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|Therapy Name||Dostarlimab + Niraparib|
|Drug Name||Trade Name||Synonyms||Drug Classes||Drug Description|
|Dostarlimab||TSR-042||Immune Checkpoint Inhibitor 98 PD-L1/PD-1 antibody 67||Dostarlimab (TSR-042) 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 (Eur J Cancer 2016 Dec; 69 (Suppl 1):S102, Abstract # 310, PMID: 31847708, PMID: 32213091).|
|Niraparib||Zejula||MK4827||PARP Inhibitor (Pan) 22||Zejula (niraparib) binds and inhibits PARP, which may result in accumulation of DNA damage and apoptosis of tumor cells (PMID: 23810788). Zejula (niraparib) is FDA-approved as maintenance therapy in patients with recurrent or newly-diagnosed epithelial ovarian, fallopian tube, or primary peritoneal cancer in complete or partial response to platinum-based chemotherapy, and in ovarian, fallopian tube, or primary peritoneal cancer that received 3 or more chemotherapies and is homologous recombination deficient as indicated by either a deleterious or suspected deleterious BRCA mutation, or genomic instability and progressed 6 months or more after response to last platinum-based chemotherapy (FDA.gov).|
|Molecular Profile||Indication/Tumor Type||Response Type||Therapy Name||Approval Status||Evidence Type||Efficacy Evidence||References|
|Clinical Trial||Phase||Therapies||Title||Recruitment Status||Covered Countries||Other Countries|
|NCT03602859||Phase III||Dostarlimab + Niraparib Niraparib||A Phase 3 Comparison of Platinum-Based Therapy With TSR-042 and Niraparib Versus Standard of Care Platinum-Based Therapy as First-Line Treatment of Stage III or IV Nonmucinous Epithelial Ovarian Cancer (FIRST)||Active, not recruiting||USA | CAN||17|
|NCT04409002||Phase II||Dostarlimab + Niraparib||Niraparib + Dostarlimab + RT in Pancreatic Cancer||Recruiting||USA||0|
|NCT03307785||Phase I||Carboplatin + Dostarlimab + Paclitaxel Dostarlimab + Niraparib||Study of Niraparib or Carboplatin-Paclitaxel in Combination With TSR-042||Active, not recruiting||USA||0|
|NCT04313504||Phase II||Dostarlimab + Niraparib||Study Evaluating the Efficacy of Niraparib and Dostarlimab (TSR-042) in Recurrent/Metastatic HNSCC||Recruiting||USA||0|
|NCT04068753||Phase II||Dostarlimab + Niraparib||Niraparib in Combination With TSR-042 in Patients With Recurrent or Progressive Cervix Cancer (STAR)||Recruiting||USA||0|
|NCT04673448||Phase I||Dostarlimab + Niraparib||Niraparib and TSR-042 for the Treatment of BRCA-Mutated Unresectable or Metastatic Breast, Pancreas, Ovary, Fallopian Tube, or Primary Peritoneal Cancer||Not yet recruiting||USA||0|
|NCT04701307||Phase II||Dostarlimab + Niraparib||Niraparib and Dostarlimab for the Treatment of Small Cell Lung Cancer and Other High-Grade Neuroendocrine Carcinomas||Recruiting||USA||0|
|NCT03308942||Phase II||Niraparib Niraparib + Pembrolizumab Dostarlimab + Niraparib||Effects of Single Agent Niraparib and Niraparib Plus Programmed Cell Death-1 (PD-1) Inhibitors in Non-Small Cell Lung Cancer Participants||Active, not recruiting||USA||0|
|NCT03955471||Phase II||Dostarlimab + Niraparib||Study to Evaluate the Efficacy and Safety of the Combination of Niraparib and Dostarlimab (TSR-042) in Participants With Platinum Resistant Ovarian Cancer (MOONSTONE)||Suspended||USA||0|
|NCT04493060||Phase II||Dostarlimab + Niraparib||Niraparib and Dostarlimab for Treatment of Germline or Somatic BRCA1/2 and PALB2 Mutated Metastatic Pancreatic Cancer||Recruiting||USA||0|
|NCT04584255||Phase II||Dostarlimab + Niraparib Niraparib||Niraparib + TSR042 In BRCA Mutated Breast Cancer||Recruiting||USA||0|