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|Therapy Name||NG-641 + Nivolumab|
|Drug Name||Trade Name||Synonyms||Drug Classes||Drug Description|
|NG-641||NG 641|NG641||NG-641 is an engineered oncolytic enadenotucirev adenovirus expressing a bispecific FAP-TAc T-cell activator that binds to fibroblast activating protein (FAP) on cancer associated fibroblasts and to CD3 on T-lymphocytes, as well as CXCL9, CXCL10, and IFN alpha, which potentially enhances T-cell activation and induces killing of FAP-positive tumor fibroblasts (Cancer Res 2019;79(13 Suppl):Abstract nr 5013).|
|Nivolumab||Opdivo||MDX-1106|BMS-936558||Immune Checkpoint Inhibitor 146 PD-L1/PD-1 antibody 86||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|
|NCT05043714||Phase I||NG-641 + Nivolumab||Study of NG-641 in Combination With Nivolumab in Metastatic or Advanced Epithelial Tumours (NEBULA)||Recruiting||USA||1|