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 147 PD-L1/PD-1 antibody 117 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 that is mismatch repair deficient (dMMR), as determined by an FDA-approved test, or microsatellite instability-high (MSI-H) (FDA.gov).
Niraparib Zejula MK4827 PARP Inhibitor (Pan) 30 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).

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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
NCT04409002 Phase II Dostarlimab-gxly + Niraparib Niraparib + Dostarlimab + RT in Pancreatic Cancer Completed USA 0
NCT05526989 Phase II Dostarlimab-gxly + Niraparib Study of the Combination Dostarlimab With Niraparib In Patients With Penile Carcinoma Recruiting USA 0
NCT06365970 Phase II Dostarlimab-gxly + Niraparib Niraparib and Dostarlimab for Patients With MMR-D/MSI-H Colorectal Cancers Not yet 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
NCT05870761 Phase II Dostarlimab-gxly + Niraparib Combination Niraparib and Dostarlimab Therapy for Recurrent or Persistent Uterine Serous Carcinoma 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 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
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
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
NCT04068753 Phase II Dostarlimab-gxly + Niraparib Niraparib in Combination With TSR-042 in Patients With Recurrent or Progressive Cervix Cancer (STAR) Recruiting USA 0
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
NCT04926324 Phase Ib/II Dostarlimab-gxly + Niraparib A Safety Study Adding Niraparib and Dostarlimab to Radiation Therapy for Rectal Cancers 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
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 | NLD | ITA | GBR | FRA | ESP | DEU | CAN | BEL 10
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
NCT04837209 Phase II Dostarlimab-gxly + Niraparib Radiation, Immunotherapy and PARP Inhibitor in Triple Negative Breast Cancer (NADiR) 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 Suspended GBR | FRA | ESP | DEU 2
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
NCT04983745 Phase II Dostarlimab-gxly + Niraparib Niraparib and Dostarlimab in HRD Solid Tumors (DIDO) Recruiting 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
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
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
NCT04681469 Phase II Dostarlimab-gxly + Niraparib Induction and Maintenance Treatment With PARP Inhibitor and Immunotherapy in HPV-negative HNSCC (PRIME) Recruiting ITA 0
NCT04584255 Phase II Dostarlimab-gxly + Niraparib Niraparib Niraparib + Dostarlimab In BRCA Mutated Breast Cancer Recruiting USA 0


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