Ignite Creation Date:
2025-12-24 @ 3:40 PM
Ignite Modification Date:
2026-01-10 @ 4:41 PM
Study NCT ID:
NCT05405192
Status:
WITHDRAWN
Last Update Posted:
2023-02-28
First Post:
2022-05-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dostarlimab in Chemoresistant Gestational Trophoblastic Neoplasia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D031901', 'term': 'Gestational Trophoblastic Disease'}], 'ancestors': [{'id': 'D014328', 'term': 'Trophoblastic Neoplasms'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D011252', 'term': 'Pregnancy Complications, Neoplastic'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000719628', 'term': 'dostarlimab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'PI is leaving the University.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2023-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2028-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-02-27', 'studyFirstSubmitDate': '2022-05-26', 'studyFirstSubmitQcDate': '2022-05-31', 'lastUpdatePostDateStruct': {'date': '2023-02-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of patients with successful normalization of beta hCG', 'timeFrame': 'Up to 24 months', 'description': 'Proportion of patients with a successful normalized serum human chorionic gonadotropin (hCG) level (complete response) as measured by serum samples.'}], 'secondaryOutcomes': [{'measure': 'Proportion of patients with objective response rate (ORR)', 'timeFrame': 'Up to 25 months', 'description': 'ORR is defined as achieving best response of complete or partial responses (CR or PR) as assessed via Response Evaluated Criteria in Solid Tumors (RECIST)'}, {'measure': 'Number of Participants with treatment related-adverse events', 'timeFrame': 'Up to 25 months', 'description': 'Non-hematological Grade 3 and higher treatment-related adverse events as evaluated by treating physician using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.'}, {'measure': 'Progression-free survival (PFS)', 'timeFrame': 'Up to 48 months', 'description': 'PFS is the elapsed time from the date of treatment initiation to date of first documentation of progression (or recurrence) or death due to any cause. Patients last known to be alive and free of disease will be censored at date of last documented progression-free status.'}, {'measure': 'Overall survival (OS)', 'timeFrame': 'Up to 48 months', 'description': 'OS is the elapsed time from treatment initiation to death. For alive patients, OS will be censored at the date last known to be alive.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gestational Trophoblastic Neoplasia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to see if Dostarlimab is an effective treatment for Gestational Trophoblastic Neoplasia (GTN).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients with persistent unresectable Gestational Trophoblastic Neoplasia (GTN) disease\n2. Female patients \\>18 years old.\n3. Pretreatment archival tissue (if available) must be submitted for correlative studies. If pre-treatment tissue is not available, this does not exclude the patient.\n4. Patients must have recovered from the effects of recent surgery or radiotherapy (persistent toxicity, CTCAE grade ≤1 except for alopecia, sensory neuropathy, or fatigue).\n\nExclusion Criteria:\n\n1. Prior therapy with anti-Programed Death (PD)1/Programed Death Ligand-1 (PD-L1) or anti-CTLA4 antibody\n2. Participant must not be simultaneously enrolled in any interventional clinical trial.\n3. Participant must not have had major surgery ≤3 weeks prior to initiating protocol therapy and participant must have recovered from any surgical effects.\n4. Participant must not have received investigational therapy ≤ 4 weeks, or within a time interval less than at least 5 half-lives of the investigational agent, whichever is shorter, prior initiating protocol therapy.'}, 'identificationModule': {'nctId': 'NCT05405192', 'briefTitle': 'Dostarlimab in Chemoresistant Gestational Trophoblastic Neoplasia', 'organization': {'class': 'OTHER', 'fullName': 'University of Miami'}, 'officialTitle': 'Phase 2 Single Agent Dostarlimab in Chemoresistant Gestational Trophoblastic Neoplasia (GTN)', 'orgStudyIdInfo': {'id': '20210967'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dostarlimab Group', 'description': 'Participants will receive a total of up to 20 cycles of Dostarlimab: 4 cycles of Dostarlimab at a dose of 500 mg on day 1 of each of the 21-day cycle and 16 cycles of Dostarlimab at a dose of 1000 mg on day 1 of each of the 42-day cycle.', 'interventionNames': ['Drug: Dostarlimab']}], 'interventions': [{'name': 'Dostarlimab', 'type': 'DRUG', 'description': 'First four cycles of Dostarlimab will be given intravenously (IV) on day 1 of each of the 21-day cycle at a dose of 500 milligrams (mg). The next 16 cycles of Dostarlimab will be given on day 1 of each of the 42-day cycles at a dose of 1,000 mg.', 'armGroupLabels': ['Dostarlimab Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami Sylvester Comprehensive Cancer Center', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}], 'overallOfficials': [{'name': 'Marilyn Huang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Miami'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Miami', 'class': 'OTHER'}, 'collaborators': [{'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}