Therapy Detail
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| Therapy Name | Ibrutinib + Nivolumab |
| Synonyms | |
| Therapy Description | |
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| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| Ibrutinib | Imbruvica | PCI-32765 | BTK inhibitor 35 EGFR Inhibitor (Pan) 59 HER2 Inhibitor 40 | 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|ABP 206|ABP-206 | Immune Checkpoint Inhibitor 146 PD-L1/PD-1 antibody 109 | 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). |
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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 |
|---|---|---|---|---|---|---|
| NCT02940301 | Phase II | Ibrutinib + Nivolumab | Ibrutinib and Nivolumab in Treating Patients With Relapsed or Refractory Classical Hodgkin Lymphoma | 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) | Completed | USA | 0 |
| NCT02899078 | Phase Ib/II | Ibrutinib + Nivolumab | Ibrutinib and Nivolumab in Treating Patients With Previously-Treated Metastatic Kidney Cancer | Completed | USA | 0 |
| NCT03770416 | Phase II | Ibrutinib + Nivolumab | Nivolumab and Ibrutinib in Treating Patients With Relapsed or Refractory Central Nervous System Lymphoma | Active, not recruiting | USA | 0 |
| NCT03525925 | Phase I | Ibrutinib + Nivolumab | Ibrutinib and Nivolumab in Treating Participants With Metastatic Solid Tumors | Unknown status | USA | 0 |
| NCT03646461 | Phase II | Ibrutinib + Nivolumab Cetuximab + Ibrutinib | Trial of Ibrutinib Combined With Nivolumab or Cetuximab to Treat Recurrent/Metastatic HNSCC | 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 | |
| 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 | Completed | USA | ESP | AUS | 3 |
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