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    Summary
    EudraCT Number:2021-001641-13
    Sponsor's Protocol Code Number:CA224-098
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-09-28
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2021-001641-13
    A.3Full title of the trial
    A Phase 3, Randomized, Double-blind Study of Adjuvant Immunotherapy with Relatlimab and Nivolumab Fixed-dose Combination versus Nivolumab Monotherapy after Complete Resection of Stage III-IV Melanoma
    Estudio Fase 3, aleatorizado, doble ciego de Inmunoterapia en adyuvancia con Relatlimab y Nivolumab en combinación a dosis fija frente a Nivolumab en monoterapia en pacientes con melanoma estadio III-IV tras resección completa
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Adjuvant Immunotherapy with Relatlimab and Nivolumab Fixed-dose Combination versus Nivolumab Monotherapy after Complete Resection of Stage III-IV Melanoma
    Inmunoterapia en Adyuvancia con Relatlimab y Nivolumab en combinación a dosis fija frente a Nivolumab en monoterapia en pacientes con melanoma estadio III-IV tras resección completa
    A.3.2Name or abbreviated title of the trial where available
    RELATIVITY 098
    RELATIVITY 098
    A.4.1Sponsor's protocol code numberCA224-098
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT05002569
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1266-6146
    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 SponsorBristol-Myers Squibb International Corporation
    B.1.3.4CountryBelgium
    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 supportBristol-Myers Squibb International Corporation
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBristol-Myers Squibb International Corporation
    B.5.2Functional name of contact pointGSM-CT
    B.5.3 Address:
    B.5.3.1Street AddressParc de l'Alliance - Avenue de Finlande, 4
    B.5.3.2Town/ cityBraine-l'Alleud
    B.5.3.3Post code1420
    B.5.3.4CountryBelgium
    B.5.4Telephone number900 150 160
    B.5.6E-mailclinical.trials@bms.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 nameRelatlimab/ Nivolumab 1:3 Fixed Dose combination (Relatlimab 80 mg/Nivolumab 240 mg)
    D.3.2Product code BMS-986213
    D.3.4Pharmaceutical form Solution for injection/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 INNNIVOLUMAB
    D.3.9.1CAS number 946414-94-4
    D.3.9.2Current sponsor codeBMS-936558
    D.3.9.3Other descriptive nameMDX-1106, ONO-4538
    D.3.9.4EV Substance CodeSUB32944
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number12
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRELATLIMAB
    D.3.9.2Current sponsor codeBMS-986016
    D.3.9.3Other descriptive nameanti-LAG-3
    D.3.9.4EV Substance CodeSUB168199
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    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 Yes
    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 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 Opdivo (100 mg/10 ml)
    D.2.1.1.2Name of the Marketing Authorisation holderBristol-Myers Squibb Pharma EEIG
    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 nameNIVOLUMAB - 10ml vial-COMMERCIAL
    D.3.2Product code BMS-936558
    D.3.4Pharmaceutical form Concentrate for 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 INNNIVOLUMAB
    D.3.9.1CAS number 946414-94-4
    D.3.9.2Current sponsor codeBMS-936558
    D.3.9.3Other descriptive nameMDX-1106, ONO-4538
    D.3.9.4EV Substance CodeSUB32944
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 Yes
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    participants with completely resected Stage III or Stage IV melanoma
    participantes con melanoma estadio III o estadio IV resecado completamente
    E.1.1.1Medical condition in easily understood language
    participants who had a stage 3 or 4 melanoma surgically removed
    participantes con melanoma estadio 3 o 4 eliminado con cirugía
    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 10025671
    E.1.2Term Malignant melanoma stage IV
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10025670
    E.1.2Term Malignant melanoma stage III
    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 compare the efficacy, as measured by RFS, provided by relatlimab and nivolumab FDC vs nivolumab monotherapy in participants with
    completely resected Stage III/IV NED melanoma.
    Comparar la eficacia, medida mediante la SLR, aportada por relatlimab y nivolumab en CDF frente a nivolumab en monoterapia en participantes con melanoma en estadio III/IV resecado completamente y SIE.
    E.2.2Secondary objectives of the trial
    -To compare the efficacy, as measured by distant metastasis-free survival (DMFS), provided by relatlimab and nivolumab FDC vs nivolumab monotherapy in participants with completely resected
    Stage III/IV NED melanoma.
    -To compare the OS provided by relatlimab and nivolumab FDC vs nivolumab monotherapy in participants with completely resected Stage III/IV NED melanoma.
    -To assess safety and toxicity of relatlimab and nivolumab FDC vs nivolumab monotherapy in participants with completely resected Stage III/IV NED melanoma.
    -To evaluate investigator-assessed outcomes on next-line therapies.
    - Comparar la eficacia, medida mediante la supervivencia libre de metástasis a distancia (SLMD), aportada por relatlimab y nivolumab en CDF frente a nivolumab en monoterapia en participantes con melanoma en estadio III/IV resecado completamente y SIE.
    - Comparar la SG obtenida por relatlimab y nivolumab en CDF frente a nivolumab en monoterapia en participantes con melanoma en estadio III/IV resecado completamente y SIE.
    - Evaluar la seguridad y la toxicidad de relatlimab y nivolumab en CDF y de nivolumab en monoterapia en participantes con melanoma en estadio III/IV resecado completamente y SIE.
    - Evaluar los resultados valorados por los investigadores en los tratamientos de líneas siguientes.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - All participants must have been diagnosed with either Stage IIIA (> 1 mm tumor in lymph node)/B/C/D or Stage IV melanoma by AJCC v8 and have histologically confirmed melanoma that is completely surgically resected (free of disease) with negative margins in order to be eligible. All melanomas, except uveal melanoma, regardless of primary site of disease, will be allowed.
    - All participants must have disease-free status documented by a complete physical examination within 14 days prior to randomization and imaging studies within 35 days prior to randomization.
    - Tumor tissue obtained from surgical specimen or biopsy during resection collected within 3 months prior to randomization, with an associated pathology report, must be submitted to the central laboratory prior to randomization.
    - Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1.
    - Participant must be ≥ 18 years of age inclusive at the time of signing the informed consent.
    - Todos los participantes deben haber sido diagnosticados de melanoma en estadio IIIA (tumor > 1 mm en ganglio linfático) /B/C/D o estadio IV según el AJCC v8 y tener melanoma confirmado histológicamente que haya sido resecado quirúrgicamente de forma completa (libre de enfermedad) con márgenes negativos para ser elegibles. Se permitirán todos los melanomas, excepto el melanoma de úvea, independientemente de la localización primaria de la enfermedad.

    - Todos los participantes deben tener estado libre de enfermedad documentado por una exploración física completa dentro de los 14 días previos a la aleatorización y pruebas de imagen dentro de los 35 días previos a la aleatorización.
    - Antes de la aleatorización, debe enviarse al laboratorio central tejido tumoral obtenido de la pieza quirúrgica o de biopsia durante la resección recogido dentro de los 3 meses previos a la aleatorización, con un informe asociado de anatomía patología.
    - Estado funcional del Eastern Cooperative Oncology Group (ECOG) ≤1.
    - El participante debe tener ≥ 18 años inclusive en el momento de la firma del consentimiento informado.
    E.4Principal exclusion criteria
    - Prior immunotherapy treatment for any prior malignancy: No prior immunotherapies are permitted (such as, but not limited to, anti-programmed death-1 (anti-PD-1), anti-programmed death ligand-1 (anti-PD-L1), anti-programmed death ligand-2 (PD-L2), or any other antibody or drug specifically targeting T-cell costimulation or immune checkpoint pathways).
    - Prior treatment with LAG-3 targeted agents.
    - Prior therapy for melanoma except surgery for the melanoma lesion(s) and/or adjuvant radiation therapy for central nervous system lesions.
    - Participants with an active, known, or suspected autoimmune disease. Participants with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
    - Tratamiento con inmunoterapia previa para cualquier neoplasia maligna previa: No se permiten inmunoterapias previas (como, entre otras, anticuerpos anti-muerte programada 1 (anti-PD-1), anti-ligando de muerte programada 1 (anti-PD-L1), anti-ligando de muerte programada 2 (PD-L2) o cualquier otro anticuerpo o fármaco que se dirija específicamente a la coestimulación de los linfocitos T o el punto de control inmunitario).
    - Tratamiento previo con agentes dirigidos a LAG-3.
    - Tratamiento previo para el melanoma, excepto cirugía para la(s) lesión(es) de melanoma
    y/o radioterapia adyuvante para lesiones del sistema nervioso central.
    - Participantes con enfermedad autoinmunitaria activa, conocida o de sospecha. Se permite reclutar a sujetos con diabetes mellitus tipo I, hipotiroidismo que sólo precise tratamiento de sustitución hormonal, trastornos cutáneos (como vitiligo, psoriasis o alopecia) que no precisen tratamiento sistémico o problemas que no se espere que recurran en ausencia de un desencadenante externo.
    E.5 End points
    E.5.1Primary end point(s)
    -RFS time as assessed by the investigator. RFS is defined as the time between the date of randomization and the first date of documented recurrence (local, regional, distant, new primary melanoma, including melanoma in situ), or death due to any cause, whichever occurs first. Comparison of relatlimab and nivolumab FDC vs nivolumab monotherapy.
    - Tiempo de SLR según la evaluación por el investigador. La SLR se define como el tiempo entre la fecha de la aleatorización y la primera fecha de recidiva documentada (local, regional, a distancia, nuevo melanoma primario, incluido melanoma in situ) o la muerte por cualquier causa, lo que suceda antes. Comparación de relatlimab y nivolumab a CDF frente a nivolumab en monoterapia.
    E.5.1.1Timepoint(s) of evaluation of this end point
    approximately 56 months from the randomization of the first participant
    aproximadamente 56 meses desde la aleatorización del primer participante
    E.5.2Secondary end point(s)
    1/DMFS, by investigator, is defined as the time between the
    date of randomization and the date of first distant metastasis
    or date of death due to any cause, whichever occurs first. Comparison of relatlimab and nivolumab FDC vs nivolumab
    monotherapy.
    2/OS is defined as the time between the date of randomization and the date of death due to any cause. Comparison of relatlimab and nivolumab FDC vs nivolumab monotherapy.
    3/ Incidence and severity of AE, SAEs, AEs leading to DC, IMAEs, drug-related AEs, deaths, laboratory abnormalities, and other
    select AEs, in all treated participants.
    4/Duration of Treatment on next-line therapies, in all randomized
    subjects who received new anticancer therapy, tumor-directed
    radiotherapy, or tumor-directed surgery.
    5/PFS2 defined as time from randomization to second recurrence/objective disease progression per investigator, or death from any cause, whichever occurs first. Evaluation of relatlimab and nivolumab FDC vs nivolumab monotherapy.
    1/ La SLMD, por el investigador, se define como el tiempo entre la fecha de la aleatorización y la fecha de la primera metástasis a distancia o la fecha de la muerte por cualquier causa, lo que suceda antes. Comparación de relatlimab y nivolumab a CDF frente a nivolumab en monoterapia.
    2/ La SG se define como el tiempo desde la fecha de la aleatorización hasta la fecha de la muerte por cualquier causa. Comparación de relatlimab y nivolumab a CDF frente a nivolumab en monoterapia.
    3/ Incidencia e intensidad de AA, AAG, AA que conducen a la suspensión, AAMI, AA relacionados con el fármaco, muertes, anomalías de laboratorio y otros AA seleccionados en todos los participantes tratados.
    4/ Duración del tratamiento con terapias de líneas siguientes, en todos los sujetos aleatorizados que recibieron nueva terapia contra el cáncer, radioterapia dirigida al tumor o cirugía dirigida al tumor.
    5/ SLP2, definida como el tiempo desde la aleatorización hasta la segunda recidiva/progresión objetiva de la enfermedad según el investigador o la muerte por cualquier causa, lo que suceda antes. Evaluación de relatlimab y nivolumab a CDF frente a nivolumab en monoterapia.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1, 3, 4, and 5/ approximately 56 months from the randomization of the first participant
    2/ approximately 72 months after the first participant is randomized
    1, 3, 4, y 5/ aproximadamente 56 meses desde la aleatorización del primer participante
    2/ aproximadamente 72 meses desde la aleatorización del primer participante
    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 Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    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 Yes
    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 No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA76
    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
    Australia
    Brazil
    Canada
    Chile
    China
    Israel
    Mexico
    United States
    Austria
    Belgium
    Denmark
    Finland
    France
    Germany
    Italy
    Norway
    Portugal
    Romania
    Spain
    Sweden
    Switzerland
    United Kingdom
    Czechia
    Argentina
    Greece
    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
    last follow-up visit of the last participant
    última visita de seguimiento del último participante
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years10
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days15
    E.8.9.2In all countries concerned by the trial years10
    E.8.9.2In all countries concerned by the trial months5
    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 No
    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) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 958
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 355
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state59
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 670
    F.4.2.2In the whole clinical trial 1313
    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)
    At the end of the study, BMS will not continue to provide BMS-supplied study intervention to participants/ investigators unless BMS chooses to extend the study. The investigator should ensure that the participant receives appropriate standard of care to treat the condition under study. See protocol section 7.8 for more details.
    Al final del estudio, BMS no continuará proporcionando la intervención del estudio suministrada por BMS a los participantes/investigadores a menos que BMS decida
    ampliar el estudio. El investigador debe asegurarse de que el participante recibe el estándar de tratamiento apropiado para tratar la afección bajo estudio. Consulte la sección 7.8 del protocolo para obtener más información.
    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 Decision2022-01-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-11-26
    P. End of Trial
    P.End of Trial StatusOngoing
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