Ignite Creation Date:
2025-12-24 @ 8:02 PM
Ignite Modification Date:
2025-12-31 @ 6:13 AM
Study NCT ID:
NCT04313504
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-08-01
First Post:
2020-03-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study Evaluating the Efficacy of Niraparib and Dostarlimab (TSR-042) in Recurrent/Metastatic HNSCC
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-08-25', 'mcpReleaseN': 11, 'releaseDate': '2025-08-07'}, {'resetDate': '2025-09-22', 'mcpReleaseN': 12, 'releaseDate': '2025-09-03'}, {'resetDate': '2025-10-23', 'mcpReleaseN': 13, 'releaseDate': '2025-10-14'}], 'estimatedResultsFirstSubmitDate': '2025-08-07'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D006258', 'term': 'Head and Neck Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C545685', 'term': 'niraparib'}, {'id': 'C000719628', 'term': 'dostarlimab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 23}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-11-04', 'type': 'ACTUAL'}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2025-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-31', 'studyFirstSubmitDate': '2020-03-16', 'studyFirstSubmitQcDate': '2020-03-17', 'lastUpdatePostDateStruct': {'date': '2024-08-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Response', 'timeFrame': '8 weeks', 'description': 'Measured by assessing best overall response using RECIST 1.1 in subjects in recurrent and/or metastatic HNSCC patients receiving combination of niraparib and dostarlimab.'}], 'secondaryOutcomes': [{'measure': 'Rate of all Adverse Events', 'timeFrame': '30 days after completion of treatment', 'description': 'As determined by CTCAE v5.0 in subjects with recurrent and/or metastatic HNSCC receiving combination of niraparib and dostarlimab.'}, {'measure': 'Progression Free Survival', 'timeFrame': '1 and 3 years', 'description': 'Measured using Kaplan Meier Curves from time of treatment start until time of progression'}, {'measure': 'Overall Survival', 'timeFrame': '5 years', 'description': 'Measured using Kaplan Meier Curves from diagnosis until time of death'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Head and Neck Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the best overall response of the combination of dostarlimab and niraparib in patients with recurrent and/or metastatic HNSCC patients.', 'detailedDescription': 'Recurrent and/or metastatic HNSCC patients will be treated with combination of the PD-1 inhibitor (dostarlimab) and PARPi (niraparib) concurrently and ORR, PFS and OS will be determined.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically, cytologically, or radiographically confirmed recurrent or metastatic non cutaneous HNSCC for which there are no surgical or radiation curative options.\n* ECOG performance status ≤2\n* Patients must be able to swallow pills\n\nExclusion Criteria:\n\n* Nasopharyngeal and salivary gland tumors\n* Patients who have not recovered from adverse events due to prior anti-cancer therapy with the exception of alopecia\n* Prior exposure to both immunotherapy drugs (PD-1, PDL-1, CTLA-4 inhibitors) and PARP inhibitors. Single exposure to either immunotherapy or PARP inhibitors is allowable.\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to niraparib or dostarlimab.\n* Patients with uncontrolled intercurrent illness.\n* Requirement of any use of steroids greater than the equivalent of 10mg prednisone daily is not allowed.'}, 'identificationModule': {'nctId': 'NCT04313504', 'briefTitle': 'Study Evaluating the Efficacy of Niraparib and Dostarlimab (TSR-042) in Recurrent/Metastatic HNSCC', 'organization': {'class': 'OTHER', 'fullName': 'University of Cincinnati'}, 'officialTitle': 'An Open-label, Phase II Study Evaluating the Efficacy of Niraparib and Dostarlimab (TSR-042) in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma Patients', 'orgStudyIdInfo': {'id': 'UCCI-HN-19-03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Niraparib & Dostarlimab', 'description': 'Niraparib starting on Day 0. Niraparib will be administered as continuous daily dose, orally 200 or 300 mg.\n\nDostarlimab IV administered via a 30-minute infusion on Day 1 of every 21 day cycle. 500mg for first 4 doses followed by 1000 mg every 6 weeks.', 'interventionNames': ['Drug: Niraparib', 'Drug: Dostarlimab']}], 'interventions': [{'name': 'Niraparib', 'type': 'DRUG', 'otherNames': ['ZEJULA'], 'description': 'Niraparib \\& Dostarlimab combination', 'armGroupLabels': ['Niraparib & Dostarlimab']}, {'name': 'Dostarlimab', 'type': 'DRUG', 'otherNames': ['TSR-042'], 'description': 'Niraparib \\& Dostarlimab combination', 'armGroupLabels': ['Niraparib & Dostarlimab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45219', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'University of Cincinnati Medical Center', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}], 'overallOfficials': [{'name': 'Trisha Wise-Draper, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Cincinnati'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Trisha Wise-Draper', 'class': 'OTHER'}, 'collaborators': [{'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Trisha Wise-Draper', 'investigatorAffiliation': 'University of Cincinnati'}}}}