Therapy Detail

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Therapy Name Spartalizumab
Synonyms
Therapy Description

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).

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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).

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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

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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


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