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Spartalizumab (PDR001) is a monoclonal antibody that targets PD-1 (PDCD1) and inhibits binding of the PD-L1 (CD274) ligand, potentially resulting in enhanced anti-tumor immune response (NCI Drug Dictionary).
|Drug Name||Trade Name||Synonyms||Drug Classes||Drug Description|
|Spartalizumab||PDR001|PDR-001||Immune Checkpoint Inhibitor 98 PD-L1/PD-1 antibody 68||Spartalizumab (PDR001) is a monoclonal antibody that targets PD-1 (PDCD1) and inhibits binding of the PD-L1 (CD274) ligand, potentially resulting in enhanced anti-tumor immune response (PMID: 32364844, PMID: 32179633).|
|Molecular Profile||Indication/Tumor Type||Response Type||Therapy Name||Approval Status||Evidence Type||Efficacy Evidence||References|
|Unknown unknown||pulmonary neuroendocrine tumor||not applicable||Spartalizumab||Case Reports/Case Series||Actionable||In a Phase I trial, Spartalizumab (PDR001) treatment in a patient with an atypical carcinoid lung tumor with initial CD8-positive lymphocyte tumor infiltration of 5.6% resulted in a partial response lasting 8.5 months, with an increase in CD8-positive lymphocyte infiltration to 37.6% after two weeks and subsequent reduction of target lesion size (PMID: 32179633; NCT02404441).||32179633|
|Unknown unknown||thyroid gland anaplastic carcinoma||not applicable||Spartalizumab||Phase II||Actionable||In a Phase II trial, Spartalizumab (PDR001) demonstrated tolerability in patients with anaplastic thyroid carcinoma, and resulted in an overall response rate of 19% (8/42), including three complete responses and five partial responses, median progression-free survival of 1.7 months, and median overall survival of 5.9 months (PMID: 32364844; NCT02404441).||32364844|
|Unknown unknown||Advanced Solid Tumor||not applicable||Spartalizumab||Phase I||Actionable||In a Phase I trial, Spartalizumab (PDR001) treatment in advanced solid tumor patients demonstrated tolerability and an overall response rate of 3.4% (2/58), with one atypical carcinoid lung tumor patient and one anal cancer patient achieving partial responses, and an additional 41.4% (24/58) of patients demonstrating stable disease (PMID: 32179633; NCT02404441).||32179633|
|Clinical Trial||Phase||Therapies||Title||Recruitment Status||Covered Countries||Other Countries|
|NCT04058756||Phase I||Spartalizumab||Rollover Study for Continued Safety and Tolerability in Subjects Treated With Spartalizumab Alone or in Combination With Other Study Treatments||Recruiting||USA | CAN||13|
|NCT02404441||Phase Ib/II||Spartalizumab||Phase I/II Study of PDR001 in Patients With Advanced Malignancies||Completed||USA | CAN||12|
|NCT02955069||Phase II||Spartalizumab||Study of Efficacy and Safety of PDR001 in Patients With Advanced or Metastatic Non-functional Neuroendocrine Tumors of Pancreatic, Gastrointestinal (GI), or Thoracic Origin||Completed||USA | CAN||11|
|NCT02608268||Phase Ib/II||Spartalizumab Sabatolimab||Safety and Efficacy of MBG453 as Single Agent and in Combination With PDR001 in Patients With Advanced Malignancies||Active, not recruiting||USA | CAN||7|
|NCT03111992||Phase I||LCL161 + Spartalizumab CJM112 + Spartalizumab Spartalizumab||Study of Single Agent CJM112, and PDR001 in Combination With LCL161 or CJM112 in Patients With Multiple Myeloma||Completed||USA||3|
|NCT02795429||Phase Ib/II||Spartalizumab Capmatinib + Spartalizumab||Phase Ib/II Study of INC280 + PDR001 or PDR001 Single Agent in Advanced HCC||Active, not recruiting||CAN||7|
|NCT02460224||Phase Ib/II||LAG525 Spartalizumab||Safety and Efficay of LAG525 Single Agent and in Combination With PDR001 in Patients With Advanced Malignancies||Completed||USA | CAN||10|
|NCT02605967||Phase II||Spartalizumab||Safety and Efficacy Study of PDR001 in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma||Active, not recruiting||USA||6|
|NCT03365791||Phase II||LAG525 Spartalizumab||PDR001 Plus LAG525 for Patients With Advanced Solid and Hematologic Malignancies||Completed||USA||0|