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|Therapy Name||Cyclophosphamide + IRX-2 + Nivolumab|
|Drug Name||Trade Name||Synonyms||Drug Classes||Drug Description|
|Cyclophosphamide||Cytoxan||CPM||Chemotherapy - Alkylating 16||Cytoxan (cyclophosphamide) is an alkylating agent, which inhibits DNA replication (NCI Drug Dictionary). Cytoxan (cyclophosphamide) is FDA approved in multiple hematological malignancies, breast cancer, neuroblastoma, ovarian cancer, and retinoblastoma (NCI Drug Dictionary).|
|IRX-2||Citoplurikin||Citoplurikin (IRX-2) is an immunotherapeutic comprising a mixture of the cytokines IL-2, IL-1beta, IFN-gamma, TNF-alpha, IL-8, IL-6, and GM-CSF, which may increase anti-tumor immune response (PMID: 19180118, PMID: 23408925, PMID: 32738599, PMID: 31831558).|
|Nivolumab||Opdivo||MDX-1106|BMS-936558||Immune Checkpoint Inhibitor 135 PD-L1/PD-1 antibody 79||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, 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 non-small cell lung cancer without EGFR or ALK alterations, 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, 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|
|NCT03758781||Phase I||Cyclophosphamide + IRX-2 + Nivolumab||IRX-2 Regimen Combined With Nivolumab in Recurrent/Metastatic Solid Tumors||Active, not recruiting||USA||0|
|NCT03655002||Phase I||Cyclophosphamide + IRX-2 + Nivolumab||IRX-2, Cyclophosphamide, and Nivolumab in Treating Participants With Recurrent or Metastatic and Refractory Liver Cancer||Recruiting||USA||0|
|NCT03575234||Phase Ib/II||Cyclophosphamide + IRX-2 + Nivolumab||Nivolumab & IRX-2 With Surgery for Resectable Stage III-IVA Oral Cavity Cancer or HPV-Positive Oropharyngeal Cancer||Withdrawn||USA||0|