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|Therapy Name||Ibrutinib + Nivolumab|
|Drug Name||Trade Name||Synonyms||Drug Classes||Drug Description|
|Ibrutinib||Imbruvica||PCI-32765||BTK inhibitor 25 EGFR Inhibitor (Pan) 46 HER2 Inhibitor 26||Imbruvica (ibrutinib) is a selective, irreversible inhibitor of Bruton's tyrosine kinase (BTK), which promotes apoptosis and inhibits B-cell mediated signaling pathways, and has additional activity against ERBB2 (HER2) and EGFR (PMID: 20615965, PMID: 21422473, PMID: 27678331). Imbruvica (Ibrutinib) is FDA approved for use in patients with mantle cell lymphoma, CLL/SLL and CLL/SLL with del 17p, Waldenstroem’s macroglobulinemia, marginal zone lymphoma, and in combination with Rituxan (rituximab) for untreated CLL/SLL (FDA.gov).|
|Nivolumab||Opdivo||MDX-1106|BMS-936558||Immune Checkpoint Inhibitor 98 PD-L1/PD-1 antibody 67||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, 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, and in combination with Cabometyx (cabozantinib) in patients with advanced renal cell carcinoma (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|
|NCT02899078||Phase Ib/II||Ibrutinib + Nivolumab||Ibrutinib and Nivolumab in Treating Patients With Previously-Treated Metastatic Kidney Cancer||Active, not recruiting||USA||0|
|NCT02420912||Phase II||Ibrutinib + Nivolumab||Nivolumab With Ibrutinib for Relapsed, Refractory or High-Risk Untreated Patients With Chronic Lymphocytic Leukemia (CLL)||Active, not recruiting||USA||0|
|NCT02940301||Phase II||Ibrutinib + Nivolumab||Ibrutinib and Nivolumab in Treating Patients With Relapsed or Refractory Classical Hodgkin Lymphoma||Active, not recruiting||USA||0|
|NCT02950038||Phase II||Ibrutinib + Nivolumab||Study of Ibrutinib Followed by Ibrutinib in Combination With Nivolumab in Non-Small Cell Lung Cancer (NSCLC)||Withdrawn||0|
|NCT03770416||Phase II||Ibrutinib + Nivolumab||Nivolumab and Ibrutinib in Treating Patients With Relapsed or Refractory Central Nervous System Lymphoma||Recruiting||USA||0|
|NCT03646461||Phase II||Ibrutinib + Nivolumab Cetuximab + Ibrutinib||Trial of Ibrutinib Combined With Nivolumab or Cetuximab to Treat Recurrent/Metastatic HNSCC||Recruiting||USA||0|
|NCT03525925||Phase I||Ibrutinib + Nivolumab||Ibrutinib and Nivolumab in Treating Participants With Metastatic Solid Tumors||Active, not recruiting||USA||0|
|NCT02329847||Phase Ib/II||Ibrutinib + Nivolumab||Pharmacokinetic and Pharmacodynamic Study to Evaluate Safety and Efficacy of the Combination of Ibrutinib With Nivolumab in Participants With Hematologic Malignancies||Active, not recruiting||USA||5|