Therapy Detail

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Therapy Name Copanlisib + Nivolumab
Synonyms
Therapy Description

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Copanlisib Aliqopa BAY80-6946|BAY806946 PIK3CA inhibitor 24 PIK3CD inhibitor 27 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 149 PD-L1/PD-1 antibody 121 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
PTEN inact mut Advanced Solid Tumor predicted - sensitive Copanlisib + Nivolumab Phase II Actionable In a Phase II trial (BaCoN), treatment with the combination of Aliqopa (copanlisib) and Opdivo (nivolumab) was well tolerated in patients with advanced solid tumors harboring an inactivating mutation in PTEN, and resulted in a complete response/partial response (CR/PR) in 20% (3/15, 3 cPR) and a clinical benefit rate (CR or PR or stable disease > 4 months) of 33% (Ann Oncol 34 (2023): S487-S488; NCT04317105). detail...
PIK3CA act mut Advanced Solid Tumor predicted - sensitive Copanlisib + Nivolumab Phase II Actionable In a Phase II trial (BaCoN), treatment with the combination of Aliqopa (copanlisib) and Opdivo (nivolumab) was well tolerated in patients with advanced solid tumors harboring an activating mutation in PIK3CA, and resulted in a complete response/partial response (CR/PR) in 27% (4/15, 1 cPR, 3 uCR/PR) and a clinical benefit rate (CR or PR or stable disease > 4 months) of 40% (Ann Oncol 34 (2023): S487-S488; NCT04317105). detail...
PIK3CA mutant colorectal cancer predicted - sensitive Copanlisib + Nivolumab Phase Ib/II Actionable In a Phase I/II trial, treatment with the combination of Aliqopa (copanlisib) and Opdivo (nivolumab) was well tolerated and resulted in 3 partial responses in 22 patients with microsatellite stable colorectal cancer harboring PIK3CA mutations (Cancer Res (2024) 84 (7_Supplement): CT007; NCT03711058). detail...

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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 Completed USA | CAN 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 Active, not recruiting USA | CAN 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 Active, not 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
NCT03884998 Phase I Copanlisib + Nivolumab Copanlisib and Nivolumab in Treating Participants With Richter's Transformation or Transformed Indolent Non-Hodgkin's Lymphoma Active, not recruiting USA 0


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