Ignite Creation Date:
2025-12-25 @ 2:17 AM
Ignite Modification Date:
2025-12-27 @ 11:02 PM
Study NCT ID:
NCT06077760
Status:
RECRUITING
Last Update Posted:
2025-12-18
First Post:
2023-10-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Intismeran Autogene (V940) Plus Pembrolizumab (MK-3475) Versus Placebo Plus Pembrolizumab in Participants With Non-small Cell Lung Cancer (V940-002)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C582435', 'term': 'pembrolizumab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 868}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-12-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2035-12-21', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-17', 'studyFirstSubmitDate': '2023-10-05', 'studyFirstSubmitQcDate': '2023-10-05', 'lastUpdatePostDateStruct': {'date': '2025-12-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-10-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-06-25', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Disease- Free Survival (DFS)', 'timeFrame': 'Up to ~78 months', 'description': 'DFS is defined as the time from randomization to any recurrence (local, locoregional, regional or distant), occurrence of new primary NSCLC, as assessed by the investigator, or death due to any cause, whichever occurs first.'}], 'secondaryOutcomes': [{'measure': 'Overall Survival (OS)', 'timeFrame': 'Up to ~12 years', 'description': 'OS is defined as the time from randomization to death due to any cause.'}, {'measure': 'Distant Metastasis-Free Survival (DMFS)', 'timeFrame': 'Up to ~12 years', 'description': 'DMFS is defined as the time from randomization to the first diagnosis of a distant metastasis as assessed by the investigator, or death due to any cause, whichever occurs first.'}, {'measure': 'Lung Cancer Specific Survival (LCSS)', 'timeFrame': 'Up to ~12 years', 'description': 'LCSS is defined as the time from randomization to death due to lung cancer.'}, {'measure': 'Change from Baseline in the European Organization for Research and Treatment of Cancer (EORTC)-Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status/Quality of Life (Items 29 and 30) Combined Score', 'timeFrame': 'Baseline and up to ~12 years', 'description': 'The EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life of cancer patients. Participant responses to the questions "How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?" will be scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores will be standardized, so that scores range from 0 to 100. Higher scores indicate a better overall health status. The change from baseline in global health status/quality of life (EORTC QLQ-C30 Items 29 and 30) combined score will be presented.'}, {'measure': 'Change from Baseline in the EORTC QLQ-C30 Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30', 'timeFrame': 'Baseline and up to ~12 years', 'description': 'The EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life of cancer patients. Participant responses to 5 questions about their physical functioning will be scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores will be standardized, so that scores range from 0 to 100. Higher scores indicate a worse level of physical functioning. The change from baseline in physical functioning (EORTC QLQ-C30 Items 1-5) combined score will be presented.'}, {'measure': 'Change from Baseline in the EORTC QLQ-C30 Role Functioning (Items 6 and 7) Combined Score on the EORTC QLQ-C30', 'timeFrame': 'Baseline and up to ~12 years', 'description': 'The EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life of cancer patients. Participant responses to the questions "Were you limited in doing either your work or other daily activities during the past week?" and " Were you limited in pursuing your hobbies or other leisure time activities during the past week?" will be scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores will be standardized, so that scores range from 0 to 100. Higher scores indicate a worse level of role functioning. The change from baseline in role functioning (EORTC QLQ-C30 Items 6 and 7) combined score will be presented.'}, {'measure': 'Change from Baseline in the EORTC QLQ-C30 Dyspnea (Item 8) Score on the EORTC QLQ-C30', 'timeFrame': 'Baseline and up to ~12 years', 'description': 'The EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life of cancer patients. Participant responses to the question "Were you short of breath?" will be scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores will be standardized, so that scores range from 0 to 100. Higher scores indicate a worse level of dyspnea. The change from baseline in dyspnea (EORTC QLQ-C30 Item 8) score will be presented.'}, {'measure': 'Change from Baseline in the EORTC QLQ-Lung Cancer Questionnaire (LC24) Coughing (Items 31 and 52) Combined Score on the EORTC QLQ-LC24', 'timeFrame': 'Baseline and up to ~12 years', 'description': 'The EORTC QLQ-LC24 is a lung cancer specific health-related quality of life questionnaire. Participant responses to questions about coughing will be scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores will be standardized, so that scores range from 0 to 100. A higher score indicates more coughing. The change from baseline in coughing (EORTC QLQ-LC24 Items 31 and 52) combined score will be presented.'}, {'measure': 'Change from Baseline in the EORTC QLQ-LC24 Chest Pain (Item 40) Score on the EORTC QLQ-LC24', 'timeFrame': 'Baseline and up to ~12 years', 'description': 'The EORTC QLQ-LC24 is a lung cancer specific health-related quality of life questionnaire. Participant responses to the question "Have you had pain in your chest?" will be scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores will be standardized, so that scores range from 0 to 100. A higher score indicates more chest pain. The change from baseline in chest pain (EORTC QLQ-LC24 Item 40) score will be presented.'}, {'measure': 'Number of Participants Who Experience an Adverse Event (AE)', 'timeFrame': 'Up to ~15 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 ~12 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': ['Non-small Cell Lung Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.merckclinicaltrials.com', 'label': 'Merck Clinical Trials Information'}, {'url': 'https://msd.trialsummaries.com/Study/StudyDetails?id=26311&tenant=MT_MSD_9011', 'label': 'Plain Language Summary'}]}, 'descriptionModule': {'briefSummary': 'The goal of this study is to evaluate intismeran autogene plus pembrolizumab versus placebo plus pembrolizumab for the adjuvant treatment of margin negative, completely resected Stage II, IIIA, IIIB (with nodal involvement \\[N2\\]) non-small cell lung cancer (NSCLC). The primary hypothesis is that intismeran autogene plus pembrolizumab is superior to placebo plus pembrolizumab with respect to disease-free survival (DFS) as assessed by the investigator.'}, '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* Has undergone margin negative, completely resected non-small cell lung cancer (NSCLC), and has pathological Stage II, IIIA, IIIB (N2) squamous or nonsquamous tumor, node, metastasis (TNM) staging per American Joint Committee on Cancer (AJCC) Eighth Edition guidelines.\n* Has no evidence of disease before randomization.\n* Has received at least one dose of adjuvant treatment with standard of care platinum doublet chemotherapy.\n* No more than 24 weeks have elapsed between surgical resection of curative intent and the first dose of pembrolizumab.\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 prior to randomization.\n* Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening.\n* Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on anti-retroviral therapy (ART).\n\nExclusion Criteria:\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Diagnosis of small cell lung cancer (SCLC) or, for mixed tumors, presence of small cell elements, or has a neuroendocrine tumor with large cell components or a sarcomatoid carcinoma.\n* HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease.\n* Received prior neoadjuvant therapy for their current NSCLC diagnosis.\n* Received or is a candidate to receive radiotherapy for their current NSCLC diagnosis.\n* Received prior therapy with an anti-programmed cell death 1 protein (PD-1), anti-PD-ligand 1 (L1), or anti-PD-L2 agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor.\n* Received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization.\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 prior to study intervention administration.\n* Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study medication.\n* Known additional malignancy that is progressing or has required active treatment within the past 5 years.\n* Active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid) is allowed.\n* History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.\n* Active infection requiring systemic therapy."}, 'identificationModule': {'nctId': 'NCT06077760', 'acronym': 'INTerpath-002', 'briefTitle': 'A Study of Intismeran Autogene (V940) Plus Pembrolizumab (MK-3475) Versus Placebo Plus Pembrolizumab in Participants With Non-small Cell Lung Cancer (V940-002)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Phase 3, Randomized, Double-blind, Placebo- and Active-Comparator-Controlled Clinical Study of Adjuvant V940 (mRNA-4157) Plus Pembrolizumab Versus Adjuvant Placebo Plus Pembrolizumab in Participants With Resected Stage II, IIIA, IIIB (N2) Non-small Cell Lung Cancer (INTerpath-002)', 'orgStudyIdInfo': {'id': 'V940-002'}, 'secondaryIdInfos': [{'id': '2023-504923-20-00', 'type': 'REGISTRY', 'domain': 'EU CT'}, {'id': 'U1111-1290-3969', 'type': 'REGISTRY', 'domain': 'UTN'}, {'id': 'jRCT2061240063', 'type': 'REGISTRY', 'domain': 'jRCT'}, {'id': 'PHRR240705-007252', 'type': 'REGISTRY', 'domain': 'PHRR'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intismeran autogene + Pembrolizumab', 'description': 'Participants will receive 1 mg of intismeran autogene via intramuscular (IM) injection once every 3 weeks for 9 doses PLUS 400 mg of pembrolizumab via intravenous (IV) infusion once every 6 weeks for up to 9 doses until disease recurrence or unacceptable toxicity or for a total treatment duration of up to approximately 1 year, whichever is sooner.', 'interventionNames': ['Biological: Intismeran autogene', 'Biological: Pembrolizumab']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Placebo + Pembrolizumab', 'description': 'Participants will receive intismeran autogene-matched placebo via IM injection once every 3 weeks for 9 doses PLUS 400 mg of pembrolizumab via IV infusion once every 6 weeks for up to 9 doses until disease recurrence or unacceptable toxicity or for a total treatment duration of up to approximately 1 year, whichever is sooner.', 'interventionNames': ['Biological: Pembrolizumab', 'Other: Placebo']}], 'interventions': [{'name': 'Intismeran autogene', 'type': 'BIOLOGICAL', 'otherNames': ['mRNA-4157', 'V940'], 'description': 'IM injection', 'armGroupLabels': ['Intismeran autogene + Pembrolizumab']}, {'name': 'Pembrolizumab', 'type': 'BIOLOGICAL', 'otherNames': ['MK-3475', 'KEYTRUDA®'], 'description': 'IV infusion', 'armGroupLabels': ['Intismeran autogene + Pembrolizumab', 'Placebo + Pembrolizumab']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'IM injection', 'armGroupLabels': ['Placebo + Pembrolizumab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '99508', 'city': 'Anchorage', 'state': 'Alaska', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '888-577-8839'}], 'facility': 'Alaska Oncology and Hematology ( Site 0039)', 'geoPoint': {'lat': 61.21806, 'lon': -149.90028}}, {'zip': '85719', 'city': 'Tucson', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '520-694-2873'}], 'facility': 'The University of Arizona Cancer Center - North Campus ( Site 0071)', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '85364', 'city': 'Yuma', 'state': 'Arizona', 'status': 'COMPLETED', 'country': 'United States', 'facility': 'YUMA REGIONAL MEDICAL CENTER CANCER CENTER ( Site 0020)', 'geoPoint': {'lat': 32.72532, 'lon': -114.6244}}, {'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '888-577-8839'}], 'facility': 'UCLA Clinical & Translational Research Center (CTRC) ( Site 0059)', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92663', 'city': 'Newport Beach', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '949-764-4060'}], 'facility': 'Hoag Memorial Hospital Presbyterian ( Site 4042)', 'geoPoint': {'lat': 33.61891, 'lon': -117.92895}}, {'zip': '92663', 'city': 'Newport Beach', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '949-764-4060'}], 'facility': 'Hoag Memorial Hospital Presbyterian ( Site 4048)', 'geoPoint': {'lat': 33.61891, 'lon': -117.92895}}, {'zip': '92868', 'city': 'Orange', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '714-541-6622'}], 'facility': 'St. Joseph Hospital-The Center for Cancer Prevention and Treatment ( Site 0074)', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '92868', 'city': 'Orange', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '888-577-8839'}], 'facility': 'University of California, Irvine (UCI) Health - UC Irvine Medical Center ( Site 0030)', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '80909', 'city': 'Colorado Springs', 'state': 'Colorado', 'status': 'COMPLETED', 'country': 'United States', 'facility': 'UCHealth Memorial Hospital-Heme Onc ( Site 0052)', 'geoPoint': {'lat': 38.83388, 'lon': -104.82136}}, {'zip': '32224', 'city': 'Jacksonville', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '904-914-7322'}], 'facility': 'Mayo Clinic Florida ( Site 4043)', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '32763', 'city': 'Orange City', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '888-577-8839'}], 'facility': 'Mid Florida Hematology and Oncology Center ( Site 0014)', 'geoPoint': {'lat': 28.94888, 'lon': -81.29867}}, {'zip': '32804', 'city': 'Orlando', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '888-577-8839'}], 'facility': 'AdventHealth Orlando-AdventHealth Medical Group Hematology & Oncology at Orlandoc ( Site 0013)', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '33612', 'city': 'Tampa', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '888-577-8839'}], 'facility': 'Moffitt Cancer Center ( Site 0078)', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '30060', 'city': 'Marietta', 'state': 'Georgia', 'status': 'COMPLETED', 'country': 'United States', 'facility': 'Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital ( Site 0012)', 'geoPoint': {'lat': 33.9526, 'lon': -84.54993}}, {'zip': '30265', 'city': 'Newnan', 'state': 'Georgia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '770-400-6305'}], 'facility': 'Southeastern Regional Medical Center ( Site 0098)', 'geoPoint': {'lat': 33.38067, 'lon': -84.79966}}, {'zip': '83854', 'city': 'Post Falls', 'state': 'Idaho', 'status': 'COMPLETED', 'country': 'United States', 'facility': 'Beacon Cancer Care ( Site 0044)', 'geoPoint': {'lat': 47.71796, 'lon': -116.95159}}, {'zip': '52242', 'city': 'Iowa City', 'state': 'Iowa', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '319-356-1616'}], 'facility': 'University of Iowa-Holden Comprehensive Cancer Center ( Site 0062)', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}, {'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 0092)', 'geoPoint': {'lat': 39.01867, 'lon': -84.58189}}, {'zip': '40202', 'city': 'Louisville', 'state': 'Kentucky', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '888-577-8839'}], 'facility': 'The University of Louisville, James Graham Brown Cancer Center ( Site 0037)', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '888-577-8839'}], 'facility': 'University of Michigan Clinical Trials Office ( Site 0058)', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '49503', 'city': 'Grand Rapids', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '888-577-8839'}], 'facility': 'Cancer and Hematology Centers of Western Michigan ( Site 4003)', 'geoPoint': {'lat': 42.96336, 'lon': -85.66809}}, {'zip': '59102', 'city': 'Billings', 'state': 'Montana', 'status': 'COMPLETED', 'country': 'United States', 'facility': 'St. Vincent Frontier Cancer Center ( Site 0043)', 'geoPoint': {'lat': 45.78329, 'lon': -108.50069}}, {'zip': '68506', 'city': 'Lincoln', 'state': 'Nebraska', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '284-564-1485'}], 'facility': 'NHO Revive Research Institute, LLC ( Site 4009)', 'geoPoint': {'lat': 40.8, 'lon': -96.66696}}, {'zip': '07920', 'city': 'Basking Ridge', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '646-888-4409'}], 'facility': 'Memorial Sloan Kettering - Basking Ridge ( Site 4056)', 'geoPoint': {'lat': 40.70621, 'lon': -74.54932}}, {'zip': '07601', 'city': 'Hackensack', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '888-577-8839'}], 'facility': 'John Theurer Cancer Center at Hackensack University Medical Center ( Site 0036)', 'geoPoint': {'lat': 40.88593, 'lon': -74.04347}}, {'zip': '07748', 'city': 'Middletown', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '646-888-4409'}], 'facility': 'Memorial Sloan Kettering - Monmouth ( Site 4057)', 'geoPoint': {'lat': 40.39428, 'lon': -74.11709}}, {'zip': '07645', 'city': 'Montvale', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '646-888-4409'}], 'facility': 'Memorial Sloan Kettering - Bergen ( Site 4059)', 'geoPoint': {'lat': 41.04676, 'lon': -74.02292}}, {'zip': '07960', 'city': 'Morristown', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '973-971-6283'}], 'facility': 'Atlantic Health Morristown Medical Center ( Site 4018)', 'geoPoint': {'lat': 40.79677, 'lon': -74.48154}}, {'zip': '12206', 'city': 'Albany', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '518-489-0044'}], 'facility': 'New York Oncology Hematology, P.C. ( Site 4012)', 'geoPoint': {'lat': 42.65258, 'lon': -73.75623}}, {'zip': '11725', 'city': 'Commack', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '646-888-4409'}], 'facility': 'Memorial Sloan-Kettering Cancer Center at Commack ( Site 4055)', 'geoPoint': {'lat': 40.84288, 'lon': -73.29289}}, {'zip': '10604', 'city': 'Harrison', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '646-888-4409'}], 'facility': 'Memorial Sloan Kettering - Westchester ( Site 4058)', 'geoPoint': {'lat': 40.96899, 'lon': -73.71263}}, {'zip': '11501', 'city': 'Mineola', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '888-577-8839'}], 'facility': 'Perlmutter Cancer Center at NYU Langone Hospital - Long Island-Clinical Research Department ( Site 0095)', 'geoPoint': {'lat': 40.74927, 'lon': -73.64068}}, {'zip': '10011', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '888-577-8839'}], 'facility': 'The Blavatnik Family- Chelsea Medical Center at Mount Sinai ( Site 4053)', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10016', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '888-577-8839'}], 'facility': 'Laura and Isaac Perlmutter Cancer Center ( Site 0010)', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10029', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '888-577-8839'}], 'facility': 'Icahn School of Medicine at Mount Sinai ( Site 0034)', 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