Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2025-12-27 @ 11:38 PM
Study NCT ID:
NCT06952660
Status:
RECRUITING
Last Update Posted:
2025-12-12
First Post:
2025-04-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ocular Assessments in Patients Treated With Tivdak® in Recurrent or Metastatic Cervical Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002583', 'term': 'Uterine Cervical Neoplasms'}, {'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D002577', 'term': 'Uterine Cervical Diseases'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}], 'ancestors': [{'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D000091662', 'term': 'Genital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-05-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2028-12-13', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-05', 'studyFirstSubmitDate': '2025-04-15', 'studyFirstSubmitQcDate': '2025-04-28', 'lastUpdatePostDateStruct': {'date': '2025-12-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-05-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-12-13', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Type, incidence and severity of ocular adverse events (AEs)', 'timeFrame': '90 days after the last dose of tisotumab vedotin'}], 'secondaryOutcomes': [{'measure': 'Time to resolution of ocular AEs', 'timeFrame': '90 days after the last dose of tisotumab vedotin'}, {'measure': 'Time to onset of ocular AEs', 'timeFrame': '90 days after the last dose of tisotumab vedotin'}, {'measure': 'Incidence of serious adverse events (SAEs)', 'timeFrame': '90 days after the last dose of tisotumab vedotin'}, {'measure': 'AEs leading to dose modifications including treatment discontinuation', 'timeFrame': '90 days after the last dose of tisotumab vedotin'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Uterine Neoplasms', 'Genital Neoplasms', 'Female Urogenital Neoplasms', 'Neoplasms by Site', 'Neoplasms Uterine', 'Cervical Diseases', 'Uterine Diseases', 'Genital Diseases, Female', 'Female Urogenital Diseases', 'Female Urogenital Diseases and Pregnancy Complications', 'Urogenital Diseases', 'Genital Diseases Uterine Cervical Neoplasms,', 'Tisotumab vedotin'], 'conditions': ['Cervical Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://pmiform.com/clinical-trial-info-request?StudyID=C5721005', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': "TIVDAK is used for the treatment of cervical cancer that has come back after chemotherapy. Chemotherapy is a treatment that uses medicines to stop the growth of cancer cells. This is done either by killing the cells or by stopping them from growing. The purpose of this study is to learn about possible side effects of TIVDAK, specially to any side effect that is related to the eye. A side effect is anything a medicine does to your body that is not part of how the medicine treats disease.\n\n* This study is seeking for participants who: Are willing to take all the required eye tests\n* Have not received TIVDAK before\n* Do not have any active eye issues.\n\nParticipants will receive TIVDAK once every 3 weeks as an infusion that will be injected into the vein. Participants will visit an eye care provider at 3 stages:\n\n* before starting the treatment,\n* before each of the first 9 infusions\n* then monthly for 3 months after they stop taking TIVDAK. Treatment with TIVDAK will continue until it is not working anymore against the participant's cancer."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria:\n\n1. Must have recurrent or metastatic cervical cancer with disease progression on or after chemotherapy\n2. Treating physician has determined that treatment with Tivdak is appropriate for the participant according to US Prescribing Information\n3. Must sign an informed consent form indicating that the participant understands the purpose and procedures required for the study and are willing to participate\n4. Must be willing to undergo repeated ocular assessments as required by the study and regular clinic visits according to local standard practice of the study site\n5. Must agree to use effective contraception according to the US Prescribing Information\n\nExclusion criteria:\n\n1. Active ocular disease at baseline per investigator assessment\n2. Previous treatment with Tivdak\n3. Previous administration of an investigational drug within 30 days\n4. Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may, in the investigator'"}, 'identificationModule': {'nctId': 'NCT06952660', 'briefTitle': 'Ocular Assessments in Patients Treated With Tivdak® in Recurrent or Metastatic Cervical Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A PROSPECTIVE LOW-INTERVENTIONAL PHASE 4 SINGLE ARM STUDY OF OCULAR ASSESSMENTS IN PATIENTS TREATED WITH TIVDAK® IN RECURRENT OR METASTATIC CERVICAL CANCER', 'orgStudyIdInfo': {'id': 'C5721005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tisotumab vedotin', 'description': 'Participants will receive tisotumab vedotin by IV infusion.', 'interventionNames': ['Drug: TIVDAK']}], 'interventions': [{'name': 'TIVDAK', 'type': 'DRUG', 'description': '2 mg/kg once every 3 weeks (Q3W)', 'armGroupLabels': ['Tisotumab vedotin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33180', 'city': 'Aventura', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Mount Sinai Comprehensive Cancer Center - Aventura', 'geoPoint': {'lat': 25.95648, 'lon': -80.13921}}, {'zip': '33065', 'city': 'Coral Springs', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Broward Health Coral Springs', 'geoPoint': {'lat': 26.27119, 'lon': -80.2706}}, {'zip': '33064', 'city': 'Deerfield Beach', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Broward Health North', 'geoPoint': {'lat': 26.31841, 'lon': -80.09977}}, {'zip': '33308', 'city': 'Fort Lauderdale', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Broward Health Imperial Point', 'geoPoint': {'lat': 26.12231, 'lon': -80.14338}}, {'zip': '33316', 'city': 'Fort Lauderdale', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Broward Health Medical Center', 'geoPoint': {'lat': 26.12231, 'lon': -80.14338}}, {'zip': '33133', 'city': 'Miami', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'HCA Mercy Hospital', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33140', 'city': 'Miami Beach', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Mount Sinai Comprehensive Cancer Center', 'geoPoint': {'lat': 25.79065, 'lon': -80.13005}}, {'zip': '33140', 'city': 'Miami Beach', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Mount Sinai Medical Center of Florida, Inc', 'geoPoint': {'lat': 25.79065, 'lon': -80.13005}}, {'zip': '32806', 'city': 'Orlando', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Orlando Health Cancer Institute', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '32806', 'city': 'Orlando', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Orlando Health Orlando Regional Medical Center', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '32806', 'city': 'Orlando', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Orlando Health Winnie Palmer Hospital for Women & Babies', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '30912', 'city': 'Augusta', 'state': 'Georgia', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'Georgia Cancer Center at Augusta University', 'geoPoint': {'lat': 33.47097, 'lon': -81.97484}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Indiana University Health University Hospital', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Indiana University Melvin and Bren Simon Comprehensive Cancer Center', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Sidney & Lois Eskenazi Hospital', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '40202', 'city': 'Louisville', 'state': 'Kentucky', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'Norton Cancer Institute - Downtown', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '40202', 'city': 'Louisville', 'state': 'Kentucky', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'Norton Hospital', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '40207', 'city': 'Louisville', 'state': 'Kentucky', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'Norton Cancer Institute St Matthews Campus', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '40207', 'city': 'Louisville', 'state': 'Kentucky', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': "Norton Women's and Children's Hospital", 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '70112', 'city': 'New Orleans', 'state': 'Louisiana', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'University Medical Center - New Orleans', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '71103', 'city': 'Shreveport', 'state': 'Louisiana', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Trials365, LLC', 'geoPoint': {'lat': 32.52515, 'lon': -93.75018}}, {'zip': '71103', 'city': 'Shreveport', 'state': 'Louisiana', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Willis Knighton Cancer Center', 'geoPoint': {'lat': 32.52515, 'lon': -93.75018}}, {'zip': '71103', 'city': 'Shreveport', 'state': 'Louisiana', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Willis Knighton Physician Network - 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Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\\_trials/trial\\_data\\_and\\_results/data\\_requests."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Genmab', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}