Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2025-12-26 @ 1:15 AM
Study NCT ID:
NCT06101134
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-04-14
First Post:
2023-10-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Evaluate Whether Participants With Melanoma Prefer Subcutaneous vs Intravenous Administration of Nivolumab and Nivolumab + Relatlimab Fixed-dose Combinations
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Argentina']}, 'conditionBrowseModule': {'meshes': [{'id': 'D008545', 'term': 'Melanoma'}, {'id': 'D057240', 'term': 'Patient Preference'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}], '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'}, {'id': 'D017060', 'term': 'Patient Satisfaction'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000729737', 'term': 'Opdualag'}, {'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': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-11-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2027-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-11', 'studyFirstSubmitDate': '2023-10-20', 'studyFirstSubmitQcDate': '2023-10-20', 'lastUpdatePostDateStruct': {'date': '2025-04-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants that prefer subcutaneous (SC) route of administration as assessed by Question 7 of the Patient Experience and Preference Questionnaire (PEPQ)', 'timeFrame': 'At Cycle 4 Day 1 (each cycle is 28 days)'}], 'secondaryOutcomes': [{'measure': 'Number of participants with Adverse Events (AEs)', 'timeFrame': 'Up to approximately 2.5 years'}, {'measure': 'Number of participants with Serious AEs (SAEs)', 'timeFrame': 'Up to approximately 2.5 years'}, {'measure': 'Number of participants with treatment-related AEs', 'timeFrame': 'Up to approximately 2.5 years'}, {'measure': 'Number of participants with AEs leading to discontinuation', 'timeFrame': 'Up to approximately 2.5 years'}, {'measure': 'Number of participants with Immune-mediated AEs (IMAEs)', 'timeFrame': 'Up to approximately 2.5 years'}, {'measure': 'Number of participants with other events of special interest (OESIs)', 'timeFrame': 'Up to approximately 2.5 years'}, {'measure': 'Number of participants with injection/infusion-related AEs', 'timeFrame': 'Up to approximately 2.5 years'}, {'measure': 'Number of deaths', 'timeFrame': 'Up to approximately 2.5 years'}, {'measure': 'Number of participants with laboratory abnormalities', 'timeFrame': 'Up to approximately 2.5 years'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Patient preference', 'Nivolumab Relatlimab IV', 'Nivolumab Relatimab SC', 'Melanoma', 'rHuPH20', 'FDC IV', 'FDC SC', 'Adjuvant', 'Metastatic', 'Switch', 'Nivolumab', 'Relatlimab'], '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.bmsclinicaltrials.com/us/en/clinical-trials/NCT06101134.html', 'label': 'BMS Clinical Trial Patient Recruiting'}]}, 'descriptionModule': {'briefSummary': "The purpose of this study is to assess the patient's preference for nivolumab subcutaneous (SC) or nivolumab + relatlimab fixed-dose combination (FDC) SC and provide patient experience data by route of administration. This study will also generate safety data which will further characterize the safety profile of patients switching the route of administration from intravenous (IV) to SC."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Must have either metastatic melanoma and have not had previous treatment for their cancer, or resected melanoma and have had the cancer removed fully with surgery no later than 12 weeks before the start of treatment and confirmed free of disease\n* Must have a low level of disability and cancer that is considered advanced for metastatic melanoma and at risk for becoming advanced (intermediate) or advanced for resected melanoma\n\nExclusion Criteria:\n\n* Must not have any brain cancer/disease treated with radiation, any cancer in the eyes or mucous membranes (cells that cover inside surface of parts of the body and keep it moist), any autoimmune disease, or any condition that is being treated with steroids for inflammation (corticosteroids) or medication to decrease the body's immune system response (immunosuppressive drugs)\n\nOther protocol-defined inclusion/exclusion criteria apply."}, 'identificationModule': {'nctId': 'NCT06101134', 'briefTitle': 'A Study to Evaluate Whether Participants With Melanoma Prefer Subcutaneous vs Intravenous Administration of Nivolumab and Nivolumab + Relatlimab Fixed-dose Combinations', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'A Phase 2 Open-label, Two-cohort Study to Evaluate Patient Preference for Nivolumab + Relatlimab Fixed-dose Combination Subcutaneous Versus Nivolumab + Relatlimab Fixed-dose Combination Intravenous and Nivolumab Subcutaneous Versus Nivolumab Intravenous in Participants With Melanoma', 'orgStudyIdInfo': {'id': 'CA224-1044'}, 'secondaryIdInfos': [{'id': 'U1111-1289-5947', 'type': 'OTHER', 'domain': 'WHO'}, {'id': '2023-504515-33-00', 'type': 'OTHER', 'domain': 'EU CTR'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort 1: Metastatic Melanoma', 'interventionNames': ['Drug: relatlimab+nivolumab', 'Drug: relatlimab+nivolumab+rHuPH20']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 2: Resected Melanoma', 'interventionNames': ['Drug: nivolumab', 'Drug: nivolumab+rHuPH20']}], 'interventions': [{'name': 'relatlimab+nivolumab', 'type': 'DRUG', 'otherNames': ['BMS-986213', 'Opdualag'], 'description': 'Specified dose on specified days', 'armGroupLabels': ['Cohort 1: Metastatic Melanoma']}, {'name': 'relatlimab+nivolumab+rHuPH20', 'type': 'DRUG', 'description': 'Specified dose on specified days', 'armGroupLabels': ['Cohort 1: Metastatic Melanoma']}, {'name': 'nivolumab', 'type': 'DRUG', 'otherNames': ['BMS-936558', 'Opdivo'], 'description': 'Specified dose on specified days', 'armGroupLabels': ['Cohort 2: Resected Melanoma']}, {'name': 'nivolumab+rHuPH20', 'type': 'DRUG', 'otherNames': ['BMS-986298'], 'description': 'Specified dose on specified days', 'armGroupLabels': ['Cohort 2: Resected Melanoma']}]}, 'contactsLocationsModule': {'locations': [{'zip': '99508-2974', 'city': 'Anchorage', 'state': 'Alaska', 'country': 'United States', 'facility': 'Local Institution - 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