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|Therapy Name||Azacitidine + Nivolumab|
|Drug Name||Trade Name||Synonyms||Drug Classes||Drug Description|
|Azacitidine||Vidaza||azacytidine|CC-486|5-azacytidine|5-AC|U-18496|Onureg||DNMT inhibitor (Pan) 5||Vidaza (azacitidine) is a cytidine analog that incorporates into DNA and RNA and binds to DNA methyltransferases (DNMTs), resulting in DNMT degradation and decreased DNA methylation, and leading to increased tumor cell death (PMID: 28159832, PMID: 28067760). Vidaza (azacitidine) is FDA-approved for use in patients with some subtypes of myelodysplastic syndrome and Onureg (azacitidine) is FDA approved for use in continued treatment of acute myeloid leukemia(FDA.gov).|
|Nivolumab||Opdivo||MDX-1106|BMS-936558||Immune Checkpoint Inhibitor 146 PD-L1/PD-1 antibody 112||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|
|NCT02397720||Phase II||Azacitidine + Nivolumab||A Study of Nivolumab (BMS-936558) in Combination With 5-azacytidine (Vidaza) for the Treatment of Patients With Refractory/ Relapsed Acute Myeloid Leukemia||Completed||USA||0|
|NCT05317000||Phase I||Azacitidine Azacitidine + Nivolumab Nivolumab||5-Azacytidine and/or Nivolumab in Resectable HPV-Associated HNSCC||Recruiting||USA||0|
|NCT03092674||Phase II||Cytarabine + Decitabine Azacitidine + Midostaurin Decitabine Azacitidine + Nivolumab Azacitidine||Azacitidine With or Without Nivolumab or Midostaurin, or Decitabine and Cytarabine Alone in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome||Active, not recruiting||USA||0|
|NCT05162976||Phase I||Azacitidine + Nivolumab||CC-486 and Nivolumab for the Treatment of Hodgkin Lymphoma Refractory to PD-1 Therapy or Relapsed||Recruiting||USA||0|
|NCT03628209||Phase Ib/II||Azacitidine + Nivolumab||Nivolumab or Nivolumab and Azacitidine in Patients With Recurrent, Resectable Osteosarcoma||Recruiting||USA||0|
|NCT04128020||Phase I||Azacitidine + Nivolumab Nivolumab||Azacitidine Plus Nivolumab Following Reduced-intensity Allogeneic PBSC Transplantation for Patients With AML and High-risk Myelodysplasia||Withdrawn||0|