Clinical Trials Register

Summary
EudraCT Number:	2016-002347-41
Sponsor's Protocol Code Number:	CA209-744
Clinical Trial Type:	Outside EU/EEA
Date on which this record was first entered in the EudraCT database:	2017-10-24
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
H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED

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A. Protocol Information

A.2

EudraCT number

2016-002347-41

A.3

Full title of the trial

Risk-based, response-adapted, Phase II open-label trial of nivolumab + brentuximab vedotin (N + Bv) for children, adolescents, and young adults with relapsed/refractory (R/R) CD30 + classic Hodgkin lymphoma (cHL) after failure of first-line therapy, followed by brentuximab + bendamustine (Bv + B) for participants with a suboptimal response. CheckMate 744: CHECKpoint pathway and nivolumab clinical Trial Evaluation

Ensayo de fase II abierto, basado en riesgo, adaptado a la respuesta, de nivolumab + brentuximab vedotina (N + Bv) en niños, adolescentes y adultos jóvenes con linfoma de Hodgkin clásico (LHc) CD30+ en recidiva/refractario (R/R) después del fracaso del tratamiento de primera línea, seguido de brentuximab + bendamustina (Bv + B) en participantes con una respuesta subóptima. CheckMate 744: Vía del punto de control y evaluación en ensayos clínicos de nivolumab.

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

A Study of Nivolumab + Brentuximab Vedotin in Children, Adolescents, and Young Adults With Classic Hodgkin Lymphoma (cHL) After Failure of First Line Therapy, Followed by Brentuximab Vedotin + Bendamustine for Participants With a Suboptimal Response (CheckMate 744)

Estudio de nivolumab + brentuximab vedotina (N + Bv) en niños, adolescentes y adultos jóvenes con linfoma de Hodgkin clásico (LHc) después del fracaso del tratamiento de primera línea, seguido de brentuximab + bendamustina (Bv + B) en participantes con una respuesta subóptima (CheckMate 744)

A.3.2

Name or abbreviated title of the trial where available

CheckMate 744

A.4.1

Sponsor's protocol code number

CA209-744

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT02927769

A.5.3

WHO Universal Trial Reference Number (UTRN)

U1111-1183-3601

A.7

Trial is part of a Paediatric Investigation Plan

Yes

A.8

EMA Decision number of Paediatric Investigation Plan

P/004/2017

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Bristol-Myers Squibb International Corporation
B.1.3.4	Country	Belgium
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Bristol-Myers Squibb International Corporation
B.4.2	Country	Belgium
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Bristol-Myers Squibb International Corporation
B.5.2	Functional name of contact point	GCT-SU
B.5.3	Address:
B.5.3.1	Street Address	Parc de l'Alliance - Avenue de Finlande, 4
B.5.3.2	Town/ city	Braine-l'Alleud
B.5.3.3	Post code	1420
B.5.3.4	Country	Belgium
B.5.6	E-mail	clinical.trials@bms.com

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Opdivo
D.2.1.1.2	Name of the Marketing Authorisation holder	Bristol-Myers Squibb Pharma EEIG
D.2.1.2	Country which granted the Marketing Authorisation	European Union
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	NIVOLUMAB
D.3.2	Product code	BMS-936558
D.3.4	Pharmaceutical form	Solution for injection/infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	NIVOLUMAB
D.3.9.1	CAS number	946414-94-4
D.3.9.2	Current sponsor code	BMS-936558-01
D.3.9.3	Other descriptive name	BMS-936558, MDX1106, ONO-4538
D.3.9.4	EV Substance Code	SUB32944
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	10
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	Yes
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	ADCETRIS
D.2.1.1.2	Name of the Marketing Authorisation holder	Takeda Pharma A/S
D.2.1.2	Country which granted the Marketing Authorisation	European Union
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form	Powder for concentrate for solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	BRENTUXIMAB VEDOTIN
D.3.9.1	CAS number	914088-09-8
D.3.9.3	Other descriptive name	BRENTUXIMAB VEDOTIN
D.3.9.4	EV Substance Code	SUB32397
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	50
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	Yes
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 3
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Bendamustine HEXAL®
D.2.1.1.2	Name of the Marketing Authorisation holder	Hexal AG
D.2.1.2	Country which granted the Marketing Authorisation	Germany
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form	Powder for concentrate for solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	BENDAMUSTINE HYDROCHLORIDE
D.3.9.1	CAS number	3543-75-7
D.3.9.4	EV Substance Code	SUB00696MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	100
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 4
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	ADCETRIS
D.2.1.1.2	Name of the Marketing Authorisation holder	Takeda Pharma A/S
D.2.1.2	Country which granted the Marketing Authorisation	European Union
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form	Powder for concentrate for solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	brentuximab vedotin
D.3.9.1	CAS number	914088-09-8
D.3.9.3	Other descriptive name	BRENTUXIMAB VEDOTIN
D.3.9.4	EV Substance Code	SUB32397
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	50
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	Yes
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another 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.1.1

Medical condition(s) being investigated

Relapsed/refractory (R/R) CD30 + classic Hodgkin lymphoma (cHL)

Linfoma de Hodgkin clásico (LHc) CD30+ en recidiva/refractario (R/R)

E.1.1.1

Medical condition in easily understood language

Hodgkin Disease

Enfermedad de Hodgkin

E.1.1.2

Therapeutic area

Diseases [C] - Cancer [C04]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	HLGT
E.1.2	Classification code	10025319
E.1.2	Term	Lymphomas Hodgkin's disease
E.1.2	System Organ Class	10005329 - Blood and lymphatic system disorders

E.1.3

Condition being studied is a rare disease

Yes

E.2 Objective of the trial

E.2.1

Main objective of the trial

- R1 (Low Risk) Cohort: To describe event-free survival (EFS) rate at 3 years, as assessed by blinded independent central review (BICR).

- R2 (Standard Risk) Cohort: to describe the complete metabolic response (CMR) rate prior to HDCT/ASCT by BICR, using Lugano 2014 response criteria

- Cohorte R1 (riesgo bajo): describir la tasa de supervivencia libre de acontecimientos (SLA) a los 3 años, evaluada mediante revisión central independiente enmascarada (RCIE).

- Cohorte R2 (riesgo estándar): describir la tasa de respuesta metabólica completa (RMC) antes de QTDA/TACP mediante RCIE, usando los criterios de respuesta de Lugano 2014

E.2.2

Secondary objectives of the trial

- To assess overall response rate (ORR) (CMR + partial metabolic response [PMR]) using Lugano 2014 criteria of the low risk and standard risk cohorts following 4 cycles of nivolumab and brentuximab vedotin by BICR
- To assess PFS rate at 3 years by BICR using Lugano 2014 criteria
- Duration of Response (DOR) will be evaluated for those participants who achieved PMR or CMR by BICR as well as for those participants who achieved CMR by BICR prior to IFRT in the low risk cohort and for those participants who achieved CMR prior to HDCT/ASCT in the standard risk cohort
- To describe the toxicity of nivolumab + brentuximab in combination in pediatric and young adult participants with relapsed or refractory classical Hodgkin’s lymphoma (cHL) after failure of first-line treatment
- To evaluate efficacy as assessed by investigators using LUGANO (2014) response criteria.

- Evaluar la tasa de respuesta global (TRO) (RMC + respuesta metabólica parcial [RMP]) usando los criterios de Lugano 2014 de las cohortes de bajo riesgo y de riesgo estándar después de 4 ciclos de nivolumab y brentuximab vedotin mediante RCIE.
- Evaluar la tasa de SLP a los 3 años mediante RCIE usando los criterios de Lugano 2014
- Se evaluará la duración de la respuesta (DdR) en los participantes que hayan alcanzado RMP o RMC mediante RCIE así como en los participantes que hayan alcanzado RMC según la RCIE antes de RTCA en la cohorte de riesgo bajo
y en los participantes que hayan alcanzado RMC antes de QTDA/TACP en la cohorte de riesgo estándar.
- Describir la toxicidad de nivolumab + brentuximab en combinación en participantes pediátricos y adultos jóvenes con linfoma de Hodgkin clásico (LHc) recidivante o refractario después del fracaso del tratamiento de primera línea.

E.2.3

Trial contains a sub-study

Yes

E.2.3.1

Full title, date and version of each sub-study and their related objectives

Retention of sample collection for additional research is mandatory for all participants, except where prohibited by local laws or regulations.
This protocol will include residual sample storage for additional research.
For additional details, pls refer to section 9.8.3 the original protocol dated 23-Sep-2016

Para todos los participantes, es obligatoria la retención de la colección de muestras para investigación adicional, excepto si lo prohíben leyes o regulaciones locales.
Este protocolo incluirá almacenamiento de muestras sobrantes para investigación adicional.
Consultar los detalles adicionales en la sección 9.8.3. del protocolo original de 23 de Septiembre de 2016.

E.3

Principal inclusion criteria

• Classic Hodgkin Lymphoma (cHL), relapsed or refractory
• Minimal limitation on activities of daily living as measured by Karnofsky ≥ 50 for participants > 16 years of age or Lansky ≥ 50 for participants ≤ 16 years of age.
• One prior anti-cancer therapy that did not work

- Linfoma de Hodgkin clásico (LHc), en recidiva o refractario
- Limitación mínima de actividades de la práctica diaria, medido mediante Karnofsky ≥ 50 para participantes con > 16 años de eada o Lansky ≥ 50 para participantes con ≤ 16 años de edad.
- Un tratamiento previo de terapia anti-cancerosa que fracasó.

E.4

Principal exclusion criteria

• Active, known, or suspected autoimmune disease or infection
• Active cerebral/meningeal disease related to the underlying malignancy
• More than one line of anti-cancer therapy or no treatment at all
• Received a stem cell transplant for Hodgkin Lymphoma and/or a solid organ transplant
• Prior treatment with any drug that targets T cell co-stimulation pathways (such as checkpoint inhibitors)

- Enfermedad autoinmune o infección activa, conocida o sospechada
- Enfermedad cerebral/meníngea activa relacionada con la enfermedad de base
- Más de una línea de tratamiento anti-canceroso o sin ningún tipo de tratamiento.
- Trasplante de células madre para el Linfoma de Hodgkin y/o trasplante de órganos sólidos
- Tratamiento previo con cualquier fármaco cuya diana sea la vía de co-estimulación de células T (como inhibidores del punto de control)

E.5 End points

E.5.1

Primary end point(s)

- Event Free Survival (EFS) ; Low Risk Group. Based on blinded independent central review (BICR)
- Complete Metabolic Response (CMR) prior to RT; Low Risk Group. The CMR rate is defined as the proportion of all response-evaluable participants who, assessed by the BICR, achieve best response of CMR using Lugano 2014 criteria.
- Complete Metabolic Response (CMR) Rate; Standard Risk Group. This is the rate prior to high-dose chemotherapy followed by autologous stem cell transplant (HDCT/ASCT) based on the blinded independent central review (BICR).

- Supervivencia libre de acontecimientos (SLA); Cohorte R1 (riesgo bajo). Basado en una revisión central independiente enmascarada (RCIE)
- Tasa de respuesta metabólica completa (RMC); Cohorte R2 (riesgo estándar).

E.5.1.1

Timepoint(s) of evaluation of this end point

Up to 5 years

Hasta 5 años

E.5.2

Secondary end point(s)

• Overall Response Rate (ORR)
Based on blinded independent central review (BICR)
• Progression Free Survival Rate (PFSR)
Based on the blinded independent central review (BICR)
• Duration of Response (DOR)
Based on the blinded independent central review (BICR)
• Incidence of serious and non-serious adverse events of nivolumab (BMS-936558) and brentuximab when given in combination
• Incidence of clinically significant abnormalities in general laboratory tests of nivolumab (BMS-936558) and brentuximab when given in combination. Hematology, Chemistry and Urinalysis
• Incidence of clinically significant vital sign measurements of nivolumab (BMS-936558) and brentuximab when given in combination. Temperature, Blood Pressure and Heart Rate
• Complete Metabolic Response (CMR)
• Complete Metabolic Response (CMR) rate at any time prior to radiation therapy
• EFS: Low Risk Group. Based on investigator assessments
• ORR: All participants, based on investigator assessments, after 4 cycles of nivolumab + brentuximab vedotin treatment
• PFSR:All participants, based on investigator assessments
• DOR: All participants, based on investigator assessments

• Tasa de respuesta global (TRO)
Evaluada mediante revisión central independiente enmascarada (RCIE)

• Supervivencia Libre de Progresión (SLP)
Evaluada mediante revisión central independiente enmascarada (RCIE)

• Duración de la respuesta (DdR) en
Evaluada mediante revisión central independiente enmascarada (RCIE)

• Incidencia de eventos adversos graves y no graves de nivolumab (BMS-936558) y brentuximab administrados en combinación

• Incidencia de las mediciones de las constantes vitales nivolumab (BMS-936558) y brentuximab administrados en combinación. Temperatura, Presión sanguínea y Tasa cardiaca
de las constantes vitales, etc.

E.5.2.1

Timepoint(s) of evaluation of this end point

- ORR: Up to 12 weeks
- Others: Up to 5 years

- TRO: hasta 12 semanas
- Otros: hasta 5 años

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

Yes

E.6.7

Pharmacodynamic

Yes

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

Yes

E.6.11

Pharmacogenomic

Yes

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

E.8.1.1

Randomised

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

Will this trial be conducted at a single site globally?

E.8.4

Will this trial be conducted at multiple sites globally?

Yes

E.8.6 Trial involving sites outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.6.3

Specify the countries outside of the EEA in which trial sites are planned

Canada

Czech Republic

France

Germany

Ireland

Italy

Netherlands

Poland

Spain

United Kingdom

United States

E.8.7

Trial 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

LVLS (Once participants reach the survival follow-up phase, either in-person visits or documented telephone calls/email correspondence to assess the participant’s status are acceptable)

Última visita del último sujetos (una vez que los participantes alcancen la fase de seguimiento de supervivencia, son aceptables tanto las visitas en persona como las llamadas telefóno/correspondencia por e-mail documentados para evaluar el estado de los participantes)

E.8.9 Initial estimate of the duration of the trial

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

Yes

F.1.1

Number of subjects for this age range:

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

Yes

F.1.1.5.1

Number of subjects for this age range:

F.1.1.6

Adolescents (12-17 years)

Yes

F.1.1.6.1

Number of subjects for this age range:

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

F.1.3

Elderly (>=65 years)

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

Yes

F.3.3.6.1

Details of subjects incapable of giving consent

Assents are allowed since this is a pediatric study

Al tratarse de un estudio pediátrico están permitidos los consentimientos.

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.2

For a multinational trial

F.4.2.2

In the whole clinical trial

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.

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 apropiado estándar de tratamiento.

G. Investigator Networks to be involved in the Trial

H.4 Third Country in which the Trial was first authorised
H.4.1	Third Country in which the trial was first authorised:	Canada

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Select Trial Status:	Select Trial Phase:
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Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
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