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 141 PD-L1/PD-1 antibody 83 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) 25 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

Filtering

  • Case insensitive filtering will display rows where any text in any cell matches the filter term
  • Simple literal full or partial string matches
  • Separate multiple filter terms with a spaces, order doesn't matter (a b c and c b a are equivalent )
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  • Use quotes to match a longer phrase which contains spaces "mtor c1483f"

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
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) Recruiting 1
NCT04584255 Phase II Dostarlimab-gxly + Niraparib Niraparib Niraparib + TSR042 In BRCA Mutated Breast Cancer Recruiting USA 0
NCT04409002 Phase II Dostarlimab-gxly + Niraparib Niraparib + Dostarlimab + RT in Pancreatic Cancer Active, not 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
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
NCT04068753 Phase II Dostarlimab-gxly + Niraparib Niraparib in Combination With TSR-042 in Patients With Recurrent or Progressive Cervix Cancer (STAR) 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
NCT04544995 Phase I Dostarlimab-gxly + Niraparib Dose Escalation and Cohort Expansion Study of Niraparib and Dostarlimab in Pediatric Participants With Solid Tumors Recruiting FRA | ESP 1
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 | ITA | FRA | ESP | DEU | CAN | BEL 12
NCT04837209 Phase II Dostarlimab-gxly + Niraparib Radiation, Immunotherapy and PARP Inhibitor in Triple Negative Breast Cancer (NADiR) 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
NCT04681469 Phase II Dostarlimab-gxly + Niraparib Induction and Maintenance Treatment With PARP Inhibitor and Immunotherapy in HPV-negative HNSCC (PRIME) Recruiting ITA 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
NCT04940637 Phase II Dostarlimab-gxly + Niraparib UNITO-001-A Phase II Study in HRR/PDL1 Positive MPM/NSCLC Recruiting ITA 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 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 Recruiting USA 0
NCT04983745 Phase II Dostarlimab-gxly + Niraparib Niraparib and Dostarlimab in HRD Solid Tumors (DIDO) Not yet recruiting USA 0
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
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


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