Clinical Trials Register

Summary
EudraCT Number:	2018-001070-20
Sponsor's Protocol Code Number:	CA224-061
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:	2018-10-25
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

2018-001070-20

A.3

Full title of the trial

A Randomized, Active-Controlled, Open-Label, Phase 2 Clinical Trial of BMS-986213, in Combination with Various Standard-of-Care Therapeutic Regimens, in Participants with Recurrent, Locally Advanced, or Metastatic Gastric Cancer (GC) or Gastroesophageal Junction (GEJ) Adenocarcinoma

Ensayo clínico fase 2 aleatorizado, con control activo, abierto, de BMS-986213, en combinación con diversos regímenes terapéuticos de referencia, en pacientes con cáncer gástrico (CG) o adenocarcinoma de la unión gastroesofágica (UGE) recidivante, localmente avanzado o metastásico

A.3.1

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

An Investigational Immuno-therapy Study to Compare Relatlimab in Combination with Nivolumab with Various Standard-of-Care Therapies in Patients with Gastric Cancer or Gastroesophageal Junction Adenocarcinoma

Estudio experimental de inmunoterapia para comparar relatlimab en combinación con nivolumab con diversos tratamientos de referencia en pacientes con cáncer gástrico o adenocarcinoma de la unión gastroesofágica

A.4.1

Sponsor's protocol code number

CA224-061

A.5.3

WHO Universal Trial Reference Number (UTRN)

U1111-1210-6859

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	Head of the 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	900150160
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	Relatlimab/ Nivolumab 1:3 Fixed Dose Combination
D.3.2	Product code	BMS-986213
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
D.3.9.3	Other descriptive name	MDX-1106, 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	12
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	RELATLIMAB
D.3.9.2	Current sponsor code	BMS-986016
D.3.9.3	Other descriptive name	anti-LAG-3
D.3.9.4	EV Substance Code	SUB168199
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	4
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	Opdivo (100 mg/10 ml)
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 - 10ml vial- COMMERCIAL
D.3.2	Product code	BMS-936558
D.3.4	Pharmaceutical form	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	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	MDX-1106, 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	Comparator
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	Cyramza 10 mg/ml concentrate for solution for infusion
D.2.1.1.2	Name of the Marketing Authorisation holder	Eli Lilly Nederland B.V.
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	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	Ramucirumab
D.3.9.1	CAS number	947687-13-0
D.3.9.3	Other descriptive name	RAMUCIRUMAB
D.3.9.4	EV Substance Code	SUB32795
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: 4
D.1.2 and D.1.3	IMP Role	Comparator
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	Paclitaxel Aurobindo 6 mg/ml, concentrate for solution for infusion
D.2.1.1.2	Name of the Marketing Authorisation holder	PUREN Pharma GmbH & Co. KG
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	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	PACLITAXEL
D.3.9.1	CAS number	33069-62-4
D.3.9.4	EV Substance Code	SUB09583MIG
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	6
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: 5
D.1.2 and D.1.3	IMP Role	Comparator
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	Paclitaxel-GRY® 6 mg/ml concentrate for solution for infusion
D.2.1.1.2	Name of the Marketing Authorisation holder	TEVA GmbH
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	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	PACLITAXEL
D.3.9.1	CAS number	33069-62-4
D.3.9.4	EV Substance Code	SUB09583MIG
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	6
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.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

Recurrent, Locally Advanced, or Metastatic Gastric Cancer (GC) or Gastroesophageal Junction (GEJ) Adenocarcinoma

Cáncer gástrico (CG) o adenocarcinoma de la unión gastroesofágica (UGE) recidivante, localmente avanzado o metastásico

E.1.1.1

Medical condition in easily understood language

Recurrent, Locally Advanced, or Metastatic Gastric Cancer (GC) or Gastroesophageal Junction (GEJ) Adenocarcinoma

Cáncer gástrico (CG) o adenocarcinoma de la unión gastroesofágica (UGE) recidivante, localmente avanzado o metastásico

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	20.1
E.1.2	Level	PT
E.1.2	Classification code	10017758
E.1.2	Term	Gastric cancer
E.1.2	System Organ Class	10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

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	10056267
E.1.2	Term	Gastroesophageal cancer
E.1.2	System Organ Class	10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Cohort A1:
to compare objective response rate (ORR) of BMS-986213 with paclitaxel versus ramucirumab with paclitaxel in participants with recurrent gastric cancer (GC) or gastroesophageal junction (GEJ) adenocarcinoma who are positive for LAG-3expression.
Cohort A2:
To compare ORR of BMS-986213 with paclitaxel versus nivolumab with paclitaxel versus ramucirumab with paclitaxel in participants with recurrent GC/GEJ who are positive for LAG-3 expression
Cohort B:
To compare ORR of BMS-986213 with nivolumab in participants with recurrent GC/GEJ who are positive for LAG-3 expression and naive to anti- PD-1/PD-L1 therapy
Cohort C:
To assess the ORR of BMS-986213 in participants with recurrent GC/GEJ who are positive for LAG-3 expression and are experienced with anti-PD-1/PD-L1 therapy

Cohorte A1:
Comparar la tasa de respuestas objetivas (TRO) de BMS-986213 con paclitaxel frente a ramucirumab con paclitaxel en pacientes con cáncer gástrico (CG) o adenocarcinoma de la unión gastroesofágica (UGE), recidivante, que sean positivos para expresión de LAG-3.
Cohorte A2:
Comparar la TRO de BMS-986213 con paclitaxel frente a nivolumab con paclitaxel frente a ramucirumab con paclitaxel en pacientes con CG/de la UGE, recidivante, que sean positivos para expresión de LAG-3.
Cohorte B:
Comparar la TRO de BMS-986213 frente a nivolumab en pacientes con CG/de la UGE, recidivante, que sean positivos para expresión de LAG-3 y no hayan recibido nunca tratamiento anti-PD-1/PD-L1.
Cohorte C:
Evaluar la TRO de BMS-986213 en pacientes con CG/de la UGE, recidivante, que sean positivos, para expresión de LAG-3 y tienen experiencia con tratamiento anti-PD-1/PD-L1.

E.2.2

Secondary objectives of the trial

* To assess the overall safety and tolerability of:
(i) BMS-986213 with paclitaxel, nivolumab with paclitaxel, and ramucirumab with paclitaxel in participants with recurrent GC/GEJ who are positive for LAG-3 expression (Cohorts A1 & A2);
(ii) BMS-986213 with nivolumab in participants with recurrent GC/GEJ who are positive for LAG-3 expression and naive to anti-PD-1/PD-L1 therapy (Cohort B);
(iii) BMS-986213 in participants with recurrent GC/GEJ who are positive for LAG-3 expression and are experienced with anti-PD-1/PDL1 therapy (Cohort C);
* To compare ORR of BMS-986213 with paclitaxel versus nivolumab with paclitaxel and ramucirumab with paclitaxel in participants with recurrent GC/GEJ who are positive for LAG-3 expression (cohort A1);
* To assess DOR, PFS, and OS of BMS-986213 with paclitaxel, nivolumab with paclitaxel, and ramucirumab with paclitaxel in participants with recurrent GC/GEJ who are positive for LAG-3 expression (Cohorts A1 & A2)

* Evaluar seguridad global y tolerabilidad de:
(i) BMS-986213 con paclitaxel, nivolumab con paclitaxel, y ramucirumab con paclitaxel en pacientes con CG/de UGE, recidivante, positivos para expresión de LAG-3 (Cohortes A1&A2)
(ii) BMS-986213 frente a nivolumab en pacientes con CG/de UGE, recidivante, positivos para expresión de LAG-3 y que no hayan recibido tratamiento anti-PD-1/PD-L1 (Cohorte B)
(iii) BMS-986213 en pacientes con CG/de UGE, recidivante, positivos para expresión de LAG-3 y que tengan experiencia con tratamiento anti-PD-1/PD-L1 (Cohorte C)
* comparar la TRO de BMS-986213 con paclitaxel frente a nivolumab con paclitaxel, y ramucirumab con paclitaxel en pacientes con CG/de UGE, recidivante, que sean positivos para expresión de LAG-3 (cohorte A1)
* evaluar la duración de la DdR, SLP y SG de BMS-986213 con paclitaxel, nivolumab con paclitaxel, y ramucirumab con paclitaxel en pacientes con CG/de UGE, recidivante, que sean positivos para expresión de LAG-3 (Cohortes A1&A2)

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

See Protocol Section 9.8.5, Additional Research Collection

Ver Sección 9.8.5. del protocolo, Recogida de muestras para investigación adicional

E.3

Principal inclusion criteria

- Histologically or cytologically confirmed locally advanced or recurrent or metastatic GC or GEJ adenocarcinoma that is considered incurable by local therapies such as radiation or surgery
- Evidence of progressive disease (PD) on at least one prior platinum and fluoropyrimidine-containing chemotherapy regimen
- Available tumor tissue for biomarker analysis

- CG o adenocarcinoma de la UGE confirmado histológicamente o citológicamente, localmente avanzado o recidivante o metastásico, que se considere incurable mediante tratamientos locales como radioterapia o cirugía.
- Evidencia de progresión de la enfermedad con al menos un régimen de quimioterapia que contuviera platino y fluoropirimidina.
- Disponibilidad de tejido tumoral para análisis de biomarcadores

E.4

Principal exclusion criteria

- Squamous cell or undifferentiated GC or GEJ
- Untreated known central nervous system (CNS) metastases
- Prior treatment with relatlimab or any other LAG-3 targeted agents

- CG o de la UGE de células escamosas o indiferenciado.
- metástasis conocidas y no tratadas en el sistema nervioso central (SNC)
- tratamiento previo con relatlimab u otros agentes dirigidos a LAG-3

E.5 End points

E.5.1

Primary end point(s)

Objective response rate (ORR)

Tasa de respuesta objetiva (TRO)

E.5.1.1

Timepoint(s) of evaluation of this end point

Approximately 31 months

Aproximadamente 31 meses

E.5.2

Secondary end point(s)

a/ Incidence of participants with nonserious Adverse Events (AEs) and Serious Adverse Events (SAEs) leading to discontinuation
b/ Incidence of deaths
c/ Incidence of laboratory abnormalities
d/ ORR (Cohort A1)
e/ Duration of response (DOR)
f/ Progression free survival (PFS)
g/ Overall survival (OS)

a) Incidencia de acontecimientos adversos (AA), AA graves (AAG), AA que conducen a discontinuación
b) Incidencia de muertes
c) Incidencia de anomalías de laboratorio en cada brazo
d) TRO (Cohorte A1)
e) Duración de la respuesta (DdR)
f) Supervivencia libre de progresión (SLP)
g) Supervivencia Global (SG)

E.5.2.1

Timepoint(s) of evaluation of this end point

a/ Approximatively 5 years
b/ Approximatively 5 years
c/ Approximatively 5 years
d/ Approximatively 5 years
e/ Approximatively 5 years
f/ Approximatively 5 years
g/ Approximatively 5 years

a) aproximadamente 5 años
b) aproximadamente 5 años
c) aproximadamente 5 años
d) aproximadamente 5 años
e) aproximadamente 5 años
f) aproximadamente 5 años
g) aproximadamente 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

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

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

Yes

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)

Yes

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

Yes

E.8.5.1

Number of sites anticipated in the EEA

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

Argentina

Australia

Brazil

Canada

Chile

Colombia

Czech Republic

France

Germany

Ireland

Israel

Italy

Mexico

Poland

Portugal

Romania

Spain

United Kingdom

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

LPLV

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 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:

1526

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

654

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

730

F.4.2.2

In the whole clinical trial

2180

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. 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. Please refer to Section 7.7.5 of the Protocol for more details.

Tras la finalización del estudio, los participantes que continúen mostrando beneficio clínico serán elegibles para recibir por parte de BMS el tratamiento en estudio. El
tratamiento en estudio será suministrado a través de una extensión del estudio, un estudio rollover que requerirá de una aprobación de la Autoridad Sanitaria
competente y de un Comité Ético o a través de cualquier otro mecanismo a discreción de BMS. Para más detalles refiérase a sección 7.7.5 del protocolo.

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

2018-12-07

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2018-10-30

P. End of Trial
P.	End of Trial Status	Prematurely Ended
P.	Date of the global end of the trial	2019-05-16

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Orphan Designation Number:
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