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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 150 PD-L1/PD-1 antibody 136 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
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 anaplastic thyroid 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
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 | AUS 4
NCT03365791 Phase II Ieramilimab Spartalizumab PDR001 Plus LAG525 for Patients With Advanced Solid and Hematologic Malignancies Completed USA 0
NCT04058756 Phase I Spartalizumab Rollover Study for Continued Safety and Tolerability in Subjects Treated With Spartalizumab Alone or in Combination With Other Study Treatments Active, not recruiting USA | POL | NLD | ITA | HUN | FRA | ESP | DEU | CZE | CHE | CAN | BEL 5
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 | NLD | ITA | CHE | CAN 4
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 | NLD | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUT | AUS 1
NCT04802876 Phase II Tislelizumab Spartalizumab Efficacy of Tislelizumab and Spartalizumab Across Multiple Cancer-types in Patients With PD1-high mRNA Expressing Tumors (ACROPOLI) Active, not recruiting ESP 0
NCT02404441 Phase Ib/II Spartalizumab Phase I/II Study of PDR001 in Patients With Advanced Malignancies Completed USA | TUR | POL | NOR | NLD | LBN | ITA | HUN | FRA | ESP | DEU | CAN 2
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
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
NCT04894370 Phase II Cisplatin + Docetaxel + Fluorouracil + Spartalizumab Spartalizumab Combination of Spartalizumab, mDCF and Radiotherapy in Patients With Metastatic Squamous Cell Anal Carcinoma (SPARTANA) Recruiting FRA 0


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