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Therapy Name | Dostarlimab-gxly + Niraparib |
Synonyms | |
Therapy Description | |
Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
---|---|---|---|---|
Dostarlimab-gxly | Jemperli | TSR-042 | Immune Checkpoint Inhibitor 149 PD-L1/PD-1 antibody 122 | 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, and in combination with Paraplatin (carboplatin) and Taxol (paclitaxel), followed by Jemperli (dostarlimab-gxly) monotherapy, in patients with primary advanced or recurrent endometrial cancer (FDA.gov). |
Niraparib | Zejula | MK4827 | PARP Inhibitor (Pan) 31 | Zejula (niraparib) binds to and inhibits PARP, which may result in the accumulation of DNA damage and apoptosis of tumor cells (PMID: 23810788). Zejula (niraparib) is FDA-approved for use as maintenance therapy in patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer in complete or partial response to first-line platinum-based chemotherapy, and as maintenance therapy in patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer harboring deleterious or suspected deleterious germline BRCA mutations and in complete or partial response to platinum-based chemotherapy (FDA.gov). |
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 |
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NCT04313504 | Phase II | Dostarlimab-gxly + Niraparib | Study Evaluating the Efficacy of Niraparib and Dostarlimab (TSR-042) in Recurrent/Metastatic HNSCC | Active, not recruiting | USA | 0 |
NCT04779151 | Phase II | Dostarlimab-gxly + Niraparib | Basket Trial Exploring the Efficacy and Safety of the Combination of Niraparib and Dostarlimab (NIRADO) | Suspended | FRA | 0 |
NCT04701307 | Phase II | Dostarlimab-gxly + Niraparib | Niraparib and Dostarlimab for the Treatment of Small Cell Lung Cancer and Other High-Grade Neuroendocrine Carcinomas | Active, not recruiting | USA | 0 |
NCT04681469 | Phase II | Dostarlimab-gxly + Niraparib | Induction and Maintenance Treatment With PARP Inhibitor and Immunotherapy in HPV-negative HNSCC (PRIME) | Recruiting | ITA | 0 |
NCT05784012 | Phase Ib/II | Dostarlimab-gxly + Niraparib Cisplatin + Dostarlimab-gxly + Niraparib | Two-cohort Study of Niraparib and Dostarlimab Plus (Chemo)RadIotherapy in Locally-Advanced Head and Neck Squamous Cell Carcinoma (RADIAN) | Recruiting | ESP | 0 |
NCT04584255 | Phase II | Dostarlimab-gxly + Niraparib Niraparib | Niraparib + Dostarlimab In BRCA Mutated Breast Cancer | Recruiting | USA | 0 |
NCT05526989 | Phase II | Dostarlimab-gxly + Niraparib | Study of the Combination Dostarlimab With Niraparib In Patients With Penile Carcinoma | Recruiting | USA | 0 |
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 | ITA | 0 |
NCT04926324 | Phase Ib/II | Dostarlimab-gxly + Niraparib | A Safety Study Adding Niraparib and Dostarlimab to Radiation Therapy for Rectal Cancers | Suspended | 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 |
NCT05870761 | Phase II | Dostarlimab-gxly + Niraparib | Combination Niraparib and Dostarlimab Therapy for Recurrent or Persistent Uterine Serous Carcinoma | 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) | Terminated | USA | 0 |
NCT04409002 | Phase II | Dostarlimab-gxly + Niraparib | Niraparib + Dostarlimab + RT in Pancreatic Cancer | Completed | USA | 0 |
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) | Active, not recruiting | FRA | 0 |
NCT06365970 | Phase II | Dostarlimab-gxly + Niraparib | Niraparib and Dostarlimab for Patients With MMR-D/MSI-H Colorectal Cancers | Not yet 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 | HUN | GBR | FRA | ESP | DEU | CZE | 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 |
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 |
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 | ROU | POL | NOR | NLD | ITA | ISR | GRC | GBR | FRA | FIN | ESP | DNK | DEU | CZE | CAN | BEL | 2 |
NCT05700721 | Phase II | Dostarlimab-gxly + Niraparib | Phase II Trial of the PARP Inhibitor Niraparib and PD-1 Inhibitor Dostarlimab in Patients With Advanced Cancers With Active Progressing Brain Metastases (STARLET) | Recruiting | USA | 0 |
NCT04940637 | Phase II | Dostarlimab-gxly + Niraparib | UNITO-001- Study in HRR/PDL1 Positive MPM/NSCLC (UNITO-001) | Recruiting | ITA | 0 |
NCT04493060 | Phase II | Dostarlimab-gxly + Niraparib | Niraparib and Dostarlimab for the Treatment of Germline or Somatic BRCA1/2 and PALB2 Mutated Metastatic Pancreatic Cancer | Active, not recruiting | USA | 0 |
NCT04837209 | Phase II | Dostarlimab-gxly + Niraparib | Radiation, Immunotherapy and PARP Inhibitor in Triple Negative Breast Cancer (NADiR) | Recruiting | USA | 0 |
NCT04983745 | Phase II | Dostarlimab-gxly + Niraparib | Niraparib and Dostarlimab in HRD Solid Tumors (DIDO) | Recruiting | USA | 0 |
NCT03654833 | Phase II | Bemcentinib + Pembrolizumab Rucaparib Abemaciclib Atezolizumab + Bevacizumab Dostarlimab-gxly + Niraparib | Mesothelioma Stratified Therapy (MiST) : A Multi-drug Phase II Trial in Malignant Mesothelioma (MiST) | Active, not recruiting | GBR | 0 |