Ignite Creation Date:
2025-12-24 @ 11:03 PM
Ignite Modification Date:
2025-12-25 @ 8:34 PM
Study NCT ID:
NCT06864169
Status:
RECRUITING
Last Update Posted:
2025-12-18
First Post:
2025-03-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of Raludotatug Deruxtecan (R-DXd) in People With Gastrointestinal Cancers (MK-5909-005)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 160}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2029-01-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-17', 'studyFirstSubmitDate': '2025-03-03', 'studyFirstSubmitQcDate': '2025-03-03', 'lastUpdatePostDateStruct': {'date': '2025-12-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-03-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective Response Rate (ORR)', 'timeFrame': 'Approximately 15 months', 'description': 'ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1. The percentage of participants who experience CR or PR as assessed by BICR will be presented.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants who Experience One or More Adverse Events (AEs)', 'timeFrame': 'Up to approximately 14 months', 'description': 'An adverse event (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 reported.'}, {'measure': 'Number of Participants who Discontinue Study Treatment due to an AE', 'timeFrame': 'Up to approximately 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. The number of participants who discontinue study treatment due to an AE will be reported.'}, {'measure': 'Duration of Response (DOR)', 'timeFrame': 'Up to approximately 49 months', 'description': 'For participants who demonstrate a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR is defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. DOR as assessed by BICR will be presented.'}, {'measure': 'Progression Free Survival (PFS)', 'timeFrame': 'Up to approximately 49 months', 'description': 'PFS is defined as the time from first day of study intervention to the first documented progressive disease (PD) or death due to any cause, whichever occurs first as assessed by BICR. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. The appearance of one or more new lesions is also considered PD. PFS as assessed by BICR will be presented.'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'Up to approximately 49 months', 'description': 'OS is defined as the time from the first dose to death due to any cause.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gastrointestinal Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.merckclinicaltrials.com', 'label': 'Merck Clinical Trials Information'}]}, 'descriptionModule': {'briefSummary': 'Researchers are looking for new ways to treat certain types of advanced gastrointestinal (GI) cancers. The study medicine raludotatug deruxtecan (also called MK-5909, R-DXd, or DS-6000a) is a type of medicine called an antibody-drug conjugate (ADC). An ADC attaches to a protein on cancer cells and delivers treatment to destroy those cells.\n\nThe main goal of this study is to learn if the cancer responds to treatment (gets smaller or goes away).'}, '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 one of the following cancers:\n\n * Unresectable or metastatic pancreatic ductal adenocarcinoma (PDAC)\n * Unresectable or metastatic adenocarcinoma of the biliary tract \\[intra- or extrahepatic holangiocarcinoma (CCA) or gallbladder cancer (GBC)\\]\n * Unresectable or metastatic colorectal adenocarcinoma\n * Unresectable or metastatic gastric adenocarcinoma\n * Gastroesophageal junction adenocarcinoma (GEJAC)\n * Esophageal adenocarcinoma (EAC)\n* Has received prior therapy for the cancer\n* Has a life expectancy of at least 3 months\n* If human immunodeficiency virus (HIV) infected, must have well controlled HIV on antiretroviral therapy (ART)\n\nExclusion Criteria:\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Has a history of (noninfectious) interstitial lung disease (ILD)/pneumonitis that required steroids or has current ILD/pneumonitis, and/or suspected ILD/pneumonitis\n* Has clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses\n* Has uncontrolled or significant cardiovascular disease\n* Has a known additional malignancy that is progressing or has required active treatment within the past 3 years\n* Has 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\n* Has not adequately recovered from major surgery or has ongoing surgical complications\n* HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease"}, 'identificationModule': {'nctId': 'NCT06864169', 'acronym': 'REJOICE-GI01', 'briefTitle': 'A Study of Raludotatug Deruxtecan (R-DXd) in People With Gastrointestinal Cancers (MK-5909-005)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Phase 2 Nonrandomized, Open-label, Multisite Study to Evaluate the Safety and Efficacy of Raludotatug Deruxtecan in Participants With Gastrointestinal Cancers', 'orgStudyIdInfo': {'id': '5909-005'}, 'secondaryIdInfos': [{'id': '2024-517416-30-00', 'type': 'OTHER', 'domain': 'EU CT'}, {'id': 'U1111-1312-2472', 'type': 'OTHER', 'domain': 'UTN'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Raludotatug Deruxtecan (R-DXd)', 'description': 'R-DXd will be administered via IV infusion.', 'interventionNames': ['Biological: Raludotatug Deruxtecan (R-DXd)']}], 'interventions': [{'name': 'Raludotatug Deruxtecan (R-DXd)', 'type': 'BIOLOGICAL', 'otherNames': ['MK-5909', 'DS 6000a'], 'description': 'Administered via intravenous (IV) infusion.', 'armGroupLabels': ['Raludotatug Deruxtecan (R-DXd)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06510', 'city': 'New Haven', 'state': 'Connecticut', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '203-314-7948'}], 'facility': 'Yale New Haven Hospital ( Site 0375)', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '20016', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '202-660-6500'}], 'facility': 'Sibley Memorial Hospital ( Site 0372)', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '33140', 'city': 'Miami Beach', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '305-535-3310'}], 'facility': 'Mt Sinai Comprehensive Cancer Center ( Site 0345)', 'geoPoint': {'lat': 25.79065, 'lon': -80.13005}}, {'zip': '59102', 'city': 'Billings', 'state': 'Montana', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '406-238-6900'}], 'facility': 'St. Vincent Healthcare Frontier Cancer Center ( Site 0347)', 'geoPoint': {'lat': 45.78329, 'lon': -108.50069}}, {'zip': '07960', 'city': 'Morristown', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '973-971-7960'}], 'facility': 'Morristown Medical Center ( Site 0349)', 'geoPoint': {'lat': 40.79677, 'lon': -74.48154}}, {'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '216-354-9912'}], 'facility': 'University Hospitals Cleveland Medical Center ( Site 0369)', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '22903', 'city': 'Charlottesville', 'state': 'Virginia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '434-327-8148'}], 'facility': 'University of Virginia Cancer Center ( Site 0365)', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}, {'zip': '53792', 'city': 'Madison', 'state': 'Wisconsin', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '608-265-9966'}], 'facility': 'University of Wisconsin Carbone Cancer Center ( Site 0348)', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}, {'zip': 'B7600FZO', 'city': 'Mar del Plata', 'state': 'Buenos Aires', 'status': 'RECRUITING', 'country': 'Argentina', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '+542234963224'}], 'facility': 'Instituto de Investigaciones Clinicas Mar del Plata ( Site 0001)', 'geoPoint': {'lat': -38.00042, 'lon': -57.5562}}, {'zip': 'C1431FWO', 'city': 'Buenos Aires', 'state': 'Buenos Aires F.D.', 'status': 'RECRUITING', 'country': 'Argentina', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '+541152990000'}], 'facility': 'Nefra Medical Care - CEMIC Saavedra ( Site 0008)', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': 'S2000CEJ', 'city': 'Rosario', 'state': 'Santa Fe Province', 'status': 'RECRUITING', 'country': 'Argentina', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '+5493469699922'}], 'facility': 'Instituto Medico de la Fundacion Estudios Clinicos ( Site 0007)', 'geoPoint': {'lat': -32.94682, 'lon': -60.63932}}, {'zip': 'F5300COE', 'city': 'La Rioja', 'status': 'RECRUITING', 'country': 'Argentina', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '+543804436443'}], 'facility': 'Fundación CORI para la Investigación y Prevención del Cáncer ( Site 0006)', 'geoPoint': {'lat': -29.41328, 'lon': -66.85637}}, {'zip': 'M4N 3M5', 'city': 'Toronto', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '4164806733'}], 'facility': 'Sunnybrook Research Institute ( Site 0044)', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'M5G 1X6', 'city': 'Toronto', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '416-946-2263'}], 'facility': 'Princess Margaret Cancer Centre ( Site 0041)', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'H2X 3E4', 'city': 'Montreal', 'state': 'Quebec', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '5148908000'}], 'facility': "Centre Hospitalier de l'Université de Montréal ( Site 0042)", 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': '7500921', 'city': 'Santiago', 'state': 'Region M. de Santiago', 'status': 'RECRUITING', 'country': 'Chile', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '+56224205098'}], 'facility': 'FALP ( Site 0062)', 'geoPoint': {'lat': -33.45694, 'lon': -70.64827}}, {'zip': '7501010', 'city': 'Santiago', 'state': 'Region M. de Santiago', 'status': 'RECRUITING', 'country': 'Chile', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '+56991612199'}], 'facility': 'Centro de Estudios Clínicos SAGA ( Site 0064)', 'geoPoint': {'lat': -33.45694, 'lon': -70.64827}}, {'zip': '7620002', 'city': 'Santiago', 'state': 'Region M. de Santiago', 'status': 'RECRUITING', 'country': 'Chile', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '+56991290140'}], 'facility': 'Clínica UC San Carlos de Apoquindo ( Site 0066)', 'geoPoint': {'lat': -33.45694, 'lon': -70.64827}}, {'zip': '8420383', 'city': 'Santiago', 'state': 'Region M. de Santiago', 'status': 'RECRUITING', 'country': 'Chile', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '+56981350156'}], 'facility': 'Bradfordhill ( Site 0069)', 'geoPoint': {'lat': -33.45694, 'lon': -70.64827}}, {'zip': '14076', 'city': 'Caen', 'state': 'Calvados', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '+33 2 31 45 50 50'}], 'facility': 'Centre François Baclesse ( Site 0085)', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'zip': '34298', 'city': 'Montpellier', 'state': 'Herault', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '33467613100'}], 'facility': 'Institut Regional du Cancer Montpellier ( Site 0084)', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '75013', 'city': 'Paris', 'state': 'Orne', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '+33142161203'}], 'facility': 'Pitie Salpetriere University Hospital ( Site 0082)', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '94800', 'city': 'Villejuif', 'state': 'Val-de-Marne', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '01 42 11 23 37'}], 'facility': 'Gustave Roussy ( Site 0081)', 'geoPoint': {'lat': 48.7939, 'lon': 2.35992}}, {'city': 'Hksar', 'status': 'RECRUITING', 'country': 'Hong Kong', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '85235052211'}], 'facility': 'Prince of Wales Hospital ( Site 0122)'}, {'city': 'Hksar', 'status': 'RECRUITING', 'country': 'Hong Kong', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '+85222553111'}], 'facility': 'Queen Mary Hospital ( Site 0121)'}, {'zip': '08916', 'city': 'Badalona', 'state': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '+34 93 497 89 25'}], 'facility': "Institut Català d'Oncologia (ICO) - Badalona ( Site 0222)", 'geoPoint': {'lat': 41.45004, 'lon': 2.24741}}, {'zip': '39008', 'city': 'Santander', 'state': 'Cantabria', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '+34 942 203 424'}], 'facility': 'Hospital Universitario Marqués de Valdecilla ( Site 0221)', 'geoPoint': {'lat': 43.46589, 'lon': -3.80493}}, {'zip': '08036', 'city': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '+34 932275402'}], 'facility': 'Hospital Clinic de Barcelona ( Site 0223)', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '28007', 'city': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '+34 914 269 070'}], 'facility': 'Hospital General Universitario Gregorio Marañón ( Site 0225)', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28040', 'city': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '34 91 550 48 00x3146'}], 'facility': 'Hospital Universitario Fundacion Jimenez Diaz ( Site 0224)', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '4031', 'city': 'Basel', 'state': 'Canton of Basel-City', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '041 61 32 55074'}], 'facility': 'Universitaetsspital Basel ( Site 0241)', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}, {'zip': '1211', 'city': 'Geneva', 'state': 'Canton of Geneva', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '+41223722901'}], 'facility': 'Hôpitaux Universitaires de Genève (HUG) ( Site 0245)', 'geoPoint': {'lat': 46.20222, 'lon': 6.14569}}, {'zip': '8091', 'city': 'Zurich', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '0442551111'}], 'facility': 'Universitaetsspital Zuerich ( Site 0242)', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}, {'zip': '40447', 'city': 'Taichung', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '+886422337675'}], 'facility': 'China Medical University Hospital ( Site 0267)', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}, {'zip': '407', 'city': 'Taichung', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '04-23592525'}], 'facility': 'Taichung Veterans General Hospital ( Site 0265)', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}, {'zip': '70403', 'city': 'Tainan', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '+886-972-401-234'}], 'facility': 'National Cheng Kung University Hospital ( Site 0263)', 'geoPoint': {'lat': 22.99083, 'lon': 120.21333}}, {'zip': '10002', 'city': 'Taipei', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '+886 2-2123456'}], 'facility': 'National Taiwan University Hospital ( Site 0261)', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'zip': '104', 'city': 'Taipei', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '+886225433535x3455'}], 'facility': 'Mackay Memorial Hospital ( Site 0266)', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'zip': '112', 'city': 'Taipei', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '+886 2-28712121'}], 'facility': 'Taipei Veterans General Hospital ( Site 0262)', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'zip': '10400', 'city': 'Bangkok', 'state': 'Bangkok', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Thailand', 'facility': 'Ramathibodi Hospital. ( Site 0282)', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}, {'zip': '10700', 'city': 'Bangkok', 'state': 'Bangkok', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Thailand', 'facility': 'Faculty of Medicine Siriraj Hospital ( Site 0281)', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}], 'centralContacts': [{'name': 'Toll Free Number', 'role': 'CONTACT', 'email': 'Trialsites@msd.com', 'phone': '1-888-577-8839'}], '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'}, 'collaborators': [{'name': 'Daiichi Sankyo', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}