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    Summary
    EudraCT Number:2015-004816-39
    Sponsor's Protocol Code Number:CA012-004
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-06-04
    Trial results View 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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2015-004816-39
    A.3Full title of the trial
    A Phase 1/2a Study of BMS-986178 Administered Alone or in Combination
    with Nivolumab or Ipilimumab in Subjects with Advanced Solid Tumors
    Uno Studio di Fase 1/2a di BMS-986178 somministrato in mono terapia o in combinazione con Nivolumab o con Ipilimumab in soggetti con tumori solidi avanzati
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of BMS-986178 Monotherapy or in Combination With Nivolumab
    and/or Ipilimumab in Subjects With Advanced Solid Tumors.
    Studio di BMS-986178 in Monoterapia o in Combinazione con Nivolumab e/o Ipilimumab in Soggetti con tumori solidi avanzati.
    A.3.2Name or abbreviated title of the trial where available
    NA
    NA
    A.4.1Sponsor's protocol code numberCA012-004
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN00000000
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02737475
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1175-8335
    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 pointGCT-SU
    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 number000
    B.5.5Fax number000
    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 nameNA
    D.3.2Product code BMS-986178
    D.3.4Pharmaceutical form Solution for injection
    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.3.9.2Current sponsor codeBMS-986178
    D.3.9.3Other descriptive nameBMS986178
    D.3.9.4EV Substance CodeSUB181367
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 Yes
    D.2.1.1.1Trade name OPDIVO
    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.3.4Pharmaceutical 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 INNNIVOLUMAB
    D.3.9.1CAS number 946414-94-4
    D.3.9.2Current sponsor codeBMS-936558-01
    D.3.9.3Other descriptive nameBMS-936558, MDX1106, ONO-4538
    D.3.9.4EV Substance CodeSUB122750
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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: 3
    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 YERVOY
    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.3.4Pharmaceutical 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 INN00323000
    D.3.9.1CAS number 477202-00-9
    D.3.9.2Current sponsor codeBMS-734016
    D.3.9.3Other descriptive nameBMS-734016
    D.3.9.4EV Substance CodeSUB22577
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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: 4
    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 TRIAXIS - 1 DOSE DA 0.5 ML SOSPENSIONE INIETTABILE 1 FLACONCINO IN VETRO DA UNA DOSE
    D.2.1.1.2Name of the Marketing Authorisation holderSANOFI PASTEUR MSD S.P.A.
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDIPHTHERIA, TETANUS, PERTUSSIS vaccine
    D.3.9.2Current sponsor codeTdap
    D.3.9.3Other descriptive nameDIPHTHERIA, TETANUS, PERTUSSIS (ACELLULAR, COMPONENT) VACCINE (ADSORBED, REDUCED ANTIGEN(S) CONTENT)
    D.3.9.4EV Substance CodeSUB180576
    D.3.10 Strength
    D.3.10.1Concentration unit ml millilitre(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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) Yes
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Advanced Solid Tumors
    Tumori Solidi Avanzati
    E.1.1.1Medical condition in easily understood language
    Advanced Solid Tumors
    Tumori Solidi Avanzati
    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 LLT
    E.1.2Classification code 10065252
    E.1.2Term Solid tumor
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the safety, tolerability, dose-limiting toxicities (DLTs), and
    maximum tolerated dose (MTD)/recommended phase 2 dose (RP2D) of
    BMS-986178 administered alone or in combination with nivolumab
    and/or ipilimumab in subjects with advanced solid tumors.
    Determinare la sicurezza, tollerabilità, tossicità limitante la dose (DLTs), massima dose tollerata (MTD)/dose raccomandata per la Fase 2 di BMS-986178 somministrato da solo o in combinazione con nivolumab e/o ipilimumab in soggetti con tumori solidi avanzati
    E.2.2Secondary objectives of the trial
    To investigate the preliminary anti-tumor activity of BMS-986178
    administered alone or in combination with nivolumab and/or ipilimumab
    in subjects with advanced solid tumors; To characterize the
    pharmacokinetics (PK) of BMS-986178 administered alone or in
    combination with nivolumab and/or ipilimumab; To characterize the
    immunogenicity of BMS-986178 administered alone or in combination
    with nivolumab and/or ipilimumab and the immunogenicity of nivolumab
    or ipilimumab administered with BMS-
    986178.
    To assess the proportion of subjects showing a change in
    pharmacodynamic biomarkers of BMS-986178 administered in
    combination with nivolumab or nivolumab monotherapy (Part 8).
    Investigare la preliminare attività anti-tumorale di BMS-986178 somministrato in monoterapia o in combinazione con nivolumab e/o ipilimumab in soggeti con tumori solidi avanzati. Caratterizzare la farmacocinetica (PK) di BMS-986178 somministrato in monoterapia o in combinazione con nivolumab e/o ipilimumab.
    Caratterizzare la immunogenicità di BMS-986178 somministrato in monoterapia o in combinazione con nivolumab e/o ipilimumab, e la immunogenicità di nivolumab o ipilimumab somministrato con BMS-986178
    Determinare la proporzione di soggetti che mostrano cambiamenti nella farmacodinamica di biomarcatori di BMS-986178 somminstrato in combinazione con nivolumab o nivolumab in monoterapia (Parte 8)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Subjects must be refractory to or intolerant of established therapy known to provide clinical benefit for their condition, i.e., subjects must not be candidates for regimens known to provide clinical benefit
    • ECOG (Eastern Cooperative Oncology Group) 0-1
    • Men and women 18 years old or older
    • At least one measurable lesion at baseline by CT (computed tomography) or MRI (magnetic resonance imaging) as per RECIST (Response Evaluation Criteria In Solid Tumors) v1.1
    • I soggetti devono essere refrattari o intolleranti a terapie stabilite note per provvedere beneficio clinico alla loro condizione, ovvero i soggetti non devono essere candidati a regimi noti per provvedere beneficio clinico
    • ECOG 0-1
    • Soggetti maggiorenni (maschili e femminili)
    • Almeno una lesione misurabile alla baseline mediante CT (tomografia computerizzata) o MRI (risonanza magnetica) come da RECIST v. 1.1
    E.4Principal exclusion criteria
    • Known central nervous system metastases or central nervous system as the only source of disease
    • Concomitant malignancies
    • Active known or suspected autoimmune disease
    • Uncontrolled or significant cardiovascular disease
    • Major surgery less than 4 weeks before the start of the study
    • Metastasi note al sistema nervoso centrale o sistema nervoso centrale come unica sede di malattia
    • Neoplasie concomitanti
    • Nota attiva o sospetta malattia autoimmune
    • Malattia cardiovascolare non controllata o significativa
    • Chirurgia importante entro 4 settimane prima dell’inizio dello Studio
    E.5 End points
    E.5.1Primary end point(s)
    Incidence of AE's (adverse events) and SAE's (serious adverse events),
    AE's leading to discontinuation, deaths and clinical laboratory test abnormalities
    primario Incidenza di Eventi Avversi (AEs) e Eventi Avversi Seri (SAEs), AE che portano a discontinuazione, morte e anormalità in risultati di test di di laboratorio
    E.5.1.1Timepoint(s) of evaluation of this end point
    Over 4 years
    Oltre 4 anni
    E.5.2Secondary end point(s)
    • Cmax (maximum observed serum concentration) for BMS-986178 alone or in combination with nivolumab and/or ipilimumab, if data permits • Tmax (time of maximum observed concentration) for BMS-986178 alone or in combination with nivolumab and/or ipilimumab, if data permits • AUC(0-t) (area under the concentration-time curve from time zero to the time) for BMS-986178 alone or in combination with nivolumab and/or ipilimumab, if data permits • AUC(TAU) (area under the concentration-time curve in 1 dosing interval) for BMS-986178 alone or in combination with nivolumab and/or ipilimumab, if data permits • Ctau (the observed concentration at the end of a dosing interval) for BMS-986178 alone or in combination with nivolumab and/or ipilimumab, if data permits • CLT (total body clearance) for BMS-986178 alone or in combination with nivolumab and/or ipilimumab, if data permits • Css-avg [average concentration over a dosing interval (AUC(TAU)/tau)] for BMS-986178 alone or in combination with nivolumab and/or ipilimumab, if data permits • AI [ratio of an exposure measure at steady state to that after the first dose (exposure measure includes AUC (TAU), Cmax and Ctau)] for BMS- 986178 alone or in combination with nivolumab and/or ipilimumab, if data permits • T-HALFeff [effective elimination half-life to explain degree of accumulation for a specific exposure measure (exposure measure includes AUC(TAU), Cmax and Ctau)] for BMS-986178 alone or in combination with nivolumab and/or ipilimumab, if data permits • Ctrough [trough observed plasma concentrations (this includes predose concentrations (C0) and Ctau)] for BMS-986178 alone or in combination with nivolumab and/or ipilimumab, if data permits • Immunoassay of anti-nivolumab antibody in combination with anti- BMS-986178 antibody • Immunoassay of anti-ipilimumab antibody in combination with anti- BMS-986178 antibody • Objective Response Rate (ORR) • Progression Free Survival Rate (PFSR) • Immunoassay of anti-BMS-986178 antibody alone
    End point secondario - Cmax (concentrazione di siero massima osservata) per BMS-986178 da solo o in combinazione con nivolumab e/o ipilimumab, se i dati lo consentono - Tmax (tempo di concentrazione massima osservata) per BMS-986178 da solo o in combinazione con nivolumab e/o ipilimumab, se i dati lo consentono - AUC (0-t) (area sotto la curva tempo-concentrazione idal tempo 0 al tempo t) per BMS-986178 da solo o in combinazione con nivolumab e/o ipilimumab, se i dati lo consentono - AUC (TAU) ((area sotto la curva tempo-concentrazione in 1 intervallo di dose) per BMS-986178 da solo o in combinazione con nivolumab e/o ipilimumab, se i dati lo consentono - Ctau (la concentrazione osservata alla fine di un intervallo di dose) BMS-986178 da solo o in combinazione con nivolumab e/o ipilimumab, se i dati lo consentono - CLT (clearance corporea totale) BMS-986178 da solo o in combinazione con nivolumab e/o ipilimumab, se i dati lo consentono - Css-avg [concentrazione media oltre l’intervallo di dose (AUC(TAU)/tau)] BMS-986178 da solo o in combinazione con nivolumab e/o ipilimumab, se i dati lo consentono - AI [rapporto di una misura di esposizione allo stato stazionario rispetto a quella dopo la prima dose (misura di esposizione include AUC (TAU), Cmax e Ctau)] BMS-986178 da solo o in combinazione con nivolumab e/o ipilimumab, se i dati lo consentono - T-HALFeff [emività di eliminazione effettiva per spiegare il grado di accumulazione per una specifica misura di esposizione (misura di esposizione include AUC(TAU), Cmax e Ctau)] BMS-986178 da solo o in combinazione con nivolumab e/o ipilimumab, se i dati lo consentono - Ctrough [concentrazioni osservate mediante plasma (include concentrazioni predose (C0) e Ctau)] BMS-986178 da solo o in combinazione con nivolumab e/o ipilimumab, se i dati lo consentono - Immunoassay di anticorpi anti-nivolumab in combinazione con anticorpi anti-BMS-986178 - immunoassay di anticorpi anti-ipilimumab in combinazione con anticorpi anti-BMS-986178 - Tasso di Risposta Obiettivo (ORR) - Tasso di Sopravvivenza Libera da Malattia (PFSS) - Immunoassay di anticorpi anti-BMS986178 da solo
    E.5.2.1Timepoint(s) of evaluation of this end point
    • Cmax; Tmax; AUC(0-t); AUC(TAU); Ctau; CLT; Css-avg; AI; T-HALFeff; Ctrough; Immunoassay of anti-nivolumab antibody in combination with anti-BMS-986178 antibody; Immunoassay of anti-ipilimumab antibody in combination with anti-BMS-986178 antibody : Approximately 100 days after the final study drug administration (end of treatment) • ORR; PFSR: Approximately 2 years • Immunoassay of anti-BMS-986178 antibody alone: Approximately 100 days after 6 months of treatment
    Cmax; Tmax; AUC(0-t); AUC(TAU); Ctau; CLT; Css-avg; AI; T-HALFeff; Ctrough; Immunoassay di anticorpi anti-nivolumab in combinazione con anticorpi anti-BMS-986178; Immunoassay di anticorpi anti-ipilimumab in combinazione con anticorpi anti-BMS-986178: approssimativamente 100 giorni sopo l’ultima somministrazione di farmaco sperimentale (fine del trattamento) • ORR; PFSR: approssimativamente 2 anni • Immunoassay di anticorpi anti-BMS986178 da solo: approssimativamente 100 giorni dopo 6 mesi di trattamento
    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: The secondary objective of immunogenicity will be assessed by the frequency of positive ADA to BMS-986178 or nivolumab or ipilimumab.
    Immunogenicitià: l'obiettivo secondario di immunogenicitià sarà determinato dalla frequeza di ADA positivi a BMS986178 o nivolumab o ipilimumab
    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 Yes
    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 No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA12
    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 Information not present in EudraCT
    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
    Israel
    United States
    France
    Italy
    Netherlands
    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
    LPLV
    LPLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days3
    E.8.9.2In all countries concerned by the trial years7
    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 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: 247
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 357
    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 state5
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 107
    F.4.2.2In the whole clinical trial 604
    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 drug to subjects and investigators unless BMS chooses to extend the study. The investigator should ensure that the subject receives appropriate standard of care to treat the condition under study.
    Alla fine dello Studio, BMS non continuerà a fornire famarci sperimenatli BMS a soggetti e investigatori a meno che BMS decida di estendere lo Studio. L'Investigatore dovrà assicurarsi che il soggetto riceva l'appropriato trattamento in base agli standard of care per la condizione in studio.
    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 Decision2017-05-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-03-23
    P. End of Trial
    P.End of Trial StatusCompleted
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