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    Summary
    EudraCT Number:2021-004453-23
    Sponsor's Protocol Code Number:R3767-ONC-2011
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2022-03-23
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedGermany - PEI
    A.2EudraCT number2021-004453-23
    A.3Full title of the trial
    A PHASE 3 TRIAL OF FIANLIMAB (REGN3767, ANTI-LAG-3) + CEMIPLIMAB VERSUS PEMBROLIZUMAB IN PATIENTS WITH PREVIOUSLY UNTREATED UNRESECTABLE LOCALLY ADVANCED OR METASTATIC MELANOMA
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical study of Fianlimab in combination with Cemiplimab in patients with previously untreated unresectable locally advanced or metastatic melanoma.
    A.4.1Sponsor's protocol code numberR3767-ONC-2011
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorRegeneron Pharmaceuticals, Inc.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportRegeneron Pharmaceuticals, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRegeneron Pharmaceuticals, Inc.
    B.5.2Functional name of contact pointClinical Trial Information
    B.5.3 Address:
    B.5.3.1Street Address777 Old Saw Mill River Road
    B.5.3.2Town/ cityTarrytown
    B.5.3.3Post code10591
    B.5.3.4CountryUnited States
    B.5.6E-mailclinicaltrials@regeneron.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameFianlimab
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFIANLIMAB
    D.3.9.2Current sponsor codeREGN3767
    D.3.9.4EV Substance CodeSUB198168
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Libtayo
    D.2.1.1.2Name of the Marketing Authorisation holderRegeneron Pharmaceuticals, Inc.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameCemiplimab
    D.3.2Product code REGN2810
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCemiplimab
    D.3.9.1CAS number 1801342-60-8
    D.3.9.4EV Substance CodeSUB189482
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 3
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Keytruda
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Sharp & Dohme
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameKeytruda
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPembrolizumab
    D.3.9.1CAS number 1374853-91-4
    D.3.9.4EV Substance CodeSUB167136
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Cutaneous Melanoma
    E.1.1.1Medical condition in easily understood language
    Cutaneous melanoma is one of the most aggressive forms of skin cancer
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10025650
    E.1.2Term Malignant melanoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate superiority of fianlimab 1600mg + cemiplimab and/or fianlimab 400mg + cemiplimab compared to pembrolizumab, as measured by PFS (progression-free survival).
    E.2.2Secondary objectives of the trial
    -Superiority of fianlimab 1600mg+ cemiplimab and/or fianlimab 400mg + cemiplimab compared to pembrolizumab as measured by OS
    -Superiority in ORR of fianlimab 1600mg+ cemiplimab and/or fianlimab 400mg + cemiplimab compared to pembro
    -Characterize ORR, PFS, and OS with fianlimab 1600mg + cemiplimab and/or fianlimab 400mg + cemiplimab compared to cemiplimab to inform the contribution of each component
    -Immunogenicity of fianlimab 1600mg and/or 400mg and cemiplimab
    -Impact of fianlimab 1600mg + cemiplimab and/or fianlimab 400mg + cemiplimab on physical functioning and role functioning and global health status/quality of life, as compared to pembro in adults
    -Safety and tolerability of treatment in patients 12 to <18 years of age
    -Characterize ORR, PFS, and OS with treatment in patients 12 to <18 years of age
    -Safety and tolerability of fianlimab + cemiplimab compared to pembro and to cemiplimab
    -Characterize PK of treatment using sparse PK sampling in patients aged ≥12 years
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age ≥12 years on the date of providing informed consent
    Note: Patients who are <18 years will be included in the territories, where accepted, per local laws and regulations.
    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.
    a. 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.
    b. 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
    a. Previously irradiated lesions can only be counted as target lesions if they have been demonstrated to progress and no other target lesion is available
    b. Cutaneous lesions should be evaluated as non-target lesions
    4. Performance status:
    a) For adult patients: Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
    b) 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.

    Please note other protocol-defined Inclusion criteria apply
    E.4Principal exclusion criteria
    Medical conditions:
    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. Patients with BRAF-mutated melanoma who present with symptoms of rapidly progressive disease and are considered by Investigator's assessment as likely to benefit from upfront treatment with BRAF/MEK-inhibitors should not be enrolled in the study.
    Prior/concomitant therapy:
    5. Systemic immune suppression:
    a. 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, provided if they are not for treatment of an autoimmune disorder.
    b. Other clinically relevant forms of systemic immune suppression.
    6. Treatment with other anti-cancer therapy including immuno- therapy, chemotherapy, radiotherapy, major surgery or biological therapy within 3 weeks 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.
    Other comorbidities:
    7. History or current evidence of significant (CTCAE Grade ≥2) local or systemic infection (e. g., cellulitis, pneumonia, septicemia) requiring systemic antibiotic treatment within 2 weeks 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:
    a. received radiotherapy or another appropriate standard therapy for the brain metastases,
    b. have neurologically returned to baseline (except for residual signs and symptoms related to the CNS treatment) for at least 14 days prior to enrollment.
    c. did not require immunosuppressive doses of corticosteroids therapy (>10mg of prednisone per day or equivalent) in the 14 days prior to enrollment.
    Note: Patients who are asymptomatic with a single untreated brain metastasis < 10 mm in size are eligible.
    9. Adolescent patients (≥12 to <18 years old) with body weight <40 kg.

    Other protocol-defined Exclusion criteria apply
    E.5 End points
    E.5.1Primary end point(s)
    PFS (progression-free survival)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Approximately 27 months
    E.5.2Secondary end point(s)
    1. Overall survival (OS)
    2. Objective response rate (ORR)
    3. Disease control rate (DCR)
    4. Duration of response (DoR)
    5. PFS
    6. Incidence of Adverse Events (AEs)
    7. Occurrence of interruption and discontinuation of study drug(s) due to AEs
    8. Incidence of deaths
    9. Incidence of laboratory abnormalities
    10. Concentrations of cemiplimab in serum
    11. Concentrations of fianlimab in serum
    12. Incidence and titer of anti-drug antibodies (ADA) to fianlimab over time
    13. Incidence and titer of ADA to cemiplimab over time
    14. Incidence of neutralizing antibodies (NAb) to fianlimab over time
    15. Incidence of NAb to cemiplimab over time
    16. Patient-reported outcomes (PROs) as measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30)
    17. PROs as measured by EQ-5D-5L
    18. PROs as measured by Functional Assessment of Cancer Therapy (FACT)-melanoma (melanoma subscale only)
    19. PROs as measured by Patient Global Impression of Severity (PGIS) 20. PROs as measured by Patient Global Impression of Change (PGIC) 21. Change in physical functioning per EORTC QLQ-C30
    22. Change in role functioning per EORTC QLQ-C30
    23. Change in global health status/quality of life (GHS/QoL) per EORTC QLQ-C30
    24. Change in physical functioning per EORTC QLQ-C30
    25. Change in role functioning per EORTC QLQ-C30
    26. Change in GHS/QoL per EORTC QLQ-C30
    E.5.2.1Timepoint(s) of evaluation of this end point
    1-4: Up to 96 months
    2-5: Up to 27 months
    6-7: Up to 90 days post last dose, approximately 6 years
    8: Up to 6 years
    9-11: Up to 90 days post last dose, approximately 6 years
    12-15: Up to 30 days post last dose, approximately 6 years
    16-18: Up to 90 days post last dose, approximately 6 years
    19-20: Up to 21 days post last dose, approximately 6 years
    21-23: Baseline to Week 25
    24-26: Baseline to end of study, approximately 6 years
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity
    Incidence and titer of anti-drug antibodies (ADA) and incidence of neutralizing antibodies (NAb) to fianlimab and cemiplimab over time.
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Pembrolizumab
    E.8.2.4Number of treatment arms in the trial4
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned22
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA121
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Argentina
    Chile
    Peru
    Ukraine
    Australia
    Brazil
    Canada
    Georgia
    Mexico
    Russian Federation
    South Africa
    United Kingdom
    United States
    Austria
    Belgium
    Czechia
    France
    Germany
    Hungary
    Ireland
    Italy
    Netherlands
    Poland
    Romania
    Spain
    Türkiye
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The end of study is defined as the date the last patient completes the last study visit withdraws from the study, or is lost to follow-up (ie, the study patient can no longer be contacted by the investigator).
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years8
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years8
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 6
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 6
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 1290
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 294
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Subjects under 18 years of age
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state143
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 708
    F.4.2.2In the whole clinical trial 1590
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    none
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2022-07-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-08-30
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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