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A Trial to See if the Combination of Fianlimab With Cemiplimab Works Better Than Pembrolizumab for Preventing or Delaying Melanoma From Coming Back After it Has Been Removed With Surgery

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 Resected High Risk Melanoma, Skin Cancer, Stage IIC, Stage III, Stage IV, LAG-3 Lymphocyte activation gene 3, Adjuvant Setting, anti-PD-1 Monoclonal Antibody

Eligibility Criteria

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

Key Inclusion Criteria: All patients must be either stage IIC, III, or stage IV per American Joint Committee on Cancer (AJCC) 8th edition and have histologically confirmed melanoma that is completely surgically resected in order to be eligible as defined by the protocol Complete surgical resection must be performed within 12 weeks prior to randomization, and enrollment may occur only after satisfactory wound healing from the surgery All patients must have disease-free status documented by a complete physical examination and imaging studies within 4 weeks prior to randomization, as described in the protocol Key Exclusion Criteria: Uveal melanoma Any evidence of residual disease after surgery by imaging, pathology, or cytology. Ongoing or recent (within 2 years) evidence of clinically significant autoimmune disease that required systemic treatment with immunosuppressive agents Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C (HCV) infection; or diagnosis of immunodeficiency that is related to, or results in chronic infection, as described in the protocol Another malignancy that is currently progressing or that required active treatment in the past 5 years, as described in the protocol Adolescent patients (≥12 to <18 years old) with body weight <40 kg Note: Other Protocol Defined Inclusion/ Exclusion Criteria Apply

Sites / Locations

  • University of California San DiegoRecruiting
  • University of California, San FranciscoRecruiting
  • John Wayne Cancer Institute - Saint John's Health CenterRecruiting
  • The Melanoma And Skin Cancer InstituteRecruiting
  • Miami Cancer InstituteRecruiting
  • Orlando Health Cancer InstituteRecruiting
  • Northwestern Medical GroupRecruiting
  • Massachusetts General Cancer CenterRecruiting
  • Rutgers Cancer Institute of New JerseyRecruiting
  • NYU Langone HealthRecruiting
  • Columbia University Medical CenterRecruiting
  • Lineberger Comprehensive Cancer CenterRecruiting
  • Duke University Medical CenterRecruiting
  • University Hospitals Cleveland Medical CenterRecruiting
  • Cleveland Clinic FoundationRecruiting
  • St. Luke's HematologyRecruiting
  • Thomas Jefferson University HospitalRecruiting
  • University of Tennessee Medical CenterRecruiting
  • Tennessee OncologyRecruiting
  • The University of Texas Southwestern Medical CenterRecruiting
  • Intermountain Medical CenterRecruiting
  • University of Virginia Health SystemRecruiting
  • Virginia Cancer Specialist Research InstituteRecruiting
  • DIABAID - Instituto de Asistencia Integral en DiabetesRecruiting
  • Calvary North Adelaid Hospital (HPS Pharmacies)Recruiting
  • Andrew Love Cancer Centre, University Hospital GeelongRecruiting
  • Alfred HealthRecruiting
  • VITAZ vzw - pharm Sara Van Opdenbosch t.a.v. apotheekRecruiting
  • Campus Kennedylaan ApotheekRecruiting
  • Instituto de Ensino e Pesquisas Sao Lucas - IEP HEMOMEDRecruiting
  • Dr. Everett Chalmers HospitalRecruiting
  • Royal Victoria Regional Health CentreRecruiting
  • Sunnybrook Research InstituteRecruiting
  • University Health Network, Princess Margaret Cancer CentreRecruiting
  • Universidad Mayor - Centro Oncologia de Precision (PROFAR)Recruiting
  • Clinica UC San Carlos de ApoquindoRecruiting
  • OncovidaRecruiting
  • Oncocentro APYSRecruiting
  • University Hospital Ostrava PharmacyRecruiting
  • CHU de NANTES Hotel DieuRecruiting
  • LTD Cancer Center of Adjara Autonomic RepublicRecruiting
  • Israeli Georgian medical research clinic HelsicoreRecruiting
  • LTD Research Institute of Clinical Medicine (LLC Todua Clinic)Recruiting
  • LTD New HospitalsRecruiting
  • High Technology Medical Center, University Clinic TbilisiRecruiting
  • Tbilisi Institute of Medicine (TIM)Recruiting
  • Universitatsmedizin GottingenRecruiting
  • Klinikum der Stadt Ludwigshafen am RheinRecruiting
  • Beaumont HospitalRecruiting
  • St Vincent's University HospitalRecruiting
  • Instituto Nazionale Tumori IRCCS Fondazione G. PascaleRecruiting
  • Farmacia Ospedaliera, Instituto Europeo di OncologiaRecruiting
  • Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Istituto Tumori Giovanni Paolo II - Ospedale Oncologico di BariRecruiting
  • Istituto Di Ricovero E Cura A Carattere Scientifico (Ircss)Recruiting
  • Azienda Ospedaliero Universitaria Maggiore della Carita, Farmacia OspedalieraRecruiting
  • Ospedale S.Chiara - APSS di Trento - Magazzino FarmaciaRecruiting
  • FAICIC S. de R.L. de C.V.Recruiting
  • Mazowiecki Szpital Wojewodzki, Siedleckie Centrum OnkologiiRecruiting
  • Wojewodzki Szpital Specjalistyczny im. J. Korczaka w SlupskuRecruiting
  • Cape Gate Oncology TrialsRecruiting
  • Hospital Universitario Virgen MacarenaRecruiting
  • Hospital Universitario Central de AsturiasRecruiting
  • Hospital Universitario Marques De ValdecillaRecruiting
  • Hospital Universitario Quiron Dexeus BarcelonaRecruiting
  • Area dassajos clinics/Medicaments en investigacio, Servei de Farmacia Hospital Clinic de Barcelona (ICMHO)Recruiting
  • Hospital Universitario Vall d'Hebron, Edificio General-Planta Baja, UITM, Unidad de Farmacia de EnsaRecruiting
  • Hospital Universitario La PazRecruiting
  • Hospital Universitario Virgen de las NievesRecruiting
  • Hospital Universitario Lucus AugustiRecruiting
  • Hospital General Universitario Gregorio Maranon (HGUGM)Recruiting
  • Hospital 12 de OctubreRecruiting
  • Hospital Universitario HM SanchinarroRecruiting
  • Fundacion Instituto Valenciano de OncologiaRecruiting
  • Hospital Clinico Universitario de ValenciaRecruiting
  • Sbu Dr. A.Y. Ankara Onkoloji SuamRecruiting
  • Gulhane Egitim ve Arastirma HastanesiRecruiting
  • Liv HospitalRecruiting
  • Ankara Memorial HospitalRecruiting
  • Dicle University, Faculty of MedicineRecruiting
  • Trakya Universitesi, Balkan Onkoloji Hastanesi Linik Arastirmar OdasiRecruiting
  • Medical Park Gaziantep HastanesiRecruiting
  • Goztepe Prof. Dr. Suleyman Yalcin City HospitalRecruiting
  • Izmir Katip Celebi University Ataturk training and Research HospitalRecruiting
  • Kocaeli University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Fianlimab HD + Cemiplimab

Fianlimab LD + Cemiplimab

Pembrolizumab

Arm Description

Patients will be administered one combination dose of fianlimab high dose (HD) and cemiplimab

Patients will be administered one combination dose of fianlimab low dose (LD) and cemiplimab

Patients will be administered one dose of pembrolizumab co-infused with saline/dextrose placebo

Outcomes

Primary Outcome Measures

Relapse free survival (RSF)
Time from randomization to the first documented recurrence of disease at any site (excluding new primary melanomas) or death from any cause, whichever occurs first.

Secondary Outcome Measures

Overall survival (OS)
Time from randomization to the date of death.
Melanoma specific survival (MSS)
Defined as death due to melanoma
Distant metastasis-free survival (DMFS)
Time between the date of randomization and the date of the first distant metastasis.
Occurrence of treatment-emergent adverse events (TEAEs)
A TEAE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment.
Occurrence of immune-mediated EAEs (im-EAEs)
imAEs are a unique set of toxicities thought to be caused by unrestrained cellular immune responses.
Occurrence of serious adverse events (SAEs)
An SAE is any untoward medical occurrence that at any dose: Results in death - includes all deaths, even those that appear to be completely unrelated to study drug (eg, a car accident in which a patient is a passenger). Is life-threatening Requires in-patient hospitalization or prolongation of existing hospitalization. Results in persistent or significant disability/incapacity Is a congenital anomaly/birth defect. Is an important medical event
Occurrence of adverse events of special interest (AESIs)
An AESI (serious or non-serious) is one of scientific and medical concern specific to the sponsor's product or program, for which ongoing monitoring and rapid communication by the Investigator to the sponsor can be appropriate. Such an event might warrant further investigation in order to characterize and understand it
Occurrence of TEAEs resulting in death
A TEAE resulting in death is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment.
Occurrence of dose-limiting toxicity (DLT)
A DLT is defined as a study-drug related TEAE, including imAEs, that could preclude enrolling additional adolescent patients at the selected dose. Dose-limiting toxicity will be evaluated in adolescents only.
Occurrence of interruption or discontinuation of study drug(s) due to TEAE
A TEAE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment.
Occurrence of laboratory abnormalities
As assessed by the NCI-CTCAE grading system (≥ Grade 3 or higher)
Concentrations of fianlimab in serum over time
The concentrations of fianlimab over time will be summarized by descriptive statistics by study arm for the overall population and for adolescent patients.
Concentrations of cemiplimab in serum over time
The concentrations of cemiplimab over time will be summarized by descriptive statistics by study arm for the overall population and for adolescent patients.
Concentration of finalimab anti-drug antibodies (ADA) and neutralizing antibodies
Immunogenicity will be characterized per drug molecule by ADA and NAb status.
Concentration of cemiplimab anti-drug antibodies (ADA) and neutralizing antibodies
Immunogenicity will be characterized per drug molecule by ADA and NAb status.
Patient report outcomes (PRO) for adults as measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
The EORTC QLQ-C30 (Version 3) uses for the questions 1 to 28 a 4-point scale. The scale scores from 1 to 4: 1 ("Not at all"), 2 ("A little"), 3 ("Quite a bit") and 4 ("Very much"). Half points are not allowed. The range is 3. For the raw score, less points are considered to have a better outcome. The EORTC QLQ-C30 (Version 3) uses for the questions 29 and 30 a 7-points scale. The scale scores from 1 to 7: 1 ("very poor") to 7 ("excellent"). Half points are not allowed. The range is 6. More points are considered to have a better outcome.
PRO for adults as measured by the European Quality of Life Dimension 5 (EQ-5D-5L)
The EQ-5D-5L a descriptive system that 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. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
PRO for adults as measured by the Functional Assessment of Cancer Therapy (FACT) - melanoma
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).
PRO for adults as determined by the Patient Global Impressions Scale (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".
PRO for adults as determined by the Patient Global Impressions of Change Scale (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".
Time to global health status/quality of life deterioration per EORTC QLQ-C30
Time to physical functioning deterioration per EORTC QLQ-C30
Time to role functioning deterioration per EORTC QLQ-C30

Full Information

First Posted
October 14, 2022
Last Updated
October 20, 2023
Sponsor
Regeneron Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT05608291
Brief Title
A Trial to See if the Combination of Fianlimab With Cemiplimab Works Better Than Pembrolizumab for Preventing or Delaying Melanoma From Coming Back After it Has Been Removed With Surgery
Official Title
A Phase 3 Trial of Fianlimab (Anti-LAG-3) and Cemiplimab Versus Pembrolizumab in the Adjuvant Setting in Patients With Completely Resected High-risk Melanoma
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 16, 2023 (Actual)
Primary Completion Date
February 27, 2030 (Anticipated)
Study Completion Date
February 27, 2030 (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 relapse free survival (RFS) The secondary objectives of the study are: To demonstrate superiority of fianlimab + cemiplimab compared to pembrolizumab, as measured by overall survival (OS) To demonstrate superiority of fianlimab + cemiplimab compared to pembrolizumab, as measured by melanoma specific survival (MSS) To evaluate whether post-operative adjuvant therapy improves distant metastasis-free survival (DMFS), in stage IIC or III patients receiving fianlimab + cemiplimab compared to pembrolizumab To assess impact of fianlimab + cemiplimab on quality of life as compared to pembrolizumab in adults To assess safety and tolerability of fianlimab + cemiplimab compared to pembrolizumab To characterize pharmacokinetics (PK) of fianlimab + cemiplimab using sparse PK sampling in patients 12 years of age and older To assess immunogenicity of fianlimab and against cemiplimab

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma
Keywords
Resected High Risk Melanoma, Skin Cancer, Stage IIC, Stage III, Stage IV, LAG-3 Lymphocyte activation gene 3, Adjuvant Setting, anti-PD-1 Monoclonal Antibody

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1530 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Fianlimab HD + Cemiplimab
Arm Type
Experimental
Arm Description
Patients will be administered one combination dose of fianlimab high dose (HD) and cemiplimab
Arm Title
Fianlimab LD + Cemiplimab
Arm Type
Experimental
Arm Description
Patients will be administered one combination dose of fianlimab low dose (LD) and cemiplimab
Arm Title
Pembrolizumab
Arm Type
Active Comparator
Arm Description
Patients will be administered one dose of pembrolizumab co-infused with saline/dextrose placebo
Intervention Type
Drug
Intervention Name(s)
Fianlimab
Other Intervention Name(s)
REGN3767
Intervention Description
Fianlimab will be administered by intravenous (IV) infusion every (Q) 3 weeks
Intervention Type
Drug
Intervention Name(s)
Cemiplimab
Other Intervention Name(s)
REGN2810, Libtayo
Intervention Description
Cemiplimab will be administered by IV infusion Q 3 weeks
Intervention Type
Drug
Intervention Name(s)
Pembrolizumab
Other Intervention Name(s)
MK-3475, lambrolizumab, Keytruda
Intervention Description
Pembrolizumab will be administered by IV infusion Q 3 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching placebo co-infused with pembrolizumab IV, will be administered by IV infusion Q 3 weeks
Primary Outcome Measure Information:
Title
Relapse free survival (RSF)
Description
Time from randomization to the first documented recurrence of disease at any site (excluding new primary melanomas) or death from any cause, whichever occurs first.
Time Frame
Up to 5 Years
Secondary Outcome Measure Information:
Title
Overall survival (OS)
Description
Time from randomization to the date of death.
Time Frame
Up to 5 Years
Title
Melanoma specific survival (MSS)
Description
Defined as death due to melanoma
Time Frame
Up to 5 Years
Title
Distant metastasis-free survival (DMFS)
Description
Time between the date of randomization and the date of the first distant metastasis.
Time Frame
Up to 5 Years
Title
Occurrence of treatment-emergent adverse events (TEAEs)
Description
A TEAE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment.
Time Frame
Up to 5 Years
Title
Occurrence of immune-mediated EAEs (im-EAEs)
Description
imAEs are a unique set of toxicities thought to be caused by unrestrained cellular immune responses.
Time Frame
Up to 5 Years
Title
Occurrence of serious adverse events (SAEs)
Description
An SAE is any untoward medical occurrence that at any dose: Results in death - includes all deaths, even those that appear to be completely unrelated to study drug (eg, a car accident in which a patient is a passenger). Is life-threatening Requires in-patient hospitalization or prolongation of existing hospitalization. Results in persistent or significant disability/incapacity Is a congenital anomaly/birth defect. Is an important medical event
Time Frame
Up to 5 Years
Title
Occurrence of adverse events of special interest (AESIs)
Description
An AESI (serious or non-serious) is one of scientific and medical concern specific to the sponsor's product or program, for which ongoing monitoring and rapid communication by the Investigator to the sponsor can be appropriate. Such an event might warrant further investigation in order to characterize and understand it
Time Frame
Up to 5 Years
Title
Occurrence of TEAEs resulting in death
Description
A TEAE resulting in death is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment.
Time Frame
Up to 5 Years
Title
Occurrence of dose-limiting toxicity (DLT)
Description
A DLT is defined as a study-drug related TEAE, including imAEs, that could preclude enrolling additional adolescent patients at the selected dose. Dose-limiting toxicity will be evaluated in adolescents only.
Time Frame
Up to 5 Years
Title
Occurrence of interruption or discontinuation of study drug(s) due to TEAE
Description
A TEAE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment.
Time Frame
Up to 5 Years
Title
Occurrence of laboratory abnormalities
Description
As assessed by the NCI-CTCAE grading system (≥ Grade 3 or higher)
Time Frame
Up to 5 Years
Title
Concentrations of fianlimab in serum over time
Description
The concentrations of fianlimab over time will be summarized by descriptive statistics by study arm for the overall population and for adolescent patients.
Time Frame
Up to 5 Years
Title
Concentrations of cemiplimab in serum over time
Description
The concentrations of cemiplimab over time will be summarized by descriptive statistics by study arm for the overall population and for adolescent patients.
Time Frame
Up to 5 Years
Title
Concentration of finalimab anti-drug antibodies (ADA) and neutralizing antibodies
Description
Immunogenicity will be characterized per drug molecule by ADA and NAb status.
Time Frame
Up to 5 Years
Title
Concentration of cemiplimab anti-drug antibodies (ADA) and neutralizing antibodies
Description
Immunogenicity will be characterized per drug molecule by ADA and NAb status.
Time Frame
Up to 5 Years
Title
Patient report outcomes (PRO) for adults as measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)
Description
The EORTC QLQ-C30 (Version 3) uses for the questions 1 to 28 a 4-point scale. The scale scores from 1 to 4: 1 ("Not at all"), 2 ("A little"), 3 ("Quite a bit") and 4 ("Very much"). Half points are not allowed. The range is 3. For the raw score, less points are considered to have a better outcome. The EORTC QLQ-C30 (Version 3) uses for the questions 29 and 30 a 7-points scale. The scale scores from 1 to 7: 1 ("very poor") to 7 ("excellent"). Half points are not allowed. The range is 6. More points are considered to have a better outcome.
Time Frame
Up to 5 Year
Title
PRO for adults as measured by the European Quality of Life Dimension 5 (EQ-5D-5L)
Description
The EQ-5D-5L a descriptive system that 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. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
Time Frame
Up to 5 Years
Title
PRO for adults as measured by the Functional Assessment of Cancer Therapy (FACT) - melanoma
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 5 Years
Title
PRO for adults as determined by the Patient Global Impressions Scale (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 5 Years
Title
PRO for adults as determined by the Patient Global Impressions of Change Scale (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 5 Years
Title
Time to global health status/quality of life deterioration per EORTC QLQ-C30
Time Frame
Up to 5 years
Title
Time to physical functioning deterioration per EORTC QLQ-C30
Time Frame
Up to 5 Years
Title
Time to role functioning deterioration per EORTC QLQ-C30
Time Frame
Up to 5 Years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: All patients must be either stage IIC, III, or stage IV per American Joint Committee on Cancer (AJCC) 8th edition and have histologically confirmed melanoma that is completely surgically resected in order to be eligible as defined by the protocol Complete surgical resection must be performed within 12 weeks prior to randomization, and enrollment may occur only after satisfactory wound healing from the surgery All patients must have disease-free status documented by a complete physical examination and imaging studies within 4 weeks prior to randomization, as described in the protocol Key Exclusion Criteria: Uveal melanoma Any evidence of residual disease after surgery by imaging, pathology, or cytology. Ongoing or recent (within 2 years) evidence of clinically significant autoimmune disease that required systemic treatment with immunosuppressive agents Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C (HCV) infection; or diagnosis of immunodeficiency that is related to, or results in chronic infection, as described in the protocol Another malignancy that is currently progressing or that required active treatment in the past 5 years, as described in the protocol Adolescent patients (≥12 to <18 years old) with body weight <40 kg 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
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94158-3214
Country
United States
Individual Site Status
Recruiting
Facility Name
John Wayne Cancer Institute - Saint John's Health Center
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404-2312
Country
United States
Individual Site Status
Recruiting
Facility Name
The Melanoma And Skin Cancer Institute
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80113
Country
United States
Individual Site Status
Recruiting
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 Cancer Institute
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Individual Site Status
Recruiting
Facility Name
Northwestern Medical Group
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Recruiting
Facility Name
Massachusetts General Cancer Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Name
Rutgers Cancer Institute of New Jersey
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Individual Site Status
Recruiting
Facility Name
NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Recruiting
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Recruiting
Facility Name
Lineberger Comprehensive Cancer Center
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Individual Site Status
Recruiting
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Individual Site Status
Recruiting
Facility Name
University Hospitals Cleveland Medical 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
St. Luke's Hematology
City
Easton
State/Province
Pennsylvania
ZIP/Postal Code
18045
Country
United States
Individual Site Status
Recruiting
Facility Name
Thomas Jefferson University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
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 Name
Tennessee Oncology
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Individual Site Status
Recruiting
Facility Name
The University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Individual Site Status
Recruiting
Facility Name
Intermountain Medical Center
City
Murray
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Virginia Health System
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Individual Site Status
Recruiting
Facility Name
Virginia Cancer Specialist Research Institute
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Individual Site Status
Recruiting
Facility Name
DIABAID - Instituto de Asistencia Integral en Diabetes
City
Ciudad Autonoma
State/Province
Buenos Aires
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Calvary North Adelaid Hospital (HPS Pharmacies)
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5006
Country
Australia
Individual Site Status
Recruiting
Facility Name
Andrew Love Cancer Centre, University Hospital Geelong
City
Geelong
State/Province
Victoria
ZIP/Postal Code
3220
Country
Australia
Individual Site Status
Recruiting
Facility Name
Alfred Health
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Individual Site Status
Recruiting
Facility Name
VITAZ vzw - pharm Sara Van Opdenbosch t.a.v. apotheek
City
Sint Niklaas
State/Province
East Flanders
ZIP/Postal Code
9100
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Campus Kennedylaan Apotheek
City
Kortrijk
State/Province
West-Vlaaderen
ZIP/Postal Code
8500
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Instituto de Ensino e Pesquisas Sao Lucas - IEP HEMOMED
City
Sao Paulo
State/Province
Sao Paulo Estado
ZIP/Postal Code
01236-030
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Dr. Everett Chalmers Hospital
City
Fredericton
State/Province
New Brunswick
ZIP/Postal Code
E3B5N5
Country
Canada
Individual Site Status
Recruiting
Facility Name
Royal Victoria Regional Health Centre
City
Barrie
State/Province
Ontario
ZIP/Postal Code
L4M 6M2
Country
Canada
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
University Health Network, Princess Margaret Cancer Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2C1
Country
Canada
Individual Site Status
Recruiting
Facility Name
Universidad Mayor - Centro Oncologia de Precision (PROFAR)
City
Santiago
State/Province
Metropolitana De Santiago
ZIP/Postal Code
7560907
Country
Chile
Individual Site Status
Recruiting
Facility Name
Clinica UC San Carlos de Apoquindo
City
Santiago
State/Province
Metropolitana De Santiago
ZIP/Postal Code
7620002
Country
Chile
Individual Site Status
Recruiting
Facility Name
Oncovida
City
Santiago
State/Province
Santiago Region Metropolitana De Santiago
ZIP/Postal Code
7510032
Country
Chile
Individual Site Status
Recruiting
Facility Name
Oncocentro APYS
City
Valparaiso
ZIP/Postal Code
2520598
Country
Chile
Individual Site Status
Recruiting
Facility Name
University Hospital Ostrava Pharmacy
City
Ostrava
State/Province
Moravia Region
ZIP/Postal Code
70852
Country
Czechia
Individual Site Status
Recruiting
Facility Name
CHU de NANTES Hotel Dieu
City
Nantes
State/Province
Pays De La Loire Région
ZIP/Postal Code
44000
Country
France
Individual Site Status
Recruiting
Facility Name
LTD Cancer Center of Adjara Autonomic Republic
City
Batumi
State/Province
Adjara
ZIP/Postal Code
6000
Country
Georgia
Individual Site Status
Recruiting
Facility Name
Israeli Georgian medical research clinic Helsicore
City
T'bilisi
State/Province
South Caucasus
ZIP/Postal Code
0112
Country
Georgia
Individual Site Status
Recruiting
Facility Name
LTD Research Institute of Clinical Medicine (LLC Todua Clinic)
City
T'bilisi
State/Province
South Caucasus
ZIP/Postal Code
0112
Country
Georgia
Individual Site Status
Recruiting
Facility Name
LTD New Hospitals
City
T'bilisi
State/Province
South Caucasus
ZIP/Postal Code
0114
Country
Georgia
Individual Site Status
Recruiting
Facility Name
High Technology Medical Center, University Clinic Tbilisi
City
T'bilisi
State/Province
South Caucasus
ZIP/Postal Code
0144
Country
Georgia
Individual Site Status
Recruiting
Facility Name
Tbilisi Institute of Medicine (TIM)
City
T'bilisi
State/Province
South Caucasus
ZIP/Postal Code
0168
Country
Georgia
Individual Site Status
Recruiting
Facility Name
Universitatsmedizin Gottingen
City
Gottingen
State/Province
Lower Saxony
ZIP/Postal Code
37075
Country
Germany
Individual Site Status
Recruiting
Facility Name
Klinikum der Stadt Ludwigshafen am Rhein
City
Ludwigshafen
State/Province
Rhindeland Palatinate
ZIP/Postal Code
67063
Country
Germany
Individual Site Status
Recruiting
Facility Name
Beaumont Hospital
City
Beaumont
State/Province
Dublin
ZIP/Postal Code
D09V2N0
Country
Ireland
Individual Site Status
Recruiting
Facility Name
St Vincent's University Hospital
City
Dublin
ZIP/Postal Code
D04 T6F4
Country
Ireland
Individual Site Status
Recruiting
Facility Name
Instituto Nazionale Tumori IRCCS Fondazione G. Pascale
City
Napoli
State/Province
Campania
ZIP/Postal Code
80131
Country
Italy
Individual Site Status
Recruiting
Facility Name
Farmacia Ospedaliera, Instituto Europeo di Oncologia
City
Milan
State/Province
Lombardy
ZIP/Postal Code
20141
Country
Italy
Individual Site Status
Recruiting
Facility Name
Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Istituto Tumori Giovanni Paolo II - Ospedale Oncologico di Bari
City
Bari
State/Province
Metropolitan City Of Bari
ZIP/Postal Code
70124
Country
Italy
Individual Site Status
Recruiting
Facility Name
Istituto Di Ricovero E Cura A Carattere Scientifico (Ircss)
City
Roma
State/Province
Rome Province
ZIP/Postal Code
00167
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda Ospedaliero Universitaria Maggiore della Carita, Farmacia Ospedaliera
City
Novara
ZIP/Postal Code
28100
Country
Italy
Individual Site Status
Recruiting
Facility Name
Ospedale S.Chiara - APSS di Trento - Magazzino Farmacia
City
Trento
ZIP/Postal Code
38123
Country
Italy
Individual Site Status
Recruiting
Facility Name
FAICIC S. de R.L. de C.V.
City
Veracruz
State/Province
Veracruz Estado
ZIP/Postal Code
91900
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Mazowiecki Szpital Wojewodzki, Siedleckie Centrum Onkologii
City
Siedlce
State/Province
Mazowieckie
ZIP/Postal Code
08-110
Country
Poland
Individual Site Status
Recruiting
Facility Name
Wojewodzki Szpital Specjalistyczny im. J. Korczaka w Slupsku
City
Slupsk
State/Province
Pomorskie
ZIP/Postal Code
16-200
Country
Poland
Individual Site Status
Recruiting
Facility Name
Cape Gate Oncology Trials
City
Windsor Park Kraaifontein
State/Province
Western Cape
ZIP/Postal Code
7570
Country
South Africa
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Virgen Macarena
City
Sevilla
State/Province
Andalucia
ZIP/Postal Code
41009
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Central de Asturias
City
Oviedo
State/Province
Asturias
ZIP/Postal Code
33011
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Marques De Valdecilla
City
Santander
State/Province
Cantabria
ZIP/Postal Code
39008
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Quiron Dexeus Barcelona
City
Barcelona
State/Province
Catalonia
ZIP/Postal Code
08028
Country
Spain
Individual Site Status
Recruiting
Facility Name
Area dassajos clinics/Medicaments en investigacio, Servei de Farmacia Hospital Clinic de Barcelona (ICMHO)
City
Barcelona
State/Province
Catalonia
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Vall d'Hebron, Edificio General-Planta Baja, UITM, Unidad de Farmacia de Ensa
City
Barcelona
State/Province
Catalonia
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario La Paz
City
Madrid
State/Province
Madrid Provincia
ZIP/Postal Code
28046
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 Name
Hospital Universitario Lucus Augusti
City
Lugo
ZIP/Postal Code
27003
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital General Universitario Gregorio Maranon (HGUGM)
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario HM Sanchinarro
City
Madrid
ZIP/Postal Code
28050
Country
Spain
Individual Site Status
Recruiting
Facility Name
Fundacion Instituto Valenciano de Oncologia
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Clinico Universitario de Valencia
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Individual Site Status
Recruiting
Facility Name
Sbu Dr. A.Y. Ankara Onkoloji Suam
City
Ankara
State/Province
Anatolia
ZIP/Postal Code
06100
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Gulhane Egitim ve Arastirma Hastanesi
City
Keçiören
State/Province
Ankara
ZIP/Postal Code
06010
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Liv Hospital
City
Ankara
State/Province
Central Anatolia
ZIP/Postal Code
06010
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Ankara Memorial Hospital
City
Ankara
State/Province
Central Anatolia
ZIP/Postal Code
06520
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Dicle University, Faculty of Medicine
City
Diyarbakir
State/Province
Diyarbakir Province
ZIP/Postal Code
21280
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Trakya Universitesi, Balkan Onkoloji Hastanesi Linik Arastirmar Odasi
City
Iskender
State/Province
Edime
ZIP/Postal Code
22130
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Medical Park Gaziantep Hastanesi
City
Sehitkamil
State/Province
Gaziantep
ZIP/Postal Code
27310
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Goztepe Prof. Dr. Suleyman Yalcin City Hospital
City
Istanbul
State/Province
Istanbul Province
ZIP/Postal Code
81450
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Izmir Katip Celebi University Ataturk training and Research Hospital
City
Izmir
State/Province
Izmir Province
ZIP/Postal Code
35360
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Kocaeli University Hospital
City
Umuttepe
State/Province
Kocaeli
ZIP/Postal Code
41380
Country
Turkey
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 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

A Trial to See if the Combination of Fianlimab With Cemiplimab Works Better Than Pembrolizumab for Preventing or Delaying Melanoma From Coming Back After it Has Been Removed With Surgery

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