Name Synonyms Drug Classes Drug Description
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 3 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 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).
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).

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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
NCT03214250 Phase Ib/II Gemcitabine + Nab-paclitaxel + Nivolumab Gemcitabine + Nab-paclitaxel + Sotigalimab Gemcitabine + Nab-paclitaxel + Nivolumab + Sotigalimab Safety and Efficacy of APX005M With Gemcitabine and Nab-Paclitaxel With or Without Nivolumab in Patients With Previously Untreated Metastatic Pancreatic Adenocarcinoma Completed USA 0


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