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|Therapy Name||Fluorouracil + Irinotecan + Leucovorin + Nivolumab|
|Drug Name||Trade Name||Synonyms||Drug Classes||Drug Description|
|Fluorouracil||Adrucil||5-FU||Chemotherapy - Antimetabolite 11||Adrucil (fluorouracil) is an antimetabolite chemotherapeutic agent, which interferes with DNA and RNA synthesis thereby preventing cancer cell growth and is FDA approved for colorectal, breast, stomach, and pancreatic cancer (FDA.gov).|
|Irinotecan||Camptosar||CPT-11|Onivyde||TOPO1 inhibitor 8||Camptosar (irinotecan) inhibits Topoisomerase-I activity, resulting in inhibition of DNA replication, and potentially leading to cell death and is indicated as a component of first-line therapy in combination with 5-fluorouracil and leucovorin for patients with metastatic or recurrent colorectal carcinoma (FDA.gov).|
|Leucovorin||Wellcovorin||Calcium folinate|Calcium citrovorum factor|folinic acid||Chemotherapy - Antimetabolite 11||Wellcovorin (leucovorin) is a metabolite of folate that enhances the efficacy of fluoruracil (PMID: 32490554).|
|Nivolumab||Opdivo||MDX-1106|BMS-936558||Immune Checkpoint Inhibitor 94 PD-L1/PD-1 antibody 65||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, small cell lung cancer, Hodgkin's lymphoma, head and neck squamous cell carcinoma, urothelial carcinoma, and esophageal squamous cell carcinoma, 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 non-small cell lung cancer without EGFR or ALK alterations, and in combination with Yervoy (ipilimumab) and platinum-based chemotherapy as first-line therapy in patients with metastatic or recurrent non-small cell lung cancer without EGFR or ALK alterations (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|
|NCT03785873||Phase Ib/II||Fluorouracil + Irinotecan + Leucovorin + Nivolumab||Phase Ib/II Trial of Nal-Irinotecan and Nivolumab as Second-Line Treatment in Patients With Advanced Biliary Tract Cancer||Recruiting|