Ignite Creation Date:
2025-12-25 @ 12:34 AM
Ignite Modification Date:
2025-12-25 @ 10:43 PM
Study NCT ID:
NCT06824467
Status:
RECRUITING
Last Update Posted:
2025-10-07
First Post:
2025-02-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Efficacy and Safety of Sacituzumab Tirumotecan (MK-2870) Treatment Versus Standard of Care in Participants With Platinum-sensitive Recurrent Ovarian Cancer (MK-2870-022/TroFuse-022/ENGOT-ov84/GOG-3103)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010051', 'term': 'Ovarian Neoplasms'}, {'id': 'D005185', 'term': 'Fallopian Tube Neoplasms'}], 'ancestors': [{'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D005184', 'term': 'Fallopian Tube Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068258', 'term': 'Bevacizumab'}, {'id': 'D006633', 'term': 'Histamine Antagonists'}, {'id': 'D006635', 'term': 'Histamine H2 Antagonists'}, {'id': 'D000082', 'term': 'Acetaminophen'}, {'id': 'D003907', 'term': 'Dexamethasone'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D018494', 'term': 'Histamine Agents'}, {'id': 'D018377', 'term': 'Neurotransmitter Agents'}, {'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 770}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-04-09', 'type': 'ACTUAL'}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2032-10-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-03', 'studyFirstSubmitDate': '2025-02-07', 'studyFirstSubmitQcDate': '2025-02-07', 'lastUpdatePostDateStruct': {'date': '2025-10-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-02-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-04-27', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Part 1: Number of participants with one or more adverse events (AEs)', 'timeFrame': 'Up to 6 weeks', '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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.'}, {'measure': 'Part 1: Number of participants who discontinue study intervention due to an AE', 'timeFrame': 'Up to 6 weeks', '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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.'}, {'measure': 'Part 2: Progression-free Survival (PFS)', 'timeFrame': 'Up to approximately 4 years', 'description': 'PFS is defined as the time from randomization to the first documented progressive disease (PD) or death from any cause, whichever occurs first. 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. PFS as assessed by BICR will be presented.'}], 'secondaryOutcomes': [{'measure': 'Part 2: Overall Survival (OS)', 'timeFrame': 'Up to approximately 4 years', 'description': 'OS is defined as the time from randomization to death due to any cause'}, {'measure': 'Part 2: Number of participants with one or more AEs', 'timeFrame': 'Up to approximately 4 years', '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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.'}, {'measure': 'Part 2: Number of participants who discontinue study intervention due to an AE', 'timeFrame': 'Up to approximately 4 years', '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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.'}, {'measure': 'Part 2: Change from Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status-Quality of Life Score', 'timeFrame': 'Baseline and up to approximately 4 years', 'description': 'The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the QoL of cancer patients. Participant responses to Item 30 (""How would you rate your overall quality of life during the past week?") is scored on a 7-point scale (1=Very Poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher value indicates a better level of function. The change from baseline in EORTC QLQ-C30 Item 30 score will be reported.'}, {'measure': 'Part 2: Change from Baseline in EORTC QLQ-C30 Physical Functioning Score', 'timeFrame': 'Baseline and up to approximately 4 years', 'description': 'The EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life of cancer patients. Participant responses to questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better level of physical functioning.'}, {'measure': 'Part 2: Change from Baseline in EORTC QLQ-C30 Role Functioning Score', 'timeFrame': 'Baseline and up to approximately 4 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 are standardized, so that scores range from 0 to 100. Higher scores indicate a more impaired level of role functioning. Change from baseline in the role functioning score will be presented.'}, {'measure': 'Part 2: Change from Baseline in EORTC Quality of Life Questionnaire-Ovarian Cancer Module 28 (QLQ-OV28) abdominal/gastrointestinal (GI) symptom scale', 'timeFrame': 'Baseline and up to approximately 4 years', 'description': 'The EORTC QLQ-OV28 is an OC-specific, and psychometrically and clinically validated module to supplement the EORTC QLQ-C30. The EORTC QLQ-OV28 abdominal/GI symptom scale is scored on a 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much).'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ovarian Cancer', 'Fallopian Tube Cancer', 'Primary Peritoneal Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.merckclinicaltrials.com/', 'label': 'Merck Clinical Trials Information'}]}, 'descriptionModule': {'briefSummary': 'The main goals of this study are to learn about the safety of sacituzumab tirumotecan with bevacizumab and if people tolerate it; and If people who take sacituzumab tirumotecan with or without bevacizumab live longer without the cancer getting worse than those who receive standard of care treatment.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Has histologically confirmed epithelial ovarian, fallopian tube, or primary peritoneal carcinoma.\n* Has received 4 or more cycles of platinum-based doublet chemotherapy in first-line and a total of 6 cycles of carboplatin-based doublet chemotherapy in second-line setting for ovarian cancer (OC).\n* Has platinum-sensitive epithelial OC,\n* Has provided tissue of a tumor lesion that was not previously irradiated\n* Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy\n* Participants who are hepatitis B surface antigen 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 allocation (Part 1) or randomization (Part 2)\n* Participants with a history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening\n* Has an ECOG performance status of 0 to 1 assessed within 7 days before allocation (Part 1) or randomization (Part 2)\n\nExclusion Criteria:\n\n* Has nonepithelial cancers (germ cell tumors and sex cord-stromal tumors), borderline tumors (low malignant potential), mucinous, seromucinous that is predominantly mucinous, malignant Brenner's tumor and undifferentiated carcinoma\n* Has platinum-resistant OC or platinum-refractory OC\n* Has history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing.\n* Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease (e.g. Crohn's disease, ulcerative colitis, or chronic diarrhea)\n* Has uncontrolled, significant cardiovascular disease or cerebrovascular disease.\n* Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.\n* HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease\n* Has received more than 2 prior lines of systemic therapy for OC.\n* Has received prior systemic anticancer therapy within 3 weeks or 5 half-lives (whichever is shorter) before allocation (Part 1) or randomization (Part 2)\n* Has received prior radiotherapy within 2 weeks of allocation (Part 1) or randomization (Part 2), or has radiation related toxicities, requiring corticosteroids\n* Has an additional malignancy that is progressing or has required active treatment within the past 3 years\n* Has active central nervous system (CNS) metastases and/or carcinomatous meningitis\n* Has an active infection requiring systemic therapy"}, 'identificationModule': {'nctId': 'NCT06824467', 'briefTitle': 'A Study to Evaluate the Efficacy and Safety of Sacituzumab Tirumotecan (MK-2870) Treatment Versus Standard of Care in Participants With Platinum-sensitive Recurrent Ovarian Cancer (MK-2870-022/TroFuse-022/ENGOT-ov84/GOG-3103)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Phase 3, Randomized, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of Sacituzumab Tirumotecan Maintenance Treatment With or Without Bevacizumab Versus Standard of Care After Second-line Platinum-based Doublet Chemotherapy in Participants With Platinum-sensitive Recurrent Ovarian Cancer (TroFuse-022/ENGOT-ov84/GOG-3103)', 'orgStudyIdInfo': {'id': '2870-022'}, 'secondaryIdInfos': [{'id': 'MK-2870-022', 'type': 'OTHER', 'domain': 'MSD'}, {'id': 'TroFuse-022', 'type': 'OTHER', 'domain': 'MSD'}, {'id': '2023-508015-23-00', 'type': 'REGISTRY', 'domain': 'EU CT'}, {'id': 'U1111-1297-4489', 'type': 'REGISTRY', 'domain': 'UTN'}, {'id': 'GOG-3103', 'type': 'OTHER', 'domain': 'Gynecologic Oncology Group'}, {'id': 'ENGOT-ov84', 'type': 'OTHER', 'domain': 'European Network of Gynaecological Oncological Trial Groups (ENGOT)'}, {'id': 'jRCT2031240722', 'type': 'REGISTRY', 'domain': 'Japan Registry of Clinical Trials (jRCT)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part 1: Sacituzumab tirumotecan + Bevacizumab', 'description': 'Participants receive 4 mg/kg of sacituzumab tirumotecan once every 2 weeks (Q2W) plus 15 mg/kg of bevacizumab once every 3 weeks (Q3W) via intravenous (IV) infusion over 6 weeks', 'interventionNames': ['Biological: Sacituzumab tirumotecan', 'Biological: Bevacizumab', 'Drug: H1 receptor antagonist', 'Drug: H2 receptor antagonist', 'Drug: Acetaminophen (or equivalent)', 'Drug: Dexamethasone (or equivalent)', 'Drug: Steroid mouthwash (dexamethasone or equivalent)']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2: Sacituzumab tirumotecan', 'description': "Participants receive 4 mg/kg of sacituzumab tirumotecan Q2W via IV infusion until progressive disease or discontinuation. At the physician's discretion, participants receive 15 mg/kg of bevacizumab Q3W via IV infusion until progressive disease or discontinuation.", 'interventionNames': ['Biological: Sacituzumab tirumotecan', 'Biological: Bevacizumab', 'Drug: H1 receptor antagonist', 'Drug: H2 receptor antagonist', 'Drug: Acetaminophen (or equivalent)', 'Drug: Dexamethasone (or equivalent)', 'Drug: Steroid mouthwash (dexamethasone or equivalent)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Part 2: Standard of care (SOC)', 'description': "Participants receive local standard of care until progressive disease or discontinuation. At the physician's discretion, participants receive 15 mg/kg of bevacizumab Q3W via IV infusion until progressive disease or discontinuation.", 'interventionNames': ['Biological: Bevacizumab']}], 'interventions': [{'name': 'Sacituzumab tirumotecan', 'type': 'BIOLOGICAL', 'otherNames': ['MK-2870', 'sac-TMT', 'SKB264'], 'description': 'IV Infusion', 'armGroupLabels': ['Part 1: Sacituzumab tirumotecan + Bevacizumab', 'Part 2: Sacituzumab tirumotecan']}, {'name': 'Bevacizumab', 'type': 'BIOLOGICAL', 'otherNames': ['Avastin', 'Altusan', 'MVASI'], 'description': 'IV Infusion', 'armGroupLabels': ['Part 1: Sacituzumab tirumotecan + Bevacizumab', 'Part 2: Sacituzumab tirumotecan', 'Part 2: Standard of care (SOC)']}, {'name': 'H1 receptor antagonist', 'type': 'DRUG', 'description': 'Rescue medication taken per approved product label before sacituzumab tirumotecan', 'armGroupLabels': ['Part 1: Sacituzumab tirumotecan + Bevacizumab', 'Part 2: Sacituzumab tirumotecan']}, {'name': 'H2 receptor antagonist', 'type': 'DRUG', 'description': 'Rescue medication taken per approved product label before sacituzumab tirumotecan', 'armGroupLabels': ['Part 1: Sacituzumab tirumotecan + Bevacizumab', 'Part 2: Sacituzumab tirumotecan']}, {'name': 'Acetaminophen (or equivalent)', 'type': 'DRUG', 'description': 'Rescue medication taken per approved product label before sacituzumab tirumotecan', 'armGroupLabels': ['Part 1: Sacituzumab tirumotecan + Bevacizumab', 'Part 2: Sacituzumab tirumotecan']}, {'name': 'Dexamethasone (or equivalent)', 'type': 'DRUG', 'description': 'Rescue medication taken per approved product label before sacituzumab tirumotecan', 'armGroupLabels': ['Part 1: Sacituzumab tirumotecan + Bevacizumab', 'Part 2: Sacituzumab tirumotecan']}, {'name': 'Steroid mouthwash (dexamethasone or equivalent)', 'type': 'DRUG', 'description': 'Rescue medication taken orally 4 times daily', 'armGroupLabels': ['Part 1: Sacituzumab tirumotecan + Bevacizumab', 'Part 2: Sacituzumab tirumotecan']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34239', 'city': 'Sarasota', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '941-917-2225'}], 'facility': 'Sarasota Memorial Hospital ( Site 0075)', 'geoPoint': {'lat': 27.33643, 'lon': -82.53065}}, {'zip': '39216', 'city': 'Jackson', 'state': 'Mississippi', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'United States', 'facility': "St. Dominic's Hospital ( Site 0064)", 'geoPoint': {'lat': 32.29876, 'lon': -90.18481}}, {'zip': '68114', 'city': 'Omaha', 'state': 'Nebraska', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '402-354-8534'}], 'facility': 'Nebraska Methodist Hospital ( Site 0053)', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '08901', 'city': 'New Brunswick', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '732-235-7258'}], 'facility': 'Rutgers Cancer Institute of New Jersey ( Site 0071)', 'geoPoint': {'lat': 40.48622, 'lon': -74.45182}}, {'zip': '45219', 'city': 'Cincinnati', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '513-584-1958'}], 'facility': 'University of Cincinnati Medical Center ( Site 0090)', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '74146', 'city': 'Tulsa', 'state': 'Oklahoma', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '918-505-3200'}], 'facility': 'Oklahoma Cancer Specialists and Research Institute, LLC ( Site 0056)', 'geoPoint': {'lat': 36.15398, 'lon': -95.99277}}, {'zip': '02905', 'city': 'Providence', 'state': 'Rhode Island', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '401-274-1100'}], 'facility': 'Women & Infants Hospital ( Site 0050)', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}, {'zip': '2148', 'city': 'Sydney', 'state': 'New South Wales', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '+61286705071'}], 'facility': 'Blacktown Hospital ( Site 0211)', 'geoPoint': {'lat': -33.86785, 'lon': 151.20732}}, {'zip': '4120', 'city': 'Brisbane', 'state': 'Queensland', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '+61733947284'}], 'facility': 'Gallipoli Medical Research Ltd ( Site 0214)', 'geoPoint': {'lat': -27.46794, 'lon': 153.02809}}, {'zip': '3002', 'city': 'East Melbourne', 'state': 'Victoria', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '+61385595000'}], 'facility': 'Epworth Freemasons ( Site 0217)', 'geoPoint': {'lat': -37.81667, 'lon': 144.9879}}, {'zip': '3199', 'city': 'Frankston', 'state': 'Victoria', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '+61409848084'}], 'facility': 'Frankston Hospital ( Site 0216)', 'geoPoint': {'lat': -38.14458, 'lon': 145.12291}}, {'zip': '830-0011', 'city': 'Kurume', 'state': 'Fukuoka', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '+81-942-35-3311'}], 'facility': 'Kurume University Hospital ( Site 1640)', 'geoPoint': {'lat': 33.31667, 'lon': 130.51667}}, {'zip': '350-1298', 'city': 'Hidaka', 'state': 'Saitama', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '+81-42-984-4111'}], 'facility': 'Saitama Medical University International Medical Center ( Site 1632)', 'geoPoint': {'lat': 35.91664, 'lon': 139.36233}}, {'zip': '135-8550', 'city': 'Koto', 'state': 'Tokyo', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '+81-3-3520-0111'}], 'facility': 'Cancer Institute Hospital of JFCR ( Site 1639)'}, {'zip': '160-8582', 'city': 'Shinjyuku', 'state': 'Tokyo', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '+81-3-3353-1211'}], 'facility': 'Keio University Hospital ( Site 1636)'}, {'zip': '951-8566', 'city': 'Niigata', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '+81-25-266-5111'}], 'facility': 'Niigata Cancer Center Hospital ( Site 1633)', 'geoPoint': {'lat': 37.92259, 'lon': 139.04125}}, {'zip': '10408', 'city': 'Goyang-si', 'state': 'Kyonggi-do', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '82-31-920-1760'}], 'facility': 'National Cancer Center ( Site 2305)', 'geoPoint': {'lat': 37.65639, 'lon': 126.835}}, {'zip': '03722', 'city': 'Seodaemun-Gu', 'state': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '82-2-2227-7969'}], 'facility': 'Severance Hospital ( Site 2302)'}, {'zip': '05505', 'city': 'Songpa-gu', 'state': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '+82-2-3010-3640'}], 'facility': 'Asan Medical Center ( Site 2304)'}, {'zip': '03080', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'phone': '82-2-2072-3511'}], 'facility': 'Seoul National University Hospital ( Site 2301)', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '06351', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Study Coordinator', 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