Ignite Creation Date:
2025-12-24 @ 12:53 PM
Ignite Modification Date:
2026-01-11 @ 3:32 AM
Study NCT ID:
NCT06460961
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-18
First Post:
2024-06-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of MK-6837 as a Monotherapy and Combination Therapy in Participants With Advanced/Metastatic Solid Tumors (MK-6837-001)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009362', 'term': 'Neoplasm Metastasis'}, {'id': 'C565324', 'term': 'Parkinson Disease 4, Autosomal Dominant Lewy Body'}], 'ancestors': [{'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C582435', 'term': 'pembrolizumab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 168}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-07-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2027-07-13', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-17', 'studyFirstSubmitDate': '2024-06-11', 'studyFirstSubmitQcDate': '2024-06-11', 'lastUpdatePostDateStruct': {'date': '2025-12-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-06-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-07-13', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants who experience one or more dose-limiting toxicities (DLTs)', 'timeFrame': 'Cycle 1 (Up to approximately 21 days); each cycle is 21 days.', 'description': 'The following events will be considered a DLT unless clearly due to underlying disease or extraneous causes: Grade 4 neutropenia lasting \\>7 days; Grade 3 or higher thrombocytopenia associated with clinically significant bleeding, regardless of duration; All Grade 3 or higher nonhematologic toxicities (with exceptions); Any abnormality that results in a drug induced liver injury; Febrile neutropenia Grade 3 or 4; Prolonged delay (\\>2 weeks) in initiating treatment after the first 21 days due to intervention-related toxicity; Any intervention-related toxicity that causes the participant to discontinue intervention during the first 21 days; Grade 5 toxicity. The number of participants who experience a DLT will be presented.'}, {'measure': 'Number of participants who experience one or more adverse events (AEs)', 'timeFrame': 'Up to approximately 59 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 intervention due to an AE', 'timeFrame': 'Up to approximately 59 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.'}], 'secondaryOutcomes': [{'measure': 'Maximum concentration (Cmax) of MK-6837 in plasma', 'timeFrame': 'Day 1 of cycles 1 and 4: Predose, ~30 minutes, 1, 2, and 4 hours postdose and once daily on Days 2, 3, 5, 8, 11, and 15 postdose; Cycles 2, 3, 5, 6, and every 6 cycles thereafter (up to ~59 months): predose and ~30 minutes postdose; each cycle is 21 days', 'description': 'The Cmax of MK-6837 in plasma will be determined.'}, {'measure': 'Minimum concentration (Ctrough) of MK-6837 in plasma', 'timeFrame': 'Day 1 of cycles 1 and 4: Predose, ~30 minutes, 1, 2, and 4 hours postdose and once daily on Days 2, 3, 5, 8, 11, and 15 postdose; Cycles 2, 3, 5, 6, and every 6 cycles thereafter (up to ~59 months): predose and ~30 minutes postdose; each cycle is 21 days', 'description': 'The Ctrough of MK-6837 in plasma will be determined.'}, {'measure': 'Area Under the Concentration-Time Curve (AUC) of MK-6837 in plasma', 'timeFrame': 'Day 1 of cycles 1 and 4: Predose, ~30 minutes, 1, 2, and 4 hours postdose and once daily on Days 2, 3, 5, 8, 11, and 15 postdose; Cycles 2, 3, 5, 6, and every 6 cycles thereafter (up to ~59 months): predose and ~30 minutes postdose; each cycle is 21 days', 'description': 'The AUC of MK-6837 in plasma will be determined.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Programmed Cell Death-1 (PD1, PD-1)', 'Programmed Cell Death 1 Ligand 1 (PDL1, PD-L1)', 'Programmed Cell Death 1 Ligand 2 (PDL2, PD-L2)'], 'conditions': ['Neoplasm Metastasis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.merckclinicaltrials.com/', 'label': 'Merck Clinical Trials Information'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of MK-6837, administered as a monotherapy and in combination with pembrolizumab (MK-3475), in participants with histologically or cytologically confirmed advanced/metastatic solid tumors that have not responded to conventional therapy. There will not be any hypothesis testing in the study.'}, '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* Histologically or cytologically confirmed solid tumor by pathology report that is advanced or metastatic\n* Human Immunodeficiency Virus (HIV)-infected participants must have well controlled HIV on Antiretroviral Therapy (ART)\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 viral load before allocation\n* Participants with history of Hepatitis C Virus (HCV) infection are eligible if HCV viral load is undetectable at screening\n\nExclusion Criteria:\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Has not recovered to Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 or better from any Adverse Events (AEs) that were due to cancer therapeutics administered more than 4 weeks earlier\n* History of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years\n* Has clinically significant cardiovascular disease\n* HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease\n* Received prior systemic anticancer therapy including investigational agents within 4 weeks before the first dose of study intervention\n* Has received any prior immunotherapy and was discontinued from that treatment due to a Grade 3 or higher immune-related AE (except endocrine disorders that can be treated with replacement therapy) or was discontinued from that treatment due to Grade 2 myocarditis or recurrent Grade 2 pneumonitis\n* Received prior radiotherapy within 2 weeks of start of study intervention, or has 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 is allowed\n* Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days before the first dose of study intervention\n* Known additional malignancy that is progressing or has required active treatment within the past 2 years\n* Known active Central Nervous System (CNS) metastases and/or carcinomatous meningitis\n* Active autoimmune disease that has required systemic treatment in the past 2 years except replacement therapy\n* History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease\n* Active infection requiring systemic therapy\n* History of allogeneic tissue/solid organ transplant\n* Participants who have not adequately recovered from major surgery or have ongoing surgical complications"}, 'identificationModule': {'nctId': 'NCT06460961', 'briefTitle': 'A Study of MK-6837 as a Monotherapy and Combination Therapy in Participants With Advanced/Metastatic Solid Tumors (MK-6837-001)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Phase 1 Open-label, Multicenter Study of MK-6837 as Monotherapy and Combination Therapy in Participants With Advanced/Metastatic Solid Tumors', 'orgStudyIdInfo': {'id': '6837-001'}, 'secondaryIdInfos': [{'id': 'MK-6837-001', 'type': 'OTHER', 'domain': 'MSD'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1: MK-6837 Monotherapy', 'description': 'Participants receive escalating doses of MK-6837 via intravenous (IV) infusion once every 3 weeks (Q3W) (Day 1 of every 21-day cycle) until progressive disease or discontinuation.', 'interventionNames': ['Biological: MK-6837', 'Drug: Rescue Medications']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 2: MK-6837 + Pembrolizumab Combination Therapy', 'description': 'Participants receive escalating doses of MK-6837 via IV infusion Q3W (Day 1 of every 21-day cycle) until progressive disease or discontinuation PLUS 200mg of pembrolizumab via IV infusion Q3W (Day 1 of every 21-day cycle) for up to 35 administrations (up to \\~2 years).', 'interventionNames': ['Biological: MK-6837', 'Biological: Pembrolizumab', 'Drug: Rescue Medications']}], 'interventions': [{'name': 'MK-6837', 'type': 'BIOLOGICAL', 'description': 'IV Infusion', 'armGroupLabels': ['Arm 1: MK-6837 Monotherapy', 'Arm 2: MK-6837 + Pembrolizumab Combination Therapy']}, {'name': 'Pembrolizumab', 'type': 'BIOLOGICAL', 'otherNames': ['MK-3475', 'KEYTRUDA®'], 'description': 'IV Infusion', 'armGroupLabels': ['Arm 2: MK-6837 + Pembrolizumab Combination Therapy']}, {'name': 'Rescue Medications', 'type': 'DRUG', 'description': 'Antihistamine, H2 receptor antagonist, acetaminophen (or equivalent), dexamethasone (or equivalent) administered per product label prior to MK-6837.', 'armGroupLabels': ['Arm 1: MK-6837 Monotherapy', 'Arm 2: MK-6837 + Pembrolizumab Combination Therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '07960', 'city': 'Morristown', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Atlantic Health System Morristown Medical Center ( Site 4001)', 'geoPoint': {'lat': 40.79677, 'lon': -74.48154}}, {'zip': '97213', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Providence Portland Medical Center ( Site 4002)', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'South Texas Accelerated Research Therapeutics (START) ( Site 4003)', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '2145', 'city': 'Westmead', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Westmead Hospital ( Site 1002)', 'geoPoint': {'lat': -33.80383, 'lon': 150.98768}}, {'zip': '3004', 'city': 'Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'The Alfred Hospital ( Site 1001)', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'zip': 'M5G 2M9', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Princess Margaret Cancer Centre ( Site 2001)', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': '5265601', 'city': 'Ramat Gan', 'country': 'Israel', 'facility': 'Sheba Medical Center-ONCOLOGY ( Site 3001)', 'geoPoint': {'lat': 32.08227, 'lon': 34.81065}}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'ipdSharingStatementModule': {'url': 'https://externaldatasharing-msd.com/', 'ipdSharing': 'YES', 'description': 'https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}