A Trial to See if the Combination of Fianlimab With Cemiplimab Works Better Than Pembrolizumab for Preventing or Delaying Melanoma From Coming Back After it Has Been Removed With Surgery
A Phase 3 Trial of Fianlimab (Anti-LAG-3) and Cemiplimab Versus Pembrolizumab in the Adjuvant Setting in Patients With Completely Resected High-risk Melanoma
2 other identifiers
interventional
1,564
22 countries
211
Brief Summary
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 an approved medication called pembrolizumab. The objective of this study is to see if the combination of fianlimab and cemiplimab is an effective treatment compared to pembrolizumab in patients that have had melanoma removal surgery but are still at high risk for the recurrence of the disease. Pembrolizumab is an approved treatment in some countries in this clinical setting. The study is looking at several other research questions, including:
- What side effects may happen from receiving the study drugs.
- How much study drug is in the blood at different times.
- Whether the body makes antibodies against the study drug (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.
- How administering the study drugs might improve quality of life.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jan 2023
Longer than P75 for phase_3
211 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 14, 2022
CompletedFirst Posted
Study publicly available on registry
November 8, 2022
CompletedStudy Start
First participant enrolled
January 16, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 16, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 15, 2030
May 13, 2025
May 1, 2025
5.3 years
October 14, 2022
May 12, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Relapse free survival (RSF)
Time from randomization to the first documented recurrence of disease at any site (excluding new primary melanomas) or death from any cause, whichever occurs first.
Up to 5 Years
Secondary Outcomes (22)
Distant metastasis-free survival (DMFS)
Up to 5 Years
Overall survival (OS)
Up to 5 Years
Occurrence of treatment-emergent adverse events (TEAEs)
Up to 5 Years
Occurrence of immune-mediated EAEs (im-EAEs)
Up to 5 Years
Occurrence of serious adverse events (SAEs)
Up to 5 Years
- +17 more secondary outcomes
Study Arms (3)
Fianlimab HD + Cemiplimab
EXPERIMENTALPatients will be administered one combination dose of fianlimab high dose (HD) and cemiplimab
Fianlimab LD + Cemiplimab
EXPERIMENTALPatients will be administered one combination dose of fianlimab low dose (LD) and cemiplimab
Pembrolizumab
ACTIVE COMPARATORPatients will be administered one dose of pembrolizumab co-infused with saline/dextrose placebo
Interventions
Fianlimab will be administered by intravenous (IV) infusion every (Q) 3 weeks
Cemiplimab will be administered by IV infusion Q 3 weeks
Pembrolizumab will be administered by IV infusion Q 3 weeks
Matching placebo co-infused with pembrolizumab IV, will be administered by IV infusion Q 3 weeks
Eligibility Criteria
You may qualify if:
- All patients must be either stage IIB, IIC, III, or stage IV per American Joint Committee on Cancer (AJCC) 8th edition and have histologically confirmed melanoma that is completely surgically resected in order to be eligible as defined by the protocol
- Complete surgical resection must be performed within 12 weeks prior to randomization, and enrollment may occur only after satisfactory wound healing from the surgery
- All patients must have disease-free status documented by a complete physical examination and imaging studies within 4 weeks prior to randomization, as described in the protocol
You may not qualify if:
- Uveal melanoma
- Any evidence of residual disease after surgery by imaging, pathology, or cytology.
- Ongoing or recent (within 2 years) evidence of clinically significant autoimmune disease that required treatment
- Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C (HCV) infection; or diagnosis of immunodeficiency that is related to, or results in chronic infection, as described in the protocol
- Another malignancy that is currently progressing or that required active treatment in the past 5 years, as described in the protocol
- Participants with a history of myocarditis
- Adolescent patients (≥12 to \<18 years old) with body weight \<40 kg
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (211)
UC San Diego
La Jolla, California, 92093, United States
UCSF Medical Center at Mission Bay
San Francisco, California, 94158, United States
John Wayne Cancer Institute (JWCI)
Santa Monica, California, 90404, United States
The Melanoma And Skin Cancer Institute
Englewood, Colorado, 80113, United States
Miami Cancer Institute at Baptist Health, Inc.
Miami, Florida, 33176, United States
Orlando Health
Orlando, Florida, 32806, United States
Moffitt Cancer Center
Tampa, Florida, 33612, United States
Northwestern University
Chicago, Illinois, 60611, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901, United States
Laura & Isaac Perlmutter Cancer Center at NYU Langone Health
New York, New York, 10016, United States
Columbia University
New York, New York, 10032, United States
University of Rochester
Rochester, New York, 14642, United States
Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599, United States
Duke Cancer Institute, University Hospital
Durham, North Carolina, 27710, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
The Ohio State University James Comprehensive Cancer Center
Columbus, Ohio, 43210, United States
St Lukes University Health Network
Easton, Pennsylvania, 18045, United States
University Of Pittsburgh
Pittsburgh, Pennsylvania, 15213, United States
University of Tennessee Medical Center
Knoxville, Tennessee, 37920, United States
Tennessee Oncology - Centennial Clinic Location
Nashville, Tennessee, 37203-1625, United States
Verdi Oncology
Nashville, Tennessee, 37203, United States
UT Southwestern Medical Center
Dallas, Texas, 75390, United States
Intermountain Medical Center
Murray, Utah, 84107, United States
University of Virginia Medical Center
Charlottesville, Virginia, 22903, United States
Fundacion Centro de Investigaciones para la Transformacion (CENIT)
Caba, Buenos Aires, 1125, Argentina
Centro de Investigacion Pergamino
Pergamino, Buenos Aires, B2700CPM, Argentina
Clinica Viedma S.A.
Viedma, Río Negro Province, 8500, Argentina
Instituto de Oncologia de Rosario
Rosario, Santa Fe Province, S2000KZE, Argentina
Centro Medico San Roque
San Miguel de Tucumán, Tucumán Province, 4000, Argentina
DIABAID - Instituto de Asistencia Integral en Diabetes
Caba, 1061, Argentina
Blacktown Cancer and Haematology Centre - Blacktown Hospital
Blacktown, New South Wales, 2148, Australia
Lismore Base Hospital
Lismore, New South Wales, 2480, Australia
Liverpool Hospital - Cancer Therapy Centre
Liverpool, New South Wales, 2170, Australia
Melanoma Institute of Australia
Wollstonecraft, New South Wales, 2065, Australia
Flinders Medical Centre
Bedford Park, South Australia, 5042, Australia
Calvary North Adelaide Hospital
North Adelaide, South Australia, 5006, Australia
Eastern Health
Box Hill, Victoria, 3128, Australia
Andrew Love Cancer Centre
Geelong, Victoria, 3220, Australia
Alfred Hospital
Melbourne, Victoria, 3004, Australia
One Clinical Research at Hollywood Private Hospital
Nedlands, Western Australia, 6009, Australia
Vitaz campus Sint-Niklaas Moerland
Sint-Niklaas, Oost-Vlaanderen, 9100, Belgium
AZ Groeninge
Kortrijk, West-Vlaanderen, 8500, Belgium
Cliniques Universitaires Saint-Luc
Brussels, 1200, Belgium
Hospital das Clinicas da Universidade Federal de Minas Gerais
Belo Horizonte, Minas Gerais, 30130-090, Brazil
Liga Paranaense de Combate ao Cancer - Hospital Erasto Gaertner
Curitiba, Paraná, 81520-060, Brazil
INCA Instituto Nacional de Cancer
Santo Cristo, Rio de Janeiro, 20220-410, Brazil
Oncosite Centro De Pesquisa Em Oncologia
Ijuí, Rio Grande do Sul, 98700-000, Brazil
Instituto do Cancer em Hospital Sao Vicente de Paulo
Passo Fundo, Rio Grande do Sul, 99010-090, Brazil
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035007, Brazil
Hospital Moinhos de vento
Porto Alegre, Rio Grande do Sul, 90440140, Brazil
Centro de Pesquisa em Oncologia PUCRS
Porto Alegre, Rio Grande do Sul, 90619900, Brazil
Catarina Pesquisa Clinica
Itajaí, Santa Catarina, 88301-220, Brazil
Instituto Joinvilense de Hematologia e Oncologia
Joinville, Santa Catarina, 89201260, Brazil
Animi Unidade de Tratamento Oncologico
Lages, Santa Catarina, 88501-001, Brazil
Fundacao Pio XII - Hospital de Amor
Barretos, São Paulo, 14784400, Brazil
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto - Hospital de Base
São José do Rio Preto, São Paulo, 15090-000, Brazil
Unimed Sorocaba
Sorocaba, São Paulo, 18052-210, Brazil
Instituto COI
Rio de Janeiro, 23793-080, Brazil
Hemomed
São Paulo, 01236030, Brazil
Hospital Sirio Libanes
São Paulo, 01308-050, Brazil
Sao Camilo Oncologia
São Paulo, 04014-002, Brazil
Dr. Everett Chalmers Hospital
Fredericton, New Brunswick, E3B 5N5, Canada
Royal Victoria Regional Health Centre
Barrie, Ontario, L4M 6M2, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5, Canada
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9, Canada
Oncocentro APYS
Viña del Mar, Región de Valparaíso, 2520598, Chile
Clinica UC San Carlos de Apoquindo
Santiago, Santiago Metropolitan, 7550000, Chile
Centro Oncologia de Precision Universidad Mayor
Santiago, Santiago Metropolitan, 7560907, Chile
Masaryk Memorial Cancer Institute
Brno, Brno Mesto, 65653, Czechia
University Hospital Hradec Kralove
Hradec Králové, North Central Czech Republic, 50005, Czechia
University Hospital Ostrava
Ostrava, 70852, Czechia
Centre Georges Francois Leclerc
Dijon, Bourgogne-Franche-Comté, 21000, France
CHU-Dijon
Dijon, Burgundy, 21000, France
Besancon Regional University Hospital Center
Besançon, Doubs, 25000, France
Chu De Bordeaux
Bordeaux, Gironde, 33075, France
Institut Claudius Regaud, IUCT-Oncopole
Toulouse, Haute-Garonne, 31059, France
CHU de Lille
Lille, Hauts-de-France, 59000, France
Service de Dermatologie CHU Saint Eloi
Montpellier, Herault, 34295, France
Centre Hospitalier Universitaire Grenoble Alpes
La Tronche, Isere, 38700, France
Centre Francois Baclesse (CFB)
Caen, Normandy, 14076, France
Centre Hospitalier Le Mans
Le Mans, Pays de la Loire Region, 72037, France
Nantes University Hospital
Nantes, Pays de la Loire Region, 44093, France
CHU Amiens-Picardie
Amiens, Picardie, 80000, France
Sainte Catherine Institut du Cancer Avignon Provence
Avignon, 84918, France
N_Hôpital Ambroise-Paré
Boulogne-Billancourt, 92100, France
CHU Estaing
Clermont-Ferrand, 63003, France
Centre Hospitalier Universitaire De Nice Hopital De L Archet
Nice, 06202, France
Centre Hospitalier de Valence
Valence, 26000, France
Institut Gustave Roussy
Villejuif, 94805, France
Hopital Avicenne
Bobigny, Île-de-France Region, 93000, France
Hospital Henri Mondor
Créteil, Île-de-France Region, 94000, France
Saint Louis Hospital
Paris, Île-de-France Region, 75010, France
Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic
Tbilisi, Caucasus, 0144, Georgia
Cancer Center of Adjara
Batumi, 6000, Georgia
Acad.Fridon Todua Medical Center- Research Institute of Clinical Medicine
Tbilisi, 0112, Georgia
Israeli Georgian Medical Research Clinic Helsicore
Tbilisi, 0112, Georgia
LTD New Hospitals
Tbilisi, 0114, Georgia
JSC K. Eristavi National Center of Experimental and Clinical Surgery
Tbilisi, 0159, Georgia
TIM - Tbilisi Institute of Medicine
Tbilisi, 0160, Georgia
University Medical Center Mannheim
Mannheim, Baden-Wurttemberg, 68167, Germany
University of Tuebingen
Tübingen, Baden-Wurttemberg, 72076, Germany
University Hospital Augsburg
Augsburg, Bavaria, 86179, Germany
Dermatology Erlangen
Erlangen, Bavaria, 91054, Germany
LMU Klinikum
Munich, Bavaria, 80337, Germany
University Hospital of Regensburg
Regensburg, Bavaria, 93053, Germany
Klinikum Darmstadt GmbH
Darmstadt, Hesse, 64283, Germany
University Clinic Frankfurt
Frankfurt am Main, Hesse, 60590, Germany
University Medical Center Goettingen
Göttingen, Lower Saxony, 37075, Germany
Helios Kliniken Schwerin
Schwerin, Mecklenburg-Vorpommern, 19055, Germany
Ruhr University Bochum
Bochum, North Rhine-Westphalia, 44791, Germany
Universitatsklinikum Essen
Essen, North Rhine-Westphalia, 45147, Germany
University Hospital Muenster
Münster, North Rhine-Westphalia, 48149, Germany
Fachklinik Hornheide
Münster, North Rhine-Westphalia, 48157, Germany
Hautklinik
Ludwigshafen am Rhein, Rhineland-Palatinate, D-67063, Germany
University Hospital Dresden
Dresden, Saxony, 01307, Germany
Skin Cancer Center Harz
Quedlinburg, Saxony-Anhalt, 06484, Germany
University Hospital of Universitatsklinikum Schleswig Holstein (UKSH) Campus Kiel
Kiel, Schleswig-Holstein, 24105, Germany
Universitatsklinikum Schleswig Holstein Campus Luebeck
Lübeck, Schleswig-Holstein, 23538, Germany
Helios Klinikum Erfurt
Erfurt, Thuringia, D-99089, Germany
Charite Universitaetsmedizin Berlin
Berlin, 10117, Germany
Klinikum Bremen Ost
Bremen, 28325, Germany
National and Kapodistrian University of Athens
Athens, Attica, 11527, Greece
Metropolitan Hospital
Neo Faliro, Attica, 18547, Greece
Ongology Theageneio Thessaloniki
Thessaloniki, 54007, Greece
BioClinic Thessaloniki
Thessaloniki, 54622, Greece
Interbalkan Medical Center
Thessaloniki, 57001, Greece
Galway University Hospital
Galway, Connacht, H91 YR71, Ireland
Cork University Hospital
Cork, T12 EC8P, Ireland
Beaumont Hospital
Dublin, D09 V2N0, Ireland
St Vincents University Hospital
Dublin, DO4YN63, Ireland
Haemek Medical Center
Afula, Northern District, 18340000, Israel
Hadassah Medical Organization
Jerusalem, 91120, Israel
Sheba Medical Center
Tel Litwinsky, 5265601, Israel
Clinica Oncologica, AOU Riuniti Ancona
Ancona, An, 60020, Italy
U.O.C. Oncologia Medica ed Ematologia (U.O.C Medical Oncology and Hematology)
Naples, Campania, 80121, Italy
Istituto Romagnolo per lo Studio dei Tumori (IRST)
Meldola, Forli Cesena, 47014, Italy
Istituto Clinico Humanitas
Milan, Lombardy, 20089, Italy
Istituto dei Tumori
Bari, 70124, Italy
Azienda Ospedaliera Santa Croce i Carle
Cuneo, 12100, Italy
Istituto Europeo di Oncologia
Milan, 20141, Italy
Instituto Nazionale Tumori Fondazione Giovanni Pascale
Naples, 80131, Italy
University of Perugia
Perugia, 06132, Italy
Fondazione Policlinico Universitrio a. Gemelli - IRCCS
Rome, 000168, Italy
Campus Bio-Medico di Roma
Rome, 00128, Italy
Istituto Dermopatico dell'Immacolata
Rome, 00167, Italy
Santa Chiara Hospital
Trento, 38122, Italy
Azienda Sanitaria Universitaria del Friuli Centrale
Udine, 33100, Italy
Preparaciones Oncologica SC
León, Guanajuato, 37178, Mexico
Antiguo Hospital Civil de Guadalajara Fray Antonio Alcalde
Guadalajara, Jalisco, 44280, Mexico
Pan American Clinical Research
Guadalajara, Jalisco, 44670, Mexico
iCan Oncology
Monterrey, Nuevo León, 64710, Mexico
Neurociencias Estudios Clinicos SC
Culiacán, Sinaloa, 80020, Mexico
Centro De Atencion E Investigacion Clinica En Oncologia SCP
Mérida, Yucatán, 97134, Mexico
Faicic Centro de Investigacion Clinica de Veracruz
Veracruz, 91910, Mexico
Mazowiecki Szpital Wojewodzki, Siedleckie Centrum Onkologii
Siedlce, Mazxowieckie, 08-110, Poland
UCK
Gdansk, Pomeranian Voivodeship, 80-214, Poland
Copernicus Podmiot Leczniczy Sp. z o.o.Wojewodzie Centrum Onkologii
Gdansk, Pomeranian Voivodeship, 80-219, Poland
Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w Słupsku Sp. z o.o.
Słupsk, Pomeranian Voivodeship, 76-200, Poland
Poznan University of Meidcla Science
Poznan, Wielkopolska, 60-788, Poland
Institute of Oncology Bucharest
Bucharest, București, 022328, Romania
Cardiomed
Cluj-Napoca, Cluj, 400015, Romania
Institute of Oncology Prof. Dr Ion Chirircuta
Cluj-Napoca, Cluj, 400015, Romania
Radiotherapy Center Cluj
Floreşti, Cluj, 407280, Romania
Sfantul Nectarie Oncology Center
Craiova, Dolj, 200347, Romania
Oncocenter Oncologie Clinica S.R.L
Timișoara, Timiș County, 300166, Romania
Oncomed
Timișoara, Timiș County, 300239, Romania
Centrul De Oncologie Euroclinic
Iași, 700106, Romania
The Medical Oncology Centre of Rosebank
Johannesburg, Gauteng, 2196, South Africa
Wilgers Oncology Centre
Pretoria, Gauteng, 0081, South Africa
Groote Schuur Hospital
Cape Town, Western Cape, 7925, South Africa
Cape Town Oncology Trials
Kraaifontein, Western Cape, 7570, South Africa
H. Germans Trias i Pujol, ICO-Badalona
Badalona, Barcelona, 08916, Spain
Hospital Universitario Marques de Valdecilla
Santander, Cantabria, 39008, Spain
Instituto Oncologico Dr Rosell Hospital Universitari Quiron Dexeus Location
Barcelona, Catalonia, 08028, Spain
Hospital Universitario Central De Asturias
Oviedo, Principality of Asturias, 33011, Spain
Hospital Vall d'Hebron
Barcelona, 08035, Spain
Hospital Clinic de Barcelona
Barcelona, 08036, Spain
Catalan Institute of Oncology (ICO) Hospitalet
Barcelona, 08908, Spain
Hospital Universitario Virgen de las Nieves
Granada, 18014, Spain
Hospital Universitario Lucus Augusti
Lugo, 27003, Spain
Hospital General Universitario Gregorio Maranon
Madrid, 28007, Spain
Hospital Universitario 12 de Octubre Universidad Complutense de Madrid UCM
Madrid, 28041, Spain
Hospital Universitario La Pa<
Madrid, 28046, Spain
Centro Integral Oncologico HM Clara Campal
Madrid, 28050, Spain
Hospital Universitario Virgen Macarena
Seville, 41009, Spain
Instituto Valenciano de Oncologia
Valencia, 46009, Spain
Incliva - Instituto de Investigacion Sanitaria
Valencia, 46010, Spain
Baskent University
Yüreğir, Adana, 01230, Turkey (Türkiye)
Dicle University - Medical Faculty Campus
Sur, Diyarbakır, 21200, Turkey (Türkiye)
Kocaeli University
İzmit, Kocaeli, 41380, Turkey (Türkiye)
Gaziantep Medicalpoint Hospital
Gaziantep, Sehitkamil, 27584, Turkey (Türkiye)
Gulhane Research And Training Hospital
Ankara, 06010, Turkey (Türkiye)
Ozel Liv Hospital
Ankara, 06100, Turkey (Türkiye)
Sbu Doctor Abdurrahman Yurtaslan Ankara Onkoloji Suam
Ankara, 06100, Turkey (Türkiye)
Memorial Ankara Hospital
Ankara, 0906520, Turkey (Türkiye)
Trakya University
Edirne, 22030, Turkey (Türkiye)
Istanbul University Cerrahpasa at Cerrahpasa Medical Faculty
Istanbul, 34450, Turkey (Türkiye)
Istanbul Medeniyet University - Prof Dr Suleyman Yalcin Sehir Hospital
Istanbul, 81450, Turkey (Türkiye)
Royal Devon and Exeter Hospital NHS Trust
Exeter, Devon, EX2 5DW, United Kingdom
Edinburgh Cancer Centre
Edinburgh, Lothian, EH4 2XU, United Kingdom
Bristol Haematology And Oncology Centre (BHOC) - Bristol Cancer Institute
Bristol, Somerset, BS2 8ED, United Kingdom
The Royal Marsden NHS Foundation Trust
Sutton, Surrey, SM2 5PT, United Kingdom
University Hospital Coventry and Warwickshire Nhs Trust
Coventry, West Midlands, CV2 2DX, United Kingdom
Saint Bartholomew's Hospital
London, EC1A 7BE, United Kingdom
University College London Hospitals
London, NW1 2PG, United Kingdom
The Christie
Manchester, M20 4BX, United Kingdom
Taunton and Somerset NHS Foundation Trust
Taunton, TA1 5DA, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trial Management
Regeneron Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 14, 2022
First Posted
November 8, 2022
Study Start
January 16, 2023
Primary Completion (Estimated)
May 16, 2028
Study Completion (Estimated)
February 15, 2030
Last Updated
May 13, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- When Regeneron has: * 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 * made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry) * the legal authority to share the data, and * ensured the ability to protect participant privacy.
- Access Criteria
- 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
All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.