Ignite Creation Date:
2025-12-24 @ 4:52 PM
Ignite Modification Date:
2025-12-29 @ 9:51 PM
Study NCT ID:
NCT05123950
Status:
COMPLETED
Last Update Posted:
2021-11-17
First Post:
2021-10-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Treatment Patterns and Clinical Outcomes in First Line Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck (1L R/M SCCHN) Participants in Europe
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000077195', 'term': 'Squamous Cell Carcinoma of Head and Neck'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}, {'id': 'D012008', 'term': 'Recurrence'}], 'ancestors': [{'id': 'D002294', 'term': 'Carcinoma, Squamous Cell'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D020969', 'term': 'Disease Attributes'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 304}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2021-03-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-15', 'studyFirstSubmitDate': '2021-10-19', 'studyFirstSubmitQcDate': '2021-11-15', 'lastUpdatePostDateStruct': {'date': '2021-11-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Distribution of demographic characteristics of 1L R/M SCCHN participants treated with nivolumab: Age', 'timeFrame': 'At Baseline', 'description': 'Recurrent/Metastatic (R/M) Squamous Cell Carcinoma of the Head \\& Neck (SCCHN)'}, {'measure': 'Distribution of demographic characteristics of 1L R/M SCCHN participants treated with nivolumab: Height', 'timeFrame': 'At Baseline'}, {'measure': 'Distribution of demographic characteristics of 1L R/M SCCHN participants treated with nivolumab: Weight', 'timeFrame': 'At Baseline'}, {'measure': 'Distribution of demographic characteristics of 1L R/M SCCHN participants treated with nivolumab: Body surface area (BSA)', 'timeFrame': 'At Baseline'}, {'measure': 'Distribution of demographic characteristics of 1L R/M SCCHN participants treated with nivolumab: Health insurance coverage', 'timeFrame': 'At Baseline'}, {'measure': 'Distribution of demographic characteristics of 1L R/M SCCHN participants treated with nivolumab: Tobacco use', 'timeFrame': 'At Baseline'}, {'measure': 'Distribution of demographic characteristics of 1L R/M SCCHN participants treated with nivolumab: Patient comorbidities', 'timeFrame': 'At Baseline'}, {'measure': 'Distribution of demographic characteristics of 1L R/M SCCHN participants treated with nivolumab: Alcohol use', 'timeFrame': 'At Baseline'}, {'measure': 'Distribution of clinical characteristics of 1L R/M SCCHN participants treated with nivolumab: Human papillomavirus(HPV) p -16 status', 'timeFrame': 'At Baseline'}, {'measure': 'Distribution of clinical characteristics of 1L R/M SCCHN participants treated with nivolumab: Date of early stage diagnosis', 'timeFrame': 'At Baseline'}, {'measure': 'Distribution of clinical characteristics of 1L R/M SCCHN participants treated with nivolumab: Receive a platinum-based agent for early stage diagnosis', 'timeFrame': 'At Baseline'}, {'measure': 'Distribution of clinical characteristics of 1L R/M SCCHN participants treated with nivolumab: Receive radiation within 6 months prior to early stage diagnosis', 'timeFrame': 'At Baseline'}, {'measure': 'Distribution of clinical characteristics of 1L R/M SCCHN participants treated with nivolumab: Undergo related surgeries within 6 months prior to early stage diagnosis', 'timeFrame': 'At Baseline'}, {'measure': 'Distribution of clinical characteristics of 1L R/M SCCHN participants treated with nivolumab: Date of R/M SCCHN diagnosis', 'timeFrame': 'At Baseline'}, {'measure': 'Distribution of clinical characteristics of 1L R/M SCCHN participants treated with nivolumab: Specialty of diagnosing physician', 'timeFrame': 'At Baseline'}, {'measure': 'Distribution of clinical characteristics of 1L R/M SCCHN participants treated with nivolumab: Primary site of SCCHN at R/M diagnosis', 'timeFrame': 'At Baseline'}, {'measure': 'Distribution of clinical characteristics of 1L R/M SCCHN participants treated with nivolumab: Clinical stage at R/M diagnosis', 'timeFrame': 'At Baseline'}, {'measure': 'Distribution of clinical characteristics of 1L R/M SCCHN participants treated with nivolumab: Primary tumor stage at R/M diagnosis', 'timeFrame': 'At Baseline'}, {'measure': 'Distribution of clinical characteristics of 1L R/M SCCHN participants treated with nivolumab: Lymph node involvement at R/M diagnosis', 'timeFrame': 'At Baseline'}, {'measure': 'Distribution of clinical characteristics of 1L R/M SCCHN participants treated with nivolumab: Metastasis at R/M diagnosis', 'timeFrame': 'At Baseline'}, {'measure': 'Distribution of clinical characteristics of 1L R/M SCCHN participants treated with nivolumab: Histologic tumor grade at R/M diagnosis', 'timeFrame': 'At Baseline'}, {'measure': 'Distribution of clinical characteristics of 1L R/M SCCHN participants treated with nivolumab: Overall prognosis at R/M diagnosis', 'timeFrame': 'At Baseline'}, {'measure': 'Distribution of clinical characteristics of 1L R/M SCCHN participants treated with nivolumab: Platinum-based grouping', 'timeFrame': 'At Baseline'}, {'measure': 'Distribution of diagnostic procedures of 1L R/M SCCHN participants treated with nivolumab', 'timeFrame': 'At Baseline'}, {'measure': 'Distribution of treatment patterns of 1L R/M SCCHN participants treated with nivolumab: First (second, third+) Line of therapy (LOT)', 'timeFrame': 'At Baseline'}, {'measure': 'Distribution of treatment patterns of 1L R/M SCCHN participants treated with nivolumab: Duration of LOT', 'timeFrame': 'At Baseline'}, {'measure': 'Distribution of treatment patterns of 1L R/M SCCHN participants treated with nivolumab: Administration form', 'timeFrame': 'At Baseline'}, {'measure': 'Distribution of treatment patterns of 1L R/M SCCHN participants treated with nivolumab: Dose', 'timeFrame': 'At Baseline'}, {'measure': 'Distribution of treatment patterns of 1L R/M SCCHN participants treated with nivolumab: Dose changes', 'timeFrame': 'At Baseline'}, {'measure': 'Distribution of treatment patterns of 1L R/M SCCHN participants treated with nivolumab: Frequency of treatment regimen', 'timeFrame': 'At Baseline'}, {'measure': 'Distribution of treatment patterns of 1L R/M SCCHN participants treated with nivolumab: Schedule of agent administration', 'timeFrame': 'At Baseline'}, {'measure': 'Distribution of treatment patterns of 1L R/M SCCHN participants treated with nivolumab: Number of planned cycles', 'timeFrame': 'At Baseline'}, {'measure': 'Distribution of treatment patterns of 1L R/M SCCHN participants treated with nivolumab: Number of completed cycles', 'timeFrame': 'At Baseline'}, {'measure': 'Distribution of treatment patterns of 1L R/M SCCHN participants treated with nivolumab: Reasons for prescribing therapy', 'timeFrame': 'At Baseline'}, {'measure': 'Distribution of treatment patterns of 1L R/M SCCHN participants treated with nivolumab: Reasons for discontinuing therapy', 'timeFrame': 'At Baseline'}, {'measure': 'Distribution of treatment patterns of 1L R/M SCCHN participants treated with nivolumab: Dose delays', 'timeFrame': 'At Baseline'}, {'measure': 'Distribution of treatment patterns of 1L R/M SCCHN participants treated with nivolumab: Radiation performed for R/M disease', 'timeFrame': 'At Baseline'}, {'measure': 'Distribution of treatment patterns of 1L R/M SCCHN participants treated with nivolumab: Surgical procedures performed for R/M disease', 'timeFrame': 'At Baseline'}, {'measure': 'Distribution of adverse events of 1L R/M SCCHN participants treated with nivolumab', 'timeFrame': 'At Baseline'}, {'measure': 'Distribution of adverse events of 1L R/M SCCHN participants treated with nivolumab: Action taken', 'timeFrame': 'At Baseline'}, {'measure': 'Distribution of adverse events of 1L R/M SCCHN participants treated with nivolumab: Resolution', 'timeFrame': 'At Baseline'}, {'measure': 'Distribution of clinical outcomes of 1L R/M SCCHN participants treated with nivolumab: Response to therapy', 'timeFrame': 'At Baseline'}, {'measure': 'Distribution of clinical outcomes of 1L R/M SCCHN participants treated with nivolumab: Duration of response', 'timeFrame': 'Up to approximately 36 months'}, {'measure': 'Distribution of clinical outcomes of 1L R/M SCCHN participants treated with nivolumab: Overall survival', 'timeFrame': 'Up to approximately 36 months'}, {'measure': 'Distribution of clinical outcomes of 1L R/M SCCHN participants treated with nivolumab: Progression free survival', 'timeFrame': 'Up to approximately 36 months'}], 'secondaryOutcomes': [{'measure': 'Comparison of patient demographics, clinical characteristics, and treatment patterns between the Cohort 1- Augment and Cohort 1', 'timeFrame': 'At Baseline'}, {'measure': 'Comparison of time to event endpoints of OS, PFS, and DOR between Cohort 1- Augment and Cohort 1', 'timeFrame': 'Up to approximately 36 months'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Metastatic', 'Nivolumab', 'Recurrent', 'SCCHN', 'Treatment patterns', 'Outcomes'], 'conditions': ['Squamous Cell Carcinoma 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'}, {'url': 'https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html', 'label': 'Investigator Inquiry Form'}, {'url': 'https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm', 'label': 'FDA Safety Alerts and Recalls'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this observational study is to collect real-world data that describes treatment patterns and clinical outcomes in participants with first line recurrent/metastatic squamous cell carcinoma of the head \\& neck (1L R/M SCCHN).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'A population of participants diagnosed with Recurrent/Metastatic Squamous cell carcinoma of the head and neck (R/M SCCHN) and treated with 1L therapy in two cohorts based on time period of initiating 1L treatment. Patients will be enrolled from France (FR), Germany (DE), and the United Kingdom (UK).', 'healthyVolunteers': False, 'eligibilityCriteria': 'For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com\n\nInclusion Criteria:\n\nParticipants are included in Cohort 1 - Augment if they meet the following criteria:\n\n* Adults18 years or older\n* Diagnosis of histologically confirmed R/M SCCHN, from any of the following primary sites only: oral cavity, oropharynx, hypopharynx, and larynx between 01-Jun-2017 and 31-June-2018.\n* Prescribed 1L treatment for R/M SCCHN\n* Treatment history and response available for medical chart abstraction from date of diagnosis until death or the end of the study in living participants\n* Have available for review one month of follow-up data available post initiation of 1L R/M SCCHN therapy\n* Informed consent form (ICF) signature/collection of living participants, as required by country regulation and local ethics committees\n\nParticipants are included in Cohort 1 if they meet the following criteria:\n\n* Adults 18 years or older\n* Diagnosis of histologically confirmed R/M SCCHN, from any of the following primary sites only: oral cavity, oropharynx, hypopharynx and larynx between 01-Jan-2014 and 31-Dec-2016.\n* Prescribed 1L treatment for R/M SCCHN\n* Treatment history and response available for medical chart abstraction from the date of diagnosis until death or the end of the study in living participants\n* Have available for review one month of follow-up data post initiation of 1L R/M SCCHN therapy\n* Informed consent form (ICF) signature/collection of living participants, as required by country regulation and local ethics committees\n\nExclusion Criteria:\n\nParticipants were excluded from either cohort if they meet the following criteria:\n\n* Were enrolled in a cancer treatment-related clinical trial since the diagnosis of R/M SCCHN\n* Recurrent or metastatic carcinoma of the nasopharynx, squamous cell carcinoma of unknown primary site, squamous cell carcinoma that originated from the skin and salivary gland or non-squamous histologies (e.g., mucosal melanoma).'}, 'identificationModule': {'nctId': 'NCT05123950', 'briefTitle': 'A Study of Treatment Patterns and Clinical Outcomes in First Line Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck (1L R/M SCCHN) Participants in Europe', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'Treatment Patterns and Clinical Outcomes in First Line Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck (1L R/M SCCHN) Patients in Europe', 'orgStudyIdInfo': {'id': 'CA209-8HX'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cohort 1', 'description': 'Participants diagnosed with R/M SCCHN between 01-Jan-2014 and 31-Dec-2016'}, {'label': 'Cohort 1- Augment', 'description': 'Participants newly initiating 1L treatment for R/M SCCHN between 01-Jun-2017 and 01-Jun-2018'}]}, 'contactsLocationsModule': {'locations': [{'zip': '07054', 'city': 'Parsippany', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Medical Data Analytics', 'geoPoint': {'lat': 40.85788, 'lon': -74.42599}}], 'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}