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    DRUG:

    Jemperli (dostarlimab-gxly)

    i
    Company:
    AnaptysBio, GSK
    Drug class:
    PD1 inhibitor
    Related drugs:
    Apply
    Evaluation of Programmed Death Ligand 1 (PDL1) Response to Treatment in Patient-derived Organoids and Immune-marker Positron Emission Tomography (PET) Scanning in Non-small Cell Lung Cancer (NSCLC) (NCT06405230)
    Phase 1/2
    GlaxoSmithKline
    Not yet recruiting
    Last update posted :
    02/17/2025
    Initiation :
    02/28/2025
    Primary completion :
    12/16/2027
    Completion :
    06/01/2028
    PD-L1
    |
    PD-L1 expression
    |
    Keytruda (pembrolizumab) • cisplatin • carboplatin • pemetrexed • Jemperli (dostarlimab-gxly)
    Phase II Trial of the PARP Inhibitor Niraparib and PD-1 Inhibitor Dostarlimab in Patients With Advanced Cancers With Active Progressing Brain Metastases (STARLET) (NCT05700721)
    Phase 2
    M.D. Anderson Cancer Center
    Recruiting
    Last update posted :
    02/17/2025
    Initiation :
    06/02/2023
    Primary completion :
    08/07/2025
    Completion :
    08/07/2027
    PD-L1 • HRD • CDK12 • CHEK2 • RAD51 • RAD51B • BRIP1 • RAD51C • RAD51D • CHEK1 • RAD54L • FANCL • RAD52
    |
    PD-L1 expression
    |
    Zejula (niraparib) • Jemperli (dostarlimab-gxly)
    A Three-arm Randomized Phase II Study of Dostarlimab Alone or with Bevacizumab Versus Nonplatinum Chemotherapy in Recurrent Gynecological Clear Cell Carcinoma: DOVE (APGOT-OV7/ ENGOT-ov80 Study) (NCT06023862)
    Phase 2
    Yonsei University
    Recruiting
    Last update posted :
    02/14/2025
    Initiation :
    01/22/2024
    Primary completion :
    08/31/2027
    Completion :
    12/31/2029
    MSI • PD-1 • WT1
    |
    Avastin (bevacizumab) • gemcitabine • paclitaxel • doxorubicin hydrochloride • Jemperli (dostarlimab-gxly) • pegylated liposomal doxorubicin
    Dose Escalation and Expansion Study of GSK3359609 in Participants With Selected Advanced Solid Tumors (INDUCE-1) (NCT02723955)
    Phase 1
    GlaxoSmithKline
    Completed
    Last update posted :
    12/27/2024
    Initiation :
    06/23/2016
    Primary completion :
    07/05/2023
    Completion :
    07/05/2023
    MSI • ICOS
    |
    MSI-H/dMMR
    |
    Keytruda (pembrolizumab) • cisplatin • carboplatin • gemcitabine • paclitaxel • docetaxel • 5-fluorouracil • pemetrexed • Jemperli (dostarlimab-gxly) • bintrafusp alfa (M7824) • cobolimab (TSR-022) • feladilimab (GSK3359609) • GSK3174998
    Endometrial Cancer Patientes MMR Deficient Comparing Chemotherapy vs Dostarlimab in First Line (DOMENICA) (NCT05201547)
    Phase 3
    ARCAGY/ GINECO GROUP
    Recruiting
    Last update posted :
    11/25/2024
    Initiation :
    04/15/2022
    Primary completion :
    04/01/2026
    Completion :
    10/01/2029
    MSI
    |
    MSI-H/dMMR
    |
    carboplatin • paclitaxel • Jemperli (dostarlimab-gxly)
    Radiation and TSR-042 (Dostarlimab) in People With Endometrial Cancer After They Receive Surgery (NCT04774419)
    Phase 2
    Memorial Sloan Kettering Cancer Center
    Recruiting
    Last update posted :
    11/11/2024
    Initiation :
    04/02/2021
    Primary completion :
    02/01/2026
    Completion :
    02/01/2026
    MSI • POLE • MLH1 • MSH6 • MSH2
    |
    MSI-H/dMMR • POLE mutation
    |
    Jemperli (dostarlimab-gxly)
    Niraparib and TSR-042 for the Treatment of BRCA-Mutated Unresectable or Metastatic Breast, Pancreas, Ovary, Fallopian Tube, or Primary Peritoneal Cancer (NCT04673448)
    Phase 1
    University of Washington
    Recruiting
    Last update posted :
    11/08/2024
    Initiation :
    10/18/2021
    Primary completion :
    12/31/2025
    Completion :
    03/30/2026
    HER-2 • PD-L1 • ER • PGR • BRCA1 • BRCA2 • BRCA
    |
    BRCA2 mutation • BRCA1 mutation
    |
    Zejula (niraparib) • Jemperli (dostarlimab-gxly)
    I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer (I-SPY 2) (NCT01042379)
    Phase 2
    QuantumLeap Healthcare Collaborative
    Recruiting
    Last update posted :
    10/22/2024
    Initiation :
    03/01/2010
    Primary completion :
    12/01/2030
    Completion :
    12/01/2031
    HER-2 • ER
    |
    ER positive • ER negative
    |
    Keytruda (pembrolizumab) • Herceptin (trastuzumab) • Lynparza (olaparib) • carboplatin • Imfinzi (durvalumab) • paclitaxel • Nerlynx (neratinib) • Perjeta (pertuzumab) • Kadcyla (ado-trastuzumab emtansine) • doxorubicin hydrochloride • Talzenna (talazoparib) • Verzenio (abemaciclib) • Zejula (niraparib) • cyclophosphamide • irinotecan • Jemperli (dostarlimab-gxly) • Tukysa (tucatinib) • letrozole • veliparib (ABT-888) • Libtayo (cemiplimab-rwlc) • MK-2206 • Datroway (datopotamab deruxtecan) • Ziihera (zanidatamab-hrii) • ganitumab (AMG 479) • amcenestrant (SAR439859) • anvatabart opadotin (JNJ-0683) • metformin • Jivadco (trastuzumab duocarmazine) • Turalio (pexidartinib) • ganetespib (ADX-1612) • vepdegestrant (ARV-471) • Cosela (trilaciclib) • Fablyn (lasofoxifene) • DAN-222 • fianlimab (REGN3767) • Oraxol (oral paclitaxel/encequidar) • ladiratuzumab vedotin (SGN-LIV1A) • nelitolimod (SD-101) • patritumab (U3-1287) • rilvegostomig (AZD2936) • trebananib (AMG 386) • Kevzara (sarilumab) • Voyager-V1
    Niraparib + Dostarlimab in BRCA Mutated Breast Cancer (TBCRC 056) (NCT04584255)
    Phase 2
    Dana-Farber Cancer Institute
    Recruiting
    Last update posted :
    09/19/2024
    Initiation :
    12/18/2020
    Primary completion :
    07/17/2025
    Completion :
    07/17/2029
    HER-2 • ER • PGR • BRCA1 • BRCA2 • BRCA
    |
    HER-2 amplification • HER-2 negative • PALB2 mutation • PGR positive
    |
    Zejula (niraparib) • Jemperli (dostarlimab-gxly)
    Safety and Efficacy of Targeting PP2A in Ovarian Clear Cell Carcinoma Using Dostarlimab and LB-100 (NCT06065462)
    Phase 1/2
    M.D. Anderson Cancer Center
    Recruiting
    Last update posted :
    08/28/2024
    Initiation :
    11/10/2023
    Primary completion :
    01/31/2026
    Completion :
    01/31/2026
    CD4
    |
    Jemperli (dostarlimab-gxly) • LB-100
    PREventing Second Cancers With DOSTARlimab (PREDOSTAR) (NCT05855811)
    Phase 2
    Centre Leon Berard
    Recruiting
    Last update posted :
    07/15/2024
    Initiation :
    07/26/2023
    Primary completion :
    07/26/2028
    Completion :
    03/26/2029
    TP53 • BRCA • IL2
    |
    TP53 mutation • BRCA mutation
    |
    Jemperli (dostarlimab-gxly)
    A Comparison of Platinum-based Therapy With TSR-042 and Niraparib Versus Standard of Care (SOC) Platinum-based Therapy as First-line Treatment of Stage III or IV Nonmucinous Epithelial Ovarian Cancer (ENGOT-0V44) (NCT03602859)
    Phase 3
    Tesaro, Inc.
    Active, not recruiting
    Last update posted :
    06/04/2024
    Initiation :
    10/11/2018
    Primary completion :
    10/25/2024
    Completion :
    06/22/2026
    PD-L1
    |
    PD-L1 expression
    |
    Avastin (bevacizumab) • carboplatin • paclitaxel • Zejula (niraparib) • Jemperli (dostarlimab-gxly)
    Study of Induction PD-1 Blockade in Subjects With Locally Advanced Mismatch Repair Deficient Solid Tumors (NCT04165772)
    Phase 2
    Memorial Sloan Kettering Cancer Center
    Recruiting
    Last update posted :
    04/23/2024
    Initiation :
    12/11/2019
    Primary completion :
    11/30/2026
    Completion :
    11/30/2026
    MSI
    |
    MSI-H/dMMR
    |
    5-fluorouracil • capecitabine • Jemperli (dostarlimab-gxly)
    Basket Trial Exploring the Efficacy and Safety of the Combination of Niraparib and Dostarlimab (NIRADO) (NCT04779151)
    Phase 2
    Gustave Roussy, Cancer Campus, Grand Paris
    Suspended
    Last update posted :
    03/26/2024
    Initiation :
    04/07/2021
    Primary completion :
    12/01/2024
    Completion :
    12/01/2027
    HER-2 • BRCA1 • BRCA2 • IDH1 • IDH2 • ARID1A • PBRM1 • CDK12 • CHEK2 • RAD51 • FANCA • BRIP1 • RAD51C • RAD51D • ARID2 • BARD1 • NBN • RAD54L • DRD
    |
    HER-2 positive • HER-2 amplification • DDR • PBRM1 mutation • CDK12 mutation • CHEK2 mutation • BRIP1 mutation • RAD51C mutation • FANCA mutation • RAD51D mutation • BARD1 mutation • NBN mutation • DRD
    |
    Zejula (niraparib) • Jemperli (dostarlimab-gxly)
    DOstarlimab in Patients With Recurrent or dMMR/MSI-H Endometrial Cancer (DORA) (NCT05728814)
    Phase N/A
    Grupo Español de Investigación en Cáncer de Ovario
    Recruiting
    Last update posted :
    02/23/2024
    Initiation :
    03/07/2023
    Primary completion :
    04/12/2024
    Completion :
    09/12/2024
    MSI
    |
    MSI-H/dMMR
    |
    Jemperli (dostarlimab-gxly)
    A Platform Study of Novel Immunotherapy Combinations in Participants With Previously Untreated, Advanced/Metastatic Non-Small-Cell Lung Cancer (NCT05565378)
    Phase 2
    GlaxoSmithKline
    Recruiting
    Last update posted :
    02/21/2024
    Initiation :
    10/14/2022
    Primary completion :
    01/17/2025
    Completion :
    01/14/2028
    PD-L1
    |
    PD-L1-H
    |
    Keytruda (pembrolizumab) • Jemperli (dostarlimab-gxly) • belrestotug (EOS-448) • nelistotug (GSK6097608)
    A Study of Dostarlimab in Untreated dMMR/MSI-H Locally Advanced Rectal Cancer (AZUR-1) (NCT05723562)
    Phase 2
    GlaxoSmithKline
    Recruiting
    Last update posted :
    02/20/2024
    Initiation :
    04/03/2023
    Primary completion :
    11/02/2026
    Completion :
    10/11/2029
    MSI
    |
    MSI-H/dMMR
    |
    Jemperli (dostarlimab-gxly)
    Study of Perioperative Dostarlimab in Participants With Untreated T4N0 or Stage III dMMR/MSI-H Resectable Colon Cancer (AZUR-2) (NCT05855200)
    Phase 3
    GlaxoSmithKline
    Recruiting
    Last update posted :
    02/20/2024
    Initiation :
    08/02/2023
    Primary completion :
    12/15/2028
    Completion :
    12/25/2030
    MSI
    |
    MSI-H/dMMR
    |
    5-fluorouracil • Jemperli (dostarlimab-gxly) • leucovorin calcium
    Efficacy Comparison of Dostarlimab Plus Chemotherapy Versus Pembrolizumab Plus Chemotherapy in Participants With Metastatic Non-squamous Non-small Cell Lung Cancer (NSCLC) (PERLA) (NCT04581824)
    Phase 2
    GlaxoSmithKline
    Active, not recruiting
    Last update posted :
    02/07/2024
    Initiation :
    11/19/2020
    Primary completion :
    08/04/2022
    Completion :
    10/20/2025
    EGFR • PD-L1 • BRAF • ALK • ROS1
    |
    BRAF V600E • BRAF V600 • ALK mutation
    |
    Keytruda (pembrolizumab) • cisplatin • carboplatin • Jemperli (dostarlimab-gxly)
    Watch-and-Wait Approach With Dostarlimab in Localized dMMR/MSI-H Gastric Cancer: GERCOR Phase II Study (DEWI) (NCT06059495)
    Phase 2
    GERCOR - Multidisciplinary Oncology Cooperative...
    Recruiting
    Last update posted :
    02/05/2024
    Initiation :
    12/18/2023
    Primary completion :
    09/01/2028
    Completion :
    09/01/2028
    MSI • MLH1 • MSH6 • MSH2
    |
    MSI-H/dMMR
    |
    Jemperli (dostarlimab-gxly)
    Study of Niraparib and TSR-042 in Recurrent Endometrial Cancer (NCT03016338)
    Phase 2
    University Health Network, Toronto
    Active, not recruiting
    Last update posted :
    01/30/2024
    Initiation :
    11/06/2017
    Primary completion :
    01/05/2021
    Completion :
    12/01/2025
    PTEN
    |
    Zejula (niraparib) • Jemperli (dostarlimab-gxly)
    Phase 2 Platform Study of Novel Immunotherapy Combinations as First-Line Treatment in Participants With PD-L1 Positive Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck (NCT06062420)
    Phase 2
    GlaxoSmithKline
    Recruiting
    Last update posted :
    01/22/2024
    Initiation :
    11/14/2023
    Primary completion :
    09/17/2025
    Completion :
    08/12/2027
    PD-L1
    |
    PD-L1 expression
    |
    Jemperli (dostarlimab-gxly) • nelistotug (GSK6097608)
    Niraparib and Dostarlimab for the Treatment of Germline or Somatic BRCA1/2 and PALB2 Mutated Metastatic Pancreatic Cancer (NCT04493060)
    Phase 2
    Mayo Clinic
    Active, not recruiting
    Last update posted :
    01/19/2024
    Initiation :
    12/28/2020
    Primary completion :
    12/07/2023
    Completion :
    09/01/2024
    PD-L1 • BRCA1 • BRCA2 • RAD51C • RAD51D • BARD1
    |
    PD-L1 expression • PD-1 expression
    |
    Zejula (niraparib) • Jemperli (dostarlimab-gxly)
    Niraparib and Dostarlimab in HRD Solid Tumors (DIDO) (NCT04983745)
    Phase 2
    West Cancer Center
    Recruiting
    Last update posted :
    12/21/2023
    Initiation :
    11/29/2021
    Primary completion :
    08/01/2024
    Completion :
    08/01/2025
    BRCA1 • BRCA2 • HRD • CDK12 • CHEK2 • RAD51B • BRIP1 • RAD51C • RAD51D • CHEK1 • BARD1 • RAD54L • FANCL • PPP2R2A • FANCI
    |
    BRCA1 mutation • HRD • ATM mutation • PALB2 mutation • CHEK2 mutation • BRIP1 mutation • HRD + BRCA1 mutation • RAD51C mutation • RAD51D mutation • RAD51B mutation • BARD1 mutation • RAD54L mutation • FANCI mutation • RAD51 mutation
    |
    Zejula (niraparib) • Jemperli (dostarlimab-gxly)
    Radiation, Immunotherapy and PARP Inhibitor in Triple Negative Breast Cancer (NADiR) (NCT04837209)
    Phase 2
    Massachusetts General Hospital
    Recruiting
    Last update posted :
    11/15/2023
    Initiation :
    07/21/2021
    Primary completion :
    04/01/2025
    Completion :
    12/01/2029
    HER-2 • PD-L1
    |
    HER-2 amplification • HER-2 negative • PD-L1 negative
    |
    Zejula (niraparib) • Jemperli (dostarlimab-gxly)
    Study of TSR-042, an Anti-programmed Cell Death-1 Receptor (PD-1) Monoclonal Antibody, in Participants With Advanced Solid Tumors (GARNET) (NCT02715284)
    Phase 1
    Tesaro, Inc.
    Recruiting
    Last update posted :
    08/22/2023
    Initiation :
    03/07/2016
    Primary completion :
    05/15/2026
    Completion :
    10/27/2027
    EGFR • ALK • MSI • MLH1 • MSH6 • MSH2
    |
    EGFR mutation • MSI-H/dMMR • ALK translocation • MSH6 expression
    |
    Jemperli (dostarlimab-gxly)
    Preliminary Assessment of Safety and Tolerability of Dostarlimab in Combination Antiretroviral Therapy (cART) Refractory HIV Associated Kaposi Sarcoma (STARKAP) (NCT05646082)
    Phase 1
    Imperial College London
    Recruiting
    Last update posted :
    08/10/2023
    Initiation :
    05/26/2023
    Primary completion :
    05/01/2024
    Completion :
    09/01/2025
    CD4
    |
    Jemperli (dostarlimab-gxly)
    Dose Escalation and Cohort Expansion Study of Niraparib and Dostarlimab in Pediatric Participants With Solid Tumors (SCOOP) (NCT04544995)
    Phase 1
    GlaxoSmithKline
    Suspended
    Last update posted :
    08/07/2023
    Initiation :
    10/06/2020
    Primary completion :
    09/28/2028
    Completion :
    04/12/2029
    TMB • BRCA1 • BRCA2 • BRCA
    |
    BRCA2 mutation • BRCA1 mutation • BRCA mutation
    |
    Zejula (niraparib) • Jemperli (dostarlimab-gxly)
    Platform Trial of Novel Regimens Versus Standard of Care (SoC) in Participants With Non-small Cell Lung Cancer (NSCLC) (NCT03739710)
    Phase 2
    GlaxoSmithKline
    Recruiting
    Last update posted :
    06/29/2023
    Initiation :
    01/24/2019
    Primary completion :
    07/08/2025
    Completion :
    07/08/2025
    BRAF
    |
    Yervoy (ipilimumab) • docetaxel • Zejula (niraparib) • Jemperli (dostarlimab-gxly) • cobolimab (TSR-022) • feladilimab (GSK3359609) • belrestotug (EOS-448) • nelistotug (GSK6097608)
    UNITO-001- Study in HRR/PDL1 Positive MPM/NSCLC (NCT04940637)
    Phase 2
    University of Turin, Italy
    Recruiting
    Last update posted :
    05/12/2023
    Initiation :
    12/23/2020
    Primary completion :
    06/30/2024
    Completion :
    06/30/2025
    EGFR • PD-L1 • ALK • ROS1 • HRD
    |
    PD-L1 expression • HRD • ALK rearrangement • ROS1 rearrangement
    |
    Zejula (niraparib) • Jemperli (dostarlimab-gxly)
    Mesothelioma Stratified Therapy (MiST) : A Multi-drug Phase II Trial in Malignant Mesothelioma (NCT03654833)
    Phase 2
    University of Leicester
    Active, not recruiting
    Last update posted :
    03/14/2023
    Initiation :
    01/28/2019
    Primary completion :
    10/31/2023
    Completion :
    10/31/2023
    PD-L1
    |
    Keytruda (pembrolizumab) • Avastin (bevacizumab) • Tecentriq (atezolizumab) • Verzenio (abemaciclib) • Zejula (niraparib) • Rubraca (rucaparib) • Jemperli (dostarlimab-gxly) • bemcentinib (BGB324)
    A Study to Evaluate the Efficacy and Safety of Novel Treatment Combinations in Participants With Ovarian Cancer (OPAL) (NCT03574779)
    Phase 1b/2
    Tesaro, Inc.
    Recruiting
    Last update posted :
    02/10/2023
    Initiation :
    11/15/2018
    Primary completion :
    08/06/2024
    Completion :
    03/31/2026
    BRCA1 • BRCA2 • BRCA
    |
    BRCA mutation
    |
    Avastin (bevacizumab) • carboplatin • paclitaxel • Zejula (niraparib) • Jemperli (dostarlimab-gxly)
    Study to Estimate Efficacy of Combining Dostarlimab and Niraparib in Relapsed EOC After Treatment With PARPi (NCT05126342)
    Phase 2
    AGO Research GmbH
    Not yet recruiting
    Last update posted :
    07/27/2022
    Initiation :
    07/01/2023
    Primary completion :
    11/01/2024
    Completion :
    11/01/2026
    MUC16
    |
    Zejula (niraparib) • Jemperli (dostarlimab-gxly)
    Maintenance Niraparib and Dostarlimab in Advanced Cholangiocarcinoma (NCT04895046)
    Phase 2
    Walid Shaib, MD
    Withdrawn
    Last update posted :
    06/29/2022
    Initiation :
    10/11/2021
    Primary completion :
    09/01/2022
    Completion :
    09/01/2023
    BRCA1 • BRCA2 • PTEN • ARID1A • BAP1 • CHEK2 • RAD51 • BRIP1 • CHEK1 • BARD1 • NBN • FANCM • EMSY • RPA1
    |
    HRD signature
    |
    Zejula (niraparib) • Jemperli (dostarlimab-gxly)
    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) (NCT04679064)
    Phase 3
    Fondazione Policlinico Universitario Agostino G...
    Recruiting
    Last update posted :
    08/27/2021
    Initiation :
    12/01/2020
    Primary completion :
    01/01/2025
    Completion :
    01/01/2025
    MUC16
    |
    Avastin (bevacizumab) • gemcitabine • paclitaxel • Zejula (niraparib) • Jemperli (dostarlimab-gxly) • pegylated liposomal doxorubicin • topotecan
    Trial Comparing Niraparib-bevacizumab-Dostarlimab and Niraparib-bevacizumab to Standard of Care in Recurrent Ovarian Cancer (ENGOT-OV42) (NCT03806049)
    Phase 3
    Nordic Society of Gynaecological Oncology - Cli...
    Withdrawn
    Last update posted :
    07/15/2021
    Initiation :
    12/01/2019
    Primary completion :
    12/01/2022
    Completion :
    12/01/2024
    PD-L1 • BRCA
    |
    PD-L1 expression • BRCA mutation
    |
    Avastin (bevacizumab) • carboplatin • paclitaxel • Zejula (niraparib) • Jemperli (dostarlimab-gxly)