Ignite Creation Date:
2025-12-24 @ 11:51 PM
Ignite Modification Date:
2025-12-25 @ 9:45 PM
Study NCT ID:
NCT06190951
Status:
RECRUITING
Last Update Posted:
2025-11-19
First Post:
2023-11-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Trial to Learn if Fianlimab and Cemiplimab Are Safe and Work Better Than Anti-PD1 Alone in Adult Participants With Resectable Stage 3 or 4 Melanoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008545', 'term': 'Melanoma'}, {'id': 'D012878', 'term': 'Skin Neoplasms'}], 'ancestors': [{'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D018326', 'term': 'Nevi and Melanomas'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000627974', 'term': 'cemiplimab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-09-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2031-04-23', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-17', 'studyFirstSubmitDate': '2023-11-09', 'studyFirstSubmitQcDate': '2023-12-19', 'lastUpdatePostDateStruct': {'date': '2025-11-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-01-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-03-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pathological complete response (pCR) rate as assessed by Blinded Independent Pathological Review (BIPR)', 'timeFrame': 'Up to 1 year'}], 'secondaryOutcomes': [{'measure': 'pCR rate as assessed by local pathologic review', 'timeFrame': 'Up to 1 year'}, {'measure': 'Event-Free Survival (EFS)', 'timeFrame': 'Up to 4 years'}, {'measure': 'Distant metastasis-free survival (DMFS)', 'timeFrame': 'Up to 4 years'}, {'measure': 'Overall survival (OS)', 'timeFrame': 'Up to 4 years'}, {'measure': 'Major pathological response (MPR) as assessed by BIPR', 'timeFrame': 'Up to 4 years'}, {'measure': 'MPR rate as assessed by local pathologic review', 'timeFrame': 'Up to 4 years'}, {'measure': 'Objective Response Rate (ORR) assessed by investigator per RECIST 1.1 criteria', 'timeFrame': 'Up to 4 years'}, {'measure': 'ORR assessed by Blinded Independent Central Review (BICR) per RECIST 1.1 criteria', 'timeFrame': 'Up to 4 years'}, {'measure': 'Relapse-free survival (RFS)', 'timeFrame': 'Up to 4 years'}, {'measure': 'Occurrence of treatment-emergent adverse events (TEAEs)', 'timeFrame': '90 days following last dose of study drug, approximately 4 years'}, {'measure': 'Occurrence of immune-mediated adverse events (imAEs)', 'timeFrame': '90 days following last dose of study drug, approximately 4 years'}, {'measure': 'Occurrence of serious adverse events (SAEs)', 'timeFrame': '90 days following last dose of study drug, approximately 4 years'}, {'measure': 'Occurrence of adverse events of special interest (AESIs)', 'timeFrame': '90 days following last dose of study drug, approximately 4 years'}, {'measure': 'Occurrence of TEAEs resulting in death', 'timeFrame': '90 days following last dose of study drug, approximately 4 years'}, {'measure': 'Occurrence of interruption or discontinuation of study drug(s) due to TEAE.', 'timeFrame': '90 days following last dose of study drug, approximately 4 years'}, {'measure': 'Occurrence of cancellation of surgery due to TEAE or delay to surgery', 'timeFrame': '90 days following last dose of study drug, approximately 4 years'}, {'measure': 'Occurrence of laboratory abnormalities', 'timeFrame': '90 days following last dose of study drug, approximately 4 years', 'description': 'Grade 3 or higher per Common Terminology Criteria for Adverse Events (CTCAE V5.0)'}, {'measure': 'Concentrations of fianlimab in serum', 'timeFrame': 'Up to 4 years'}, {'measure': 'Concentrations of cemiplimab in serum', 'timeFrame': 'Up to 4 years'}, {'measure': 'Anti-drug antibodies (ADA) in serum to fianlimab', 'timeFrame': 'Up to 4 years'}, {'measure': 'ADA in serum to cemiplimab', 'timeFrame': 'Up to 4 years'}, {'measure': 'Change from baseline in disease-related symptoms per Functional Assessment of Cancer Therapy-Melanoma (FACT-M) subscale', 'timeFrame': 'Up to 4 years', 'description': 'The FACT-M is a melanoma-specific quality of life questionnaire that is composed of items from the Functional Assessment of Cancer Therapy-General (FACT-G). The FACT-M is scored on a 5-point Likert-scale: "Not at all", "A little bit", "Somewhat", "Quite a bit", and "Very much.". A Higher score represents higher Health Related Quality of Life (HRQoL).'}, {'measure': 'Change from baseline in functioning per European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (QoL) C30 (EORTC QLQ-C30)', 'timeFrame': 'Up to 4 years', 'description': 'EORTC-QLQ-C30 is a 30-item subject self-report questionnaire composed of both multi-item and single scales, including a global health status/quality of life (GHS/QoL) scale. Participants rate items on a four-point scale, with 1 as "not at all" and 4 as "very much." A change of 5 - 10 points is considered a small change. A change of 10 - 20 points is considered a moderate change.'}, {'measure': 'Change from baseline in global health status/QoL per EORTC QLQ-C30', 'timeFrame': 'Up to 4 years'}, {'measure': 'Change from baseline in overall health state per European Quality of Life Dimension 5 (EQ-5D-5L)', 'timeFrame': 'Up to 4 years', 'description': 'The EQ-5D-5L consists of EQ-5D descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Skin cancer', 'Fully resectable stage III melanoma', 'Fully resectable stage IV melanoma'], 'conditions': ['Melanoma']}, 'descriptionModule': {'briefSummary': 'This study is researching an experimental drug called REGN3767, also known as fianlimab (R3767), when combined with another medication called cemiplimab (each individually called a "study drug" or called "study drugs" when combined) compared with cemiplimab alone. These types of immunotherapy study drugs are collectively known as immune checkpoint inhibitors. Immunotherapies are treatments that use the immune system to recognize and kill cancer cells. The study is focused on participants with a type of skin cancer known as melanoma.\n\nThe objective of this study is to see if the combination of fianlimab and cemiplimab is an effective treatment compared to cemiplimab in participants with high-risk, resectable melanoma. Participants will receive treatment before surgery, undergo resection, and then will have the option to continue treatment after resection.\n\nThe study is looking at several other research questions, including:\n\n* What side effects may happen from receiving the study drug(s).\n* How much study drug(s) is in the blood at different times.\n* Whether the body makes antibodies against the study drug(s) (which could make the drug less effective or could lead to side effects). Antibodies are proteins that are naturally found in the blood stream that fight infections.\n* How administering the study drugs might improve quality of life.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n1. All patients must be either stage III (IIIB, IIIC, IIID) or stage IV (M1a, M1b, M1c) per American Joint Committee on Cancer (AJCC) 8th edition (Amin 2017) and have histologically confirmed cutaneous melanoma that is deemed completely surgically resectable in order to be eligible as described in the protocol.\n2. Patients with stage III melanoma must have clinically detectable disease that is confirmed as malignant on the pathology report. The pathology report must be reviewed, signed and dated by the investigator; this process will be confirmed during the interactive voice response system (IVRS) process as described in the protocol.\n3. Patients must be candidates for full resection with curative intent and must be able to be surgically rendered free of disease with negative margins on resected specimens at surgery. The treatment plan including date of surgery must be documented by the investigator prior to randomization.\n4. All patients must undergo full disease staging through a complete physical examination and imaging studies within 4 weeks prior to randomization. Imaging must include a computer tomography (CT) scan of the chest, abdomen, pelvis (if the primary tumor is on the head/neck then include a CT scan of head/neck), and all known sites of previously resected disease (if applicable) and brain magnetic resonance imaging (MRI) (or brain CT with contrast allowed if MRI is contraindicated).\n5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1\n\nKey Exclusion Criteria:\n\nMedical conditions:\n\n1. Primary uveal melanoma\n2. Ongoing or recent (within 2 years) evidence of an autoimmune disease that required systemic treatment with immunosuppressive agents. The following are non-exclusionary: vitiligo, childhood asthma that has resolved, residual hypothyroidism that requires only hormone replacement, psoriasis not requiring systemic treatment.\n3. Patients must not have received any prior systemic anti-cancer therapy for melanoma. Prior radiotherapy for melanoma is allowed if not given to a target lesion or, if given to a target lesion, there is pathological evidence of disease progression in the same lesion.\n4. Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B (HBV) or hepatitis C virus (HCV) infection; or diagnosis of immunodeficiency that is related to or results in chronic infection as described in the protocol.\n\n Prior/concomitant therapy:\n5. Use of immunosuppressive doses of corticosteroids (≥10mg of prednisone per day or equivalent) within 14 days of the first dose of study medication as described in the protocol.\n6. Treatment with any anti-cancer therapy for malignancies other than melanoma, including immuno- therapy, chemotherapy, radiotherapy, or biological therapy in the 5 years prior to randomization as described in the protocol.\n\n Other comorbidities:\n7. Participants with a history of myocarditis.\n8. History or current evidence of significant (CTCAE grade ≥2) local or systemic infection (e. g., cellulitis, pneumonia, septicemia) requiring systemic antibiotic treatment within 2 weeks prior to the first dose of trial medication.\n\nNote: Other protocol-defined inclusion/ exclusion criteria apply'}, 'identificationModule': {'nctId': 'NCT06190951', 'briefTitle': 'A Trial to Learn if Fianlimab and Cemiplimab Are Safe and Work Better Than Anti-PD1 Alone in Adult Participants With Resectable Stage 3 or 4 Melanoma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Regeneron Pharmaceuticals'}, 'officialTitle': 'A Phase 2 Peri-operative Trial of Fianlimab and Cemiplimab Compared With Anti-PD1 Alone in Patients With Resectable Stage III and IV Melanoma', 'orgStudyIdInfo': {'id': 'R3767-ONC-2208'}, 'secondaryIdInfos': [{'id': '2022-502825-17-00', 'type': 'CTIS'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Arm A', 'description': 'As described in the protocol', 'interventionNames': ['Drug: cemiplimab', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Arm B', 'description': 'As described in the protocol', 'interventionNames': ['Drug: Fixed Dose Combination (FDC) cemiplimab+fianlimab']}, {'type': 'EXPERIMENTAL', 'label': 'Arm C', 'description': 'As described in the protocol', 'interventionNames': ['Drug: Fixed Dose Combination (FDC) cemiplimab+fianlimab']}], 'interventions': [{'name': 'cemiplimab', 'type': 'DRUG', 'otherNames': ['REGN2810', 'Libtayo'], 'description': 'Administered per the protocol', 'armGroupLabels': ['Arm A']}, {'name': 'Fixed Dose Combination (FDC) cemiplimab+fianlimab', 'type': 'DRUG', 'otherNames': ['REGN2810', 'Libtayo', 'REGN3767'], 'description': 'Or coadministration, depending on availability.', 'armGroupLabels': ['Arm B', 'Arm C']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Administered per the protocol', 'armGroupLabels': ['Arm A']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92093', 'city': 'La Jolla', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'UC San Diego', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '90089', 'city': 'Los Angeles', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'USC Norris Comprehensive Cancer Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92663', 'city': 'Newport Beach', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Hoag Family Cancer Institute', 'geoPoint': {'lat': 33.61891, 'lon': -117.92895}}, {'zip': '94115', 'city': 'San Francisco', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'California Pacific Medical Center Research Institute', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'University of California San Francisco (UCSF)', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '90404', 'city': 'Santa Monica', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': "St John's Cancer Institute", 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}, {'zip': '06102', 'city': 'Hartford', 'state': 'Connecticut', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Hartford Hospital', 'geoPoint': {'lat': 41.76371, 'lon': -72.68509}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Emory Healthcare, Emory Clinic', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '60201', 'city': 'Evanston', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'NorthShore University HealthSystem', 'geoPoint': {'lat': 42.04114, 'lon': -87.69006}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 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-74.45182}}, {'zip': '11042', 'city': 'Lake Success', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Northwell Health Cancer Institute', 'geoPoint': {'lat': 40.77066, 'lon': -73.71763}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Duke Cancer Institute, University Hospital', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Seidman Cancer Center', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Cleveland Clinic Foundation', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Thomas Jefferson University Hospital', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '15232', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'University of Pittsburgh', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '37920', 'city': 'Knoxville', 'state': 'Tennessee', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'University of Tennessee Medical Center', 'geoPoint': {'lat': 35.96064, 'lon': -83.92074}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'University of Texas MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '22908', 'city': 'Charlottesville', 'state': 'Virginia', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'University of Virginia', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}, {'zip': '2480', 'city': 'Lismore', 'state': 'New South Wales', 'status': 'RECRUITING', 'country': 'Australia', 'facility': 'Lismore Base Hospital', 'geoPoint': {'lat': -28.81354, 'lon': 153.2773}}, {'zip': '2145', 'city': 'Westmead', 'state': 'New South Wales', 'status': 'RECRUITING', 'country': 'Australia', 'facility': 'Westmead Hospital', 'geoPoint': {'lat': -33.80383, 'lon': 150.98768}}, {'zip': '2065', 'city': 'Wollstonecraft', 'state': 'New South Wales', 'status': 'RECRUITING', 'country': 'Australia', 'facility': 'Melanoma Institute of Australia', 'geoPoint': {'lat': -33.8328, 'lon': 151.18981}}, {'zip': '4655', 'city': 'Hervey Bay', 'state': 'Queensland', 'status': 'RECRUITING', 'country': 'Australia', 'facility': 'Hervey Bay Hospital', 'geoPoint': {'lat': -25.28762, 'lon': 152.76936}}, {'zip': '5011', 'city': 'Woodville', 'state': 'South Australia', 'status': 'RECRUITING', 'country': 'Australia', 'facility': 'The Queen Elizabeth Hospital', 'geoPoint': {'lat': -34.877, 'lon': 138.54291}}, {'zip': '3128', 'city': 'Box Hill', 'state': 'Victoria', 'status': 'RECRUITING', 'country': 'Australia', 'facility': 'Eastern Health', 'geoPoint': {'lat': -37.81887, 'lon': 145.12545}}, {'zip': '3052', 'city': 'Melbourne', 'state': 'Victoria', 'status': 'RECRUITING', 'country': 'Australia', 'facility': 'Peter MacCallum Cancer Centre', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'zip': '6009', 'city': 'Nedlands', 'state': 'Western Australia', 'status': 'RECRUITING', 'country': 'Australia', 'facility': 'One Clinical Research at Hollywood Private Hospital', 'geoPoint': {'lat': -31.98184, 'lon': 115.8073}}, {'zip': 'M5G 2M9', 'city': 'Toronto', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'facility': 'Princess Margaret Cancer Centre', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'H2X 0C1', 'city': 'Montreal', 'state': 'Quebec', 'status': 'RECRUITING', 'country': 'Canada', 'facility': "Centre Hospitalier de l'Universite de Montreal (CHUM)", 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'G1J 1Z4', 'city': 'Québec', 'status': 'RECRUITING', 'country': 'Canada', 'facility': 'CHU de Quebec - Universite Laval', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}, {'zip': '21000', 'city': 'Dijon', 'state': 'Burgundy', 'status': 'RECRUITING', 'country': 'France', 'facility': 'CHU-Dijon', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}, {'zip': '37044', 'city': 'Tours', 'state': 'Centre-Val de Loire', 'status': 'RECRUITING', 'country': 'France', 'facility': 'CHRU de Tours', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}, {'zip': '33075', 'city': 'Bordeaux', 'state': 'Gironde', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Chu De Bordeaux', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '14000', 'city': 'Caen', 'state': 'Normandy', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Centre Francois Baclesse', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'zip': '92104', 'city': 'Boulogne', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Hopital Ambroise Pare', 'geoPoint': {'lat': 46.79346, 'lon': -1.3194}}, {'zip': '63003', 'city': 'Clermont-Ferrand', 'status': 'RECRUITING', 'country': 'France', 'facility': 'CHU Estaing', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'zip': '59037', 'city': 'Lille', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Regional University Hospital of Lille 2208', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '13385', 'city': 'Marseille', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Hopital Timone', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '06202', 'city': 'Nice', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Centre Hospitalier Universitaire De Nice Hopital De L Archet', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'zip': '75010', 'city': 'Paris', 'state': 'Île-de-France Region', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Saint Louis Hospital', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '94800', 'city': 'Villejuif', 'state': 'Île-de-France Region', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Gustave Roussy', 'geoPoint': {'lat': 48.7939, 'lon': 2.35992}}, {'zip': '35385', 'city': 'Giessen', 'state': 'Hesse', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'University Hospital Giessen', 'geoPoint': {'lat': 50.58727, 'lon': 8.67554}}, {'zip': '04103', 'city': 'Leipzig', 'state': 'Saxony', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Universitatsklinikum Leipzig, AoR', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}, {'zip': '10117', 'city': 'Berlin', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Charite University Medicine', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '44124', 'city': 'Ferrara', 'status': 'RECRUITING', 'country': 'Italy', 'facility': 'Azienda Ospedaliero-Universitaria Ferrara', 'geoPoint': {'lat': 44.83804, 'lon': 11.62057}}, {'zip': '56126', 'city': 'Pisa', 'status': 'RECRUITING', 'country': 'Italy', 'facility': 'U.O. Oncologia Medica 2 Universitaria, Azienda Ospedaliero Universitaria Pisana', 'geoPoint': {'lat': 43.70853, 'lon': 10.4036}}, {'zip': '08028', 'city': 'Barcelona', 'state': 'Catalonia', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Instituto Oncologico Dr Rosell', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08029', 'city': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'facility': "Vall d'Hebron Hospital", 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08036', 'city': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Hospital Clinic de Barcelona', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '37007', 'city': 'Salamanca', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Hospital Clinico Universitario de Salamanca', 'geoPoint': {'lat': 40.96882, 'lon': -5.66388}}], 'centralContacts': [{'name': 'Clinical Trials Administrator', 'role': 'CONTACT', 'email': 'clinicaltrials@regeneron.com', 'phone': '844-734-6643'}], 'overallOfficials': [{'name': 'Clinical Trial Management', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Regeneron Pharmaceuticals'}]}, 'ipdSharingStatementModule': {'url': 'https://vivli.org/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'When Regeneron has:\n\n* received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication or has globally discontinued development of the product for all indications on or after April 2020 and has no plans for future development\n* made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry)\n* the legal authority to share the data, and\n* ensured the ability to protect participant privacy', 'ipdSharing': 'YES', 'description': 'All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing', 'accessCriteria': "Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf"}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Regeneron Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}