Ignite Creation Date:
2025-12-24 @ 3:45 PM
Ignite Modification Date:
2025-12-28 @ 12:38 PM
Study NCT ID:
NCT05298592
Status:
COMPLETED
Last Update Posted:
2024-09-26
First Post:
2022-03-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of BMS-986406 as Monotherapy and Combination Therapies in Participants With Advanced Tumors
Sponsor:
Organization:
Raw JSON
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'D011688', 'term': 'Purinones'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D005971', 'term': 'Glutamates'}, {'id': 'D024342', 'term': 'Amino Acids, Acidic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000600', 'term': 'Amino Acids, Dicarboxylic'}, {'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 77}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-03-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2024-08-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-25', 'studyFirstSubmitDate': '2022-03-17', 'studyFirstSubmitQcDate': '2022-03-17', 'lastUpdatePostDateStruct': {'date': '2024-09-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with adverse events (AEs)', 'timeFrame': 'Up to 100 days'}, {'measure': 'Number of participants with serious adverse events (SAEs)', 'timeFrame': 'Up to 100 days'}, {'measure': 'Number of participants with AEs meeting protocol defined dose-limiting toxicity (DLT) criteria', 'timeFrame': 'Up to 28 days'}, {'measure': 'Number of participants with AEs leading to discontinuation', 'timeFrame': 'Up to 100 days'}, {'measure': 'Number of participants with death', 'timeFrame': 'Up to 100 days'}], 'secondaryOutcomes': [{'measure': 'Maximum observed plasma concentration (Cmax)', 'timeFrame': 'Up to 14 days'}, {'measure': 'Time of maximum observed plasma concentration (Tmax)', 'timeFrame': 'Up to 14 days'}, {'measure': 'Trough observed plasma concentration (Ctrough)', 'timeFrame': 'Up to 14 days'}, {'measure': 'Incidence of anti-drug antibody (ADAs)', 'timeFrame': 'Up to 14 days'}, {'measure': 'Objective response rate (ORR)', 'timeFrame': 'Up to 24 months'}, {'measure': 'Disease control rate (DCR)', 'timeFrame': 'Up to 24 months'}, {'measure': 'Duration of response (DOR) per tumor appropriate criteria: Modified Response Evaluation Criteria in Solid Tumors (mRECIST) for mesothelioma', 'timeFrame': 'Up to 24 months'}, {'measure': 'DOR per tumor appropriate criteria: Prostate Cancer Working Group 3 (PCWG3) for prostate cancer', 'timeFrame': 'Up to 24 months'}, {'measure': 'DOR per tumor appropriate criteria: Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) for other solid tumor types', 'timeFrame': 'Up to 24 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Opdivo®', 'Immunotherapy'], 'conditions': ['Advanced Cancer']}, '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', 'label': 'BMS Clinical Trial Patient Recruiting'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the safety and tolerability of BMS-986406 administered alone, in combination with nivolumab, or in combination with nivolumab and platinum-doublet chemotherapy (PDCT) in participants with advanced tumors.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nParts 1A, 1B, 1C:\n\n* Histologically or cytologically confirmed locally advanced unresectable, metastatic, or recurrent malignant tumor. Eligible tumor types are non-small cell lung cancer (NSCLC), renal cell carcinoma (RCC), pancreatic ductal adenocarcinoma (PDAC), gastric/gastroesophageal junction, castration-resistant prostate cancer (CRPC), ovarian, squamous cell carcinoma of the head and neck (SCCHN), bladder, melanoma, mesothelioma, triple negative breast cancer (TNBC), and soft tissue sarcoma, except for participants with tumors with central nervous system (CNS) metastases as the only site of active disease\n\nPart 1D:\n\n* Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) of non-squamous or squamous histology with Stage IV A/B (as defined by the 8th International Association for the Study of Lung Cancer Classification) or recurrent disease following multi-modal therapy for locally advanced disease, who have not had systemic therapy for metastatic or recurrent disease.\n\nAll Parts:\n\n* Measurable disease by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), Prostate Cancer Working Group 3 (PCWG3) (for prostate cancer), or modified Response Evaluation Criteria in Solid tumors (mRECIST) (for mesothelioma)\n* Eastern Cooperative Oncology Group Performance Status of 0 or 1\n* Adequate organ function\n\nExclusion Criteria:\n\n* Prior organ or tissue allograft\n* Leptomeningeal metastases\n* Untreated CNS metastases\n* Serious or uncontrolled medical disorders\n\nOther protocol-defined inclusion/exclusion criteria apply'}, 'identificationModule': {'nctId': 'NCT05298592', 'briefTitle': 'A Study of BMS-986406 as Monotherapy and Combination Therapies in Participants With Advanced Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'A Phase 1 First-in-human Study of BMS-986406 as Monotherapy and Combination Therapies in Participants With Advanced Malignant Tumors', 'orgStudyIdInfo': {'id': 'CA111-001'}, 'secondaryIdInfos': [{'id': '2021-006872-17', 'type': 'EUDRACT_NUMBER'}, {'id': 'U1111-1270-3670', 'type': 'REGISTRY', 'domain': 'WHO'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part 1A: BMS-986406 (Monotherapy Dose Escalation)', 'interventionNames': ['Biological: BMS-986406']}, {'type': 'EXPERIMENTAL', 'label': 'Part 1B: BMS-986406 + Nivolumab (Combination Dose Escalation)', 'interventionNames': ['Biological: BMS-986406', 'Biological: Nivolumab']}, {'type': 'EXPERIMENTAL', 'label': 'Part 1C: BMS-986406 + Nivolumab (Indication-Specific Dose Expansion)', 'interventionNames': ['Biological: BMS-986406', 'Biological: Nivolumab']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2: BMS-986406 + Nivolumab (Expansion Cohorts)', 'interventionNames': ['Biological: BMS-986406', 'Biological: Nivolumab']}, {'type': 'EXPERIMENTAL', 'label': 'Part 1D: BMS-986406 + Nivolumab + Carboplatin with Pemetrexed or Paclitaxel', 'interventionNames': ['Biological: BMS-986406', 'Biological: Nivolumab', 'Drug: Carboplatin', 'Drug: Pemetrexed', 'Drug: Paclitaxel']}], 'interventions': [{'name': 'BMS-986406', 'type': 'BIOLOGICAL', 'description': 'Specified dose on specified days', 'armGroupLabels': ['Part 1A: BMS-986406 (Monotherapy Dose Escalation)', 'Part 1B: BMS-986406 + Nivolumab (Combination Dose Escalation)', 'Part 1C: BMS-986406 + Nivolumab (Indication-Specific Dose Expansion)', 'Part 1D: BMS-986406 + Nivolumab + Carboplatin with Pemetrexed or Paclitaxel', 'Part 2: BMS-986406 + Nivolumab (Expansion Cohorts)']}, {'name': 'Nivolumab', 'type': 'BIOLOGICAL', 'otherNames': ['BMS-936558', 'Opdivo'], 'description': 'Specified dose on specified days', 'armGroupLabels': ['Part 1B: BMS-986406 + Nivolumab (Combination Dose Escalation)', 'Part 1C: BMS-986406 + Nivolumab (Indication-Specific Dose Expansion)', 'Part 1D: BMS-986406 + Nivolumab + Carboplatin with Pemetrexed or Paclitaxel', 'Part 2: BMS-986406 + Nivolumab (Expansion Cohorts)']}, {'name': 'Carboplatin', 'type': 'DRUG', 'description': 'Specified dose on specified days', 'armGroupLabels': ['Part 1D: BMS-986406 + Nivolumab + Carboplatin with Pemetrexed or Paclitaxel']}, {'name': 'Pemetrexed', 'type': 'DRUG', 'description': 'Specified dose on specified days', 'armGroupLabels': ['Part 1D: BMS-986406 + Nivolumab + Carboplatin with Pemetrexed or Paclitaxel']}, {'name': 'Paclitaxel', 'type': 'DRUG', 'description': 'Specified dose on specified days', 'armGroupLabels': ['Part 1D: BMS-986406 + Nivolumab + Carboplatin with Pemetrexed or Paclitaxel']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35213', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Local Institution - 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