Clinical Study of Fianlimab in Combination With Cemiplimab in Adolescent and Adult Patients With Previously Untreated Unresectable Locally Advanced or Metastatic Melanoma

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ClinicalTrials.gov Identifier: NCT05352672

Recruitment Status : Recruiting

First Posted : April 29, 2022

Last Update Posted : February 22, 2024

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Sponsor:

Information provided by (Responsible Party):

Regeneron Pharmaceuticals

Study Description

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

Condition or disease	Intervention/treatment	Phase
Melanoma	Drug: Fianlimab Drug: Cemiplimab Drug: Pembrolizumab Drug: Placebo	Phase 2 Phase 3

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	1925 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	A Phase 2 and Phase 3 Trial of Fianlimab (REGN3767, Anti-LAG-3) + Cemiplimab Versus Pembrolizumab in Patients With Previously Untreated Unresectable Locally Advanced or Metastatic Melanoma
Actual Study Start Date :	July 14, 2022
Estimated Primary Completion Date :	March 3, 2026
Estimated Study Completion Date :	August 31, 2032

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma

MedlinePlus related topics: Melanoma

Drug Information available for: Pembrolizumab

Genetic and Rare Diseases Information Center resources: Neuroendocrine Tumor Neuroepithelioma

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: A: fianlimab+cemiplimab dose 1 Phase 2 and Phase 3	Drug: Fianlimab Intravenous (IV) infusion Other Name: REGN3767 Drug: Cemiplimab IV infusion Other Names: REGN2810 Libtayo
Experimental: A1: fianlimab+cemiplimab dose 2 Phase 2 and Phase 3 (except for PA1 patients as described in the protocol)	Drug: Fianlimab Intravenous (IV) infusion Other Name: REGN3767 Drug: Cemiplimab IV infusion Other Names: REGN2810 Libtayo
Experimental: B: pembrolizumab+placebo Phase 2 and Phase 3	Drug: Pembrolizumab IV infusion Other Names: MK-3475 lambrolizumab Keytruda Drug: Placebo IV infusion
Experimental: C: cemiplimab+placebo Phase 2 (as described in the protocol)	Drug: Cemiplimab IV infusion Other Names: REGN2810 Libtayo Drug: Placebo IV infusion

Outcome Measures

Primary Outcome Measures :

Objective response rate (ORR) [ Time Frame: Approximately 27 months ]
Phase 2 Per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 based on Blinded Independent Central Review (BICR)
Progression-free survival (PFS) [ Time Frame: Approximately 27 months ]
Phase 3 Per RECIST 1.1 based on BICR

Secondary Outcome Measures :

PFS [ Time Frame: Up to 27 months ]
Per RECIST 1.1 based on BICR or investigator assessment according to RECIST 1.1 and immune RECIST (iRECIST)
Overall survival (OS) [ Time Frame: Up to 96 months ]
ORR [ Time Frame: Up to 27 months ]
Per RECIST 1.1 based on BICR or investigator assessment according to RECIST 1.1 and iRECIST
Disease control rate (DCR) [ Time Frame: Up to 27 months ]
Per RECIST 1.1 based on BICR or investigator assessment according to RECIST 1.1 and iRECIST
Duration of response (DoR) [ Time Frame: Up to 27 months ]
Per RECIST 1.1 based on BICR or investigator assessment according to RECIST 1.1 and iRECIST
Incidence of Adverse Events (AEs) [ Time Frame: Up to 90 days post last dose, approximately 6 years ]
Including treatment emergent adverse events (TEAEs), serious adverse events (SAEs), adverse events of special interest (AESIs), and/ or immune-related adverse event (imAEs)
Occurrence of interruption and discontinuation of study drug(s) due to AEs [ Time Frame: Up to 90 days post last dose, approximately 6 years ]
Including TEAEs, AESIs, and/ or imAEs
Incidence of deaths related to TEAEs [ Time Frame: Up to 6 years ]
Incidence of laboratory abnormalities [ Time Frame: Up to 90 days post last dose, approximately 6 years ]
Will be graded using the current version of the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) grading system (version 5.0)
Concentrations of cemiplimab in serum [ Time Frame: Up to 90 days post last dose, approximately 6 years ]
Concentrations of fianlimab in serum [ Time Frame: Up to 90 days post last dose, approximately 6 years ]
Incidence of anti-drug antibodies (ADA) to fianlimab over time [ Time Frame: Up to 30 days post last dose, approximately 6 years ]
Titer of anti-drug antibodies (ADA) to fianlimab over time [ Time Frame: Up to 30 days post last dose, approximately 6 years ]
Incidence of ADA to cemiplimab over time [ Time Frame: Up to 30 days post last dose, approximately 6 years ]
Titer of ADA to cemiplimab over time [ Time Frame: Up to 30 days post last dose, approximately 6 years ]
Incidence of neutralizing antibodies (NAb) to fianlimab over time [ Time Frame: Up to 30 days post last dose, approximately 6 years ]
Incidence of NAb to cemiplimab over time [ Time Frame: Up to 30 days post last dose, approximately 6 years ]
Patient-reported outcomes (PROs) as measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30) [ Time Frame: Up to 90 days post last dose, approximately 6 years ]
EORTC-QLQ-C30 is a 30-item participant 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.
PROs as measured by EQ-5D-5L [ Time Frame: Up to 90 days post last dose, approximately 6 years ]
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. Overall scores range from 0 to 1, with low scores representing a higher level of dysfunction.
PROs as measured by Functional Assessment of Cancer Therapy melanoma (FACTM) (melanoma subscale only) [ Time Frame: Up to 90 days post last dose, approximately 6 years ]
The FACTM is a melanoma-specific quality of life questionnaire that is composed of items from the Functional Assessment of Cancer Therapy-General (FACT-G). The FACTM 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).
PROs as measured by Patient Global Impression of Severity (PGIS) [ Time Frame: Up to 21 days post last dose, approximately 6 years ]
The PGIS is a single 1-item questionnaire designed to assess participant's overall impression of disease severity at a given point in time by using a 4-point Likert scale that ranges from (1) = "none (no symptoms)" to (4) = "severe".
PROs as measured by Patient Global Impression of Change (PGIC) [ Time Frame: Up to 21 days post last dose, approximately 6 years ]
The PGIC is a single-item questionnaire designed to assess the participant's overall sense of whether there has been a change since starting treatment as rated on a 5-point Likert scale anchored by (1) "much better" to (5) "much worse", with (4) = "no change"
Change in physical functioning per EORTC QLQ-C30 [ Time Frame: Baseline to Week 25 ]
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.
Change in role functioning per EORTC QLQ-C30 [ Time Frame: Baseline to Week 25 ]
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.
Change in global health status/quality of life (GHS/QoL) per EORTC QLQ-C30 [ Time Frame: Baseline to Week 25 ]
Global Health Status/Quality of Life (GHS/Qol) Score (Items 29 and 30) using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30). 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.
Change in physical functioning per EORTC QLQ-C30 [ Time Frame: Baseline to end of study, approximately 6 years ]
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.
Change in role functioning per EORTC QLQ-C30 [ Time Frame: Baseline to end of study, approximately 6 years ]
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.
Change in GHS/QoL per EORTC QLQ-C30 [ Time Frame: Baseline to end of study, approximately 6 years ]
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.

Eligibility Criteria

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Ages Eligible for Study:	12 Years and older (Child, Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Key Inclusion Criteria:

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
1. Patients who received adjuvant and/or neoadjuvant systemic therapies are eligible if they did not have evidence of progression or recurrence of disease and/or discontinued due to occurrence of unmanageable imAEs ≥ grade 3 (with the exclusion of endocrinopathies which are fully controlled by hormone replacement) while on such therapies. Also, patients must have had a treatment-free and disease-free interval of >6 months. Accrual of these patients is limited to approximately 10% of the total population enrolled in each of the Phase 2 and Phase 3 parts of the study.
2. Patients with acral and mucosal melanomas are eligible. Combined accrual will be limited to 10% of the total population enrolled in the Phase 3 part of the study.
Measurable disease per RECIST v1.1
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
2. Cutaneous lesions should be evaluated as non-target lesions
Performance status:
1. For adult patients: Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
2. 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

Key Exclusion Criteria:

Uveal melanoma
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.
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 v-Raf murine sarcoma viral oncogene homolog B1 (BRAF) V600 mutation status as described in the protocol
Systemic immune suppression:
1. 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.
2. 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.
Participants with a history of myocarditis.
Active or untreated brain metastases or spinal cord compression. Patients with leptomeningeal disease are excluded. Patients with known brain metastases are eligible if they:
1. Received radiotherapy or another appropriate standard therapy for the brain metastases,
2. Have neurologically returned to baseline (except for residual signs and symptoms related to the CNS treatment) for at least 14 days prior to enrollment
3. Did not require immunosuppressive doses of corticosteroids therapy (>10mg of prednisone per day or equivalent) in the 14 days prior to enrollment
4. Are asymptomatic with a single untreated brain metastasis <10 mm in size

Note: Other protocol-defined Inclusion/ Exclusion criteria apply

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05352672

Contacts

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Contact: Clinical Trials Administrator	844-734-6643	clinicaltrials@regeneron.com

Locations

Show 205 study locations

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United States, California
University of California San Diego	Recruiting
La Jolla, California, United States, 92093
The Angeles Clinic and Research Institute	Recruiting
Los Angeles, California, United States, 90025
Contact 310-496-0679
United States, Florida
Miami Cancer Institute	Recruiting
Miami, Florida, United States, 33176
Orlando Health, Inc	Recruiting
Orlando, Florida, United States, 32806
Contact 321-841-9821
United States, New Jersey
Atlantic Health System - Morristown Medical Center	Recruiting
Morristown, New Jersey, United States, 07962
United States, Ohio
University Hospitals Seidmand Cancer Center	Recruiting
Cleveland, Ohio, United States, 44106
Cleveland Clinic Foundation	Recruiting
Cleveland, Ohio, United States, 44195
United States, Tennessee
University of Tennessee Medical Center	Recruiting
Knoxville, Tennessee, United States, 37920
Contact 865-305-4893
Argentina
DIABAID - Instituto de Asistencia Integral en Diabetes	Recruiting
Buenos Aires, Argentina, C1061
Clinica Adventista Belgrano	Recruiting
Caba, Argentina, C1430EGF
Fundacion CENIT Centro Medico de Neurociencias	Recruiting
Ciudad Autonoma de Buenos Aires, Argentina, C1125ABD
Instituto de Oncologia de Rosario	Recruiting
Rosario, Argentina, S2000KZE
Centro Medico San Roque	Recruiting
San Miguel de Tucuman, Argentina, 4000
Australia
Calvary North Adelaide Hospital	Recruiting
Adelaide, Australia, 05006
Barwon Health Andrew Love Cancer Centre, University Hospital Geelong	Recruiting
Geelong, Australia, 03220
Icon Cancer Centre Hobart	Recruiting
Hobart, Australia, 7000
Contact 362402600
The Alfred Hospital	Recruiting
Melbourne, Australia, 03004
Gold Coast University Hospital	Suspended
Southport, Australia, 4215
The Townsville Hospital and Health Service	Recruiting
Townsville, Australia, 04814
Ballarat Oncology and Haematology Clinical Trials Unit	Recruiting
Wendouree, Australia, 03355
Austria
Medical University Innsbruck	Recruiting
Innsbruck, Tyrol, Austria, 6020
Medical University of Graz	Recruiting
Graz, Austria, 8036
University Hospital St. Poelten	Recruiting
St. Poelten, Austria, 3100
Medical University Of Vienna	Recruiting
Vienna, Austria, 01090
Belgium
Cliniques Universitaires Saint-Luc	Recruiting
Brussels, Belgium, 01200
AZ Groeninge, Campus Kennedylaan	Recruiting
Kortrijk, Belgium, 08500
Clinique et Maternite Sainte-Elisabeth (CMSE)	Recruiting
Namur, Belgium, 05000
AZ Nikolaas	Recruiting
Sint Niklaas, Belgium, 09100
Brazil
Fundacao Pio XII - Hospital de Amor de Barretos	Recruiting
Barretos, Brazil, 14784-400
Centro Avancado de Tratamento Oncologico (CENANTRON)	Recruiting
Belo Horizonte, Brazil, 30130-090
Liga Paranaense de Combate ao Cancer - Hospital Erasto Gaertner	Recruiting
Curitiba, Brazil, 81520-060
Oncosite Centro De Pesquisa Clinica Em Oncologia	Recruiting
Ijui, Brazil, 98700-000
Clinica de Neoplasias Litoral/atarina Pesquisa Clínica	Recruiting
Itajai, Brazil, 88301-220
Instituto Joinvilense De Hematologia E Oncologia	Recruiting
Joinville, Brazil, 89201-260
Animi Unidade de Tratamento Oncologico Ltda	Recruiting
Lages, Brazil, 88501-001
Hospital Bruno Born	Recruiting
Lajeado, Brazil, 95900-000
Hospital Sao Vicente de Paulo (HSVP) Instituto do Cancer	Recruiting
Passo Fundo, Brazil, 99010-080
Hospital Moinhos de Vento	Recruiting
Porto Alegre, Brazil, 90035-001
Hospital de Clinicas de Porto Alegre (HCPA)	Recruiting
Porto Alegre, Brazil, 90035-903
CPO - Centro de Pesquisas em Oncologia	Recruiting
Porto Alegre, Brazil, 90610-000
Fundacao PIO XII - Hospital de Amor Amazonia	Recruiting
Porto Velho, Brazil, 76834-899
Instituto COI	Recruiting
Rio de Janeiro, Brazil, 22793080
Hospital Sao Rafael	Recruiting
Salvador, Brazil, 41253- 190
INCA - Brazilian National Cancer Institute	Recruiting
Santo Cristo, Brazil, 20220-410
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto	Recruiting
Sao Jose do Rio Preto, Brazil, 15090-000
Hemomed	Recruiting
Sao paulo, Brazil, 01236-030
Hospital Sirio Libanes (HSL)	Recruiting
Sao Paulo, Brazil, 01308-050
Sao Camilo Oncologia	Recruiting
Sao Paulo, Brazil, 04014-002
Canada, Ontario
Sunnybrook Research Institute	Recruiting
Toronto, Ontario, Canada, M4N 3M5
Canada
Royal Victoria Regional Health Centre	Recruiting
Barrie, Canada, L4M 6M2
Cross Cancer Institute (CCI)	Recruiting
Edmonton, Canada, T6G-1Z2
Dr. Everett Chalmers Hospital	Recruiting
Fredericton, Canada, E3B5N5
Saskatoon Cancer Centre (SCC)	Recruiting
Saskatoon, Canada, S7N 4H4
University Health Network, Princess Margaret Cancer Centre	Recruiting
Toronto, Canada, M5G 2M9
Chile
Centro De Investigacion Clinica Bradford Hill	Recruiting
Recoleta, Chi, Chile, 8420000
Oncovida	Recruiting
Santiago, Region Metropolitana De Santiago, Chile, 7510032
Centro Oncologico Antofagasta Bradford Hill Norte	Recruiting
Antofagasta, Chile, 1240000
Universidad Mayor - Centro Oncologia de Precision	Recruiting
Santiago, Chile, 7560907
Oncocentro	Recruiting
Vina del Mar, Chile, 2520598
Czechia
Fakultni Nemocnice Hradec Kralove	Recruiting
Hradec Kralove, Czechia, 50005
University Hospital Ostrava	Recruiting
Ostrava, Czechia, 70852
Fakultni nemocnice Kralovske Vinohrady, Dermatovenerologicka klinika	Recruiting
Prague 10, Czechia, 10034
France
CHU Jean MINJOZ	Recruiting
Besancon Cedex, France, 25030
Hopital Avicenne Service de Dermatologie du Pr Caux	Recruiting
Bobigny, France, 93000
HOPITAL SAINT ANDRE Chu De Bordeaux	Recruiting
Bordeaux Cedex, France, 033075
Hopital Ambroise Pare	Recruiting
Boulogne Billancourt, France, 92100
CHU Estaing, Service de Dermatologie	Recruiting
Clermont-Ferrand, France, 63003
Hopitaux Universitaires Henri-Mondor	Recruiting
Creteil, France, 94010
CHU de DIJON - Service de Dermatologie	Recruiting
Dijon, France, 021000
Centre Hospitalier Universitaire De Grenoble Alpes Service Dermatologie	Recruiting
Grenoble, France, 38700
CH Le Mans - Plateforme de recherche clinique	Recruiting
Le Mans, France, 72037
Chru De Lille	Recruiting
Lille Cedex, France, 59037
Centre Leon Berard	Recruiting
Lyon cedex 08, France, 69373
Centre Hospitalier Universitaire de Nantes (CHU de Nantes) Hotel Dieu	Recruiting
Nantes, France, 44000
Hopital Cochin APHP	Recruiting
Paris, France, 75005
Hospices Civils de Lyon	Recruiting
Pierre Benite Cedex, France, 69495
Hopital de la Miletrie Centre Hospitalier Universitaire de Poitiers	Recruiting
Poitiers Cedex, France, 86021
CHU Charles Nicolle Dermatologie	Recruiting
Rouen, France, 76031
CHU Saint-Etienne - Hopital Nord	Recruiting
Saint-Etienne, France, 42055
Clinique Sainte Anne/Strasbourg Oncologie Liberale	Recruiting
Strasbourg, France, 67000
Institut Gustave Roussy Cancer Center DITEP	Recruiting
Villejuif Cedex, France, 94805
Georgia
LTD High Technology Hospital Medcenter	Recruiting
Batumi, Georgia, 6000
Contact 568999559
Israeli Georgian medical research clinic Helsicore	Recruiting
Tbilisi, Georgia, 0112
LTD New Hospitals	Recruiting
Tbilisi, Georgia, 0114
Contact 95599373303
LTD Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic	Recruiting
Tbilisi, Georgia, 0144
Contact 851667553
JSC K. Eristavi National Center of Experimental and Clinical Surgery	Recruiting
Tbilisi, Georgia, 0159
TIM -Tbilisi Institute of Medicine	Recruiting
Tbilisi, Georgia, 0160
Contact 995 595959570
Medulla - Clinics And Medical Centers	Recruiting
Tbilisi, Georgia, 0168
Contact 995 568 155 755
LLC Todua Clinic	Recruiting
Tbilisi, Georgia, 112
Contact +995 599117976
Germany
Universitatsklinikum Augsburg Klinik fur Dermatologie und Allergologie Campus Sud	Recruiting
Augsburg, Germany, 86179
Charite - Universitaetsmedizin Berlin	Recruiting
Berlin, Germany, 10117
Universitaetsklinikum der Ruhr Universitaet Bochum (UKRUB) St Josef Hospital	Recruiting
Bochum, Germany, 44791
Elbekliniken Buxtehude	Recruiting
Buxtehude, Germany, 21614
Universitaetsklinikum Carl Gustav Carus an der Technischen Universitaet	Recruiting
Dresden, Germany, 01307
Helios Klinikum Erfurt Klinik fur Hautkrankheiten und Allergologie	Recruiting
Erfurt, Germany, 99089
Universitatsklinik Frankfurt	Suspended
Frankfurt, Germany, 60590
University Hospital Giessen	Recruiting
Giessen, Germany, 35392
Universitatsmedizin Gottingen Klinik fur Dermatologie	Recruiting
Göttingen, Germany, 37075
University of Kiel	Recruiting
Kiel, Germany, 24105
Universitaetsklinikum Leipzig	Recruiting
Leipzig, Germany, 4103
Universitaetsklinikum Schleswig-Holstein Campus Luebeck	Recruiting
Luebeck, Germany, 23538
University Medical Center Mannheim	Recruiting
Mannheim, Germany, 68167
Fachklinik Hornheide	Recruiting
Muenster, Germany, 48157
Harzklinikum, Klinik fur Dermatologie und Allergologie	Recruiting
Quedlinburg, Germany, 06484
University Clinic Regensburg	Recruiting
Regensburg, Germany, 93053
Helios Klinik Schwerin	Recruiting
Schwerin, Germany, 19055
Hungary
University of Debrecen	Recruiting
Debrecen, Hungary, 4032
Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktato Korhazak	Recruiting
Nyíregyhaza, Hungary, 04400
University of Pecs Medical School	Recruiting
Pecs, Hungary, 7632
University of Szeged	Recruiting
Szeged, Hungary, 06720
Ireland
Cork University Hospital	Recruiting
Cork, Ireland, T12 E8YV
St. Vincents University Hospital	Recruiting
Dublin 4, Ireland, D04 T6F4
St. James Hospital	Recruiting
Dublin, Ireland, D08 NHY1
University College Hospital Galway	Recruiting
Galway, Ireland, H91 YR71
Italy
Istituto dei Tumori	Recruiting
Bari, Italy, 70124
ASST Spedali Civili Brescia	Recruiting
Brescia, Italy, 25123
Istituto di Candiolo, FPO IRCCS	Recruiting
Candiolo, Italy, 10060
Azienda Sanitaria Ospedaliera Santa Croce E Carle - Cuneo	Recruiting
Cuneo, Italy, 12100
Ospedale Policlinico San Martino - IRCCS	Recruiting
Genova, Italy, 16132
Fondazione IRCCS San Gerardo dei Tintori	Recruiting
Monza, Italy, 20052
Università della Campania Luigi Vanvitella	Recruiting
Napoli, Italy, 80121
IRCCS Istituto Nazionale dei Tumori di Napoli Fondazione G. Pascale	Recruiting
Napoli, Italy, 80131
SCDU di Oncologia AOU Maggiore Della Carita	Recruiting
Novara, Italy, 28100
IOV - Istituto Oncologico Veneto - IRCCS	Recruiting
Padova, Italy, 35128
U.O. Oncologia Medica Universitaria - Istituto Toscano Tumori Polo Oncologico	Recruiting
Pisa, Italy, 56126
Campus Bio-Medico di Roma	Recruiting
Rome, Italy, 00128
Istituto Dermopatico Dell'Immacolata Irccs	Recruiting
Rome, Italy, 00167
Fondazione IRCSS Casa Sollievo Della Sofferenza	Recruiting
San Giovanni Rotondo, Italy, 71013
Azienda Ospedaliera S. Maria	Recruiting
Terni, Italy, 05100
Santa Chiara Regional Hospital	Recruiting
Trento, Italy, 38123
AOU Citta della Salute e della Scienza di Torino	Recruiting
Turin, Italy, 10126
Azienda Sanitaria Universitaria Friuli Centrale (ASU FC) - Ospedale Udine	Recruiting
Udine, Italy, 33100
Mexico
Centro Estatal de Cancerologia de Chihuahua	Recruiting
Chihuahua, Mexico, 31000
Neurociencias Estudios Clinicos SC	Recruiting
Culiacan, Mexico, 80020
Antiguo Hospital Civil de Guadalajara Fray Antonio Alcalde	Recruiting
Guadalajara, Mexico, 44280
Preparaciones Oncologicas SC	Recruiting
Leon, Mexico, 37178
Centro De Atencion E Investigacion Clinica En Oncologia Scp	Recruiting
Merida, Mexico, 97134
iCan Oncology Center	Suspended
Monterrey, Mexico, 64710
Centro De Estudios Y Prevencion Del Cancer A. C.	Recruiting
Tuxtla Gutierrez, Mexico, 290838
FAICIC S. de R.L. de C.V.	Recruiting
Veracruz, Mexico, 91900
Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V.	Recruiting
Zapopan, Mexico, 45070
Netherlands
The Netherlands Cancer Institute (NKI) - Antoni van Leeuwenhoek Hospital	Recruiting
Amsterdam, Netherlands, 1066 CX
University Medical Center Groningen	Recruiting
Groningen, Netherlands, 9713 GZ
Peru
Centro Medico Monte Carmelo	Recruiting
Arequipa, Peru, 04001
Hospital Nacional Daniel Alcides Carrion	Recruiting
Bellavista, Peru, 07001
Instituto Regional de Enfermedades Neoplasicas del Centro - IREN CENTRO	Recruiting
Concepcion, Peru, 12125
Instituto Peruano de Oncologia and Radioterapia	Suspended
Lima, Peru, 15036
Clinica Peruano Americana	Recruiting
Trujillo, Peru, 13011
Poland
Uniwersyteckie Centrum Kliniczne (UCK)	Recruiting
Gdansk, Poland, 80-214
Narodowego Instytutu Onkologii im Maria Sklodowska Curie	Recruiting
Krakow, Poland, 31-115
Uniwersytecki Szpital Kliniczny w Poznaniu	Recruiting
Poznan, Poland, 60-780
Mazowiecki Szpital Wojewodzki, Siedleckie Centrum Onkologii	Recruiting
Siedlce, Poland, 08-110
Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka	Recruiting
Slupsk, Poland, 76-200
Klinika Nowotworow Tkanek Miekkich, Kosci i Czerniakow	Recruiting
Warszawa, Poland, 02-781
Romania
Institute of Oncology Bucharest	Recruiting
Bucharest, Romania, 22328
Medisprof	Recruiting
Cluj Napoca, Romania, 400641
Cardiomed SRL	Recruiting
Cluj-Napoca, Romania, 400015
SC Radiotherapy Center Cluj SRL	Recruiting
Cluj, Romania, 407280
Centrul de Oncologie Sf. Nectarie S.R.L	Recruiting
Craiova, Romania, 200347
SC Centrul de Oncologie Euroclinic SRL	Recruiting
Iasi, Romania, 700106
Regional Institute of Oncology	Recruiting
Iasi, Romania, 700383
RTC Radiology Therapeutic Center SRL	Recruiting
Otopeni, Romania, 075100
Oncocenter Oncologie Clinica S.R.L	Recruiting
Timisoara, Romania, 300210
Oncomed	Recruiting
Timisoara, Romania, 300239
South Africa
Groote Schuur Hospital	Recruiting
Cape Town, South Africa, 7925
The Medical Oncology Centre of Rosebank	Recruiting
Johannesburg, South Africa, 02196
Cape Town Oncology Trials	Recruiting
Kraaifontein, South Africa, 7570
Spain
Hospital Teresa Herrera-Chuac (CHUAC)	Recruiting
A Coruna, Spain, 15009
Hospital Universitari Germans Trias i Pujol (HUGTP)	Recruiting
Badalona, Spain, 08916
Instituto Oncologico Dr Rosel	Recruiting
Barcelona, Spain, 08028
Hospital de la Santa Creu i Sant Pau	Suspended
Barcelona, Spain, 08041
Catalan Institute of Oncology (ICO) Hospitalet	Recruiting
Barcelona, Spain, 08907
Hospital Universitario Reina Sofia	Recruiting
Cordoba, Spain, 14004
Catalan Institute Of Oncology - Girona	Recruiting
Girona, Spain, 17007
Hospital Universitario Virgen de las Nieves	Recruiting
Granada, Spain, 18014
Contact 34 958020000
Hospital Universitario Lucus Augusti	Recruiting
Lugo, Spain, 27003
Hospital General Universitario Gregorio Maranon	Recruiting
Madrid, Spain, 28007
Hospital Universitario Ramon y Cajal	Recruiting
Madrid, Spain, 28034
Hospital Fundacion Jimenez Diaz	Recruiting
Madrid, Spain, 28040
Hospital Universitario La Paz	Recruiting
Madrid, Spain, 28046
Centro integral Oncologico HM Clara Campal	Recruiting
Madrid, Spain, 28050
Hospital Regional Universitario de Malaga	Recruiting
Malaga, Spain, 29011
Hospital Universitario Virgen de la Arrixaca	Recruiting
Múrcia, Spain, 30120
Hospital Universitario Central de Asturias	Recruiting
Oviedo, Spain, 33011
Onkologikoa	Recruiting
San Sebastian, Spain, 20014
Hospital Universitario Virgen Macarena	Recruiting
Sevilla, Spain, 41009
Instituto Valenciano de Oncologia	Recruiting
Valencia, Spain, 46009
INCLIVA-Instituto de Investigacion Sanitaria	Recruiting
Valencia, Spain, 46010
Turkey
Adana Baskent Hospital	Recruiting
Adana, Turkey, 01120
Gulhane Training and Research Hospital	Recruiting
Ankara, Turkey, 06010
Memorial Ankara Hospital	Recruiting
Ankara, Turkey, 06520
Ozel Liv Hospital	Recruiting
Ankara, Turkey, 06680
Dicle University Medical Faculty	Recruiting
Diyarbakir, Turkey, 21200
Trakya University	Recruiting
Edirne, Turkey, 22000
Gaziantep University Medical Faculty	Recruiting
Gaziantep, Turkey, 27584
Bezmialem University	Recruiting
Istanbul, Turkey, 34093
Cerrahpasa Medical Hospital	Recruiting
Istanbul, Turkey, 34098
Bakirkoy Sadi Konuk Training Hospital	Recruiting
Istanbul, Turkey, 34147
Prof. Dr. Suleyman Yalcin Sehir Hospital	Recruiting
Istanbul, Turkey, 34722
Kocaeli Universitesi	Recruiting
Kocaeli, Turkey, 41100
United Kingdom
Royal Devon and Exeter Hospital NHS Trust	Recruiting
Exeter, Devon, United Kingdom, EX2 5DW
Royal Surrey NHS Foundation Trust	Recruiting
Guildford, United Kingdom, GU2 7XX
Hull University Teaching Hospitals NHS Trust	Recruiting
Hull, United Kingdom, HU16 5JQ
Leeds Teaching Hospitals NHS Trust	Recruiting
Leeds, United Kingdom, LS9 7TF
Guy's Hospital	Suspended
London, United Kingdom, SE1 9RT

Sponsors and Collaborators

Regeneron Pharmaceuticals

Investigators

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Study Director:	Clinical Trial Management	Regeneron Pharmaceuticals

More Information

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Responsible Party:	Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT05352672
Other Study ID Numbers:	R3767-ONC-2011 2021-004453-23 ( EudraCT Number ) 2023-505772-30-00 ( Registry Identifier: EUCT Number )
First Posted:	April 29, 2022 Key Record Dates
Last Update Posted:	February 22, 2024
Last Verified:	February 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Yes
Plan Description:	All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
Supporting Materials:	Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (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, has made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry), has the legal authority to share the data, and has 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
URL:	https://vivli.org/

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Studies a U.S. FDA-regulated Drug Product:	Yes
Studies a U.S. FDA-regulated Device Product:	No

Keywords provided by Regeneron Pharmaceuticals:


Unresectable Metastatic Stage III Stage IV Anti-Lymphocyte-activation gene 3 Pathway (LAG-3)

Additional relevant MeSH terms:

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Melanoma Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Nerve Tissue Nevi and Melanomas Skin Neoplasms	Neoplasms by Site Skin Diseases Pembrolizumab Cemiplimab Antineoplastic Agents, Immunological Antineoplastic Agents Immune Checkpoint Inhibitors Molecular Mechanisms of Pharmacological Action

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