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Clinical trials for Dostarlimab

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
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    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44339   clinical trials with a EudraCT protocol, of which   7369   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
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    20 result(s) found for: Dostarlimab. Displaying page 1 of 1.
    EudraCT Number: 2020-003433-37 Sponsor Protocol Number: 213410 Start Date*: 2021-03-10
    Sponsor Name:GlaxoSmithKline Research & Development Limited
    Full Title: A RANDOMIZED, OPEN-LABEL PHASE 2/3 STUDY COMPARING COBOLIMAB + DOSTARLIMAB + DOCETAXEL TO DOSTARLIMAB + DOCETAXEL TO DOCETAXEL ALONE IN PARTICIPANTS WITH ADVANCED NON-SMALL CELL LUNG CANCER WHO HAV...
    Medical condition: Nonsmall Cell Lung Cancer (NSCLC)
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10061873 Non-small cell lung cancer PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Trial now transitioned) FR (Trial now transitioned) IT (Trial now transitioned) PL (Trial now transitioned) SE (Trial now transitioned) NL (Trial now transitioned) RO (Trial now transitioned) GR (Trial now transitioned) BE (Trial now transitioned) FI (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2019-001576-11 Sponsor Protocol Number: 4010-03-001 Start Date*: 2019-09-10
    Sponsor Name:TESARO, Inc.
    Full Title: A Phase 3, Randomized, Double-blind, Multicenter Study of Dostarlimab (TSR-042) plus Carboplatin-paclitaxel versus Placebo Plus Carboplatin-paclitaxel in Patients with Recurrent or Primary Advanced...
    Medical condition: Recurrent or primary advanced (Stage III or IV) endometrial cancer
    Disease: Version SOC Term Classification Code Term Level
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10014740 Endometrial cancer stage III PT
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10014741 Endometrial cancer stage IV PT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: HU (Trial now transitioned) DK (Trial now transitioned) NO (Trial now transitioned) PL (Trial now transitioned) FI (Trial now transitioned) DE (Trial now transitioned) BE (Trial now transitioned) NL (Trial now transitioned) GB (GB - no longer in EU/EEA) GR (Trial now transitioned) IT (Trial now transitioned) ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2023-000183-65 Sponsor Protocol Number: TTCC-2022-01-RADIAN Start Date*: 2023-08-23
    Sponsor Name:Grupo Español de Tratamiento de Tumores de Cabeza y Cuello (TTCC)
    Full Title: Phase Ib/II non-randomized non-comparative two-cohort study of Niraparib and Dostarlimab plus (Chemo)RadIotherapy in Locally-Advanced head and Neck squamous cell carcinoma (RADIAN)
    Medical condition: Locally-Advanced head and Neck squamous cell carcinoma
    Disease: Version SOC Term Classification Code Term Level
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10060121 Squamous cell carcinoma of head and neck PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2020-002359-39 Sponsor Protocol Number: 213406 Start Date*: 2020-09-18
    Sponsor Name:GlaxoSmithKline Research & Development Limited
    Full Title: A PHASE 1, MULTICENTRE, OPEN-LABEL, DOSE-ESCALATION AND COHORT EXPANSION STUDY OF NIRAPARIB AND DOSTARLIMAB IN PAEDIATRIC PATIENTS WITH RECURRENT OR REFRACTORY SOLID TUMOURS
    Medical condition: Recurrent or refractory solid tumour
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004864 10065147 Malignant solid tumor LLT
    21.1 100000004864 10065252 Solid tumor LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: ES (Ongoing) GB (GB - no longer in EU/EEA) FR (Trial now transitioned) DE (Trial now transitioned) HU (Trial now transitioned) CZ (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2021-005115-32 Sponsor Protocol Number: 213824 Start Date*: 2022-09-16
    Sponsor Name:GlaxoSmithKline Research & Development Limited
    Full Title: A Phase 2, Randomized, Open-label Platform Study Utilizing a Master Protocol to Evaluate Novel Immunotherapy Combinations in Participants with Previously Untreated Locally Advanced/Metastatic Prog...
    Medical condition: Non-small Cell Lung Cancer
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10059515 Non-small cell lung cancer metastatic PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FI (Trial now transitioned) ES (Ongoing) NL (Trial now transitioned) BE (Trial now transitioned) DE (Trial now transitioned) IT (Trial now transitioned) PL (Trial now transitioned) PT (Trial now transitioned) HU (Trial now transitioned) GR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2021-001329-29 Sponsor Protocol Number: TIG-006 Start Date*: 2021-07-15
    Sponsor Name:iTeos Belgium SA
    Full Title: A Multicenter, Open-Label, Phase I/II Study of EOS884448 in combination with standard of care and/or investigational therapies in participants with advanced solid tumors
    Medical condition: Advanced solid tumors
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Trial now transitioned) IT (Trial now transitioned) ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2022-003289-18 Sponsor Protocol Number: 219369 Start Date*: 2023-03-10
    Sponsor Name:GlaxoSmithKline Research & Development Limited
    Full Title: A Phase 2, Single-Arm, Open-Label Study with Dostarlimab Monotherapy in Participants with Untreated Stage II/III dMMR/MSI-H Locally Advanced Rectal Cancer
    Medical condition: Untreated Stage II/III dMMR/MSI-H locally advanced rectal cancer
    Disease: Version SOC Term Classification Code Term Level
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10038049 Rectal cancer stage II PT
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10038050 Rectal cancer stage III PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned) DE (Trial now transitioned) IT (Trial now transitioned) NL (Trial now transitioned) ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2020-002766-14 Sponsor Protocol Number: 2020-3093 Start Date*: 2020-10-26
    Sponsor Name:Gustave Roussy
    Full Title: An open label phase II basket trial exploring the efficacy and safety of the combination of Niraparib and Dostarlimab in patients with DNA repair-deficient or platinum-sensitive solid tumors
    Medical condition: Patients with DNA repair-deficient or platinum-sensitive solid tumors
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2020-000109-10 Sponsor Protocol Number: UNITO-001/2020 Start Date*: 2020-09-30
    Sponsor Name:DIPARTIMENTO DI ONCOLOGIA-UNIVERSITA' DEGLI STUDI DI TORINO
    Full Title: A Phase II, Open-Label, Single Arm, prospective, multicenter study of niraparib plus dostarlimab in patients with advanced non-small cell lung cancer and malignant pleural mesothelioma, positive fo...
    Medical condition: patients with advanced non-small cell lung cancer and malignant pleural mesothelioma, positive for PD-L1 expression and germ or somatic mutations in DNA damage repair genes
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10062042 Lung neoplasm PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10045155 Tumor of pleura LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2020-002327-11 Sponsor Protocol Number: 213403 Start Date*: 2021-02-05
    Sponsor Name:GlaxoSmithKline Research & Development Ltd
    Full Title: A RANDOMIZED, PHASE 2, DOUBLE-BLIND STUDY TO EVALUATE THE EFFICACY OF DOSTARLIMAB PLUS CHEMOTHERAPY VERSUS PEMBROLIZUMAB PLUS CHEMOTHERAPY IN METASTATIC NON-SQUAMOUS NON-SMALL CELL LUNG CANCER
    Medical condition: Metastatic non-squamous non-small cell lung cancer
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10061873 Non-small cell lung cancer PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10079440 Non-squamous non-small cell lung cancer LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Trial now transitioned) FR (Trial now transitioned) IT (Trial now transitioned) RO (Trial now transitioned)
    Trial results: View results
    EudraCT Number: 2018-000413-20 Sponsor Protocol Number: 3000-03-005/ENGOT-OV44/GSK213350 Start Date*: 2018-11-07
    Sponsor Name:TESARO, Inc.
    Full Title: A Randomized, Double-Blind, 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 Non-muc...
    Medical condition: Stage 3 or 4 High Grade Non-mucinous epithelial ovarian cancer (serous, endometrial, clear cell, carcinosarcoma, and mixed pathologies)
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10070907 Ovarian cancer stage III PT
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10070908 Ovarian cancer stage IV PT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: FI (Trial now transitioned) BE (Trial now transitioned) GB (GB - no longer in EU/EEA) DK (Trial now transitioned) CZ (Trial now transitioned) FR (Trial now transitioned) GR (Trial now transitioned) PL (Trial now transitioned) NL (Ongoing) ES (Ongoing) NO (Trial now transitioned) IT (Trial now transitioned) RO (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2017-003353-41 Sponsor Protocol Number: 0627 Start Date*: 2018-07-05
    Sponsor Name:University of Leicester
    Full Title: Mesothelioma Stratified Therapy (MiST): A stratified multi-arm phase IIa clinical trial to enable accelerated evaluation of targeted therapies for relapsed malignant mesothelioma.
    Medical condition: Malignant Mesothelioma (MM) - pleural and peritoneal
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2019-004875-38 Sponsor Protocol Number: PRIMEH&N Start Date*: 2020-11-12
    Sponsor Name:Fondazione GONO
    Full Title: The induction and maintenance treatment with PARP inhibitor and immunotherapy in HPV-negative Head and Neck Squamous Cell Carcinoma (HNSCC)
    Medical condition: HPV-negative Head and Neck Squamous Cell Carcinoma (HNSCC)
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10031112 Oropharyngeal squamous cell carcinoma PT
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10023856 Laryngeal squamous cell carcinoma PT
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10066471 Squamous cell carcinoma of pharynx PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2021-002124-21 Sponsor Protocol Number: GINECO-EN105b Start Date*: 2021-12-21
    Sponsor Name:ARCAGY-GINECO
    Full Title: Randomized phase III trial in MMR deficient endometrial cancer patients comparing chemotherapy alone versus Dostarlimab in first line advanced/metastatic setting: DOMENICA STUDY (GINECO-EN105b/ENGO...
    Medical condition: Endometrial cancer
    Disease: Version SOC Term Classification Code Term Level
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10014733 Endometrial cancer PT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: FR (Trial now transitioned) ES (Ongoing) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2016-004368-21 Sponsor Protocol Number: ISG-ACCesS Start Date*: 2020-09-15
    Sponsor Name:ITALIAN SARCOMA GROUP
    Full Title: Phase II study on TSR-042 in advanced clear cells sarcoma
    Medical condition: Advanced clear cells sarcoma
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10073140 Clear cell sarcoma of soft tissue PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: IT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2020-000146-33 Sponsor Protocol Number: MITO33 Start Date*: 2020-10-09
    Sponsor Name:FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS UNIVERSITA' CATTOLICA DEL SACRO CUORE
    Full Title: Randomized phase III trial on NIraparib-TSR-042 (dostarlimab) vs physician’s choice CHEmotherapy in recurrent, ovarian, fallopian tube or primary peritoneal cancer patients not candidate for platin...
    Medical condition: Recurrent ovarian, fallopian tube or primary peritoneal cancer.
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10061344 Peritoneal neoplasm PT
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10066697 Ovarian cancer recurrent PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10016180 Fallopian tube cancer PT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: IT (Trial now transitioned) DE (Trial now transitioned) FR (Trial now transitioned) CZ (Trial now transitioned) GR (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2019-002662-12 Sponsor Protocol Number: GINECO-EN203b Start Date*: 2020-01-16
    Sponsor Name:ARCAGY-GINECO
    Full Title: A multicentric randomized phase II/III evaluating TSR-042 (anti-PD-1 mAb) in combination with Niraparib (parpi) versus Niraparib alone compared to chemotherapy in the treatment of metastatic or rec...
    Medical condition: metastatic or recurrent endometrial or ovarian carcinosarcoma
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10057529 Ovarian cancer metastatic PT
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10066697 Ovarian cancer recurrent PT
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10014734 Endometrial cancer metastatic PT
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10014736 Endometrial cancer recurrent PT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: FR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2019-001138-32 Sponsor Protocol Number: 208887 Start Date*: 2020-09-18
    Sponsor Name:GlaxoSmithKline Research & Development Ltd
    Full Title: A Phase I/II, Randomized, Open-label Platform Study Utilizing a Master Protocol to Study GSK2857916 as Monotherapy and in Combination with Anti-Cancer Treatments in Participants with Relapsed/Refra...
    Medical condition: Relapsed/Refractory Multiple Myeloma
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004864 10028228 Multiple myeloma LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) SE (Trial now transitioned) NL (Completed) ES (Temporarily Halted) NO (Trial now transitioned) GR (Completed)
    Trial results: View results
    EudraCT Number: 2020-004414-35 Sponsor Protocol Number: IMPRESSNorway Start Date*: 2021-02-19
    Sponsor Name:Oslo University Hospital
    Full Title: Improving public cancer care by implementing precision medicine in Norway
    Medical condition: Patients with a biomarker indicating response to IMP can be included in IMPRESS-Norway. Patients with disease characteristics covered in present indications for the IMP are not eligible.
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NO (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2018-001316-29 Sponsor Protocol Number: 205801 Start Date*: 2019-03-15
    Sponsor Name:GlaxoSmithKline Research and Development Ltd.
    Full Title: A Phase II, Randomized, Open-label Platform Trial Utilizing a Master Protocol to Study Novel Regimens Versus Standard of Care Treatment in NSCLC Participants
    Medical condition: non-small cell lung cancer (NSCLC)
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10061873 Non-small cell lung cancer PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed) DE (Completed) SE (Completed) FR (Completed) DK (Prematurely Ended) IT (Completed) RO (Prematurely Ended)
    Trial results: View results
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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