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    The EU Clinical Trials Register currently displays   43974   clinical trials with a EudraCT protocol, of which   7312   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2021-001188-26
    Sponsor's Protocol Code Number:CA052-002
    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:2021-11-19
    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 number2021-001188-26
    A.3Full title of the trial
    A Phase 1/2 Study of BMS-986340 as Monotherapy and in Combination with Nivolumab in Participants with Advanced Solid Tumors
    Estudio fase 1/2 de BMS-986340 en monoterapia y en combinación con
    nivolumab en pacientes con tumores sólidos avanzados
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    CA052002 is a Phase 1/2, multi-center, open-label study of BMS-986340 administered as a single agent and in combination with nivolumab in participants with select advanced solid tumors
    CA052002 es un estudio fase 1/2 multicéntrico, abierto, de BMS-986340 en monoterapia y en combinación con nivolumab en pacientes con tumores sólidos avanzados
    A.4.1Sponsor's protocol code numberCA052-002
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04895709
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1265-4508
    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.5.6E-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 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.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 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 nameBMS-986340
    D.3.2Product code BMS-986340
    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 INNN/A
    D.3.9.2Current sponsor codeBMS-986340
    D.3.9.3Other descriptive nameBMS-986340
    D.3.9.4EV Substance CodeSUB223407
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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
    Male and female participants ≥ 18 years of age with advanced or metastatic cancers .
    Participantes varones y mujeres ≥ 18 años con cánceres avanzados o metastásicos.
    E.1.1.1Medical condition in easily understood language
    Advanced or metastatic cancers of the following types: NSCLC, SCCHN, MSS-CRC, gastric/GE junction adenocarcinoma, or cervical cancer (SCC or adenocarcinoma).
    Cánceres avanzados o metastásicos de los siguientes tipos: CPNM, CCECC, CRC-MSS, adenocarcinoma
    gástrico/de la unión GE o cáncer del cuello uterino (CCE o adenocarcinoma).
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the safety, tolerability, and to determine the MTD, MAD, and/or RP2D(s) of BMS-986340 administered as monotherapy and in combination with nivolumab
    Evaluar la seguridad, la tolerabilidad y determinar la DMT, la DMA y/o la(s) DRF2 de BMS-986340 administrada como monoterapia y en combinación con nivolumab
    E.2.2Secondary objectives of the trial
    - To characterize the PK profile of BMS-986340 administered as monotherapy and in combination with nivolumab
    - To characterize the immunogenicity of BMS-986340 administered as monotherapy and in combination with nivolumab
    - To assess the preliminary anti-tumor activity of BMS-986340 as monotherapy and in combination with nivolumab
    - caracterizar el perfil FC de BMS-986340 administrado en monoterapia y en combinación con nivolumab
    - caracterizar la inmunogenicidad de BMS-986340 administrado en monoterapia y en combinación con nivolumab
    - evaluar la actividad antitumoral preliminar de BMS-986340 en monoterapia y en combinación con nivolumab
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Fresh pre-treatment and on-treatment tumor biopsy must be provided for biomarker analysis
    • Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and at least 1 lesion accessible for biopsy
    • Eastern Cooperative Oncology Group Performance Status of 0 or 1
    • Radiographically documented progressive disease on or after the most recent therapy
    • Received standard-of-care therapies, including an available programmed death (ligand)-1 inhibitor known to be effective in the tumor type for which they are being evaluated
    • Parts 1A, 1B, and 2A: Advanced or metastatic non-small cell lung cancer, squamous cell carcinoma of head and neck, microsatellite stable colorectal cancer, gastric/ gastroesophageal junction adenocarcinoma, or cervical cancer, and have received, be refractory to, not be a candidate for, or be intolerant of existing therapies known to provide clinical benefit for the condition of the participant
    Other protocol-defined inclusion criteria apply
    • Debe proporcionarse biopsia reciente antes del tratamiento o durante el tratamiento del tumor para el análisis de biomarcadores
    • Enfermedad medible por Criterios de Evaluación de Respuesta en Tumores Sólidos (RECIST) v1.1 y al menos 1 lesión accesible por biopsia
    • Eastern Cooperative Oncology Group Performance Status de 0 or 1
    • Enfermedad progresiva documentada radiográficamente durante o después del tratamiento más reciente
    • Se deben haber recibido terapias estándar de referencia, incluyendo un inhibidor del ligando-1 de muerte programada que haya demostrado efectividad frente al tipo de tumor que se está evaluando
    • Partes 1A, 1B, y 2A: Sujetos con cáncer avanzado o metastásico de pulmón no microcítico (CPNM), carcinoma de células escamosas de cabeza y cuello (CCECC), cáncer colorrectal con microsatélites estables (CRC-MSS), adenocarcinoma gástrico/de la unión gastroesofágica (GE), o cáncer de cuello uterino, que hayan recibido, sean refractarios, no sean candidatos, o sean intolerantes a las terapias existentes que hayan demostrados beneficio clínico para la condición del sujeto participante.

    Otros criterios de inclusión definidos en el protocolo
    E.4Principal exclusion criteria
    • Women who are pregnant or breastfeeding
    • Primary central nervous system (CNS) malignancy
    • Untreated CNS metastases
    • Leptomeningeal metastases
    • Concurrent malignancy requiring treatment or history of prior malignancy active within 2 years prior to the first dose of study treatment
    • Active, known, or suspected autoimmune disease
    • Condition requiring systemic treatment with either corticosteroids within 14
    days or other immunosuppressive medications within 30 days of the first dose of study treatment
    • Prior organ or tissue allograft
    • Uncontrolled or significant cardiovascular disease
    • Major surgery within 4 weeks of study drug administration
    • History of or with active interstitial lung disease or pulmonary fibrosis
    Other protocol-defined exclusion criteria apply
    • Mujeres embarazadas o en periodo de lactancia
    • Neoplasia primaris del Sistema Nervioso Central (SNC)
    • Metástasis no tratadas del SNC
    • Metástasis leptomeningeas
    • Neoplasia simultánea que requiera tratamiento, o historial de neoplasia previa activa durante 2 años antes de la primera dosis del fármaco de estudio
    • Enfermedad autoinmune activa, conocida o sospechada
    • Condiciones clínicas que requiera tratamiento sistémico con corticosteriorides en los 14 días anteriores a la primera dosis del fármaco de estudio, o con otros farmacos inmunosupresores en los 30 días anteriores a la primera dosis del fármaco de estudio
    • Trasplante alogénico previo de órganos o tejidos
    • Enfermedad cardiovascular no controlada o significativa
    • Cirugía mayor en las 4 semanas previas a la administración del fármaco de estudio
    • Historial de enfermedad pulmonar intersticial (EPI) o EPI activa o fibrosis pulmonar

    Otros criterios de exclusión definidos en el protocolo
    E.5 End points
    E.5.1Primary end point(s)
    Incidence of AEs, SAEs, AEs meeting protocol defined DLT criteria, AEs leading to discontinuation and death, and laboratory abnormalities
    Incidencia de AA, AAG, AA que cumplan los criterios de TLD definidos en el protocolo, AA que conduzcan a la discontinuación y a la muerte y anomalías de laboratorio
    E.5.1.1Timepoint(s) of evaluation of this end point
    continuously
    de forma continua
    E.5.2Secondary end point(s)
    1) Summary measures of PK parameters of BMS-986340 administered as monotherapy and in combination with nivolumab
    2) Incidence of anti-drug antibodies to BMS-986340 when BMS-986340 is administered as monotherapy and in combination with nivolumab
    3) ORR, DCR, DOR, and PFSR
    1) Conjunto de medidas de parámetros FC de BMS-986340 administrado en monoterapia y en combinación con nivolumab
    2) Incidencia de anticuerpos anti-fármaco frente a BMS-986340 cuando BMS-986340 se administra como monoterapia y en combinación con nivolumab
    3) TRO, TCE, DdR y TSLP
    E.5.2.1Timepoint(s) of evaluation of this end point
    1) depends on the cycles
    2) continuously
    3) at 6 months and 1 year per RECIST v1.1 by investigator
    1) en función a los ciclos
    2) de forma continua
    3) a los 6 meses y 1 año según los RECIST v1.1 por el investigador
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Asignación secuencial
    Sequential Assignment
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA11
    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
    Canada
    United States
    Germany
    Italy
    Spain
    E.8.7Trial has a data monitoring committee No
    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 visit or scheduled procedure shown in the Schedule of Activities of the protocol for the last
    participant.
    Útima visita o último procedimiento programado del último paciente, tal como se muestra en el Esquema de Actividades del protocolo
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days24
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months2
    E.8.9.2In all countries concerned by the trial days28
    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: 63
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 42
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 54
    F.4.2.2In the whole clinical trial 105
    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 treatment 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
    Al final del estudio, BMS no continuará proporcionando el tratamiento de estudio suministrado por BMS a los participantes/investigadores a menos que BMS elija extender el estudio. El investigador debe asegurar que el participante recibe el estándar de tratamiento apropiado para tratar la condición en estudio.
    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 Decision2022-04-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-12-20
    P. End of Trial
    P.End of Trial StatusOngoing
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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