Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43865   clinical trials with a EudraCT protocol, of which   7286   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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2021-003606-53
    Sponsor's Protocol Code Number:CA224-106
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-04-12
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2021-003606-53
    A.3Full title of the trial
    A Phase 1/2, Safety Confirmation and Double-blind, Placebo-controlled, Randomized Study of Relatlimab in Combination with Nivolumab and Bevacizumab in Treatment-naive Advanced/Metastatic Hepatocellular Carcinoma
    Studio di fase 1/2 randomizzato, in doppio cieco, controllato con placebo e di conferma della sicurezza di Relatlimab in combinazione con Nivolumab e Bevacizumab nel carcinoma epatocellulare avanzato/metastatico naive al trattamento
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase 1/2 study of Relatlimab and Nivolumab in Combination with Bevacizumab in First-line HCC
    Studio di fase 1/2 su relatlimab e nivolumab in combinazione con bevacizumab per il trattamento di prima linea dell’HCC
    A.3.2Name or abbreviated title of the trial where available
    RELATIVITY-106
    RELATIVITY-106
    A.4.1Sponsor's protocol code numberCA224-106
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1267-1579
    A.5.4Other Identifiers
    Name:INDNumber:140,464
    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.3.9.4EV 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 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 Avastin 25 mg/ml concentrate for solution for infusion
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration GmbH
    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 nameBevacizumab
    D.3.2Product code [-]
    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 INNBevacizumab
    D.3.9.1CAS number 216974-75-3
    D.3.9.2Current sponsor code-
    D.3.9.4EV Substance CodeSUB16402MIG
    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: 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 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 - 130 mg/ml
    D.3.2Product code [BMS-986016]
    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 INNrelatlimab
    D.3.9.2Current sponsor codeBMS-986016
    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 number130
    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.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 injection/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
    Advanced/metastatic hepatocellular carcinoma (HCC)
    Carcinoma epatocellulare avanzato/metastatico (HCC)
    E.1.1.1Medical condition in easily understood language
    Advanced/metastatic hepatocellular carcinoma (HCC)
    Carcinoma epatocellulare avanzato/metastatico (HCC)
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10073071
    E.1.2Term Hepatocellular carcinoma
    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 determine the RP2D (recommended Phase 2 dose) of relatlimab, nivolumab, and bevacizumab triplet combination in participants with advanced/metastatic HCC (hepatocellular carcinoma) who have not received prior systemic therapy
    - To compare PFS (progression-free survival) of the relatlimab, nivolumab, and bevacizumab triplet combination to nivolumab and bevacizumab doublet combination in all randomized participants with advanced/metastatic HCC who have not received prior systemic therapy
    - Determinare la RP2D (dose raccomandata per la fase 2) della combinazione con tripletta di relatlimab, nivolumab e bevacizumab in partecipanti con HCC (carcinoma epatocellulare) avanzato/metastatico che non hanno ricevuto una precedente terapia sistemica
    - Confrontare la PFS (sopravvivenza libera da progressione) della combinazione con tripletta di relatlimab, nivolumab e bevacizumab rispetto alla combinazione con doppietta di nivolumab e bevacizumab in tutti i partecipanti randomizzati con HCC avanzato/metastatico che non hanno ricevuto una precedente terapia sistemica
    E.2.2Secondary objectives of the trial
    - To estimate key efficacy endpoints of the relatlimab, nivolumab, and bevacizumab triplet combination and the nivolumab and bevacizumab in doublet combination in all randomized participants with advanced/metastatic HCC who have not received prior systemic therapy and all randomized participants who express LAG-3 (lymphocyte activation gene-3) (> and = 1%) by immunohistochemistry (IHC)
    - To determine the safety and tolerability of the relatlimab, nivolumab, and bevacizumab triplet combination in all treated participants with advanced/metastatic HCC who have not received prior systemic therapy
    - Stimare i principali endpoint di efficacia della combinazione con tripletta di relatlimab, nivolumab e bevacizumab e la combinazione con doppietta di nivolumab e bevacizumab in tutti i partecipanti trattati, con HCC avanzato/metastatico, che non hanno ricevuto una precedente terapia sistemica e in tutti i partecipanti randomizzati che esprimono LAG-3 (gene di attivazione dei linfociti 3) (> e = 1%) mediante immunoistochimica (IHC)
    - Determinare la sicurezza e la tollerabilità della combinazione con tripletta di relatlimab, nivolumab e bevacizumab in tutti i partecipanti randomizzati con HCC avanzato/metastatico che non hanno ricevuto una precedente terapia sistemica
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - 18 years of age
    - previously untreated for advanced/metastatic HCC
    - ECOG 0-1
    - Child-Pugh A
    - Barcelona Clinical Liver Cancer stage B or C
    For detailed inclusion criteria, please refer to clinical protocol.
    - 18 anni di età
    - precedentemente non trattato per HCC avanzato/metastatico
    - ECOG 0-1
    - Child-Pugh A
    - Barcelona Clinical Liver Cancer stadio B o C
    Per i criteri di inclusione dettagliati, fare riferimento al protocollo clinico.
    E.4Principal exclusion criteria
    - fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC
    - prior disease history with increased risk of bleeding
    - clinically significant ascites
    - use of anticoagulant therapies
    For detailed exclusion criteria, please refer to clinical protocol.
    - HCC fibrolamellare, HCC sarcomatoide o colangiocarcinoma misto e HCC
    - precedente storia di malattia con aumentato rischio di sanguinamento
    - ascite clinicamente significativa
    - uso di terapie anticoagulanti
    Per i criteri di esclusione dettagliati, fare riferimento al protocollo clinico.
    E.5 End points
    E.5.1Primary end point(s)
    1/ DLTs (dose-limiting toxicities) assessed by Investigator within a 6- week DLT window for the first approximately 12, 24, 36, or 48 treated participants in 2 arms combined, depending on data
    2/ Progression-Free Survival PFS (treatment policy) assessed by BICR using RECIST v1.1
    1/ DLT (tossicità dose-limitante) valutate dallo sperimentatore nell’arco di 6 settimane per i primi circa 12, 24, 36 o 48 partecipanti trattati in 2 bracci di combinazione, a seconda dei dati
    2/ Sopravvivenza libera da progressione PFS (politica terapeutica) valutata dalla BICR utilizzando i criteri RECIST v1.1.
    E.5.1.1Timepoint(s) of evaluation of this end point
    1/ 6-week DLT window after first dose date or until a DLT is observed in both relatlimab and bevacizumab (if it occurs less than 6 weeks)
    2/ Tumor assessments should continue until disease progression (including progression on treatment beyond initial progression) or death or consent withdrawal, whichever is earlier, up to 5 years after last participant randomized
    1/ Finestra DLT di 6 settimane dopo la data della prima dose o fino a quando non si osserva una DLT sia in relatlimab che in bevacizumab (se si verifica in meno di 6 settimane)
    2/ Le valutazioni del tumore devono continuare fino alla progressione della malattia (inclusa la progressione del trattamento oltre la progressione iniziale) o alla morte o alla revoca del consenso, a seconda di quale sia la prima, fino a 5 anni dopo l'ultimo partecipante randomizzato
    E.5.2Secondary end point(s)
    1/ All endpoints assessed at the time of PFS primary endpoint assessment:
    - PFS (treatment policy) assessed by BICR using RECIST v1.1 in all randomized LAG-3 positive (> and = 1% by IHC) participants
    - Objective Response Rate (ORR) assessed by BICR using RECIST v1.1 in all randomized participants
    - ORR assessed by BICR using RECIST v1.1 in all randomized LAG-3 positive (> and =1% by IHC) participants
    - Overall Survival (OS) in all randomized participants
    - OS in all randomized LAG-3 positive (> and = 1% by IHC) participants
    2/ Adverse Events (AEs), Serious Adverse Events (SAEs), select AEs, IMAEs (Immune-Mediated Adverse Events), related or not, from first dose to 30- or 135-days after the last dose
    1/ Tutti gli endpoint valutati al momento della valutazione dell’endpoint primario della PFS:
    - PFS (politica terapeutica) valutata dalla BICR utilizzando i criteri RECIST v1.1 in tutti i partecipanti randomizzati LAG-3-positivi (> e = 1% mediante IHC)
    - tasso di risposta obiettiva (ORR) valutato dalla BICR utilizzando i criteri RECIST v1.1 in tutti i partecipanti randomizzati
    - ORR valutato dalla BICR utilizzando i criteri RECIST v1.1 in tutti i partecipanti randomizzati LAG-3 positivi (> e = 1% mediante IHC)
    - sopravvivenza complessiva (OS) in tutti i partecipanti randomizzati
    - OS in tutti i partecipanti randomizzati LAG-3-positivi (> e = 1% mediante IHC)
    2/ eventi avversi (EA), eventi avversi gravi (SAE), EA selezionati, IMAE (evento avverso immuno-mediato), correlati o meno, dalla prima dose a 30 o 135 giorni dall’ultima dose
    E.5.2.1Timepoint(s) of evaluation of this end point
    1/ PFS and ORR: Same Timeframe as primary endpoint of PFS by BICR
    OS: Up to 5 years after last participant randomized
    2/ from first dose to 135-days after the last dose
    1/ PFS e ORR: stesso intervallo di tempo dell'endpoint primario di PFS da BICR
    OS: Fino a 5 anni dopo l'ultimo partecipante randomizzato
    2/ dalla prima dose a 135 giorni dopo l'ultima dose
    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 Yes
    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
    Tolerability
    Tollerabilità
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Safety Confirmation and Clinical Efficacy of triplet therapy
    Conferma di sicurezza ed efficacia clinica della terapia con tripletta
    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 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) No
    E.8.2.2Placebo Yes
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA22
    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
    Australia
    Canada
    China
    Hong Kong
    Japan
    Korea, Republic of
    Singapore
    Taiwan
    United States
    France
    Germany
    Italy
    Poland
    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
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months10
    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: 129
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 33
    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
    In situations where consent cannot be given by participants, consent can be given by their legally acceptable representatives (as per country regulation) in accordance with ICH GCP Guidelines.
    Nelle situazioni in cui il consenso non può essere fornito dai partecipanti, il consenso può essere fornito dai loro rappresentanti legalmente accettabili (come da regolamento nazionale) in conformità con le linee guida ICH GCP.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state11
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 57
    F.4.2.2In the whole clinical trial 162
    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 conclusion of the study, participants who continue to demonstrate clinical benefit will be eligible to receive BMS supplied study treatment for maximum treatment duration as specified in the protocol. Study treatment will be provided via an extension of the study, a rollover study requiring approval by responsible health authority and ethics committee or through another mechanism at the
    discretion of BMS.
    Al termine dello studio, i partecipanti che continuano a dimostrare benefici clinici potranno ricevere il trattamento in studio fornito da BMS per la durata massima del trattamento come specificato nel protocollo. Il trattamento dello studio sarà fornito tramite un'estensione dello studio, uno studio di rollover che richiede l'approvazione dell'autorità sanitaria responsabile e del comitato etico o attraverso un altro meccanismo a discrezione di BMS.
    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 Decision2022-09-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-04-21
    P. End of Trial
    P.End of Trial StatusOngoing
    For support, Contact us.
    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.

    European Medicines Agency © 1995-Sun Apr 28 08:37:11 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA