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 (PMID: 32364844, PMID: 32179633).

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Spartalizumab PDR001|PDR-001 Immune Checkpoint Inhibitor 151 PD-L1/PD-1 antibody 98 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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  • Use quotes to match a longer phrase which contains spaces "mtor c1483f"

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
CD274 positive anal canal cancer predicted - sensitive Spartalizumab Case Reports/Case Series Actionable In a Phase I trial, Spartalizumab (PDR001) treatment in a patient with CD274 (PD-L1)-positive anal cancer resulted in a partial response lasting 1.8 months, with a combined 31% reduction of target lesion size (PMID: 32179633; NCT02404441). 32179633
CD274 positive thyroid gland anaplastic carcinoma predicted - sensitive Spartalizumab Phase II Actionable In a Phase II trial, Spartalizumab (PDR001) was tolerated in patients with anaplastic thyroid carcinoma, and resulted in an overall response rate (ORR) of 19% (8/42, 3 complete responses, 5 partial responses), median progression-free survival of 1.7 mo, and median overall survival of 5.9 mo; ORR was higher in patients with tumor PD-L1 >=1% compared to PD-L1<1% (29%, 8/28 vs 0%, 0/12, p=0.079), and highest ORR (35%) was observed in patients with PD-L1 >= 50% (PMID: 32364844; NCT02404441). 32364844

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
NCT03365791 Phase II Ieramilimab Spartalizumab PDR001 Plus LAG525 for Patients With Advanced Solid and Hematologic Malignancies Completed USA 0
NCT02795429 Phase Ib/II Spartalizumab Capmatinib + Spartalizumab Phase Ib/II Study of INC280 + PDR001 or PDR001 Single Agent in Advanced HCC Completed ITA | FRA | DEU | CAN 4
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 | ITA | FRA | ESP | DEU | CAN | BEL 10
NCT02404441 Phase Ib/II Spartalizumab Phase I/II Study of PDR001 in Patients With Advanced Malignancies Completed USA | ITA | FRA | ESP | DEU | CAN 8
NCT02608268 Phase Ib/II Spartalizumab Sabatolimab Safety and Efficacy of MBG453 as Single Agent and in Combination With PDR001 in Patients With Advanced Malignancies Terminated USA | ITA | CAN 6
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 | ITA | FRA | ESP | DEU | CAN | BEL | AUT 4
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 | ITA | ESP | DEU 0
NCT04802876 Phase II Spartalizumab Efficacy of Spartalizumab Across Multiple Cancer-types in Patients With PD1-high mRNA Expressing Tumors (ACROPOLI) Active, not recruiting ESP 0
NCT02605967 Phase II Spartalizumab Safety and Efficacy Study of PDR001 in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma Completed USA | FRA 5
NCT02460224 Phase Ib/II Ieramilimab Spartalizumab Safety and Efficay of LAG525 Single Agent and in Combination With PDR001 in Patients With Advanced Malignancies Completed USA | ITA | FRA | ESP | DEU | CAN | BEL 5


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