Ignite Creation Date:
2025-12-24 @ 2:08 PM
Ignite Modification Date:
2025-12-27 @ 9:15 PM
Study NCT ID:
NCT07091695
Status:
COMPLETED
Last Update Posted:
2025-11-12
First Post:
2025-07-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Real-world Outcomes Among Patients With Melanoma Treated With Neoadjuvant Nivolumab+Relatlimab or Nivolumab+Ipilimumab
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008545', 'term': 'Melanoma'}], 'ancestors': [{'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D018326', 'term': 'Nevi and Melanomas'}, {'id': 'D012878', 'term': 'Skin Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077594', 'term': 'Nivolumab'}, {'id': 'C000721227', 'term': 'relatlimab'}, {'id': 'D000074324', 'term': 'Ipilimumab'}], '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': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-05-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-11-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-11', 'studyFirstSubmitDate': '2025-07-22', 'studyFirstSubmitQcDate': '2025-07-22', 'lastUpdatePostDateStruct': {'date': '2025-11-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-07-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Participant baseline demographics', 'timeFrame': 'Baseline'}, {'measure': 'Participant baseline clinical characteristics', 'timeFrame': 'Baseline'}, {'measure': 'Participant treatment history', 'timeFrame': 'Baseline'}, {'measure': 'Number of doses of index therapies received (neoadjuvant therapies)', 'timeFrame': 'Day 1'}, {'measure': 'Types of surgeries received for melanoma after the index date', 'timeFrame': 'Up to 42-months'}, {'measure': 'Date of last radiation received for melanoma after the index date', 'timeFrame': 'Up to 42-months'}, {'measure': 'Types of regimens received for melanoma post-surgery in the adjuvant setting', 'timeFrame': 'Up to 42-months'}, {'measure': 'Number of doses of adjuvant therapies received (post-surgery)', 'timeFrame': 'Up to 42-months'}, {'measure': 'Dose modifications received by participants', 'timeFrame': 'Up to 42-months'}, {'measure': 'Rationale for dose modifications', 'timeFrame': 'Up to 42-months'}, {'measure': 'Rationale for treatment discontinuation', 'timeFrame': 'Up to 42-months'}, {'measure': 'Overall survival (OS)', 'timeFrame': 'Up to 42-months'}, {'measure': 'Time to treatment discontinuation (TTD)', 'timeFrame': 'Up to 42-months'}, {'measure': 'Duration of treatment (DOT)', 'timeFrame': 'Up to 42-months'}, {'measure': 'Time from neoadjuvant index treatment to adjuvant therapy', 'timeFrame': 'Up to 42-months'}, {'measure': 'Time from neoadjuvant index treatment to surgery', 'timeFrame': 'Up to 42-months'}, {'measure': 'Time from surgery to adjuvant therapy', 'timeFrame': 'Up to 42-months'}, {'measure': 'Pathologic complete response (PCR)', 'timeFrame': 'Up to 42-months'}, {'measure': 'Event-free survival (EFS)', 'timeFrame': 'Up to 42-months'}, {'measure': 'Distant metastasis-free survival (DMFS)', 'timeFrame': 'Up to 42-months'}, {'measure': 'Participant adverse events (AEs)', 'timeFrame': 'Up to 42-months'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Melanoma']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html', 'label': 'BMS Clinical Trial Information'}, {'url': 'https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts', 'label': 'FDA Safety Alerts and Recalls'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to understand the characteristics of adults diagnosed with with clinically palpable stage III resectable melanoma, the associated treatment patterns for their disease, and outcomes associated with the real-world use of neoadjuvant nivolumab+relatlimab or nivolumab+ipilimumab'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "The study population will comprise of adult diagnosed with clinically palpable stage III resectable melanoma in the U.S. managed by physicians in Cardinal Health's OPEN treated with neoadjuvant nivolumab+relatimab or nivolumab+ipilimumab from 18 March 2022.", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants at least 18 years old at diagnosis of clinically palpable stage III resectable melanoma\n* Participants treated with nivolumab+relatimab (nivo+rela) or nivolumab+ipilimumab (nivo+ipi) in the neoadjuvant setting\n* Participants with at least 6 months of follow-up from initiation of neoadjuvant therapy, unless deceased prior to 6 months of follow-up\n\nExclusion Criteria:\n\n* Participants received nivo+rela or nivo+ipi for clinically palpable stage III resectable melanoma as part of a therapeutic clinical trial\n* Participants had history of diagnosis of any malignancy (except for non-melanoma skin cancer) in the last 2 years.\n* Participants received adjuvant nivo+rela or adjuvant nivo+ipi after neoadjuvant nivo+ipi\n* Participants received adjuvant nivo+ipi after neoadjuvant nivo+rela\n* Participants received any systemic therapy prior to the initiation of neoadjuvant nivo+rela or nivo+ipi'}, 'identificationModule': {'nctId': 'NCT07091695', 'briefTitle': 'Real-world Outcomes Among Patients With Melanoma Treated With Neoadjuvant Nivolumab+Relatlimab or Nivolumab+Ipilimumab', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'Real-world Outcomes Among Patients With Melanoma Treated With Neoadjuvant Nivolumab+Relatlimab (Nivo+Rela) or Nivolumab+Ipilimumab (Nivo+Ipi)', 'orgStudyIdInfo': {'id': 'CA224-1084'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Participants receiving nivolumab + relatlimab treatment', 'interventionNames': ['Biological: Nivolumab + relatlimab']}, {'label': 'Participants receiving nivolumab + ipilimumab treatment', 'interventionNames': ['Biological: Nivolumab + ipilimumab']}], 'interventions': [{'name': 'Nivolumab + relatlimab', 'type': 'BIOLOGICAL', 'description': 'As prescribed by the treating clinician', 'armGroupLabels': ['Participants receiving nivolumab + relatlimab treatment']}, {'name': 'Nivolumab + ipilimumab', 'type': 'BIOLOGICAL', 'description': 'As prescribed by the treating clinician', 'armGroupLabels': ['Participants receiving nivolumab + ipilimumab treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43017', 'city': 'Dublin', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cardinal Health', 'geoPoint': {'lat': 40.09923, 'lon': -83.11408}}], 'overallOfficials': [{'name': 'Bristol Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}