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

Primary Purpose

Melanoma

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Fianlimab
Cemiplimab
Pembrolizumab
Placebo
Sponsored by
Regeneron Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Melanoma focused on measuring Unresectable, Metastatic, Stage III, Stage IV, Anti-Lymphocyte-activation gene 3 Pathway (LAG-3)

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

  1. Age ≥12 years on the date of providing informed consent

  2. 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 irAEs ≥ 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.
    2. Patients with acral and mucosal melanomas are eligible. Accrual will be limited to 10% of the total population.

  3. 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

  4. 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)
  5. Anticipated life expectancy of at least 3 months

Key Exclusion Criteria:

  1. Uveal melanoma
  2. 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.
  3. 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
  4. Unknown BRAF V600 mutation status as described in the protocol

  5. 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
  6. 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.
  7. 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.

  8. 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

Sites / Locations

  • University of California San DiegoRecruiting
  • The Angeles Clinic and Research InstituteRecruiting
  • Miami Cancer InstituteRecruiting
  • Orlando Health, IncRecruiting
  • Atlantic Health System - Morristown Medical CenterRecruiting
  • University Hospitals Seidmand Cancer CenterRecruiting
  • Cleveland Clinic FoundationRecruiting
  • University of Tennessee Medical CenterRecruiting
  • DIABAID - Instituto de Asistencia Integral en DiabetesRecruiting
  • Clinica Adventista BelgranoRecruiting
  • Fundacion CENIT Centro Medico de NeurocienciasRecruiting
  • Centro Medico San RoqueRecruiting
  • Calvary North Adelaide HospitalRecruiting
  • Barwon Health Andrew Love Cancer Centre, University Hospital GeelongRecruiting
  • Icon Cancer Centre HobartRecruiting
  • The Alfred HospitalRecruiting
  • Gold Coast HospitalRecruiting
  • The Townsville Hospital and Health ServiceRecruiting
  • Medical University InnsbruckRecruiting
  • Medical University of GrazRecruiting
  • University Hospital St. PoeltenRecruiting
  • Medical University Of ViennaRecruiting
  • Cliniques Universitaires Saint-LucRecruiting
  • AZ Groeninge, Campus KennedylaanRecruiting
  • Clinique et Maternite Sainte-Elisabeth (CMSE)Recruiting
  • AZ NikolaasRecruiting
  • Fundacao Pio XII - Hospital de Amor de BarretosRecruiting
  • Centro Avancado de Tratamento Oncologico (CENANTRON)Recruiting
  • Liga Paranaense de Combate ao Cancer - Hospital Erasto GaertnerRecruiting
  • Oncosite Centro De Pesquisa Clinica Em OncologiaRecruiting
  • Clinica de Neoplasias Litoral/atarina Pesquisa ClínicaRecruiting
  • Instituto Joinvilense De Hematologia E OncologiaRecruiting
  • Animi Unidade de Tratamento Oncologico LtdaRecruiting
  • Hospital Bruno BornRecruiting
  • Hospital Sao Vicente de Paulo (HSVP) Instituto do CancerRecruiting
  • Hospital Moinhos de VentoRecruiting
  • CPO - Centro de Pesquisas em OncologiaRecruiting
  • Fundacao PIO XII - Hospital de Amor AmazoniaRecruiting
  • Instituto COIRecruiting
  • INCA - Brazilian National Cancer InstituteRecruiting
  • Fundacao Faculdade Regional de Medicina de Sao Jose do Rio PretoRecruiting
  • HemomedRecruiting
  • Hospital Sirio Libanes (HSL)Recruiting
  • Sao Camilo OncologiaRecruiting
  • Sunnybrook Research InstituteRecruiting
  • Royal Victoria Regional Health CentreRecruiting
  • Cross Cancer Institute (CCI)Recruiting
  • Dr. Everett Chalmers HospitalRecruiting
  • Saskatoon Cancer Centre (SCC)Recruiting
  • University Health Network, Princess Margaret Cancer CentreRecruiting
  • Centro De Investigacion Clinica Bradford HillRecruiting
  • OncovidaRecruiting
  • Centro Oncologico Antofagasta Bradford Hill NorteRecruiting
  • Universidad Mayor - Centro Oncologia de PrecisionRecruiting
  • OncocentroRecruiting
  • Fakultni Nemocnice Hradec KraloveRecruiting
  • University Hospital OstravaRecruiting
  • Fakultni nemocnice Kralovske Vinohrady, Dermatovenerologicka klinikaRecruiting
  • CHU Jean MINJOZRecruiting
  • Hopital Avicenne Service de Dermatologie du Pr CauxRecruiting
  • HOPITAL SAINT ANDRE Chu De BordeauxRecruiting
  • Hopital Ambroise PareRecruiting
  • CHU Estaing, Service de DermatologieRecruiting
  • Hopitaux Universitaires Henri-MondorRecruiting
  • CHU de DIJON - Service de DermatologieRecruiting
  • Centre Hospitalier Universitaire De Grenoble Alpes Service DermatologieRecruiting
  • CH Le Mans - Plateforme de recherche cliniqueRecruiting
  • Chru De LilleRecruiting
  • Centre Leon BerardRecruiting
  • Centre Hospitalier Universitaire de Nantes (CHU de Nantes) Hotel DieuRecruiting
  • Hopital Cochin APHPRecruiting
  • Hospices Civils de LyonRecruiting
  • Hopital de la Miletrie Centre Hospitalier Universitaire de PoitiersRecruiting
  • CHU Charles Nicolle DermatologieRecruiting
  • CHU Saint-Etienne - Hopital NordRecruiting
  • Clinique Sainte Anne/Strasbourg Oncologie LiberaleRecruiting
  • Institut Gustave Roussy Cancer Center DITEPRecruiting
  • LTD High Technology Hospital MedcenterRecruiting
  • Israeli Georgian medical research clinic HelsicoreRecruiting
  • LTD New HospitalsRecruiting
  • LTD Tbilisi State Medical University and Ingorokva High Medical Technology University ClinicRecruiting
  • JSC K. Eristavi National Center of Experimental and Clinical SurgeryRecruiting
  • TIM -Tbilisi Institute of MedicineRecruiting
  • Medulla - Clinics And Medical CentersRecruiting
  • LLC Todua ClinicRecruiting
  • Universitatsklinikum Augsburg Klinik fur Dermatologie und Allergologie Campus SudRecruiting
  • Charite - Universitaetsmedizin BerlinRecruiting
  • Universitaetsklinikum der Ruhr Universitaet Bochum (UKRUB) St Josef HospitalRecruiting
  • Elbekliniken BuxtehudeRecruiting
  • Helios Klinikum Erfurt Klinik fur Hautkrankheiten und AllergologieRecruiting
  • Universitatsklinik FrankfurtRecruiting
  • University Hospital GiessenRecruiting
  • Universitatsmedizin Gottingen Klinik fur DermatologieRecruiting
  • University of KielRecruiting
  • Universitaetsklinikum Schleswig-Holstein Campus LuebeckRecruiting
  • University Medical Center MannheimRecruiting
  • Westfalische Wilhelms Universitaet zu Muenster Fachklinik HornheideRecruiting
  • Harzklinikum, Klinik fur Dermatologie und AllergologieRecruiting
  • University Clinic RegensburgRecruiting
  • Helios Klinik SchwerinRecruiting
  • University of DebrecenRecruiting
  • Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktato KorhazakRecruiting
  • University of Pecs Medical SchoolRecruiting
  • University of SzegedRecruiting
  • Cork University HospitalRecruiting
  • St. Vincents University HospitalRecruiting
  • St. James HospitalRecruiting
  • University College Hospital GalwayRecruiting
  • Istituto dei TumoriRecruiting
  • ASST Spedali Civili BresciaRecruiting
  • Istituto di Candiolo, FPO IRCCSRecruiting
  • Azienda Sanitaria Ospedaliera Santa Croce E Carle - CuneoRecruiting
  • Ospedale Policlinico San Martino - IRCCSRecruiting
  • Fondazione IRCCS San Gerardo dei TintoriRecruiting
  • Università della Campania Luigi VanvitellaRecruiting
  • IRCCS Istituto Nazionale dei Tumori di Napoli Fondazione G. PascaleRecruiting
  • SCDU di Oncologia AOU Maggiore Della CaritaRecruiting
  • U.O. Oncologia Medica Universitaria - Istituto Toscano Tumori Polo OncologicoRecruiting
  • Campus Bio-Medico di RomaRecruiting
  • Istituto Dermopatico Dell'Immacolata IrccsRecruiting
  • Fondazione IRCSS Casa Sollievo Della SofferenzaRecruiting
  • Azienda Ospedaliera S. MariaRecruiting
  • Santa Chiara Regional HospitalRecruiting
  • Azienda Sanitaria Universitaria Friuli Centrale (ASU FC) - Ospedale UdineRecruiting
  • Centro Estatal de Cancerologia de ChihuahuaRecruiting
  • Neurociencias Estudios Clinicos SCRecruiting
  • Antiguo Hospital Civil de Guadalajara Fray Antonio AlcaldeRecruiting
  • Preparaciones Oncologicas SCRecruiting
  • Centro De Atencion E Investigacion Clinica En Oncologia ScpRecruiting
  • Centro De Estudios Y Prevencion Del Cancer A. C.Recruiting
  • FAICIC S. de R.L. de C.V.Recruiting
  • Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V.Recruiting
  • The Netherlands Cancer Institute (NKI) - Antoni van Leeuwenhoek HospitalRecruiting
  • University Medical Center GroningenRecruiting
  • Centro Medico Monte CarmeloRecruiting
  • Instituto Peruano de Oncologia and RadioterapiaRecruiting
  • Uniwersyteckie Centrum Kliniczne (UCK)Recruiting
  • Narodowego Instytutu Onkologii im Maria Sklodowska CurieRecruiting
  • Uniwersytecki Szpital Kliniczny w PoznaniuRecruiting
  • Mazowiecki Szpital Wojewodzki, Siedleckie Centrum OnkologiiRecruiting
  • Wojewodzki Szpital Specjalistyczny im. Janusza KorczakaRecruiting
  • Klinika Nowotworow Tkanek Miekkich, Kosci i CzerniakowRecruiting
  • Institute of Oncology BucharestRecruiting
  • MedisprofRecruiting
  • Cardiomed SRLRecruiting
  • SC Radiotherapy Center Cluj SRLRecruiting
  • Centrul de Oncologie Sf. Nectarie S.R.LRecruiting
  • SC Centrul de Oncologie Euroclinic SRLRecruiting
  • Regional Institute of OncologyRecruiting
  • RTC Radiology Therapeutic Center SRLRecruiting
  • Oncocenter Oncologie Clinica S.R.LRecruiting
  • OncomedRecruiting
  • Groote Schuur HospitalRecruiting
  • The Medical Oncology Centre of RosebankRecruiting
  • Cape Town Oncology TrialsRecruiting
  • Hospital Teresa Herrera-Chuac (CHUAC)Recruiting
  • Instituto Oncologico Dr RoselRecruiting
  • Hospital de la Santa Creu i Sant PauRecruiting
  • Hospital Universitario Reina SofiaRecruiting
  • Catalan Institute Of Oncology - GironaRecruiting
  • Hospital Universitario Virgen de las NievesRecruiting
  • Hospital Universitario Lucus AugustiRecruiting
  • Hospital Universitario Ramon y CajalRecruiting
  • Hospital Fundacion Jimenez DiazRecruiting
  • Hospital Universitario La PazRecruiting
  • Centro integral Oncologico HM Clara CampalRecruiting
  • Hospital Regional Universitario de MalagaRecruiting
  • Hospital Universitario Virgen de la ArrixacaRecruiting
  • Hospital Universitario Central de AsturiasRecruiting
  • OnkologikoaRecruiting
  • Hospital Universitario Virgen MacarenaRecruiting
  • Instituto Valenciano de OncologiaRecruiting
  • INCLIVA-Instituto de Investigacion SanitariaRecruiting
  • Gulhane Training and Research HospitalRecruiting
  • Memorial Ankara HospitalRecruiting
  • Ozel Liv HospitalRecruiting
  • Dicle University Medical FacultyRecruiting
  • Trakya UniversityRecruiting
  • Gaziantep University Medical FacultyRecruiting
  • Bezmialem UniversityRecruiting
  • Cerrahpasa Medical HospitalRecruiting
  • Bakirkoy Sadi Konuk Training HospitalRecruiting
  • Prof. Dr. Suleyman Yalcin Sehir HospitalRecruiting
  • Kocaeli UniversitesiRecruiting
  • Royal Devon and Exeter Hospital NHS TrustRecruiting
  • Royal Surrey NHS Foundation TrustRecruiting
  • Hull University Teaching Hospitals NHS TrustRecruiting
  • Leeds Teaching Hospitals NHS TrustRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

A: fianlimab+cemiplimab dose 1

A1: fianlimab+cemiplimab dose 2

B: pembrolizumab+placebo

C: cemiplimab+placebo

Arm Description

Protocol Amendment 1: 40 participants randomized 2:1:1 (Futility Analysis) Protocol Amendment 3: 140 participants randomized 2:2:2:1 Protocol Amendment 3: 1050 participants randomized 2:2:2:1 ((PFS population) Protocol Amendment 3: 360 participants randomized 1:1:1 (OS Analysis)

Protocol Amendment 3: 140 participants randomized 2:2:2:1 Protocol Amendment 3: 1050 participants randomized 2:2:2:1 ((PFS population) Protocol Amendment 3: 360 participants randomized 1:1:1 (OS Analysis)

Protocol Amendment 1: 40 participants randomized 2:1:1 (Futility Analysis) Protocol Amendment 3: 140 participants randomized 2:2:2:1 Protocol Amendment 3: 1050 participants randomized 2:2:2:1 ((PFS population) Protocol Amendment 3: 360 participants randomized 1:1:1 (OS Analysis)

Protocol Amendment 1: 40 participants randomized 2:1:1 (Futility Analysis) Protocol Amendment 3: 140 participants randomized 2:2:2:1 Protocol Amendment 3: 1050 participants randomized 2:2:2:1 ((PFS population)

Outcomes

Primary Outcome Measures

Progression-free survival (PFS)
per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 based on Blinded Independent Central Review (BICR)

Secondary Outcome Measures

Overall survival (OS)
Objective response rate (ORR)
per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 based on Blinded Independent Central Review (BICR) or based on investigator assessment according to RECIST 1.1 and immune RECIST (iRECIST)
Disease control rate (DCR)
per RECIST 1.1 based on BICR or based on investigator assessment according to RECIST 1.1 and immune RECIST (iRECIST)
Duration of response (DoR)
per RECIST 1.1 via BICR or based on investigator assessment according to RECIST 1.1 and immune RECIST (iRECIST)
PFS
Based on investigator assessment according to RECIST 1.1 and immune RECIST (iRECIST)
Incidence of Adverse Events (AEs)
Including treatment emergent adverse events (TEAEs), serious adverse events (SAEs), adverse events of special interest (AESIs), and/ or immune-related adverse event (irAEs)
Occurrence of interruption and discontinuation of study drug(s) due to AEs
Including TEAEs, AESIs, and/ or irAEs
Incidence of deaths
Incidence of laboratory abnormalities
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
Concentrations of fianlimab in serum
Incidence of anti-drug antibodies (ADA) to fianlimab over time
Titer of anti-drug antibodies (ADA) to fianlimab over time
Incidence of ADA to cemiplimab over time
Titer of ADA to cemiplimab over time
Incidence of neutralizing antibodies (NAb) to fianlimab over time
Incidence of NAb to cemiplimab over time
Patient-reported outcomes (PROs) as measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30)
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
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 (FACT)-melanoma (melanoma subscale only)
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).
PROs as measured by Patient Global Impression of Severity (PGIS)
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)
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
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
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
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
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
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
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.

Full Information

First Posted
April 6, 2022
Last Updated
October 16, 2023
Sponsor
Regeneron Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT05352672
Brief Title
Clinical Study of Fianlimab in Combination With Cemiplimab in Adolescent and Adult Patients With Previously Untreated Unresectable Locally Advanced or Metastatic Melanoma
Official Title
A Phase 3 Trial of Fianlimab (REGN3767, Anti-LAG-3) + Cemiplimab Versus Pembrolizumab in Patients With Previously Untreated Unresectable Locally Advanced or Metastatic Melanoma
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 14, 2022 (Actual)
Primary Completion Date
December 27, 2025 (Anticipated)
Study Completion Date
April 20, 2031 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Regeneron Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The primary objective of the study is to demonstrate superiority of fianlimab + cemiplimab compared to pembrolizumab, as measured by progression-free survival (PFS) The secondary objectives of the study are: To demonstrate superiority of fianlimab (REGN3767) + cemiplimab compared to pembrolizumab, as measured by overall survival (OS) To demonstrate superiority in objective response rate (ORR) with fianlimab + cemiplimab compared to pembrolizumab To characterize ORR, PFS, and OS with fianlimab + cemiplimab compared to cemiplimab to inform the contribution of each component To assess immunogenicity of fianlimab and cemiplimab To assess impact of fianlimab + cemiplimab on physical functioning and role functioning and global health status/quality of life, as compared to pembrolizumab in adults To characterize safety and tolerability of treatment in patients 12 to <18 years of age To characterize ORR, PFS, and OS with treatment in patients 12 to <18 years of age To assess the safety and tolerability of fianlimab + cemiplimab compared to pembrolizumab and to cemiplimab To characterize pharmacokinetics (PK) of fianlimab and cemiplimab using sparse PK sampling in patients aged ≥12 years

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma
Keywords
Unresectable, Metastatic, Stage III, Stage IV, Anti-Lymphocyte-activation gene 3 Pathway (LAG-3)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1590 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A: fianlimab+cemiplimab dose 1
Arm Type
Experimental
Arm Description
Protocol Amendment 1: 40 participants randomized 2:1:1 (Futility Analysis) Protocol Amendment 3: 140 participants randomized 2:2:2:1 Protocol Amendment 3: 1050 participants randomized 2:2:2:1 ((PFS population) Protocol Amendment 3: 360 participants randomized 1:1:1 (OS Analysis)
Arm Title
A1: fianlimab+cemiplimab dose 2
Arm Type
Experimental
Arm Description
Protocol Amendment 3: 140 participants randomized 2:2:2:1 Protocol Amendment 3: 1050 participants randomized 2:2:2:1 ((PFS population) Protocol Amendment 3: 360 participants randomized 1:1:1 (OS Analysis)
Arm Title
B: pembrolizumab+placebo
Arm Type
Experimental
Arm Description
Protocol Amendment 1: 40 participants randomized 2:1:1 (Futility Analysis) Protocol Amendment 3: 140 participants randomized 2:2:2:1 Protocol Amendment 3: 1050 participants randomized 2:2:2:1 ((PFS population) Protocol Amendment 3: 360 participants randomized 1:1:1 (OS Analysis)
Arm Title
C: cemiplimab+placebo
Arm Type
Experimental
Arm Description
Protocol Amendment 1: 40 participants randomized 2:1:1 (Futility Analysis) Protocol Amendment 3: 140 participants randomized 2:2:2:1 Protocol Amendment 3: 1050 participants randomized 2:2:2:1 ((PFS population)
Intervention Type
Drug
Intervention Name(s)
Fianlimab
Other Intervention Name(s)
REGN3767
Intervention Description
Intravenous (IV) infusion
Intervention Type
Drug
Intervention Name(s)
Cemiplimab
Other Intervention Name(s)
REGN2810, Libtayo
Intervention Description
IV infusion
Intervention Type
Drug
Intervention Name(s)
Pembrolizumab
Other Intervention Name(s)
MK-3475, lambrolizumab, Keytruda
Intervention Description
IV infusion
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
IV infusion
Primary Outcome Measure Information:
Title
Progression-free survival (PFS)
Description
per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 based on Blinded Independent Central Review (BICR)
Time Frame
Approximately 27 months
Secondary Outcome Measure Information:
Title
Overall survival (OS)
Time Frame
Up to 96 months
Title
Objective response rate (ORR)
Description
per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 based on Blinded Independent Central Review (BICR) or based on investigator assessment according to RECIST 1.1 and immune RECIST (iRECIST)
Time Frame
Up to 27 months
Title
Disease control rate (DCR)
Description
per RECIST 1.1 based on BICR or based on investigator assessment according to RECIST 1.1 and immune RECIST (iRECIST)
Time Frame
Up to 27 months
Title
Duration of response (DoR)
Description
per RECIST 1.1 via BICR or based on investigator assessment according to RECIST 1.1 and immune RECIST (iRECIST)
Time Frame
Up to 27 months
Title
PFS
Description
Based on investigator assessment according to RECIST 1.1 and immune RECIST (iRECIST)
Time Frame
Up to 27 months
Title
Incidence of Adverse Events (AEs)
Description
Including treatment emergent adverse events (TEAEs), serious adverse events (SAEs), adverse events of special interest (AESIs), and/ or immune-related adverse event (irAEs)
Time Frame
Up to 90 days post last dose, approximately 6 years
Title
Occurrence of interruption and discontinuation of study drug(s) due to AEs
Description
Including TEAEs, AESIs, and/ or irAEs
Time Frame
Up to 90 days post last dose, approximately 6 years
Title
Incidence of deaths
Time Frame
Up to 6 years
Title
Incidence of laboratory abnormalities
Description
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)
Time Frame
Up to 90 days post last dose, approximately 6 years
Title
Concentrations of cemiplimab in serum
Time Frame
Up to 90 days post last dose, approximately 6 years
Title
Concentrations of fianlimab in serum
Time Frame
Up to 90 days post last dose, approximately 6 years
Title
Incidence of anti-drug antibodies (ADA) to fianlimab over time
Time Frame
Up to 30 days post last dose, approximately 6 years
Title
Titer of anti-drug antibodies (ADA) to fianlimab over time
Time Frame
Up to 30 days post last dose, approximately 6 years
Title
Incidence of ADA to cemiplimab over time
Time Frame
Up to 30 days post last dose, approximately 6 years
Title
Titer of ADA to cemiplimab over time
Time Frame
Up to 30 days post last dose, approximately 6 years
Title
Incidence of neutralizing antibodies (NAb) to fianlimab over time
Time Frame
Up to 30 days post last dose, approximately 6 years
Title
Incidence of NAb to cemiplimab over time
Time Frame
Up to 30 days post last dose, approximately 6 years
Title
Patient-reported outcomes (PROs) as measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30)
Description
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.
Time Frame
Up to 90 days post last dose, approximately 6 years
Title
PROs as measured by EQ-5D-5L
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. Overall scores range from 0 to 1, with low scores representing a higher level of dysfunction.
Time Frame
Up to 90 days post last dose, approximately 6 years
Title
PROs as measured by Functional Assessment of Cancer Therapy (FACT)-melanoma (melanoma subscale only)
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).
Time Frame
Up to 90 days post last dose, approximately 6 years
Title
PROs as measured by Patient Global Impression of Severity (PGIS)
Description
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".
Time Frame
Up to 21 days post last dose, approximately 6 years
Title
PROs as measured by Patient Global Impression of Change (PGIC)
Description
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"
Time Frame
Up to 21 days post last dose, approximately 6 years
Title
Change in physical functioning per EORTC QLQ-C30
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.
Time Frame
Baseline to Week 25
Title
Change in role functioning per EORTC QLQ-C30
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.
Time Frame
Baseline to Week 25
Title
Change in global health status/quality of life (GHS/QoL) per EORTC QLQ-C30
Description
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.
Time Frame
Baseline to Week 25
Title
Change in physical functioning per EORTC QLQ-C30
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.
Time Frame
Baseline to end of study, approximately 6 years
Title
Change in role functioning per EORTC QLQ-C30
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.
Time Frame
Baseline to end of study, approximately 6 years
Title
Change in GHS/QoL per EORTC QLQ-C30
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.
Time Frame
Baseline to end of study, approximately 6 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility 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 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 irAEs ≥ 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. 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 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 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 Note: Other protocol-defined Inclusion/ Exclusion criteria apply
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Clinical Trials Administrator
Phone
844-734-6643
Email
clinicaltrials@regeneron.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trial Management
Organizational Affiliation
Regeneron Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
University of California San Diego
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Individual Site Status
Recruiting
Facility Name
The Angeles Clinic and Research Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90025
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
310-496-0679
Facility Name
Miami Cancer Institute
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Individual Site Status
Recruiting
Facility Name
Orlando Health, Inc
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
321-841-9821
Facility Name
Atlantic Health System - Morristown Medical Center
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07962
Country
United States
Individual Site Status
Recruiting
Facility Name
University Hospitals Seidmand Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Individual Site Status
Recruiting
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Tennessee Medical Center
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
865-305-4893
Facility Name
DIABAID - Instituto de Asistencia Integral en Diabetes
City
Buenos Aires
ZIP/Postal Code
C1061
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Clinica Adventista Belgrano
City
Caba
ZIP/Postal Code
C1430EGF
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Fundacion CENIT Centro Medico de Neurociencias
City
Ciudad Autonoma de Buenos Aires
ZIP/Postal Code
C1125ABD
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Centro Medico San Roque
City
San Miguel de Tucuman
ZIP/Postal Code
4000
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Calvary North Adelaide Hospital
City
Adelaide
ZIP/Postal Code
05006
Country
Australia
Individual Site Status
Recruiting
Facility Name
Barwon Health Andrew Love Cancer Centre, University Hospital Geelong
City
Geelong
ZIP/Postal Code
03220
Country
Australia
Individual Site Status
Recruiting
Facility Name
Icon Cancer Centre Hobart
City
Hobart
ZIP/Postal Code
7000
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
Phone
362402600
Facility Name
The Alfred Hospital
City
Melbourne
ZIP/Postal Code
03004
Country
Australia
Individual Site Status
Recruiting
Facility Name
Gold Coast Hospital
City
Southport
ZIP/Postal Code
4215
Country
Australia
Individual Site Status
Recruiting
Facility Name
The Townsville Hospital and Health Service
City
Townsville
ZIP/Postal Code
04814
Country
Australia
Individual Site Status
Recruiting
Facility Name
Medical University Innsbruck
City
Innsbruck
State/Province
Tyrol
ZIP/Postal Code
6020
Country
Austria
Individual Site Status
Recruiting
Facility Name
Medical University of Graz
City
Graz
ZIP/Postal Code
8036
Country
Austria
Individual Site Status
Recruiting
Facility Name
University Hospital St. Poelten
City
St. Poelten
ZIP/Postal Code
3100
Country
Austria
Individual Site Status
Recruiting
Facility Name
Medical University Of Vienna
City
Vienna
ZIP/Postal Code
01090
Country
Austria
Individual Site Status
Recruiting
Facility Name
Cliniques Universitaires Saint-Luc
City
Brussels
ZIP/Postal Code
01200
Country
Belgium
Individual Site Status
Recruiting
Facility Name
AZ Groeninge, Campus Kennedylaan
City
Kortrijk
ZIP/Postal Code
08500
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Clinique et Maternite Sainte-Elisabeth (CMSE)
City
Namur
ZIP/Postal Code
05000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
AZ Nikolaas
City
Sint Niklaas
ZIP/Postal Code
09100
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Fundacao Pio XII - Hospital de Amor de Barretos
City
Barretos
ZIP/Postal Code
14784-400
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Centro Avancado de Tratamento Oncologico (CENANTRON)
City
Belo Horizonte
ZIP/Postal Code
30130-090
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Liga Paranaense de Combate ao Cancer - Hospital Erasto Gaertner
City
Curitiba
ZIP/Postal Code
81520-060
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Oncosite Centro De Pesquisa Clinica Em Oncologia
City
Ijui
ZIP/Postal Code
98700-000
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Clinica de Neoplasias Litoral/atarina Pesquisa Clínica
City
Itajai
ZIP/Postal Code
88301-220
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Instituto Joinvilense De Hematologia E Oncologia
City
Joinville
ZIP/Postal Code
89201-260
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Animi Unidade de Tratamento Oncologico Ltda
City
Lages
ZIP/Postal Code
88501-001
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Hospital Bruno Born
City
Lajeado
ZIP/Postal Code
95900-000
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Hospital Sao Vicente de Paulo (HSVP) Instituto do Cancer
City
Passo Fundo
ZIP/Postal Code
99010-080
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Hospital Moinhos de Vento
City
Porto Alegre
ZIP/Postal Code
90035-001
Country
Brazil
Individual Site Status
Recruiting
Facility Name
CPO - Centro de Pesquisas em Oncologia
City
Porto Alegre
ZIP/Postal Code
90610-000
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Fundacao PIO XII - Hospital de Amor Amazonia
City
Porto Velho
ZIP/Postal Code
76834-899
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Instituto COI
City
Rio de Janeiro
ZIP/Postal Code
22793080
Country
Brazil
Individual Site Status
Recruiting
Facility Name
INCA - Brazilian National Cancer Institute
City
Santo Cristo
ZIP/Postal Code
20220-410
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto
City
Sao Jose do Rio Preto
ZIP/Postal Code
15090-000
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Hemomed
City
Sao paulo
ZIP/Postal Code
01236-030
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Hospital Sirio Libanes (HSL)
City
Sao Paulo
ZIP/Postal Code
01308-050
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Sao Camilo Oncologia
City
Sao Paulo
ZIP/Postal Code
04014-002
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Sunnybrook Research Institute
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Individual Site Status
Recruiting
Facility Name
Royal Victoria Regional Health Centre
City
Barrie
ZIP/Postal Code
L4M 6M2
Country
Canada
Individual Site Status
Recruiting
Facility Name
Cross Cancer Institute (CCI)
City
Edmonton
ZIP/Postal Code
T6G-1Z2
Country
Canada
Individual Site Status
Recruiting
Facility Name
Dr. Everett Chalmers Hospital
City
Fredericton
ZIP/Postal Code
E3B5N5
Country
Canada
Individual Site Status
Recruiting
Facility Name
Saskatoon Cancer Centre (SCC)
City
Saskatoon
ZIP/Postal Code
S7N 4H4
Country
Canada
Individual Site Status
Recruiting
Facility Name
University Health Network, Princess Margaret Cancer Centre
City
Toronto
ZIP/Postal Code
M5G 2M9
Country
Canada
Individual Site Status
Recruiting
Facility Name
Centro De Investigacion Clinica Bradford Hill
City
Recoleta
State/Province
Chi
ZIP/Postal Code
8420000
Country
Chile
Individual Site Status
Recruiting
Facility Name
Oncovida
City
Santiago
State/Province
Region Metropolitana De Santiago
ZIP/Postal Code
7510032
Country
Chile
Individual Site Status
Recruiting
Facility Name
Centro Oncologico Antofagasta Bradford Hill Norte
City
Antofagasta
ZIP/Postal Code
1240000
Country
Chile
Individual Site Status
Recruiting
Facility Name
Universidad Mayor - Centro Oncologia de Precision
City
Santiago
ZIP/Postal Code
7560907
Country
Chile
Individual Site Status
Recruiting
Facility Name
Oncocentro
City
Vina del Mar
ZIP/Postal Code
2520598
Country
Chile
Individual Site Status
Recruiting
Facility Name
Fakultni Nemocnice Hradec Kralove
City
Hradec Kralove
ZIP/Postal Code
50005
Country
Czechia
Individual Site Status
Recruiting
Facility Name
University Hospital Ostrava
City
Ostrava
ZIP/Postal Code
70852
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Fakultni nemocnice Kralovske Vinohrady, Dermatovenerologicka klinika
City
Prague 10
ZIP/Postal Code
10034
Country
Czechia
Individual Site Status
Recruiting
Facility Name
CHU Jean MINJOZ
City
Besancon Cedex
ZIP/Postal Code
25030
Country
France
Individual Site Status
Recruiting
Facility Name
Hopital Avicenne Service de Dermatologie du Pr Caux
City
Bobigny
ZIP/Postal Code
93000
Country
France
Individual Site Status
Recruiting
Facility Name
HOPITAL SAINT ANDRE Chu De Bordeaux
City
Bordeaux Cedex
ZIP/Postal Code
033075
Country
France
Individual Site Status
Recruiting
Facility Name
Hopital Ambroise Pare
City
Boulogne Billancourt
ZIP/Postal Code
92100
Country
France
Individual Site Status
Recruiting
Facility Name
CHU Estaing, Service de Dermatologie
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France
Individual Site Status
Recruiting
Facility Name
Hopitaux Universitaires Henri-Mondor
City
Creteil
ZIP/Postal Code
94010
Country
France
Individual Site Status
Recruiting
Facility Name
CHU de DIJON - Service de Dermatologie
City
Dijon
ZIP/Postal Code
021000
Country
France
Individual Site Status
Recruiting
Facility Name
Centre Hospitalier Universitaire De Grenoble Alpes Service Dermatologie
City
Grenoble
ZIP/Postal Code
38700
Country
France
Individual Site Status
Recruiting
Facility Name
CH Le Mans - Plateforme de recherche clinique
City
Le Mans
ZIP/Postal Code
72037
Country
France
Individual Site Status
Recruiting
Facility Name
Chru De Lille
City
Lille Cedex
ZIP/Postal Code
59037
Country
France
Individual Site Status
Recruiting
Facility Name
Centre Leon Berard
City
Lyon cedex 08
ZIP/Postal Code
69373
Country
France
Individual Site Status
Recruiting
Facility Name
Centre Hospitalier Universitaire de Nantes (CHU de Nantes) Hotel Dieu
City
Nantes
ZIP/Postal Code
44000
Country
France
Individual Site Status
Recruiting
Facility Name
Hopital Cochin APHP
City
Paris
ZIP/Postal Code
75005
Country
France
Individual Site Status
Recruiting
Facility Name
Hospices Civils de Lyon
City
Pierre Benite Cedex
ZIP/Postal Code
69495
Country
France
Individual Site Status
Recruiting
Facility Name
Hopital de la Miletrie Centre Hospitalier Universitaire de Poitiers
City
Poitiers Cedex
ZIP/Postal Code
86021
Country
France
Individual Site Status
Recruiting
Facility Name
CHU Charles Nicolle Dermatologie
City
Rouen
ZIP/Postal Code
76031
Country
France
Individual Site Status
Recruiting
Facility Name
CHU Saint-Etienne - Hopital Nord
City
Saint-Etienne
ZIP/Postal Code
42055
Country
France
Individual Site Status
Recruiting
Facility Name
Clinique Sainte Anne/Strasbourg Oncologie Liberale
City
Strasbourg
ZIP/Postal Code
67000
Country
France
Individual Site Status
Recruiting
Facility Name
Institut Gustave Roussy Cancer Center DITEP
City
Villejuif Cedex
ZIP/Postal Code
94805
Country
France
Individual Site Status
Recruiting
Facility Name
LTD High Technology Hospital Medcenter
City
Batumi
ZIP/Postal Code
6000
Country
Georgia
Individual Site Status
Recruiting
Facility Contact:
Phone
568999559
Facility Name
Israeli Georgian medical research clinic Helsicore
City
Tbilisi
ZIP/Postal Code
0112
Country
Georgia
Individual Site Status
Recruiting
Facility Name
LTD New Hospitals
City
Tbilisi
ZIP/Postal Code
0114
Country
Georgia
Individual Site Status
Recruiting
Facility Contact:
Phone
95599373303
Facility Name
LTD Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic
City
Tbilisi
ZIP/Postal Code
0144
Country
Georgia
Individual Site Status
Recruiting
Facility Contact:
Phone
851667553
Facility Name
JSC K. Eristavi National Center of Experimental and Clinical Surgery
City
Tbilisi
ZIP/Postal Code
0159
Country
Georgia
Individual Site Status
Recruiting
Facility Name
TIM -Tbilisi Institute of Medicine
City
Tbilisi
ZIP/Postal Code
0160
Country
Georgia
Individual Site Status
Recruiting
Facility Contact:
Phone
995 595959570
Facility Name
Medulla - Clinics And Medical Centers
City
Tbilisi
ZIP/Postal Code
0168
Country
Georgia
Individual Site Status
Recruiting
Facility Contact:
Phone
995 568 155 755
Facility Name
LLC Todua Clinic
City
Tbilisi
ZIP/Postal Code
112
Country
Georgia
Individual Site Status
Recruiting
Facility Contact:
Phone
+995 599117976
Facility Name
Universitatsklinikum Augsburg Klinik fur Dermatologie und Allergologie Campus Sud
City
Augsburg
ZIP/Postal Code
86179
Country
Germany
Individual Site Status
Recruiting
Facility Name
Charite - Universitaetsmedizin Berlin
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitaetsklinikum der Ruhr Universitaet Bochum (UKRUB) St Josef Hospital
City
Bochum
ZIP/Postal Code
44791
Country
Germany
Individual Site Status
Recruiting
Facility Name
Elbekliniken Buxtehude
City
Buxtehude
ZIP/Postal Code
21614
Country
Germany
Individual Site Status
Recruiting
Facility Name
Helios Klinikum Erfurt Klinik fur Hautkrankheiten und Allergologie
City
Erfurt
ZIP/Postal Code
99089
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitatsklinik Frankfurt
City
Frankfurt
ZIP/Postal Code
60590
Country
Germany
Individual Site Status
Recruiting
Facility Name
University Hospital Giessen
City
Giessen
ZIP/Postal Code
35392
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitatsmedizin Gottingen Klinik fur Dermatologie
City
Göttingen
ZIP/Postal Code
37075
Country
Germany
Individual Site Status
Recruiting
Facility Name
University of Kiel
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitaetsklinikum Schleswig-Holstein Campus Luebeck
City
Luebeck
ZIP/Postal Code
23538
Country
Germany
Individual Site Status
Recruiting
Facility Name
University Medical Center Mannheim
City
Mannheim
ZIP/Postal Code
68167
Country
Germany
Individual Site Status
Recruiting
Facility Name
Westfalische Wilhelms Universitaet zu Muenster Fachklinik Hornheide
City
Muenster
ZIP/Postal Code
48157
Country
Germany
Individual Site Status
Recruiting
Facility Name
Harzklinikum, Klinik fur Dermatologie und Allergologie
City
Quedlinburg
ZIP/Postal Code
06484
Country
Germany
Individual Site Status
Recruiting
Facility Name
University Clinic Regensburg
City
Regensburg
ZIP/Postal Code
93053
Country
Germany
Individual Site Status
Recruiting
Facility Name
Helios Klinik Schwerin
City
Schwerin
ZIP/Postal Code
19055
Country
Germany
Individual Site Status
Recruiting
Facility Name
University of Debrecen
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktato Korhazak
City
Nyíregyhaza
ZIP/Postal Code
04400
Country
Hungary
Individual Site Status
Recruiting
Facility Name
University of Pecs Medical School
City
Pecs
ZIP/Postal Code
7632
Country
Hungary
Individual Site Status
Recruiting
Facility Name
University of Szeged
City
Szeged
ZIP/Postal Code
06720
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Cork University Hospital
City
Cork
ZIP/Postal Code
T12 E8YV
Country
Ireland
Individual Site Status
Recruiting
Facility Name
St. Vincents University Hospital
City
Dublin 4
ZIP/Postal Code
D04 T6F4
Country
Ireland
Individual Site Status
Recruiting
Facility Name
St. James Hospital
City
Dublin
ZIP/Postal Code
D08 NHY1
Country
Ireland
Individual Site Status
Recruiting
Facility Name
University College Hospital Galway
City
Galway
ZIP/Postal Code
H91 YR71
Country
Ireland
Individual Site Status
Recruiting
Facility Name
Istituto dei Tumori
City
Bari
ZIP/Postal Code
70124
Country
Italy
Individual Site Status
Recruiting
Facility Name
ASST Spedali Civili Brescia
City
Brescia
ZIP/Postal Code
25123
Country
Italy
Individual Site Status
Recruiting
Facility Name
Istituto di Candiolo, FPO IRCCS
City
Candiolo
ZIP/Postal Code
10060
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda Sanitaria Ospedaliera Santa Croce E Carle - Cuneo
City
Cuneo
ZIP/Postal Code
12100
Country
Italy
Individual Site Status
Recruiting
Facility Name
Ospedale Policlinico San Martino - IRCCS
City
Genova
ZIP/Postal Code
16132
Country
Italy
Individual Site Status
Recruiting
Facility Name
Fondazione IRCCS San Gerardo dei Tintori
City
Monza
ZIP/Postal Code
20052
Country
Italy
Individual Site Status
Recruiting
Facility Name
Università della Campania Luigi Vanvitella
City
Napoli
ZIP/Postal Code
80121
Country
Italy
Individual Site Status
Recruiting
Facility Name
IRCCS Istituto Nazionale dei Tumori di Napoli Fondazione G. Pascale
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Individual Site Status
Recruiting
Facility Name
SCDU di Oncologia AOU Maggiore Della Carita
City
Novara
ZIP/Postal Code
28100
Country
Italy
Individual Site Status
Recruiting
Facility Name
U.O. Oncologia Medica Universitaria - Istituto Toscano Tumori Polo Oncologico
City
Pisa
ZIP/Postal Code
56126
Country
Italy
Individual Site Status
Recruiting
Facility Name
Campus Bio-Medico di Roma
City
Rome
ZIP/Postal Code
00128
Country
Italy
Individual Site Status
Recruiting
Facility Name
Istituto Dermopatico Dell'Immacolata Irccs
City
Rome
ZIP/Postal Code
00167
Country
Italy
Individual Site Status
Recruiting
Facility Name
Fondazione IRCSS Casa Sollievo Della Sofferenza
City
San Giovanni Rotondo
ZIP/Postal Code
71013
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda Ospedaliera S. Maria
City
Terni
ZIP/Postal Code
05100
Country
Italy
Individual Site Status
Recruiting
Facility Name
Santa Chiara Regional Hospital
City
Trento
ZIP/Postal Code
38123
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda Sanitaria Universitaria Friuli Centrale (ASU FC) - Ospedale Udine
City
Udine
ZIP/Postal Code
33100
Country
Italy
Individual Site Status
Recruiting
Facility Name
Centro Estatal de Cancerologia de Chihuahua
City
Chihuahua
ZIP/Postal Code
31000
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Neurociencias Estudios Clinicos SC
City
Culiacan
ZIP/Postal Code
80020
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Antiguo Hospital Civil de Guadalajara Fray Antonio Alcalde
City
Guadalajara
ZIP/Postal Code
44280
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Preparaciones Oncologicas SC
City
Leon
ZIP/Postal Code
37178
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Centro De Atencion E Investigacion Clinica En Oncologia Scp
City
Merida
ZIP/Postal Code
97134
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Centro De Estudios Y Prevencion Del Cancer A. C.
City
Tuxtla Gutierrez
ZIP/Postal Code
290838
Country
Mexico
Individual Site Status
Recruiting
Facility Name
FAICIC S. de R.L. de C.V.
City
Veracruz
ZIP/Postal Code
91900
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V.
City
Zapopan
ZIP/Postal Code
45070
Country
Mexico
Individual Site Status
Recruiting
Facility Name
The Netherlands Cancer Institute (NKI) - Antoni van Leeuwenhoek Hospital
City
Amsterdam
ZIP/Postal Code
1066 CX
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
University Medical Center Groningen
City
Groningen
ZIP/Postal Code
9713 GZ
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Centro Medico Monte Carmelo
City
Arequipa
ZIP/Postal Code
04001
Country
Peru
Individual Site Status
Recruiting
Facility Name
Instituto Peruano de Oncologia and Radioterapia
City
Lima
ZIP/Postal Code
15036
Country
Peru
Individual Site Status
Recruiting
Facility Name
Uniwersyteckie Centrum Kliniczne (UCK)
City
Gdansk
ZIP/Postal Code
80-214
Country
Poland
Individual Site Status
Recruiting
Facility Name
Narodowego Instytutu Onkologii im Maria Sklodowska Curie
City
Krakow
ZIP/Postal Code
31-115
Country
Poland
Individual Site Status
Recruiting
Facility Name
Uniwersytecki Szpital Kliniczny w Poznaniu
City
Poznan
ZIP/Postal Code
60-780
Country
Poland
Individual Site Status
Recruiting
Facility Name
Mazowiecki Szpital Wojewodzki, Siedleckie Centrum Onkologii
City
Siedlce
ZIP/Postal Code
08-110
Country
Poland
Individual Site Status
Recruiting
Facility Name
Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka
City
Slupsk
ZIP/Postal Code
76-200
Country
Poland
Individual Site Status
Recruiting
Facility Name
Klinika Nowotworow Tkanek Miekkich, Kosci i Czerniakow
City
Warszawa
ZIP/Postal Code
02-781
Country
Poland
Individual Site Status
Recruiting
Facility Name
Institute of Oncology Bucharest
City
Bucharest
ZIP/Postal Code
22328
Country
Romania
Individual Site Status
Recruiting
Facility Name
Medisprof
City
Cluj Napoca
ZIP/Postal Code
400641
Country
Romania
Individual Site Status
Recruiting
Facility Name
Cardiomed SRL
City
Cluj-Napoca
ZIP/Postal Code
400015
Country
Romania
Individual Site Status
Recruiting
Facility Name
SC Radiotherapy Center Cluj SRL
City
Cluj
ZIP/Postal Code
407280
Country
Romania
Individual Site Status
Recruiting
Facility Name
Centrul de Oncologie Sf. Nectarie S.R.L
City
Craiova
ZIP/Postal Code
200347
Country
Romania
Individual Site Status
Recruiting
Facility Name
SC Centrul de Oncologie Euroclinic SRL
City
Iasi
ZIP/Postal Code
700106
Country
Romania
Individual Site Status
Recruiting
Facility Name
Regional Institute of Oncology
City
Iasi
ZIP/Postal Code
700383
Country
Romania
Individual Site Status
Recruiting
Facility Name
RTC Radiology Therapeutic Center SRL
City
Otopeni
ZIP/Postal Code
075100
Country
Romania
Individual Site Status
Recruiting
Facility Name
Oncocenter Oncologie Clinica S.R.L
City
Timisoara
ZIP/Postal Code
300210
Country
Romania
Individual Site Status
Recruiting
Facility Name
Oncomed
City
Timisoara
ZIP/Postal Code
300239
Country
Romania
Individual Site Status
Recruiting
Facility Name
Groote Schuur Hospital
City
Cape Town
ZIP/Postal Code
7925
Country
South Africa
Individual Site Status
Recruiting
Facility Name
The Medical Oncology Centre of Rosebank
City
Johannesburg
ZIP/Postal Code
02196
Country
South Africa
Individual Site Status
Recruiting
Facility Name
Cape Town Oncology Trials
City
Kraaifontein
ZIP/Postal Code
7570
Country
South Africa
Individual Site Status
Recruiting
Facility Name
Hospital Teresa Herrera-Chuac (CHUAC)
City
A Coruna
ZIP/Postal Code
15009
Country
Spain
Individual Site Status
Recruiting
Facility Name
Instituto Oncologico Dr Rosel
City
Barcelona
ZIP/Postal Code
08028
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital de la Santa Creu i Sant Pau
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Reina Sofia
City
Cordoba
ZIP/Postal Code
14004
Country
Spain
Individual Site Status
Recruiting
Facility Name
Catalan Institute Of Oncology - Girona
City
Girona
ZIP/Postal Code
17007
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Virgen de las Nieves
City
Granada
ZIP/Postal Code
18014
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
Phone
34 958020000
Facility Name
Hospital Universitario Lucus Augusti
City
Lugo
ZIP/Postal Code
27003
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Ramon y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Fundacion Jimenez Diaz
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Individual Site Status
Recruiting
Facility Name
Centro integral Oncologico HM Clara Campal
City
Madrid
ZIP/Postal Code
28050
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Regional Universitario de Malaga
City
Malaga
ZIP/Postal Code
29011
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Virgen de la Arrixaca
City
Múrcia
ZIP/Postal Code
30120
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Central de Asturias
City
Oviedo
ZIP/Postal Code
33011
Country
Spain
Individual Site Status
Recruiting
Facility Name
Onkologikoa
City
San Sebastian
ZIP/Postal Code
20014
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Virgen Macarena
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Individual Site Status
Recruiting
Facility Name
Instituto Valenciano de Oncologia
City
Valencia
ZIP/Postal Code
46009
Country
Spain
Individual Site Status
Recruiting
Facility Name
INCLIVA-Instituto de Investigacion Sanitaria
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Individual Site Status
Recruiting
Facility Name
Gulhane Training and Research Hospital
City
Ankara
ZIP/Postal Code
06010
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Memorial Ankara Hospital
City
Ankara
ZIP/Postal Code
06520
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Ozel Liv Hospital
City
Ankara
ZIP/Postal Code
06680
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Dicle University Medical Faculty
City
Diyarbakir
ZIP/Postal Code
21200
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Trakya University
City
Edirne
ZIP/Postal Code
22000
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Gaziantep University Medical Faculty
City
Gaziantep
ZIP/Postal Code
27584
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Bezmialem University
City
Istanbul
ZIP/Postal Code
34093
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Cerrahpasa Medical Hospital
City
Istanbul
ZIP/Postal Code
34098
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Bakirkoy Sadi Konuk Training Hospital
City
Istanbul
ZIP/Postal Code
34147
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Prof. Dr. Suleyman Yalcin Sehir Hospital
City
Istanbul
ZIP/Postal Code
34722
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Kocaeli Universitesi
City
Kocaeli
ZIP/Postal Code
41100
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Royal Devon and Exeter Hospital NHS Trust
City
Exeter
State/Province
Devon
ZIP/Postal Code
EX2 5DW
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Royal Surrey NHS Foundation Trust
City
Guildford
ZIP/Postal Code
GU2 7XX
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Hull University Teaching Hospitals NHS Trust
City
Hull
ZIP/Postal Code
HU16 5JQ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Leeds Teaching Hospitals NHS Trust
City
Leeds
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
IPD Sharing 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.
IPD Sharing 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
IPD Sharing URL
https://vivli.org/

Learn more about this trial

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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