Ignite Creation Date:
2025-12-24 @ 12:38 PM
Ignite Modification Date:
2025-12-28 @ 1:04 PM
Study NCT ID:
NCT04050761
Status:
COMPLETED
Last Update Posted:
2025-07-02
First Post:
2019-08-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Nivolumab in Patients With Head and Neck Cancer.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006258', 'term': 'Head and Neck Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077594', 'term': 'Nivolumab'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 502}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-06-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2024-07-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-30', 'studyFirstSubmitDate': '2019-08-02', 'studyFirstSubmitQcDate': '2019-08-07', 'lastUpdatePostDateStruct': {'date': '2025-07-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Survival', 'timeFrame': '3 Years'}], 'secondaryOutcomes': [{'measure': 'Overall Survival within Sub groups', 'timeFrame': '3 year'}, {'measure': 'Progression-free survival (PFS)', 'timeFrame': '3 Years'}, {'measure': 'Overall response rate (ORR)', 'timeFrame': '3 years'}, {'measure': 'Best overall response rate (BORR)', 'timeFrame': '3 years'}, {'measure': 'Time to response (TTR)', 'timeFrame': '3 years'}, {'measure': 'Duration of response (DOR)', 'timeFrame': '3 years'}, {'measure': 'Incidents of Adverse Events (AEs)', 'timeFrame': '3 years'}, {'measure': 'Incidents of immune-related Adverse Events', 'timeFrame': '3 years'}, {'measure': 'Incident of treatment-related Adverse Events', 'timeFrame': '3 years'}, {'measure': 'Number of socio-demographic characteristics in adult patients with SCCHN', 'timeFrame': '3 years'}, {'measure': 'Number of clinical characteristics in adult patients with SCCHN', 'timeFrame': '3 Years'}, {'measure': 'Number of treatment characteristics in adult patients with SCCHN', 'timeFrame': '3 Years'}, {'measure': 'Functional Assessment of Cancer Therapy - Head & Neck (FACT-H&N) Score', 'timeFrame': '3 Years'}, {'measure': 'Quality of life of caregiver (CarGoQoL ) Score', 'timeFrame': '3 Years'}, {'measure': 'Supportive Care Needs Survey for Partners and Caregivers (SCNS-P&C) Assessment score', 'timeFrame': '3 Years'}, {'measure': 'European Quality of Life-5 Dimensions (EQ-5D) score', 'timeFrame': '3 Years'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Squamous Cell Carcinoma of the Head and Neck; Head and Neck Cancer; Head and Neck Carcinoma; Cancer of the Head and Neck']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html', 'label': 'BMS Clinical Trial Information'}]}, 'descriptionModule': {'briefSummary': 'A prospective real world evidence study of Nivolumab use in France in patient with recurrent or metastatic squamous cell carcinoma of the Head and Neck progressing on or after a platinum based therapy'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'adult patients who are at least 18 years of age with the diagnosis of Squamous Cell Carcinoma Head and Neck that the physician has already decided to initiate a treatment with nivolumab for the first time.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of Squamous Cell Carcinoma Head and Neck (SCCHN) patients progressing on or after platinum-based therapy.\n* Diagnosis of SCCHN has been confirmed by histology or cytology (either at initial diagnosis or any time later during the course of the disease)\n* Treatment decision to initiate a treatment with nivolumab for the first time for the treatment of SCCHN (according to the label approved in France) has already been taken\n\nExclusion Criteria:\n\n* Patients previously treated with Nivolumab, Ipilimumab, or any other antibody or drug specifically targeting T-Cell Co stimulation or immune Checkpoint pathway.\n* Patients currently included in an interventional clinical trial for their SCCHN.\n\nOther protocol defined inclusion/exclusion criteria could apply'}, 'identificationModule': {'nctId': 'NCT04050761', 'acronym': 'ProNiHN', 'briefTitle': 'A Study of Nivolumab in Patients With Head and Neck Cancer.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'A French Prospective, Non-interventional Research ( NIR) of Nivolumab in Patients With Squamous Cell Carcinoma of the Head and Neck (SCCHN) Progressing on or After a Platinum-based Therapy', 'orgStudyIdInfo': {'id': 'CA209-9T9'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Monotherapy', 'description': 'Participants diagnosed with recurrent or metastatic squamous cell carcinoma of the Head and Neck and whose physician has decided to initiate a treatment with Nivolumab for the first time for the treatment of SCCHN.', 'interventionNames': ['Biological: Nivolumab']}], 'interventions': [{'name': 'Nivolumab', 'type': 'BIOLOGICAL', 'description': 'Specified dose on Specific Days', 'armGroupLabels': ['Monotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75005', 'city': 'Paris', 'state': 'Île-de-France Region', 'country': 'France', 'facility': 'Local Institution - 0001', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}