Therapy Detail

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Therapy Name Azacitidine + Nivolumab
Synonyms
Therapy Description

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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 147 PD-L1/PD-1 antibody 117 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).

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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
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
NCT03628209 Phase Ib/II Azacitidine + Nivolumab Nivolumab or Nivolumab and Azacitidine in Patients With Recurrent, Resectable Osteosarcoma Active, not recruiting USA 0
NCT05317000 Phase I Azacitidine Azacitidine + Nivolumab Nivolumab 5-Azacytidine and/or Nivolumab in Resectable HPV-Associated HNSCC Recruiting USA 0
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
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


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