Ignite Creation Date:
2025-12-24 @ 2:53 PM
Ignite Modification Date:
2025-12-25 @ 6:21 PM
Study NCT ID:
NCT06136559
Status:
RECRUITING
Last Update Posted:
2025-12-19
First Post:
2023-11-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Nemtabrutinib (MK-1026) Versus Comparator (Investigator's Choice of Ibrutinib or Acalabrutinib) in First Line (1L) Chronic Lymphocytic Leukemia (CLL)/ Small Lymphocytic Lymphoma (SLL) (MK-1026-011/BELLWAVE-011)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015451', 'term': 'Leukemia, Lymphocytic, Chronic, B-Cell'}], 'ancestors': [{'id': 'D015448', 'term': 'Leukemia, B-Cell'}, {'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'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': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000721068', 'term': 'ARQ531'}, {'id': 'C551803', 'term': 'ibrutinib'}, {'id': 'C000604908', 'term': 'acalabrutinib'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1200}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-12-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2032-09-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-18', 'studyFirstSubmitDate': '2023-11-13', 'studyFirstSubmitQcDate': '2023-11-13', 'lastUpdatePostDateStruct': {'date': '2025-12-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-11-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2032-09-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective Response Rate (ORR) per Chronic Lymphocytic Leukemia (iwCLL) Criteria 2018 as assessed by Blinded Independent Central Review (BICR)', 'timeFrame': 'Up to ~33 months', 'description': "ORR is defined as the percentage of participants with complete response (CR), complete response with an incomplete recovery of the participant's bone marrow (CRi), nodular partial response (nPR), or partial response (PR), per iwCLL Criteria 2018 as assessed by BICR."}, {'measure': 'Progression-Free Survival (PFS) per iwCLL Criteria 2018 as assessed by BICR', 'timeFrame': 'Up to ~104 months', 'description': 'PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. PD is evaluated per iwCLL Criteria 2018 as assessed by BICR.'}], 'secondaryOutcomes': [{'measure': 'Overall Survival (OS)', 'timeFrame': 'Up to ~104 months', 'description': 'OS is defined as the time from randomization to death due to any cause.'}, {'measure': 'Duration of Response (DOR) per iwCLL Criteria 2018 as assessed by BICR', 'timeFrame': 'Up to ~104 months', 'description': "For participants who demonstrate a complete response (CR), complete response with an incomplete recovery of the participant's bone marrow (CRi), nodular partial response (nPR), or partial response (PR) per iwCLL Criteria 2018 as assessed by BICR, DOR is defined as the time from the first documented evidence of CR, CRi, nPR, or PR that led to response until disease progression or death due to any cause, whichever occurs first."}, {'measure': 'Number of Participants Who Experience One or More Adverse Events (AEs)', 'timeFrame': 'Up to ~104 months', 'description': 'An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.'}, {'measure': 'Number of Participants Who Discontinue Study Treatment Due to an AE', 'timeFrame': 'Up to ~104 months', 'description': 'An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Lymphocytic Leukemia', 'Small Lymphocytic Lymphoma']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.merckclinicaltrials.com', 'label': 'Merck Clinical Trials Information'}, {'url': 'https://msd.trialsummaries.com/Study/StudyDetails?id=26310&tenant=MT_MSD_9011', 'label': 'Plain Language Summary'}]}, 'descriptionModule': {'briefSummary': "The goal of this study is to evaluate nemtabrutinib compared with investigator's choice of ibrutinib or acalabrutinib in participants with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) who have not received any prior therapy. The primary hypotheses are that (1) nemtabrutinib is non-inferior to ibrutinib or acalabrutinib with respect to objective response rate (ORR) per International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Criteria 2018 by blinded independent central review (BICR) and (2) nemtabrutinib is superior to ibrutinib or acalabrutinib with respect to progression free survival (PFS) per iwCLL Criteria 2018 by BICR."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nThe main inclusion criteria include but are not limited to the following:\n\n* Confirmed diagnosis of CLL/SLL and active disease clearly documented to have a need to initiate therapy.\n* Has at least 1 marker of disease burden.\n* Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 within 7 days before randomization.\n* Has the ability to swallow and retain oral medication.\n* Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV deoxyribonucleic acid (DNA) viral load before randomization.\n* Participants with history of hepatitis C virus (HCV) infection are eligible if HCV ribonucleic acid (RNA) viral load is undetectable at screening.\n* Participants with human immunodeficiency virus (HIV) who meet ALL eligibility criteria.\n\nExclusion Criteria:\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Has an active hepatitis B virus/ hepatitis C virus (HBV/HCV) infection.\n* Has gastrointestinal (GI) dysfunction that may affect drug absorption.\n* Has diagnosis of Richter Transformation or active central nervous system (CNS) involvement by CLL/SLL.\n* Has had acquired immune deficiency syndrome (AIDS)-defining opportunistic infection in the past 12 months before screening.\n* Has clinically significant cardiovascular disease.\n* Has hypersensitivity to nemtabrutinib or contraindication to ibrutinib or acalabrutinib, or any of the excipients.\n* Has history of severe bleeding disorder.\n* Has known additional malignancy that is progressing or has required active treatment within the past 2 years.\n* Has received any systemic anticancer therapy for CLL/SLL.\n* Is currently being treated with p-glycoprotein (P-gp) substrates with a narrow therapeutic index, cytochrome P450 3A (CYP3A) strong or moderate inducers or CYP3A strong inhibitors.\n* Received prior radiotherapy within 2 weeks of start of study intervention, or radiation-related toxicities, requiring corticosteroids.\n* Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed.\n* Has received an investigational agent or has used an investigational device within 4 weeks before study intervention administration.\n* Has active infection requiring systemic therapy, including intravenous (IV) antibiotics during screening.\n* Participants who have not adequately recovered from major surgery or have ongoing surgical complications.'}, 'identificationModule': {'nctId': 'NCT06136559', 'briefTitle': "A Study of Nemtabrutinib (MK-1026) Versus Comparator (Investigator's Choice of Ibrutinib or Acalabrutinib) in First Line (1L) Chronic Lymphocytic Leukemia (CLL)/ Small Lymphocytic Lymphoma (SLL) (MK-1026-011/BELLWAVE-011)", 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': "A Phase 3, Randomized Study to Compare Nemtabrutinib Versus Comparator (Investigator's Choice of Ibrutinib or Acalabrutinib) in Participants With Untreated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (BELLWAVE-011)", 'orgStudyIdInfo': {'id': '1026-011'}, 'secondaryIdInfos': [{'id': '2022-501697-19-00', 'type': 'REGISTRY', 'domain': 'EU CT'}, {'id': 'U1111-1281-7895', 'type': 'REGISTRY', 'domain': 'UTN'}, {'id': 'MK-1026-011', 'type': 'OTHER', 'domain': 'MSD'}, {'id': 'BELLWAVE-011', 'type': 'OTHER', 'domain': 'MSD'}, {'id': 'jRCT2031230697', 'type': 'REGISTRY', 'domain': 'jRCT'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nemtabrutinib', 'description': 'Participants will receive nemtabrutinib at specified dose until disease progression, unacceptable toxicity or until discontinuation criteria are met.', 'interventionNames': ['Drug: Nemtabrutinib']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Ibrutinib/Acalabrutinib', 'description': "Participants will receive investigator's choice of ibrutinib or acalabrutinib at specified dose until disease progression, unacceptable toxicity or until discontinuation criteria are met.", 'interventionNames': ['Drug: Ibrutinib', 'Drug: Acalabrutinib']}], 'interventions': [{'name': 'Nemtabrutinib', 'type': 'DRUG', 'otherNames': ['MK-1026', 'ARQ 531'], 'description': 'Administered orally', 'armGroupLabels': ['Nemtabrutinib']}, {'name': 'Ibrutinib', 'type': 'DRUG', 'description': 'Administered orally', 'armGroupLabels': ['Ibrutinib/Acalabrutinib']}, {'name': 'Acalabrutinib', 'type': 'DRUG', 'description': 'Administered orally', 'armGroupLabels': ['Ibrutinib/Acalabrutinib']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36604', 'city': 'Mobile', 'state': 'Alabama', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '888-577-8839'}], 'facility': 'USA Mitchell Cancer Institute ( Site 0014)', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '86301', 'city': 'Prescott', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '888-577-8839'}], 'facility': 'Arizona Oncology Associates - NAHOA ( Site 8007)', 'geoPoint': {'lat': 34.54002, 'lon': -112.4685}}, {'zip': '94704', 'city': 'Berkeley', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '888-577-8839'}], 'facility': 'Alta Bates Summit Medical Center ( Site 0004)', 'geoPoint': {'lat': 37.87159, 'lon': -122.27275}}, {'zip': '92093-0698', 'city': 'La Jolla', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '888-577-8839'}], 'facility': 'Moores Cancer Center ( Site 0003)', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '80218', 'city': 'Denver', 'state': 'Colorado', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '888-577-8839'}], 'facility': 'Saint Joseph Hospital ( Site 0026)', 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'Indiana', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '888-577-8839'}], 'facility': 'Parkview Research Center at Parkview Regional Medical Center ( Site 0002)', 'geoPoint': {'lat': 41.1306, 'lon': -85.12886}}, {'zip': '52242', 'city': 'Iowa City', 'state': 'Iowa', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '888-577-8839'}], 'facility': 'University of Iowa-Holden Comprehensive Cancer Center ( Site 0017)', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}, {'zip': '50263', 'city': 'Waukee', 'state': 'Iowa', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '515-282-2921'}], 'facility': 'University of Iowa ( Site 0057)', 'geoPoint': {'lat': 41.61166, 'lon': -93.88523}}, {'zip': '41017', 'city': 'Edgewood', 'state': 'Kentucky', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '888-577-8839'}], 'facility': 'Saint Elizabeth Healthcare ( Site 0041)', 'geoPoint': {'lat': 39.01867, 'lon': -84.58189}}, {'zip': '49503', 'city': 'Grand Rapids', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '888-577-8839'}], 'facility': 'Corewell Health-Lemmon Holton Cancer Pavilion ( Site 0011)', 'geoPoint': {'lat': 42.96336, 'lon': -85.66809}}, {'zip': '55416', 'city': 'Saint Louis Park', 'state': 'Minnesota', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '952-993-3252'}], 'facility': 'Regions Hospital ( Site 0042)', 'geoPoint': {'lat': 44.9483, 'lon': -93.34801}}, {'zip': '64132', 'city': 'Kansas City', 'state': 'Missouri', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Coordinator', 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University Medical Center ( Site 0016)', 'geoPoint': {'lat': 40.88593, 'lon': -74.04347}}, {'zip': '14263', 'city': 'Buffalo', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '888-577-8839'}], 'facility': 'Roswell Park Cancer Institute ( Site 0023)', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}, {'zip': '28207', 'city': 'Charlotte', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '704-342-1900'}], 'facility': 'Oncology Specialists of Charlotte ( Site 0054)', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '27534', 'city': 'Goldsboro', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '919-587-9088'}], 'facility': 'Southeastern Medical Oncology Center ( Site 0049)', 'geoPoint': 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'37203', 'city': 'Nashville', 'state': 'Tennessee', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '615-986-4350'}], 'facility': 'Tennessee Oncology ( Site 0031)', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '78705', 'city': 'Austin', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '888-577-8839'}], 'facility': 'Texas Oncology - Central/South Texas ( Site 8008)', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '76104', 'city': 'Fort Worth', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '817-759-7013'}], 'facility': 'The Center for Cancer and Blood Disorders ( Site 0032)', 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}, {'zip': '78217', 'city': 'San Antonio', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '888-577-8839'}], 'facility': 'Texas Oncology - San Antonio ( Site 8006)', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '75702', 'city': 'Tyler', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '888-577-8839'}], 'facility': 'Texas Oncology - Northeast Texas ( Site 8012)', 'geoPoint': {'lat': 32.35126, 'lon': -95.30106}}, {'zip': '22903', 'city': 'Charlottesville', 'state': 'Virginia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '434-243-2649'}], 'facility': 'University of Virginia Cancer Center ( Site 0040)', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}, {'zip': '22031', 'city': 'Fairfax', 'state': 'Virginia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '888-577-8839'}], 'facility': 'Inova Schar Cancer Institute ( Site 0015)', 'geoPoint': {'lat': 38.84622, 'lon': -77.30637}}, {'zip': '23298', 'city': 'Richmond', 'state': 'Virginia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '804-628-2072'}], 'facility': 'Virginia Commonwealth University (VCU) Medical Center ( Site 0030)', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}, {'zip': '99208', 'city': 'Spokane', 'state': 'Washington', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '888-577-8839'}], 'facility': 'Medical Oncology Associates, PS (dba Summit Cancer Centers) ( Site 0010)', 'geoPoint': {'lat': 47.65966, 'lon': -117.42908}}, {'zip': '53715', 'city': 'Madison', 'state': 'Wisconsin', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '608-410-2700'}], 'facility': 'SSM Health Dean Medical Group - South Madison Campus Health Research/Circuit Clinical ( Site 0048)', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}, {'zip': '53792', 'city': 'Madison', 'state': 'Wisconsin', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '888-577-8839'}], 'facility': 'University Hospital and UW Health Clinics ( Site 0006)', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}, {'zip': '2065', 'city': 'St Leonards', 'state': 'New South Wales', 'status': 'COMPLETED', 'country': 'Australia', 'facility': 'Royal North Shore Hospital ( Site 2806)', 'geoPoint': {'lat': -33.82344, 'lon': 151.19836}}, {'zip': '2800', 'city': 'Mechelen', 'state': 'Antwerpen', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '+3215892080'}], 'facility': 'AZ Sint-Maarten, Campus Leopoldstraat 2 ( Site 0205)', 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