Therapy Detail
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| Therapy Name | Dostarlimab-gxly + Niraparib |
| Synonyms | |
| Therapy Description | |
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| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| Dostarlimab-gxly | Jemperli | TSR-042 | Immune Checkpoint Inhibitor 135 PD-L1/PD-1 antibody 79 | Jemperli (dostarlimab-gxly) 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: 34313545). Jemperli (dostarlimab-gxly) is FDA approved for use in patients with recurrent or advanced endometrial cancer or solid tumors harboring mismatch repair deficient (dMMR), as determined by an FDA-approved test, who have progressed on prior treatments (FDA.gov). |
| Niraparib | Zejula | MK4827 | PARP Inhibitor (Pan) 23 | 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). |
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| Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| NCT04940637 | Phase II | Dostarlimab-gxly + Niraparib | UNITO-001-A Phase II Study Niraparib Plus Dostarlimab in HRR/PDL1 Positive MPM/NSCLC (UNITO-001) | Recruiting | 1 | |
| NCT03307785 | Phase I | Carboplatin + Dostarlimab-gxly + Paclitaxel Dostarlimab-gxly + Niraparib | Study of Niraparib or Carboplatin-Paclitaxel in Combination With TSR-042 | Active, not recruiting | USA | 0 |
| NCT03651206 | Phase II | Paclitaxel + Pegylated liposomal-doxorubicin + Topotecan Doxorubicin + Gemcitabine + Paclitaxel Niraparib Dostarlimab-gxly + Niraparib | Recurrent Ovarian CarcinoSarcoma Anti-pd-1 Niraparib (ROCSAN) | Recruiting | 1 | |
| NCT04837209 | Phase II | Dostarlimab-gxly + Niraparib | Radiation, Immunotherapy and PARP Inhibitor in Triple Negative Breast Cancer (NADiR) | Recruiting | USA | 0 |
| NCT04673448 | Phase I | Dostarlimab-gxly + Niraparib | Niraparib and TSR-042 for the Treatment of BRCA-Mutated Unresectable or Metastatic Breast, Pancreas, Ovary, Fallopian Tube, or Primary Peritoneal Cancer | Recruiting | USA | 0 |
| NCT04701307 | Phase II | Dostarlimab-gxly + Niraparib | Niraparib and Dostarlimab for the Treatment of Small Cell Lung Cancer and Other High-Grade Neuroendocrine Carcinomas | Recruiting | USA | 0 |
| NCT03955471 | Phase II | Dostarlimab-gxly + 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) | Active, not recruiting | USA | 0 |
| NCT04068753 | Phase II | Dostarlimab-gxly + Niraparib | Niraparib in Combination With TSR-042 in Patients With Recurrent or Progressive Cervix Cancer (STAR) | Recruiting | USA | 0 |
| NCT04313504 | Phase II | Dostarlimab-gxly + Niraparib | Study Evaluating the Efficacy of Niraparib and Dostarlimab (TSR-042) in Recurrent/Metastatic HNSCC | Recruiting | USA | 0 |
| NCT03308942 | Phase II | Niraparib Niraparib + Pembrolizumab Dostarlimab-gxly + Niraparib | Effects of Single Agent Niraparib and Niraparib Plus Programmed Cell Death-1 (PD-1) Inhibitors in Non-Small Cell Lung Cancer Participants | Completed | USA | 0 |
| NCT04409002 | Phase II | Dostarlimab-gxly + Niraparib | Niraparib + Dostarlimab + RT in Pancreatic Cancer | Active, not recruiting | USA | 0 |
| NCT04544995 | Phase I | Dostarlimab-gxly + Niraparib | Dose Escalation and Cohort Expansion Study of Niraparib and Dostarlimab in Pediatric Participants With Solid Tumors | Recruiting | 2 | |
| NCT04493060 | Phase II | Dostarlimab-gxly + Niraparib | Niraparib and Dostarlimab for Treatment of Germline or Somatic BRCA1/2 and PALB2 Mutated Metastatic Pancreatic Cancer | Recruiting | USA | 0 |
| NCT04681469 | Phase II | Dostarlimab-gxly + Niraparib | Induction and Maintenance Treatment With PARP Inhibitor and Immunotherapy in HPV-negative HNSCC (PRIME) | Recruiting | 1 | |
| NCT04679064 | Phase III | Bevacizumab + Gemcitabine Dostarlimab-gxly + Niraparib Pegylated liposomal-doxorubicin Bevacizumab + Topotecan Paclitaxel Topotecan Bevacizumab + Paclitaxel Bevacizumab + Pegylated liposomal-doxorubicin Gemcitabine | Trial on NIraparib-TSR-042 (Dostarlimab) vs Physician's Choice CHEmotherapy in Recurrent, Ovarian, Fallopian Tube or Primary Peritoneal Cancer Patients Not Candidate for Platinum Retreatment (NItCHE-MITO33) | Recruiting | 1 | |
| NCT04584255 | Phase II | Dostarlimab-gxly + Niraparib Niraparib | Niraparib + TSR042 In BRCA Mutated Breast Cancer | Recruiting | USA | 0 |
| NCT03602859 | Phase III | Dostarlimab-gxly + 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 |
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