Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2026-01-09 @ 1:35 AM
Study NCT ID:
NCT06419634
Status:
RECRUITING
Last Update Posted:
2025-10-30
First Post:
2024-05-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of BMS-986497 (ORM-6151) as a Monotherapy, in Double and Triple Combination With Azacitidine and Venetoclax in Participants With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015470', 'term': 'Leukemia, Myeloid, Acute'}, {'id': 'D009190', 'term': 'Myelodysplastic Syndromes'}], 'ancestors': [{'id': 'D007951', 'term': 'Leukemia, Myeloid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D001855', 'term': 'Bone Marrow Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001374', 'term': 'Azacitidine'}, {'id': 'C579720', 'term': 'venetoclax'}], 'ancestors': [{'id': 'D001372', 'term': 'Aza Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D012263', 'term': 'Ribonucleosides'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 105}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-05-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2030-09-16', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-29', 'studyFirstSubmitDate': '2024-05-14', 'studyFirstSubmitQcDate': '2024-05-14', 'lastUpdatePostDateStruct': {'date': '2025-10-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-05-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-02-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of dose-limiting toxicities (DLTs)', 'timeFrame': 'Up to 21 days'}, {'measure': 'Incidence of treatment-emergent adverse events (TEAEs)', 'timeFrame': 'Up to 2 years'}, {'measure': 'Determine the Recommended Phase 2 Dose (RP2D) of BMS-986497 as Monotherapy', 'timeFrame': 'Up to 2 years'}, {'measure': 'RP2D of BMS-986497 as Combination Therapy', 'timeFrame': 'Up to 2 years', 'description': 'The combination therapy included BMS-986497 and Azacitidine'}, {'measure': 'RP2D of BMS-986497 as Triple Combination Therapy', 'timeFrame': 'Up to 2 years', 'description': 'The triple combination therapy included BMS-986497, Azacitidine and Venetoclax.'}], 'secondaryOutcomes': [{'measure': 'Maximum concentration (Cmax)', 'timeFrame': 'Up to 2 years'}, {'measure': 'Time to reach Cmax (Tmax)', 'timeFrame': 'Up to 2 years'}, {'measure': 'Area under the curve from time 0 to last quantifiable concentration (AUC0-last)', 'timeFrame': 'Up to 2 years'}, {'measure': 'Overall response rate (ORR)', 'timeFrame': 'Up to 4 years'}, {'measure': 'Duration of response (DoR)', 'timeFrame': 'Up to 4 years'}, {'measure': 'Best overall response (BOR)', 'timeFrame': 'Up to 4 years'}, {'measure': 'Complete remission (CR)', 'timeFrame': 'Up to 4 years'}, {'measure': 'Complete remission with incomplete hematologic recovery (Cri)', 'timeFrame': 'Up to 4 years'}, {'measure': 'Complete remission with partial hematologic recovery (CRh) rate', 'timeFrame': 'Up to 4 years'}, {'measure': 'Event-free survival (EFS)', 'timeFrame': 'Up to 4 years'}, {'measure': 'Transition rate to allogeneic hematopoietic stem cell transplantation (HSCT)', 'timeFrame': 'Up to 4 years'}, {'measure': 'Incidence of Anti-drug antibody (ADA) against BMS-986497', 'timeFrame': 'Up to 2 years'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['BMS-986497', 'First-in-Human', 'ORM-6151', 'Acute myeloid leukemia (AML)', 'Myelodysplastic syndrome (MDS)', 'Cluster of differentiation 33 (CD33)', 'G1 to S phase transition 1 (GSPT1)', 'Open label study'], 'conditions': ['Acute Myeloid Leukemia', 'Myelodysplastic Syndrome']}, '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/NCT06419634.html', 'label': 'BMS Clinical Trial Patient Recruiting'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the safety, tolerability, drug levels, drug efficacy and determine the recommended dose of BMS-986497 as a monotherapy, in double combination with Azacitidine and in triple combination with Azacitidine and Venetoclax in participants with relapsed or refractory acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults with primary or secondary relapsed and/or refractory acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS).\n* Detectable levels of cluster of differentiation 33 (CD33) expression.\n* Failed alternative therapies with established benefit.\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤2 and adequate organ function.\n\nExclusion Criteria:\n\n* Acute Promyelocytic Leukemia.\n* Clinically active central nervous system leukemia.\n* Active malignant solid tumor.\n* Pregnant or breastfeeding.\n* Other protocol-defined inclusion/exclusion criteria apply.'}, 'identificationModule': {'nctId': 'NCT06419634', 'briefTitle': 'Study of BMS-986497 (ORM-6151) as a Monotherapy, in Double and Triple Combination With Azacitidine and Venetoclax in Participants With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'Phase I Multicenter, Open-Label, First-in-Human Study of BMS-986497 (ORM-6151) as a Monotherapy, in Double Combination With Azacitidine and in Triple Combination With Azacitidine and Venetoclax in Subjects With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome', 'orgStudyIdInfo': {'id': 'CA235-0001'}, 'secondaryIdInfos': [{'id': '2024-519537-29', 'type': 'OTHER', 'domain': 'EU CTR'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part 1: Dose Escalation BMS-986497 (Monotherapy)', 'interventionNames': ['Drug: BMS-986497']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2, Cohort A: Dose Expansion BMS-986497 (Combination Therapy)', 'interventionNames': ['Drug: BMS-986497', 'Drug: Azacitidine']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2, Cohort B: Dose Expansion BMS-986497 (Triple Combination Therapy)', 'interventionNames': ['Drug: BMS-986497', 'Drug: Azacitidine', 'Drug: Venetoclax']}], 'interventions': [{'name': 'BMS-986497', 'type': 'DRUG', 'otherNames': ['ORM-6151'], 'description': 'Specified dose on specified days', 'armGroupLabels': ['Part 1: Dose Escalation BMS-986497 (Monotherapy)', 'Part 2, Cohort A: Dose Expansion BMS-986497 (Combination Therapy)', 'Part 2, Cohort B: Dose Expansion BMS-986497 (Triple Combination Therapy)']}, {'name': 'Azacitidine', 'type': 'DRUG', 'description': 'Specified dose on specified days', 'armGroupLabels': ['Part 2, Cohort A: Dose Expansion BMS-986497 (Combination Therapy)', 'Part 2, Cohort B: Dose Expansion BMS-986497 (Triple Combination Therapy)']}, {'name': 'Venetoclax', 'type': 'DRUG', 'description': 'Specified dose on specified days', 'armGroupLabels': ['Part 2, Cohort B: Dose Expansion BMS-986497 (Triple Combination Therapy)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06510', 'city': 'New Haven', 'state': 'Connecticut', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Amer Zeidan, Site 0011', 'role': 'CONTACT', 'phone': '203-737-7078'}], 'facility': 'Yale-New Haven Hospital', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jessica Altman, Site 0010', 'role': 'CONTACT', 'phone': '312-503-1794'}], 'facility': 'Northwestern Memorial Hospital', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'WITHDRAWN', 'country': 'United States', 'facility': 'Local Institution - 0007', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Rupa Narayan, Site 0014', 'role': 'CONTACT', 'phone': '617-724-3456'}], 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '63108', 'city': 'St Louis', 'state': 'Missouri', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Geoffrey Uy, Site 0013', 'role': 'CONTACT', 'phone': '314-273-1039'}], 'facility': 'Washington University School of Medicine, Siteman Cancer Center', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '07601', 'city': 'Hackensack', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jamie Koprivnikar, Site 0008', 'role': 'CONTACT', 'phone': '551-996-3925'}], 'facility': 'John Theurer Cancer Center at Hackensack University Medical Center', 'geoPoint': {'lat': 40.88593, 'lon': -74.04347}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'status': 'WITHDRAWN', 'country': 'United States', 'facility': 'Columbia University Irving Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Abhishek Maiti, Site 0006', 'role': 'CONTACT', 'phone': '832-696-8407'}], 'facility': 'University of Texas MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '22031', 'city': 'Fairfax', 'state': 'Virginia', 'status': 'WITHDRAWN', 'country': 'United States', 'facility': 'Local Institution - 0009', 'geoPoint': {'lat': 38.84622, 'lon': -77.30637}}, {'zip': 'M5G 2M9', 'city': 'Toronto', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Andre Schuh, Site 0002', 'role': 'CONTACT', 'phone': '4168998644'}], 'facility': 'Princess Margaret Cancer Centre', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'H3T 1E2', 'city': 'Montreal', 'state': 'Quebec', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Sarit Assouline, Site 0003', 'role': 'CONTACT', 'phone': '5143408222x28434'}], 'facility': 'Jewish General Hospital', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': '13273', 'city': 'Marseille', 'state': 'Bouches-du-Rhône', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Site 0017', 'role': 'CONTACT'}], 'facility': 'Local Institution - 0017', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '75010', 'city': 'Paris', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Site 0018', 'role': 'CONTACT'}], 'facility': 'Local Institution - 0018', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '31100', 'city': 'Toulouse', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Site 0022', 'role': 'CONTACT'}], 'facility': 'Local Institution - 0022', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '08036', 'city': 'Barcelona', 'state': 'Catalunya [Cataluña]', 'status': 'NOT_YET_RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Site 0020', 'role': 'CONTACT'}], 'facility': 'Local Institution - 0020', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}], 'centralContacts': [{'name': 'BMS Study Connect Contact Center www.BMSStudyConnect.com', 'role': 'CONTACT', 'email': 'Clinical.Trials@bms.com', 'phone': '855-907-3286'}, {'name': 'First line of the email MUST contain NCT # and Site #.', 'role': 'CONTACT'}], 'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': "BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria.\n\nAdditional information regarding Bristol Myer Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and research/disclosurecommitment.html"}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}