Ignite Creation Date:
2025-12-25 @ 12:53 AM
Ignite Modification Date:
2026-01-01 @ 5:34 PM
Study NCT ID:
NCT05508867
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-10-07
First Post:
2022-08-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Coformulated Favezelimab/Pembrolizumab (MK-4280A) Versus Physician's Choice Chemotherapy in PD-(L)1-refractory, Relapsed or Refractory Classical Hodgkin Lymphoma (MK-4280A-008)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006689', 'term': 'Hodgkin Disease'}, {'id': 'C565324', 'term': 'Parkinson Disease 4, Autosomal Dominant Lewy Body'}], 'ancestors': [{'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C582435', 'term': 'pembrolizumab'}, {'id': 'D000069461', 'term': 'Bendamustine Hydrochloride'}, {'id': 'D000093542', 'term': 'Gemcitabine'}], 'ancestors': [{'id': 'D002087', 'term': 'Butyrates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D001562', 'term': 'Benzimidazoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 203}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-10-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2026-01-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-06', 'studyFirstSubmitDate': '2022-08-18', 'studyFirstSubmitQcDate': '2022-08-18', 'lastUpdatePostDateStruct': {'date': '2025-10-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-08-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression Free Survival (PFS) per Lugano Response Criteria as Assessed by investigator', 'timeFrame': 'Up to approximately 39 months', 'description': 'PFS is defined as the time from randomization to the first documented disease progression per Lugano criteria 2014 as assessed by investigator or death due to any cause, whichever occurs first.'}], 'secondaryOutcomes': [{'measure': 'Overall Survival (OS)', 'timeFrame': 'Up to approximately 39 months', 'description': 'OS is defined as the time from randomization to death due to any cause.'}, {'measure': 'Objective Response Rate (ORR) per Lugano Response Criteria as Assessed by investigator', 'timeFrame': 'Up to approximately 39 months', 'description': 'ORR is defined as the percentage of participants who achieve a complete response (CR) or partial response (PR) per Lugano criteria 2014 as assessed by investigator.'}, {'measure': 'Duration of Response (DOR) per Lugano Response Criteria as Assessed by investigator', 'timeFrame': 'Up to approximately 39 months', 'description': 'For participants who demonstrate CR or PR per Lugano criteria 2014 as assessed by investigator, DOR is defined as the time from the first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first.'}, {'measure': 'Number of Participants Who Experienced At Least One Adverse Event (AE)', 'timeFrame': 'Up to approximately 25 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. The number of participants who experience an AE will be presented.'}, {'measure': 'Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE)', 'timeFrame': 'Up to approximately 24 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. The number of participants who discontinue study treatment due to an AE will be presented.'}]}, 'oversightModule': {'oversightHasDmc': True, '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': ['Hodgkin Lymphoma']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.merckclinicaltrials.com/', 'label': 'Merck Clinical Trials Information'}, {'url': 'https://msd.trialsummaries.com/Study/StudyDetails?id=26284&tenant=MT_MSD_9011', 'label': 'Plain Language Summary'}]}, 'descriptionModule': {'briefSummary': 'Researchers are looking for a way to treat classical Hodgkin lymphoma (cHL) that is relapsed (the cancer has come back after treatment) or refractory (current treatment has stopped working to slow or stop cancer growth). Researchers want to learn if people who receive coformulated favezelimab/pembrolizumab (MK-4280A) live longer without the cancer getting worse compared to those who receive chemotherapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Has histologically confirmed diagnosis of classical Hodgkin lymphoma (cHL) that is 2-fluorodeoxyglucose-avid (FDG-avid).\n* Has relapsed (defined as disease progression after most recent therapy) or refractory (defined as failed to achieve CR or PR to most recent therapy) cHL and exhausted all available treatment options with known clinical benefit.\n* Has progressed on treatment with an anti-PD-(L)1 monoclonal antibody (mAb) administered either as monotherapy or in combination with other checkpoint inhibitors or other therapies.\n* Submits an archival (≤5 years) or newly obtained tumor tissue sample which has not been previously irradiated.\n\nExclusion Criteria:\n\n* Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy.\n* History of central nervous system (CNS) metastases or active CNS involvement.\n* Has an active autoimmune disease that has required systemic treatment in 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* Has an active infection requiring systemic treatment.\n* History of hemophagocytic lymphohisticytosis.\n* Has an active seizure disorder that is not well controlled.\n* Has clinically significant (ie, active) cardiovascular disease.\n* Received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization.\n* Received prior radiotherapy within 2 weeks of start of study intervention or radiation related toxicities requiring corticosteroids.\n* Has not adequately recovered from major surgical procedure.\n* Known additional malignancy that is progressing or has required active treatment within the past 3 years.\n* History of human immunodeficiency virus (HIV).\n* Has had an allogeneic hematopoietic stem cell or solid organ transplantation within the last 5 years.'}, 'identificationModule': {'nctId': 'NCT05508867', 'briefTitle': "A Study of Coformulated Favezelimab/Pembrolizumab (MK-4280A) Versus Physician's Choice Chemotherapy in PD-(L)1-refractory, Relapsed or Refractory Classical Hodgkin Lymphoma (MK-4280A-008)", 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': "A Phase 2 Randomized Clinical Study of MK-4280A (Coformulated Favezelimab [MK-4280] Plus Pembrolizumab [MK-3475]) Versus Physician's Choice Chemotherapy in PD-(L)1-refractory, Relapsed or Refractory Classical Hodgkin Lymphoma (KEYFORM-008)", 'orgStudyIdInfo': {'id': '4280A-008'}, 'secondaryIdInfos': [{'id': 'MK-4280A-008', 'type': 'OTHER', 'domain': 'MSD'}, {'id': '2023-503615-14-00', 'type': 'REGISTRY', 'domain': 'EU CT'}, {'id': 'U1111-1287-5864', 'type': 'REGISTRY', 'domain': 'UTN'}, {'id': '2022-000371-39', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Favezelimab/Pembrolizumab', 'description': 'Participants will receive coformulated favezelimab/pembrolizumab (800 mg/200 mg) by intravenous (IV) infusion on Day 1, then every three weeks (Q3W), for up to 35 infusions.', 'interventionNames': ['Biological: favezelimab/pembrolizumab']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Chemotherapy (Bendamustine or Gemcitabine)', 'description': "Participants will receive physician's choice of EITHER bendamustine by IV infusion at a dose between 90 and 120 mg/m\\^2 on Day 1 and Day 2 of either a 3- or 4-week cycle for up to 6 cycles OR gemcitabine by IV infusion at a dose between 800 and 1200 mg/m\\^2 on Day 1 and Day 8 of a 3-week cycle for up to 6 cycles.", 'interventionNames': ['Drug: bendamustine', 'Drug: gemcitabine']}], 'interventions': [{'name': 'favezelimab/pembrolizumab', 'type': 'BIOLOGICAL', 'otherNames': ['MK-4820A'], 'description': 'Coformulated favezelimab/pembrolizumab (800 mg/200 mg), IV infusion', 'armGroupLabels': ['Favezelimab/Pembrolizumab']}, {'name': 'bendamustine', 'type': 'DRUG', 'otherNames': ['BENDEKA®'], 'description': 'IV infusion', 'armGroupLabels': ['Chemotherapy (Bendamustine or Gemcitabine)']}, {'name': 'gemcitabine', 'type': 'DRUG', 'otherNames': ['GEMZAR®'], 'description': 'IV infusion', 'armGroupLabels': ['Chemotherapy (Bendamustine or Gemcitabine)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85719', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'The University of Arizona Cancer Center - North Campus ( Site 2216)', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '90404', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'UCLA Hematology/Oncology - Santa Monica ( Site 2208)', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90502', 'city': 'Torrance', 'state': 'California', 'country': 'United States', 'facility': 'Lundquist Institute for Biomedical Innovation at Harbor-UCLA-Hematology and Medical Oncology ( Site', 'geoPoint': {'lat': 33.83585, 'lon': -118.34063}}, {'zip': '33612', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Moffitt Cancer Center ( Site 2200)', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '40536', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'University of Kentucky Chandler Medical Center ( Site 2201)', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'zip': '21201', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'University of Maryland-Greenebaum Comprehensive Cancer Center ( Site 2210)', 'geoPoint': {'lat': 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