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|Therapy Name||Nivolumab + Varlilumab|
|Drug Name||Trade Name||Synonyms||Drug Classes||Drug Description|
|Nivolumab||Opdivo||MDX-1106|BMS-936558||Immune Checkpoint Inhibitor 94 PD-L1/PD-1 antibody 63||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, and 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 (FDA.gov).|
|Varlilumab||anti-CD27 monoclonal antibody CDX-1127||Varlilumab is an activating monoclonal antibody that binds to CD27 and potentially increases antibody-dependent cellular cytotoxicity towards CD27 positive tumor cells (PMID: 22589397).|
|Molecular Profile||Indication/Tumor Type||Response Type||Therapy Name||Approval Status||Evidence Type||Efficacy Evidence||References|
|Unknown unknown||ovarian cancer||not applicable||Nivolumab + Varlilumab||Phase Ib/II||Actionable||In a Phase I/II trial, Varlilumab and Opdivo (nivolumab) combination treatment resulted in partial response in 10% (5/49) and stable disease in 39% (19/49) of ovarian cancer patients, with treatment-induced increase of PD-L1 expression and CD8+ T cells more common in patients with better responses (Journal of Clinical Oncology 36, no. 15_suppl (May 20 2018) 3001-3001; NCT02335918).||detail...|
|Unknown unknown||colorectal cancer||not applicable||Nivolumab + Varlilumab||Phase Ib/II||Actionable||In a Phase I/II trial, Varlilumab and Opdivo (nivolumab) combination treatment resulted in partial response in 5% (2/41) and stable disease in 17% (7/41) of colorectal cancer patients, with infrequent treatment-induced increase of PD-L1 expression and CD8+ T cells (Journal of Clinical Oncology 36, no. 15_suppl (May 20 2018) 3001-3001; NCT02335918).||detail...|
|Clinical Trial||Phase||Therapies||Title||Recruitment Status|
|NCT02413827||Phase Ib/II||Nivolumab + Varlilumab Rasdegafusp alfa Poly ICLC||A Study of Varlilumab (Anti-CD27) and Ipilimumab and CDX-1401 in Patients With Unresectable Stage III or IV Melanoma||Terminated|
|NCT02335918||Phase Ib/II||Nivolumab + Varlilumab||A Dose Escalation and Cohort Expansion Study of Anti-CD27 (Varlilumab) and Anti-PD-1 (Nivolumab) in Advanced Refractory Solid Tumors||Completed|
|NCT03038672||Phase II||Nivolumab + Varlilumab Nivolumab||Nivolumab With or Without Varlilumab in Treating Patients With Relapsed or Refractory Aggressive B-cell Lymphomas||Recruiting|