Ignite Creation Date:
2025-12-24 @ 9:45 PM
Ignite Modification Date:
2025-12-25 @ 7:25 PM
Study NCT ID:
NCT06710132
Status:
RECRUITING
Last Update Posted:
2025-12-19
First Post:
2024-11-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of Anti-CEACAM5 ADC M9140 in Participants With Advanced Solid Tumors (PROCEADE PanTumor)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Germany']}, 'conditionBrowseModule': {'meshes': [{'id': 'D013274', 'term': 'Stomach Neoplasms'}, {'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}, {'id': 'D010190', 'term': 'Pancreatic Neoplasms'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'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'}, {'id': 'D013272', 'term': 'Stomach Diseases'}, {'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': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 250}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-01-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2028-01-26', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-18', 'studyFirstSubmitDate': '2024-11-22', 'studyFirstSubmitQcDate': '2024-11-25', 'lastUpdatePostDateStruct': {'date': '2025-12-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-11-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-01-26', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Substudies GC/NSCLC/PDAC: Objective Response (OR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Investigators', 'timeFrame': 'Time from first study treatment to (planned) final assessment at approximately 48 months'}], 'secondaryOutcomes': [{'measure': 'Substudies GC/NSCLC/PDAC: Number of Participants with Adverse Events (AEs) and Treatment Related AEs', 'timeFrame': 'Time from first study treatment to (planned) final assessment at approximately 48 months'}, {'measure': 'Substudies GC/NSCLC/PDAC: Duration of Response (DoR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Investigators', 'timeFrame': 'Time from first study treatment to (planned) final assessment at approximately 48 months'}, {'measure': 'Substudies GC/NSCLC/PDAC: Number of Participants with Disease Control', 'timeFrame': 'At Week 12'}, {'measure': 'Substudies GC/NSCLC/PDAC: Time to Response according to RECIST v1.1 as Assessed by Investigators', 'timeFrame': 'Time from first study treatment to (planned) final assessment at approximately 48 months'}, {'measure': 'Substudies GC/NSCLC/PDAC: Progression-free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Investigators', 'timeFrame': 'Time from first study treatment throughout the study duration until progressive disease or death due to any cause, whichever occur first, approximately 48 months'}, {'measure': 'Substudies GC/ NSCLC/ PDAC: Pharmacokinetic (PK) Plasma Concentrations of M9140', 'timeFrame': 'Cycle (C) 1 Day (D) 1 to C3D15, C4D1 and from C8D1 every 4 cycles on D1 until treatment discontinuation (each cycle is of 21 days), assessed up to approximately 12 months'}, {'measure': 'Substudies GC/NSCLC/PDAC: Number of Participants with Anti-Drug Antibodies (ADA) Against M9140', 'timeFrame': 'Predose (C1D1, C3D1, C8D1) and end of study intervention, assessed up to approximately 12 months'}, {'measure': 'Substudy GC: CEACAM5 expression in tumor', 'timeFrame': 'Day 1'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ADC', 'TOP1 inhibitor', 'Gastric Cancer', 'Gastroesophageal junction cancer', 'Non-Small Cell Lung Cancer', 'Pancreatic Cancer', 'Solid Tumors'], 'conditions': ['Solid Tumors', 'Gastric Cancer', 'Non-Small Cell Lung Cancer (NSCLC)', 'Pancreatic Cancer', 'Pancreatic Ductal Adenocarcinoma (PDAC)']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://clinicaltrials.emdgroup.com/en/trial-details/?id=MS202329_0010', 'label': 'Trial Awareness and Transparency website'}, {'url': 'https://www.merckgroup.com/en/company/contact-us/medinfo-contact-map.html', 'label': 'Medical Information Location Map - Med Info Contacts'}]}, 'descriptionModule': {'briefSummary': 'The PROCEADE PanTumor study aims to investigate M9140 in multiple tumor types which express carcinoembryonic antigen-related cell adhesion molecule 5 (CEACAM5) and it is therefore designed as a matrix study. This study aims to assess the antitumor activity, tolerability, safety, and pharmacokinetics (PK) of M9140 as monotherapy or in combination treatments in adult participants with locally advanced/metastatic CEACAM5 expressing tumors. There will be 3 substudies under this Master Protocol that may be conducted in parallel.\n\n* PROCEADE PanTumor: A Phase 1b/2, Multicenter, Open-Label Study of Anti-CEACAM5 Antibody-Drug Conjugate M9140 in Participants with Advanced Gastric Cancer (Substudy GC);\n* PROCEADE PanTumor: A Phase 1b/2, Multicenter, Open-Label Study of Anti-CEACAM5 Antibody-Drug Conjugate M9140 in Participants with Advanced Non-Small Cell Lung Cancer (Substudy NSCLC);\n* PROCEADE PanTumor: A Phase 1b/2, Multicenter, Open Label Study of Anti-CEACAM5 Antibody-Drug Conjugate M9140 in Participants With Advanced Pancreatic Cancer (Substudy PDAC).', 'detailedDescription': 'The study follows a master protocol concept with several separate substudies in specific indications.\n\n* Substudy GC: The study duration per participant is on an average approximately 10 months. This includes a 28-day Screening period, infusion (approximately 1 hour) on Day 1 of every cycle, and Safety Follow-up Visit 30 (± 3) days after the last dose of M9140.\n* Substudy NSCLC: Study duration per participant is approximately 12 months. This includes a 28-day Screening period, infusion (approximately 1 hour) on Day 1 of every cycle, and Safety Follow-up Visit 30 (± 3) days after the last dose of M9140.\n* Substudy PDAC: Study duration per participant is on an average approximately 8 months. This includes a 28-day Screening period, infusion (approximately 1 hour) on Day 1 of every cycle, and Safety Follow-up Visit 30 (±3) days after the last dose of M9140.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Participants are capable of signing informed consent as defined in protocol\n* Eastern Cooperative Oncology Group Performance Status (ECOG PS) below or equal to 1\n* Participants with adequate hematologic, hepatic and renal function as defined in protocol\n* Participant must have at least 1 lesion that is measurable using RECIST v1.1.\n* Other protocol defined inclusion criteria could apply\n\nSubstudy GC:\n\n* Participants in Part A and Part B with documented histopathological diagnosis of advanced or metastatic, HER2 negative, gastric or GEJ (with an epicenter 2 centimeter (cm) proximal or distal to the GEJ) adenocarcinoma, who were intolerant/refractory to or progressed after systemic therapies for the advanced/metastatic stage that must have included (provided there is no medical contraindication and these agents are locally approved and available) a fluoropyrimidine and a platinum agent and an Immune checkpoint inhibitors (ICI) for participants with a known microsatellite instability-high (MSI-H) status or participants whose tumor express PD-L1 with a CPS greater than or equal (\\>=) 1\n* Participants must have received and progressed (according to RECIST 1.1) on at least 1 line of therapy for the treatment of advanced/metastatic disease but no more than 2\n* Participants in Part A with CEACAM5high GC/GEJC (defined as IHC \\>= 2+ staining in \\>= 50% of tumor cells)\n* Participants in Part B with CEACAM5low GC/GEJC (defined as IHC \\>= 2+ staining in less than (\\<) 50% of tumor cells)\n* Other protocol defined inclusion criteria could apply\n\nSubstudy NSCLC:\n\n* Participants in Part A and Part B with histologically or cytologically documented advanced (Stage III not eligible for resection or curative radiation) or metastatic NSCLC with or without driver genomic alterations\n* Participants must have been intolerant/refractory to or progressed after systemic therapies for the advanced/metastatic stage\n* Participants must have received and progressed (according to RECIST 1.1) on at least 1 line of therapy for the treatment of advanced/metastatic disease but no more than 3\n* Participants who received a platinum-containing regimen or a targeted therapy as (neo)-adjuvant therapy for early-stage disease, if relapse or metastases occurred during or within 3 months after regimen completion, are considered to have received a line of treatment in the advanced setting\n* Participants in Part A with CEACAM5 high-expressing EGFR tumors (including participants with any driver genomic alterations other than EGFR mutations\n* Participants in Part B with CEACAM5 high known EGFR mutated tumors as assessed according to local clinical practice\n* Other protocol defined inclusion criteria could apply\n\nSubstudy PDAC:\n\n* Participants with histologically or cytologically confirmed advanced or metastatic PDAC, who were intolerant/refractory to or progressed after systemic therapies for the advanced metastatic stage that must have included (provided there is no medical contraindications, and these agents are locally approved and available; FOLFIRINOX regimen or NALIRIFNOX regimen or Nab-paclitaxel/gemcitabine regimen\n* Participants must have received and progressed (according to RECIST 1.1) on at least one 1 line of therapy for the treatment of advanced/metastatic disease but no more than 2\n* All participants will be screened using an IHC test to define CEACAM5 expression. Only participants with CEACAM5high expressing tumors will be eligible\n* Other protocol defined inclusion criteria could apply\n\nExclusion Criteria:\n\n* Participant has a history of malignancy within 3 years before the date of enrollment (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, benign prostate neoplasm/hypertropia, or malignancy that in the opinion of the Investigator, with concurrence with the Sponsor's Medical Monitor, is considered cured with minimal risk of recurrence within 3 years)\n* Participants with known brain metastases, except those meeting the following criteria: Brain metastases that have been treated locally and are clinically stable for at least 4 weeks prior to the start of treatment; No ongoing neurological symptoms that are related to the brain localization of the disease (sequelae that are a consequence of the treatment of the brain metastases are acceptable)\n* Participants with diarrhea (liquid stool) or ileus Grade \\> 1\n* Participants with active chronic inflammatory bowel disease (e.g., ulcerative colitis, Crohn's disease, intestinal perforation) and/or bowel obstruction\n* Cardiac arrhythmia, unstable angina, myocardial infarction, congestive heart failure (New York Heart Association \\[NYHA\\] \\>= II) or a coronary revascularization procedure within 180 days of study entry. Calculated QTc average (using the Fridericia correction calculation) of \\> 470 milliseconds (ms)\n* Cerebrovascular accident/stroke (\\< 6 months prior to enrollment)\n* Other protocol defined exclusion criteria could apply\n\nSubstudy GC - Participants with prior therapy with irinotecan\n\nSubstudy NSCLC:\n\n\\- Participants with prior therapy with irinotecan\n\nSubstudy PDAC: none"}, 'identificationModule': {'nctId': 'NCT06710132', 'briefTitle': 'Study of Anti-CEACAM5 ADC M9140 in Participants With Advanced Solid Tumors (PROCEADE PanTumor)', 'organization': {'class': 'INDUSTRY', 'fullName': 'EMD Serono'}, 'officialTitle': 'PROCEADE PanTumor: A Phase 1b/2, Multicenter, Open-Label Study of Anti-CEACAM5 Antibody-Drug Conjugate M9140 in Participants With Advanced Solid Tumors (Master Protocol)', 'orgStudyIdInfo': {'id': 'MS202329_0010'}, 'secondaryIdInfos': [{'id': '2024-517817-34-00', 'type': 'OTHER', 'domain': 'CTIS'}, {'id': '2024-517818-15-00', 'type': 'OTHER', 'domain': 'CTIS'}, {'id': '2024-517819-74-00', 'type': 'OTHER', 'domain': 'CTIS'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Substudy GC: M9140 Monotherapy - Part A CEACAM5 High', 'interventionNames': ['Drug: M9140']}, {'type': 'EXPERIMENTAL', 'label': 'Substudy GC: M9140 Monotherapy - Part B CEACAM5 Low', 'interventionNames': ['Drug: M9140']}, {'type': 'EXPERIMENTAL', 'label': 'Substudy NSCLC: M9140 Monotherapy - Part A CEACAM5 High EGFR Wt', 'interventionNames': ['Drug: M9140']}, {'type': 'EXPERIMENTAL', 'label': 'Substudy NSCLC: M9140 Monotherapy - Part B CEACAM5 High EGFR mut', 'interventionNames': ['Drug: M9140']}, {'type': 'EXPERIMENTAL', 'label': 'Substudy PDAC: M9140 Monotherapy - Part A CEACAM5 High', 'interventionNames': ['Drug: M9140']}], 'interventions': [{'name': 'M9140', 'type': 'DRUG', 'otherNames': ['Precemtabart tocentecan'], 'description': 'All participants will receive 2.8 milligram per kilogram (mg/kg) M9140 intravenously (i.v.) every 3 weeks (q3w) on Day 1 of consecutive 21-day cycles.', 'armGroupLabels': ['Substudy GC: M9140 Monotherapy - Part A CEACAM5 High', 'Substudy GC: M9140 Monotherapy - Part B CEACAM5 Low', 'Substudy NSCLC: M9140 Monotherapy - Part A CEACAM5 High EGFR Wt', 'Substudy NSCLC: M9140 Monotherapy - Part B CEACAM5 High EGFR mut', 'Substudy PDAC: M9140 Monotherapy - Part A CEACAM5 High']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90404', 'city': 'Santa Monica', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Zev A Wainberg', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of California - Los Angeles - 300208353', 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}, {'zip': '95403', 'city': 'Santa Rosa', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ian C Anderson', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Providence Medical Foundation', 'geoPoint': {'lat': 38.44047, 'lon': -122.71443}}, {'zip': '29605', 'city': 'Greenville', 'state': 'South Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'William J Edenfield', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Prisma Health Cancer Institute, ITOR, CRU', 'geoPoint': {'lat': 34.85262, 'lon': -82.39401}}, {'zip': '38120', 'city': 'Memphis', 'state': 'Tennessee', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Osarenren Ogbeide', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Baptist Memorial Health Care -Memphis', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Natalie Vokes', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Texas M. D. Anderson Cancer Center - Partner', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '22031', 'city': 'Fairfax', 'state': 'Virginia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'email': 'aspira@nextoncology.com'}, {'name': 'Alexander I Spira', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'NEXT Virginia', 'geoPoint': {'lat': 38.84622, 'lon': -77.30637}}, {'city': 'Bedford Park', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Amitesh C Roy', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Flinders Medical Centre', 'geoPoint': {'lat': -35.02204, 'lon': 138.56815}}, {'city': 'Kingswood', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'role': 'CONTACT', 'email': 'deme.karikios@health.nsw.gov.au'}, {'name': 'Deme Karikios', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Nepean Cancer Care Centre', 'geoPoint': {'lat': -33.75614, 'lon': 150.72346}}, {'city': 'South Brisbane', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Vikram K Jain', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Mater Misericordiae Ltd - PARENT', 'geoPoint': {'lat': -27.48034, 'lon': 153.02049}}, {'city': 'Sydney', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Andrew O Parsonson', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Macquarie University Hospital - PARENT', 'geoPoint': {'lat': -33.86785, 'lon': 151.20732}}, {'city': 'Linz', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Michael Schumacher', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ordensklinikum Linz Krankenhaus der Elisabethinen Linz - Pneumology', 'geoPoint': {'lat': 48.30639, 'lon': 14.28611}}, {'city': 'Salzburg', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Lukas Weiss', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'LKH - Universitätsklinikum der PMU Salzburg - Innere Med III/Hämatologie und Onkologie', 'geoPoint': {'lat': 47.79941, 'lon': 13.04399}}, {'city': 'Bordeaux', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Simon Pernot', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Institut Bergonié - Service d'Oncologie Médicale", 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'city': 'Dijon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Francois Ghiringhelli', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Centre Georges François Leclerc - Unité de Phase I', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}, {'city': 'Lille', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Nicolas Penel', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Centre Oscar Lambret - cancerologie generale', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'city': 'Lille', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Simon Baldacci', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hopital Albert Calmette - CHU Lille - CHU Lille - Institut Coeur Poumon', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Julien Taieb', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hôpital Européen Georges Pompidou - Hématologie Oncologie', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Romain Cohen', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hôpital Saint-Antoine - Oncologie Médicale', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Saint-Herblain', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Judith Raimbourg', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "ICO - Site René Gauducheau - Service d'Oncologie medicale", 'geoPoint': {'lat': 47.21154, 'lon': -1.651}}, {'city': 'Suresnes', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Jaafar Bennouna', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Hôpital Foch - Service d'Oncologie Médicale", 'geoPoint': {'lat': 48.87143, 'lon': 2.22929}}, {'city': 'Toulouse', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Iphigenie Korakis', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Hopital Rangueil - Service d'Oncologie médicale", 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'city': 'Villejuif', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Cristina Smolenschi', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Institut Gustave Roussy - Pathologie Thoracique', 'geoPoint': {'lat': 48.7939, 'lon': 2.35992}}, {'city': 'Reggio Emilia', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Maria Banzi', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Arcispedale S. Maria Nuova Azienda Ospedaliera di Reggio Emilia - Servizio di Oncologia', 'geoPoint': {'lat': 44.69825, 'lon': 10.63125}}, {'city': 'Roma', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Gennaro Daniele', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Dipartimento di Medicina Interna e Scienze Mediche', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'city': 'Torrette Di Ancona', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Rossana Berardi', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Azienda Ospedaliero Universitaria Ospedali Riuniti - UOC Clinica di Oncologia Medica'}, {'city': 'Chūōku', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Hidekazu Hirano', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'National Cancer Center Hospital', 'geoPoint': {'lat': 33.63867, 'lon': 130.67068}}, {'city': 'Kashihara-shi', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Masayuki Takeda', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Nara Medical University Hospital - Dept of Oncology', 'geoPoint': {'lat': 34.50896, 'lon': 135.7929}}, {'city': 'Kōtoku', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Shota Fukuoka', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Cancer Institute Hospital of JFCR', 'geoPoint': {'lat': 42.50417, 'lon': 143.14297}}, {'city': 'Kumamoto', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'role': 'CONTACT', 'email': 'kodai-kawamura@saiseikaikumamoto.jp'}, {'name': 'Kodai Kawamura', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Saiseikai Kumamoto Hospital - 300175708', 'geoPoint': {'lat': 32.80589, 'lon': 130.69181}}, {'city': 'Kurume-shi', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Koichi Azuma', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Kurume University Hospital'}, {'city': 'Niigata', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Hiroshi Tanaka', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Niigata Cancer Center Hospital - 300176282', 'geoPoint': {'lat': 37.92259, 'lon': 139.04125}}, {'city': 'Osakasayama-shi', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Junko Tanizaki', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Kindai University Hospital'}, {'city': 'Sapporo', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Noriyuki Yamada', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'NHO Hokkaido Cancer Center - 300175802', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'city': 'Busan', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Jung Seop Eom', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Pusan National University Hospital', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'city': 'Daegu', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'role': 'CONTACT', 'email': 'shinyup@knu.ac.kr'}, {'name': 'Shin Yup Lee', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Kyungpook National University Chilgok Hospital', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'city': 'Hwasun-gun', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Young-Chul Kim', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Chonnam National University Hwasun Hospital'}, {'city': 'Seongnam', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Keun-Wook Lee', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Seoul National University Bundang Hospital', 'geoPoint': {'lat': 35.54127, 'lon': 127.39683}}, {'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Dae Ho Lee', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Asan Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Sung Yong Lee', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Korea University Guro Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'role': 'CONTACT', 'email': 'seungtaekim321@gmail.com'}, {'name': 'Seung Tae Kim', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Do-Youn Oh', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Hye Jin Choi', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Severance Hospital, Yonsei University Health System - Division of Infectious Diseases', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '14004', 'city': 'Córdoba', 'state': 'Córdoba', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'role': 'CONTACT', 'email': 'isidoroc.barneto@gmail.com'}, {'name': 'Isidoro Carlos Barneto Aranda', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Universitario Reina Sofia - Dept of Oncology', 'geoPoint': {'lat': 37.89155, 'lon': -4.77275}}, {'city': 'Badalona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Cinta Hierro Carbó', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'ICO Badalona - Hospital Universitari Germans Trias i Pujol - Servicio de Oncologia Medica', 'geoPoint': {'lat': 41.45004, 'lon': 2.24741}}, {'zip': '08036', 'city': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'role': 'CONTACT', 'email': 'ivictori@recerca.clinic.cat'}, {'name': 'Ivan Manuel Victoria Ruiz', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Clinic de Barcelona - Servicio de Oncologia', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Tatiana Hernandez Guerrero', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital HM Nou Delfos - START Barcelona', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': "L'Hospitalet de Llobregat", 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Mariona Calvo Campos', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "ICO l'Hospitalet - Hospital Duran i Reynals - Servicio de Oncologia", 'geoPoint': {'lat': 41.35967, 'lon': 2.10028}}, {'zip': '28007', 'city': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'role': 'CONTACT', 'email': 'rosa.alvarez.al@gmail.com'}, {'name': 'Rosa Alvarez Alvarez', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital General Universitario Gregorio Marañon - Servicio de Oncologia Medica', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Maria Jose de Miguel Luken', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Centro Integral Oncologico Clara Campal - Unidad de Fase I-Oncologica', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Bernard Gaston Doger de Speville Uribe', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Universitario Fundacion Jimenez Diaz - START Madrid FJD - Oncology Phase I', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Federico Longo Munoz', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Universitario Ramon y Cajal - Servicio de Oncologia', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Pozuelo de Alarcón', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Valentina Boni', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'NEXT Madrid - Hospital Universitario Quironsalud Madrid', 'geoPoint': {'lat': 40.43293, 'lon': -3.81338}}, {'zip': '41009', 'city': 'Seville', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'role': 'CONTACT', 'email': 'tgarciamanrique.onco@gmail.com'}, {'name': 'Teresa Garcia Manrique', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Universitario Virgen Macarena - Oncology Service', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'zip': '46026', 'city': 'Valencia', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'role': 'CONTACT', 'email': 'juan_osc@gva.es'}, {'name': 'Oscar Jose Juan Vidal', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Universitari i Politecnic La Fe - Oncology Department', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}], 'centralContacts': [{'name': 'Communication Center', 'role': 'CONTACT', 'email': 'service@emdgroup.com', 'phone': '+496151725200'}], 'overallOfficials': [{'name': 'Medical Responsible', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany'}]}, 'ipdSharingStatementModule': {'url': 'https://bit.ly/IPD21', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'Within six months after the approval of a new product or a new indication for an approved product in both the United States and the European Union', 'ipdSharing': 'YES', 'description': 'We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in both the US and European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website bit.ly/IPD21', 'accessCriteria': "Qualified scientific and medical researchers can request the data. Such requests must be submitted in writing to the company's portal and will be internally reviewed regarding criteria for researchers' qualification and legitimacy of the research proposal."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'EMD Serono Research & Development Institute, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany', 'class': 'INDUSTRY'}, {'name': 'Merck KGaA, Darmstadt, Germany', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}