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|Therapy Name||Copanlisib + Nivolumab|
|Drug Name||Trade Name||Synonyms||Drug Classes||Drug Description|
|Copanlisib||Aliqopa||BAY80-6946|BAY806946||PIK3CA inhibitor 16 PIK3CD inhibitor 25||Aliqopa (copanlisib) is a selective PIK3CA and PIK3CD inhibitor that prevents activation of Akt, resulting in inhibition of cell cycle progression and increased apoptosis (PMID: 24013662, PMID: 25528022). Aliqopa (copanlisib) is FDA approved for adult patients with follicular lymphoma (FDA.gov).|
|Nivolumab||Opdivo||MDX-1106|BMS-936558||Immune Checkpoint Inhibitor 135 PD-L1/PD-1 antibody 80||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, 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 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, 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|
|NCT03735628||Phase Ib/II||Copanlisib + Nivolumab||An Study to Evaluate the Safety and Efficacy of Copanlisib in Combination With Nivolumab in Patients With Advanced Solid Tumors||Active, not recruiting||USA | CAN||0|
|NCT03884998||Phase I||Copanlisib + Nivolumab||Copanlisib and Nivolumab in Treating Participants With Richter's Transformation or Transformed Indolent Non-Hodgkin's Lymphoma||Recruiting||USA||0|
|NCT04317105||Phase Ib/II||Copanlisib + Ipilimumab + Nivolumab Copanlisib + Nivolumab||Testing the Addition of an Anti-cancer Drug, Copanlisib, to the Usual Immunotherapy (Nivolumab With or Without Ipilimumab) in Patients With Advanced Solid Cancers That Have Changes in the Following Genes: PIK3CA and PTEN||Recruiting||USA||0|
|NCT03484819||Phase II||Copanlisib + Nivolumab||Copanlisib and Nivolumab in Treating Participants With Recurrent or Refractory Diffuse Large B-cell Lymphoma or Primary Mediastinal Large B-cell Lymphoma||Active, not recruiting||USA||0|
|NCT03502733||Phase I||Copanlisib + Nivolumab||Copanlisib and Nivolumab in Treating Patients With Metastatic Solid Tumors or Lymphoma||Active, not recruiting||USA||0|
|NCT03711058||Phase Ib/II||Copanlisib + Nivolumab||Study of PI3Kinase Inhibition (Copanlisib) and Anti-PD-1 Antibody Nivolumab in Relapsed/Refractory Solid Tumors With Expansions in Mismatch-repair Proficient (MSS) Colorectal Cancer||Recruiting||USA||0|