Clinical Trials Register

Summary
EudraCT Number:	2017-000238-73
Sponsor's Protocol Code Number:	CA021-002
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Prematurely Ended
Date on which this record was first entered in the EudraCT database:	2018-10-09
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

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A. Protocol Information

A.1

Member State Concerned

Spain - AEMPS

A.2

EudraCT number

2017-000238-73

A.3

Full title of the trial

A Phase 1/2 Dose Escalation and Combination Cohort Study to Evaluate the Safety and Tolerability, Pharmacokinetics, and Efficacy of BMS-986226 (anti-ICOS mAb) Alone or in Combination with Nivolumab or Ipilimumab in Patients with Advanced Solid Tumors

Estudio fase 1/2 de escalada de dosis y cohorte de combinación para evaluar la seguridad y tolerabilidad, farmacocinética y eficacia de BMS-986226 (anticuerpo monoclonal anti-ICOS) en monoterapia o en combinación con nivolumab o ipilimumab en pacientes con tumores sólidos avanzados

A.3.1

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

A.4.1

Sponsor's protocol code number

CA021-002

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

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.5.4	Telephone number	900 150 160
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	No
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	anti-ICOS mAb
D.3.2	Product code	BMS-986226
D.3.4	Pharmaceutical form	Solution for injection
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	anti-ICOS mAb
D.3.9.2	Current sponsor code	BMS-986226-01
D.3.9.3	Other descriptive name	BMS986226; Anti-ICOS, Anti-ICOS mAb
D.3.9.4	EV Substance Code	SUB185528
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	No
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
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
D.3.9.3	Other descriptive name	BMS936558, 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: 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	No
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	Ipilimumab
D.3.2	Product code	BMS-734016
D.3.4	Pharmaceutical form	Solution for injection
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	IPILIMUMAB
D.3.9.1	CAS number	477202-00-9
D.3.9.2	Current sponsor code	BMS-734016, BMS734016 , MDX010
D.3.9.3	Other descriptive name	BMS734016
D.3.9.4	EV Substance Code	SUB22577
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	5
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: 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.2.1.2	Country which granted the Marketing Authorisation	Spain
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	Tetanus vaccine
D.3.4	Pharmaceutical form	Suspension for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intramuscular use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	DIPHTHERIA, TETANUS, PERTUSSIS vaccine
D.3.9.2	Current sponsor code	Tdap
D.3.9.3	Other descriptive name	DIPHTHERIA, TETANUS, PERTUSSIS (ACELLULAR, COMPONENT) VACCINE (ADSORBED, REDUCED ANTIGEN(S) CONTENT)
D.3.9.4	EV Substance Code	SUB180576
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)	Yes
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.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

Advanced Solid Tumor

Tumores sólidos avanzados

E.1.1.1

Medical condition in easily understood language

Advanced Solid Tumor

Tumores sólidos avanzados

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	LLT
E.1.2	Classification code	10065252
E.1.2	Term	Solid tumor
E.1.2	System Organ Class	100000004864

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

To characterize the safety and tolerability of BMS-986226 administered alone and in combination with nivolumab or ipilimumab in participants with advanced solid tumors.

Caracterizar la seguridad y la tolerabilidad de BMS-986226 administrado en monoterapia y en combinación con nivolumab o ipilimumab en pacientes con tumores sólidos avanzados.

E.2.2

Secondary objectives of the trial

_To explore the preliminary efficacy of BMS-986226 administered alone and in combination with either nivolumab or ipilimumab in participants with advanced solid tumors;
_To characterize the PK of BMS-986226 when administered alone and in combination with nivolumab or ipilimumab in participants with advanced solid tumors;
_To characterize the immunogenicity of BMS-986226 when administered alone and in combination with nivolumab or ipilimumab in participants with advanced solid tumors;
_To monitor target engagement of BMS-986226 administered alone and in combination with either nivolumab or ipilimumab in participants with advanced solid tumors.

_Explorar la eficacia preliminar de BMS-986226 administrado en monoterapia y en combinación con nivolumab o ipilimumab en pacientes con tumores sólidos avanzados;
_Caracterizar la FC de BMS-986226 cuando se administra en monoterapia y en combinación con nivolumab o ipilimumab en pacientes con tumores sólidos avanzados;
_Caracterizar la inmunogenicidad de BMS-986226 cuando se administra en monoterapia y en combinación con nivolumab o ipilimumab en pacientes con tumores sólidos avanzados;
_Vigilar la conexión de BMS- 986226 con su diana, administrado en monoterapia y en combinación con nivolumab o ipilimumab en pacientes con tumores sólidos avanzados.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

_Advanced solid tumors;
_Histological or cytological confirmation of a malignancy that is advanced (metastatic and/or unresectable) with measureable disease as defined by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1;
_At least 1 lesion accessible for biopsy in addition to the target lesion;
_Participants must have received, and then progressed or been intolerant to, at least 1 standard treatment regimen;
_Eastern Cooperative Oncology Group (ECOG) performance status ≤2.

_Tumores sólidos avanzados;
_Confirmación histológica o citológica de una neoplasia maligna que sea avanzada (metastásica y/o irresecable) con enfermedad medible según se define en los Criterios de Evaluación de la Respuesta en Tumores Sólidos (RECIST) v1.1;
_ Al menos 1 lesión accesible para biopsia además de la lesión diana;
_Los pacientes deben haber recibido, y luego haber progresado o haber sido intolerantes a, al menos 1 régimen de tratamiento estándar;
_ Estado ECOG (Eastern Cooperative Oncology Group) ≤ 2.

E.4

Principal exclusion criteria

_Participants with active central nervous system (CNS) metastases, untreated CNS metastases, or with the CNS as the only site of disease are excluded (controlled brain metastases will be allowed to enroll);
_Participants with carcinomatous meningitis;
_Prior malignancy active within the previous 2 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in
situ of the prostate, cervix, or breast;
_Active, known, or suspected autoimmune disease;
_Uncontrolled or significant cardiovascular disease.

_ Participantes con metástasis activas del sistema nervioso central (SNC), metástasis del SNC no tratadas o con el SNC como el único sitio de la enfermedad (se permitirá la inclusión de metástasis cerebrales controladas);
_Participantes con meningitis carcinomatosa;
_ Malignidad previa activa dentro de los 2 años anteriores excepto cánceres localmente curables que aparentemente han sido curados, como cáncer de piel basal o de células escamosas, cáncer superficial de vejiga o carcinoma in situ de próstata, cuello uterino o mama;
_Enfermedad autoinmune activa, conocida o sospechada;
_Enfermedad cardiovascular no controlada o significativa.

E.5 End points

E.5.1

Primary end point(s)

_Incidence of adverse events (AE) [Time Frame: Approximately 2 years]
_Incidence of serious adverse events (SAE) [Time Frame: Approximately 2 years];
_Incidence of AE due to discontinuation [Time Frame: Approximately 2 years];
_Incidence of AE resulting in death [Time Frame: Approximately 2 years];
_Incidence of AEs meeting protocol defined dose-limiting toxicity (DLT) criteria [Time Frame: Approximately 2 years];
_Incidence of clinical laboratory test abnormalities graded according to common terminology criteria for adverse events (CTCAE) [Time Frame: Approximately 2 years].

_Incidencia de Acontecimientos Adversos (AA) [Periodo de tiempo: aproximadamente 2 años]
_Incidencia de Acontecimientos Adversos Graves (AAG) [Periodo de tiempo: aproximadamente 2 años]
_Incidencia de Acontecimientos Adversos que conduzcan a la suspensión [Periodo de tiempo: aproximadamente 2 años]
_Incidencia de Acontecimientos Adversos que conduzcan a la muerte [Periodo de tiempo: aproximadamente 2 años]
_Incidencia de Acontecimientos Adversos que cumplan los criterios de TLD (toxicidad limitante de la dosis) definidos en el protocolo [Periodo de tiempo: aproximadamente 2 años]
_Incidencia de anomalías en análisis de laboratorio clínico graduadas de acuerdo con los criterios de terminología frecuente para acontecimientos adversos (CTCAE) [Periodo de tiempo: aproximadamente 2 años]

E.5.1.1

Timepoint(s) of evaluation of this end point

Approximately 2 years

Aproximadamente 2 años

E.5.2

Secondary end point(s)

_Objective response rate (ORR) measure by Clopper-Pearson method [Time Frame: Approximately 2 years];
_Median Duration of Response (mDOR) measured by Kaplan-Meier method [Time Frame: Approximately 2 years];
_Progression Free Survival (PFS) measured by Kaplan-Meier method [Time Frame: At 24 weeks];
_Maximum observed plasma concentration (Cmax) [Time Frame: Approximately 2 years];
_Time of maximum observed plasma concentration (Tmax) [Time Frame: Approximately 2 years];
_Area under the concentration-time curve from time 0 to the time of the last [AUC (0-T)] [Time Frame: Approximately 2 years];
_Area under the concentration-time curve in 1 dosing interval [AUC(TAU)] [Time Frame: Approximately 2 years];
_Incidence of anti-drug antibodies to BMS-986226 assessed by immunoassay [Time Frame: Approximately 2 years];
_Change from baseline in immunoassay for BMS-986226 [Time Frame: Approximately 2 years].

_Tasa de respuesta objetiva (TRO) medida por el método de Clopper-Pearson [Periodo de tiempo: aproximadamente 2 años];
_ Mediana de la duración de la respuesta (mDdR) medida por el método de Kaplan-Meier [Periodo de tiempo: aproximadamente 2 años];
_Supervivencia libre de progresión (SLP) medida por el método de Kaplan-Meier [Periodo de tiempo: a las 24 semanas];
_ Concentración máxima observada en plasma (Cmax) [Periodo de tiempo: Aproximadamente 2 años];
_Tiempo de la concentración plasmática máxima observada (Tmax) [Periodo de tiempo: aproximadamente 2 años];
_Área bajo la curva de concentración-tiempo desde el tiempo 0 hasta el momento de la última [AUC (0-T)] [Periodo de tiempo: aproximadamente 2 años];
_Área bajo la curva de concentración-tiempo en 1 intervalo de dosificación [AUC (TAU)] [Periodo de tiempo: aproximadamente 2 años];
_Incidencia de anticuerpos anti-fármaco para BMS-986226 evaluados por inmunoensayo [Periodo de tiempo: aproximadamente 2 años];
_Cambio desde el inicio en inmunoensayo para BMS-986226 [Periodo de tiempo: aproximadamente 2 años];

E.5.2.1

Timepoint(s) of evaluation of this end point

Approximately 2 years for all except 24 weeks for PFS.

Aproximadamente 2 años excepto 24 meses para SLP.

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

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

Yes

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

Yes

E.6.13.1

Other scope of the trial description

Immunogenicity.

Inmunogenicidad.

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

Yes

E.7.1.1

First administration to humans

Yes

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

Yes

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

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

Canada

Spain

Switzerland

United States

E.8.7

Trial has a data monitoring committee

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

Última visita del último paciente

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

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

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)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

140

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

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

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

F.4.2.2

In the whole clinical trial

234

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 may be eligible to receive BMS-supplied study treatment. Study treatment will be provided via an extension of the study, a rollover study requiring approval by responsible health authority and EC, or through another mechanism at the discretion of BMS.

Al finalizar el estudio, los pacientes que continúen demostrando beneficio clínico serán elegibles para recibir el tratamiento de estudio suministrado por BMS. El tratamiento del estudio se proporcionará como una extensión del estudio, un estudio de seguimiento que requiera aprobación por las autoridades sanitarias y comités éticos o a través de cualquier otro mecanismo a decisión de BMS.

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2019-01-15

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2018-11-27

P. End of Trial
P.	End of Trial Status	Prematurely Ended
P.	Date of the global end of the trial	2021-12-20

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