Clinical Study of Fianlimab in Combination With Cemiplimab Versus Pembrolizumab in Adolescent and Adult Patients With Previously Untreated Unresectable Locally Advanced or Metastatic Melanoma
A Phase 3 Trial of Fianlimab (REGN3767, Anti-LAG-3) + Cemiplimab Versus Pembrolizumab in Patients With Previously Untreated Unresectable Locally Advanced or Metastatic Melanoma
3 other identifiers
interventional
1,546
23 countries
206
Brief Summary
This study is researching an experimental drug called REGN3767, also known as fianlimab (R3767), when combined with another medication called REGN2810, also known as cemiplimab (each individually called a "study drug" or called "study drugs" when combined). The study is focused on patients with a type of skin cancer known as melanoma. The aims of the study are to see how effective the combination of fianlimab and cemiplimab are in treating the melanoma skin cancer, in comparison with a medication, pembrolizumab, approved for the treatment of melanoma skin cancer in adults, and to observe any similarities, or differences, in how the study drugs work in adolescent participants compared with adult participants. 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 drugs (which could make the drugs 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 Jul 2022
Longer than P75 for phase_3
206 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
April 6, 2022
CompletedFirst Posted
Study publicly available on registry
April 29, 2022
CompletedStudy Start
First participant enrolled
July 14, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 12, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
September 16, 2031
ExpectedApril 22, 2026
April 1, 2026
3.7 years
April 6, 2022
April 21, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression-free survival (PFS)
Per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 based on Blinded Independent Central Review (BICR)
Approximately 27 months
Secondary Outcomes (28)
Overall survival (OS)
Up to 96 months
Objective response rate (ORR)
Up to 27 months
Disease control rate (DCR)
Up to 27 months
Duration of response (DoR)
Up to 27 months
PFS
Up to 27 months
- +23 more secondary outcomes
Study Arms (4)
A: fianlimab+cemiplimab dose 1
EXPERIMENTALAs defined in Protocol Amendment 5
A1: fianlimab+cemiplimab dose 2
EXPERIMENTALAs defined in Protocol Amendment 5
B: pembrolizumab+placebo
EXPERIMENTALAs defined in Protocol Amendment 5
C: cemiplimab+placebo
EXPERIMENTALAs defined in Protocol Amendment 5
Interventions
Intravenous (IV) infusion
IV infusion
Eligibility Criteria
You may qualify if:
- Age ≥12 years on the date of providing informed consent
- Patients with histologically confirmed unresectable Stage III and Stage IV (metastatic) melanoma (AJCC, 8th revised edition) who have not received prior systemic therapy for advanced unresectable disease
- Patients with acral and mucosal melanomas are eligible. Accrual will be limited to 10% of the total population.
- Measurable disease per RECIST v1.1
- Previously irradiated lesions can only be counted as target lesions if they have been demonstrated to progress and no other target lesion is available
- Cutaneous lesions should be evaluated as non-target lesions
- Performance status:
- For adult patients: Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
- For pediatric patients: Karnofsky performance status ≥70 (patients ≥16 years) or Lansky performance status ≥70 (patients ≤16 years)
- Anticipated life expectancy of at least 3 months
You may not qualify if:
- Uveal melanoma
- 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
- Unknown BRAF V600 mutation status as described in the protocol
- Systemic immune suppression:
- Use of immunosuppressive doses of corticosteroids (\>10mg of prednisone per day or equivalent) within 14 days of the first dose of study medication. Physiologic replacement doses are allowed up to and including 10mg of prednisone/day or equivalent. Inhaled or topical steroids are permitted, if they are not for treatment of an autoimmune disorder.
- Other clinically relevant forms of systemic immune suppression
- Treatment with other anti-cancer therapy including immuno- therapy, chemotherapy, major surgery or biological therapy within 21 days prior to the first dose of trial treatment. Adjuvant hormonotherapy used for breast cancer or other hormone-sensitive cancers in long term remission is allowed.
- History or current evidence of significant (CTCAE Grade ≥2) local or systemic infection (e. g., cellulitis, pneumonia, septicemia) requiring systemic antibiotic treatment within 14 days prior to the first dose of trial medication.
- Active or untreated brain metastases or spinal cord compression. Patients with leptomeningeal disease are excluded. Patients with known brain metastases are eligible if they:
- Received radiotherapy or another appropriate standard therapy for the brain metastases,
- Have neurologically returned to baseline (except for residual signs and symptoms related to the CNS treatment) for at least 14 days prior to enrollment
- Did not require immunosuppressive doses of corticosteroids therapy (\>10mg of prednisone per day or equivalent) in the 14 days prior to enrollment
- Are asymptomatic with a single untreated brain metastasis \<10 mm in size
- Participants with a history of myocarditis.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (210)
UC San Diego
La Jolla, California, 92093, United States
The Angeles Clinic and Research Institute
Los Angeles, California, 90025, United States
Orlando Health
Orlando, Florida, 32806, United States
Seidman Cancer Center
Cleveland, Ohio, 44106, United States
University of Tennessee Medical Center
Knoxville, Tennessee, 37920, United States
DIABAID - Instituto de Asistencia Integral en Diabetes
Ciudad Autonoma de Buenos Aires, Buenos Aires, 1061, Argentina
Centro Medico Austral
Ciudad Autonoma de Buenos Aires, Buenos Aires, 1408, Argentina
Centro de Investigacion Pergamino
Pergamino, Buenos Aires, B2700CPM, Argentina
Instituto de Oncologia de Rosario
Rosario, Santa Fe Province, S2000KZE, Argentina
Centro de Investigaciones Medicas y Desarrollo LC S.R.L. (LC Investigacion)
Buenos Aires, 1125, Argentina
Exelsus
San Miguel de Tucumán, 4000, Argentina
Gold Coast Hospital and Health Service
Southport, Queensland, 4215, Australia
Townsville University Hospital
Townsville, Queensland, 4814, Australia
Calvary North Adelaide Hospital
North Adelaide, South Australia, 5006, Australia
Icon Cancer Centre Hobart
Hobart, Tasmania, 7000, Australia
Andrew Love Cancer Centre
Geelong, Victoria, 3220, Australia
Alfred Hospital
Melbourne, Victoria, 3004, Australia
University Hospital Saint Poelten
Sankt Pölten, Lower Austria, 3100, Austria
Medical University of Graz
Graz, Styria, 8036, Austria
Medical University Innsbruck
Innsbruck, Tyrol, 6020, Austria
Medical University Vienna
Vienna, 1090, Austria
AZ Groeninge
Kortrijk, West-Vlaanderen, 8500, Belgium
AZ Nikolaas
Sint-Niklaas, West-Vlaanderen, 9100, Belgium
Cliniques Universitaires Saint-Luc
Brussels, 1200, Belgium
Centre Hospitalier Universitaire Universite Catholique de Louvain Namur Site Sainte Elisabeth
Namur, B5000, Belgium
Hospital Sao Rafael
Salvador, Estado de Bahia, 41253900, Brazil
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
Hospital Bruno Born
Lajeado, Rio Grande do Sul, 95900-022, 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
Fundacao Pio XII - Hospital de Amor Amazonia
Porto Velho, Rondônia, 76834-899, 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
São José do Rio Preto, São Paulo, 15090-000, Brazil
Oncosite Centro De Pesquisa Em Oncologia
Ijuí, 98700-000, Brazil
INCA - Brazilian National Cancer Institute
Rio de Janeiro, 20220-280, 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
Cross Cancer Institute
Edmonton, Alberta, T6G172, Canada
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
Hospital Clinico Universidad de Chile
Santiago, Independencia, 8380456, Chile
Centro Oncologia de Precision Universidad Mayor
Santiago, Santiago Metropolitan, 7560907, Chile
Oncovida
Santiago, Santiago Metropolitan, Providencia, Chile
Oncocentro APYS
Viña del Mar, Valparaiso, 2520598, Chile
Centro Oncologico del Norte
Antofagasta, 1240000, Chile
Bradford Hill
Santiago, 8940575, Chile
University Hospital Hradec Kralove
Hradec Králové, North Central Czech Republic, 50005, Czechia
Fn Kralovske Vinohrady, Dermatological Clinic
Vinohrady, Prague, 10034, Czechia
University Hospital Ostrava
Ostrava, 70852, Czechia
Hospices Civils de Lyon
Pierre-Bénite, Auvergne-Rhône-Alpes, 69495, France
CHU-Dijon
Dijon, Burgundy, 21000, France
Besancon Regional University Hospital Center
Besançon, Doubs, 25000, France
Chu De Bordeaux
Bordeaux, Gironde, 33075, France
Centre Hospitalier Universitaire (CHU) de Lille
Lille, Hauts-de-France, 59000, France
Centre Hospitalier Universitaire Grenoble Alpes
La Tronche, Isere, 38700, France
Centre Hospitalier Universitaire De Poitiers
Poitiers, New Aquitaine, 86000, France
CHU Charles Nicolle
Rouen, Normandy, 76031, France
Centre Hospitalier Le Mans
Le Mans, Pays de la Loire Region, 72037, France
CHU de St Etienne
Saint Priest En Jarez, Pays de la Loire Region, 42270, France
Gustave Rroussy
Villejuif, Val de Marne / Ile de France, 94805, France
Hopital Ambroise Pare
Boulogne, 92104, France
CHU Estaing
Clermont-Ferrand, 63003, France
Centre Leon Berard
Lyon, 69008, France
Nantes University Hospital
Nantes, 44000, France
Clinique Sainte Anne
Strasbourg, 67000, France
Hopital Avicenne
Bobigny, Île-de-France Region, 93000, France
Hospital Henri Mondor
Créteil, Île-de-France Region, 94000, France
Cochin Hospital
Paris, Île-de-France Region, 75014, France
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
Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic
Tbilisi, 0144, Georgia
JSC K. Eristavi National Center of Experimental and Clinical Surgery
Tbilisi, 0159, Georgia
TIM - Tbilisi Institute of Medicine
Tbilisi, 0160, Georgia
ltd Multiprofile Clinic Consilium Medulla
Tbilisi, 186, Georgia
University Medical Center Mannheim
Mannheim, Baden-Wurttemberg, 68167, Germany
University of Tuebingen
Tübingen, Baden-Wurttemberg, 72076, Germany
LMU Klinikum
Munich, Bavaria, 80337, Germany
Klinikum Nurnberg, Hautklinik, Universitatsklinik fur Dermatologie der Paracelsus Medizinischen Privatuniversitat
Nuremberg, Bavaria, 90408, Germany
University Hospital of Regensburg
Regensburg, Bavaria, 93053, Germany
University Clinic Frankfurt
Frankfurt am Main, Hesse, 60590, Germany
University Hospital Giessen
Giessen, Hesse, 35385, Germany
Elbekliniken Stade Buxtehude
Buxtehude, Lower Saxony, 21614, Germany
Ruhr University Bochum
Bochum, North Rhine-Westphalia, 44791, Germany
Fachklinik Hornheide
Münster, North Rhine-Westphalia, 48157, Germany
Universitatsmedizin der Johannes-Gutenberg Universitat Mainz
Mainz, Rhineland-Palatinate, 55131, Germany
University Hospital Dresden
Dresden, Saxony, 01307, Germany
Universitatsklinikum Leipzig, AoR
Leipzig, Saxony, 04103, Germany
Dermatologie
Dessau, Saxony-Anhalt, 06847, 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
University Medical Center Gottingen
Göttingen, 37075, Germany
Helios Kliniken Schwerin
Schwerin, 19055, Germany
University of Pecs Medical School
Pécs, Baranya, 7632, Hungary
University of Debrecen
Debrecen, Hajdú-Bihar, H-4032, Hungary
Szabolcs Szatmar Bereg Megyei Korhazak Es Egyetemi Oktatokorhaz
Nyíregyháza, Szabolcs-Szatmár-Bereg, 4400, Hungary
Galway University Hospital
Galway, Connacht, H91 YR71, Ireland
Cork University Hospital
Cork, T12 EC8P, Ireland
Tallaght University Hospital
Dublin, D24NROA, Ireland
St Vincents University Hospital
Dublin, DO4YN63, Ireland
U.O.C. Oncologia Medica ed Ematologia (U.O.C Medical Oncology and Hematology)
Naples, Campania, 80121, Italy
IRCCS Casa Sollievo della Sofferenza
San Giovanni Rotondo, Foggia, 71013, Italy
IRCCS Ospedale Policlinico San Martino
Genoa, Liguria, 16132, Italy
Istituto Clinico Humanitas
Rozzano, Milan, 20089, Italy
FPO IRCCS Candiolo
Candiolo, Torino, 10060, Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, Tuscany, 56126, Italy
Istituto dei Tumori
Bari, 70124, Italy
Azienda Socio Sanitaria Territoriale (ASST) degli Spedali Civili di Brescia
Brescia, 25123, Italy
Azienda Ospedaliera Santa Croce i Carle
Cuneo, 12100, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori.
Milan, 20133, Italy
Istituto Europeo di Oncologia
Milan, 20141, Italy
Universita Degli Studi Di Milano-Bicocca - Azienda Ospedaliera San Gerardo Di Monza
Monza, 20052, Italy
Istituto Nazionale Tumori IRCCS Fondazione G Pascale
Naples, 80131, Italy
Azienda Ospedaliero-Universitaria Maggiore della Carita - Oncology
Novara, 28100, Italy
Vento Institute of Oncology IOV-IRCCS
Padova, 35128, Italy
Campus Bio-Medico di Roma
Rome, 00128, Italy
IRCCS Regina Elena National Cancer Institute
Rome, 00144, Italy
Istituto Dermopatico dell'Immacolata
Rome, 00167, Italy
Aou Citta della Salute e della Scienza di Torino - SC Dermatologia U
Torino, 10126, Italy
Santa Chiara Hospital
Trento, 38122, Italy
Azienda Sanitaria Universitaria del Friuli Centrale
Udine, 33100, Italy
Centro De Estudios Y Prevention Del Cancer
Tuxtla Gutiérrez, Chiapas, 29038, Mexico
Preparaciones Oncologica SC
León, Guanajuato, 37178, Mexico
Antiguo Hospital Civil de Guadalajara Fray Antonio Alcalde
Guadalajara, Jalisco, 44280, Mexico
Investigacion Biomedica para el Desarrollo de Farmacos SA de CV
Zapopan, Jalisco, 45070, 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
Centro Estatal de Cancerologia
Chihuahua City, 31000, Mexico
FAICIC S. de R.L. de C.V.
Veracruz, 91910, Mexico
Netherlands Cancer Institute
Amsterdam, 1066 CX, Netherlands
University Medical Centre Groningen
Groningen, 9713 GZ, Netherlands
Instituto Regional de Enfermedades Neoplasicas del Centro - IREN CENTRO
Concepción, Departamento de Junín, 12125, Peru
Clinica Peruano Americana (Private practice)
Trujillo, La Libertad, 13001, Peru
Clinica Oncosalud
San Borja, Lima region, 41, Peru
Instituto Nacional de Enfermedades Neoplasicas
Surquillo, Lima region, 34, Peru
Hospital Nacional Daniel A. Carrion
Lima, Provincia Constitucional del Callao, 07016, Peru
Hospital Goyeneche
Arequipa, 04000, Peru
Centro Medico Monte Carmelo
Arequipa, 054, Peru
Clinica Internacional SA
Lima, 15036., Peru
Mazowiecki Szpital Wojewodzki, Siedleckie Centrum Onkologii
Siedlce, Mazxowieckie, 08-110, Poland
Uniwersyteckie Centrum Kliniczne (UCK)
Gdansk, Pomeranian Voivodeship, 80-214, Poland
Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w Slupsku Sp. z o.o.
Słupsk, Pomeranian, 76-200, Poland
Poznan University of Meidcla Science
Poznan, Wielkopolska, 60-788, Poland
Maria Sklodowska-Curie National Research Institute of Oncology
Warsaw, 02-781, Poland
Institute of Oncology Bucharest
Bucharest, Bucharest, 022328, Romania
Cardiomed
Cluj-Napoca, Cluj, 400015, Romania
Medisprof
Cluj-Napoca, Cluj, 400124, Romania
Radiotherapy Center Cluj
Floreşti, Cluj, 407280, Romania
Sfantul Nectarie Oncology Center
Craiova, Dolj, 200347, Romania
SC RTC Radiology Therapeutic Center SRL
Otopeni, Ilfov, 075100, Romania
Oncocenter Oncologie Clinica S.R.L
Timișoara, Timiș County, 300166, Romania
Oncomed
Timișoara, Timiș County, 300239, Romania
Centrul De Oncologie Euroclinic
Iași, 7000106, Romania
Regional Institute of Oncology
Iași, 700383, Romania
The Medical Oncology Centre of Rosebank
Johannesburg, Gauteng, 2196, South Africa
Cape Town Oncology Trials
Cape Town, Western Cape, 7570, South Africa
Groote Schuur Hospital
Cape Town, Western Cape, 7925, South Africa
Hospital Universitario Reina Sofia
Córdoba, Andalusia, 14004, Spain
H. Germans Trias i Pujol, ICO-Badalona
Badalona, Barcelona, 08916, Spain
Instituto Oncologico Dr Rosell Hospital Universitari Quiron Dexeus Location
Barcelona, Catalonia, 08028, Spain
Onkologikoa
Donostia / San Sebastian, Gipuzkoa, 20014, Spain
Hospital Clinico Universitario Virgen De La Arrixaca
El Palmar, Murcia, 30120, Spain
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, 33011, Spain
Hospital Teresa Herrera-Chuac
A Coruña, Spain/La Coruna, 15006, Spain
Catalan Institute of Oncology (ICO) Hospitalet
Barcelona, 08908, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, 8025, Spain
Catalan Institute Of Oncology
Girona, 17007, 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 Ramon y Cajal
Madrid, 28034, Spain
Hospital Universitario Fundacion Jimenez Diaz
Madrid, 28040, Spain
Hospital Universitario La Pa<
Madrid, 28046, Spain
Centro Integral Oncologico HM Clara Campal
Madrid, 28050, Spain
Hospital Regional Universitario de Malaga
Málaga, 29011, 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)
Medical oncology
Istanbul, Bakirkoy, 34147, Turkey (Türkiye)
Ege University
Izmir, Bornova, 35100, Turkey (Türkiye)
Kocaeli University
İzmit, Kocaeli, 41380, Turkey (Türkiye)
Gaziantep Medicalpoint Hospital
Gaziantep, Sehitkamil, 27584, Turkey (Türkiye)
Bezmialem University
Istanbul, Turkey, 34093, Turkey (Türkiye)
Gulhane Training and Research Hospital
Ankara, 06010, Turkey (Türkiye)
Ozel Liv Hospital
Ankara, 06100, Turkey (Türkiye)
Memorial Ankara Hospital
Ankara, 0906520, Turkey (Türkiye)
Dicle University - Medical Faculty Campus
Diyarbakır, 21200, 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
Hull University Teaching Hospitals NHS Trust
Cottingham, East Yorkshire, HU16 5JQ, United Kingdom
Leeds Teaching Hospitals NHS Trust
Leeds, West Yorkshire, LS6 2HA, United Kingdom
Royal Surrey County Hospital
Guildford, GU2 7XX, United Kingdom
Related Publications (1)
Bautista J, Echeverria CE, Maldonado-Noboa I, Adatty-Molina J, Suarez Urresta S, Coral-Riofrio EC, Araujo-Abad S, Kyriakidis NC, Lopez-Cortes A. Next-Generation Immune Checkpoints and Tumor Microenvironment Modulation in Cancer Immunotherapy. J Immunol Res. 2026;2026(1):e7864229. doi: 10.1155/jimr/7864229.
PMID: 41811823DERIVED
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
April 6, 2022
First Posted
April 29, 2022
Study Start
July 14, 2022
Primary Completion
March 12, 2026
Study Completion (Estimated)
September 16, 2031
Last Updated
April 22, 2026
Record last verified: 2026-04
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