Clinical Trials Register

Summary
EudraCT Number:	2018-000416-21
Sponsor's Protocol Code Number:	CA030-001
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:	2021-06-17
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

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A. Protocol Information

A.1

Member State Concerned

Italy - Italian Medicines Agency

A.2

EudraCT number

2018-000416-21

A.3

Full title of the trial

A Phase 1/2 First-in-Human Study of BMS-986249 Alone and in Combination with Nivolumab in Advanced Solid Tumors

Studio di fase 1/2 di BMS-986249, somministrato per la prima volta nell’uomo, da solo e in combinazione con Nivolumab in tumori solidi in stadio avanzato

A.3.1

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

A Phase 1/2 First-in-Human Study of BMS-986249 Alone and in
Combination with Nivolumab in Advanced Solid Tumors

Studio di fase 1/2 di BMS-986249, somministrato per la prima volta nell’uomo, da solo e in combinazione con Nivolumab in tumori solidi in stadio avanzato

A.3.2

Name or abbreviated title of the trial where available

ooo

A.4.1

Sponsor's protocol code number

CA030-001

A.5.1

ISRCTN (International Standard Randomised Controlled Trial) Number

ISRCTN00000000

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT00000000

A.5.3

WHO Universal Trial Reference Number (UTRN)

U1111-1208-7059

A.5.4

Other Identifiers

Name:

ooo

Number:

ooo

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	000000000000
B.5.5	Fax number	000000000000000000
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	a-CTLA-4 Probody mAb
D.3.2	Product code	[BMS-986249-01]
D.3.4	Pharmaceutical form	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	Anti-CTLA-4 Probody mAb
D.3.9.2	Current sponsor code	BMS-986249, BMS-986249-01
D.3.9.3	Other descriptive name	BMS986249
D.3.9.4	EV Substance Code	SUB192929
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	40
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	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
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 - CLINICAL, no commercial
D.3.2	Product code	[BMS-936558]
D.3.4	Pharmaceutical form	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	ooo
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	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
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	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	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	na
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	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
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.2.1.1.1	Trade name	Yervoy
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	Ipilimumab
D.3.2	Product code	[BMS-734016]
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	ipilimumab
D.3.9.1	CAS number	477202-00-9
D.3.9.2	Current sponsor code	BMS-734016
D.3.9.3	Other descriptive name	BMS734016 / MDX010
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	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
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

Advanced Solid Tumors

Tumori solidi in stadio avanzato

E.1.1.1

Medical condition in easily understood language

Advanced Solid Tumors

Tumori solidi in stadio avanzato

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	21.1
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, tolerability, and DLTs and to determine the
MTD/RP2D of BMS-986249 administered as monotherapy and in
combination with nivolumab in participants with advanced solid tumors
(Parts 1A and 1B).

Caratterizzare la sicurezza, la tollerabilità e le DLT e determinare le MTD/RP2D di BMS-986249 somministrato in monoterapia e in combinazione con nivolumab in partecipanti affetti da tumori solidi in stadio avanzato (parti 1A e 1B).

E.2.2

Secondary objectives of the trial

To characterize the PK of BMS-986249 when administered alone and in
combination with nivolumab;
_To assess the preliminary efficacy of BMS-986249 alone and in
combination with nivolumab in advanced solid tumors (Parts 1A and 1B)
using RECIST v1.1 or PCWG3 (for prostate cancer).

Caratterizzare la farmacocinetica di BMS-986249 quando somministrato da solo e in combinazione con nivolumab; valutare l’efficacia preliminare di BMS-986249 da solo e in combinazione con nivolumab in tumori solidi in stadio avanzato (parti 1A e 1B) utilizzando i criteri RECIST v1.1 oppure PCWG3 (per il cancro della prostata).

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

Pharmacogenetics
Version: rev03
Date: 25/05/2018
Title: Phase 1/2 First-in-Human Study of BMS-986249 Alone and in Combination with Nivolumab in Advanced Solid Tumors – section 9.8.4 of protocol
Objectives: Sample retention for additional research is mandatory for all participants, except where prohibited by local laws or regulations. All residual blood PK/ADA, biomarker and tumor biopsy samples will be stored for additional research.

Pharmacogenomics
Version: rev03
Date: 25/05/2018
Title: Phase 1/2 First-in-Human Study of BMS-986249 Alone and in Combination with Nivolumab in Advanced Solid Tumors – section 9.8.4 of protocol
Objectives: Sample retention for additional research is mandatory for all participants, except where prohibited by local laws or regulations. All residual blood PK/ADA, biomarker and tumor biopsy samples will be stored for additional research.

Farmacogenetica
Versione: rev03
Data: 25/05/2018
Titolo: Studio di fase 1/2 di BMS-986249, somministrato per la prima volta nell’uomo, da solo e in combinazione con Nivolumab in tumori solidi in stadio avanzato – sezione 9.8.4 del protocollo
Obiettivi: La ricerca addizionale è obbligatoria per tutti i partecipanti, ad eccezione dove proibito dalle leggi e normative locali.
Questo protocollo prevede lo stoccaggio del campione residuo per ulteriori ricerche. I campioni in oggetto sono campioni di sangue per PK/ADA, biomarcatori e tessuto tumorale.

Farmacogenomica
Versione: rev03
Data: 25/05/2018
Titolo: Studio di fase 1/2 di BMS-986249, somministrato per la prima volta nell’uomo, da solo e in combinazione con Nivolumab in tumori solidi in stadio avanzato – sezione 9.8.4 del protocollo
Obiettivi: La ricerca addizionale è obbligatoria per tutti i partecipanti, ad eccezione dove proibito dalle leggi e normative locali.
Questo protocollo prevede lo stoccaggio del campione residuo per ulteriori ricerche. I campioni in oggetto sono campioni di sangue per PK/ADA, biomarcatori e tessuto tumorale.

E.3

Principal inclusion criteria

_Participants must be at least 18 years old;
_have histologic or cytologic confirmation of a solid tumor that is
advanced (metastatic, recurrent, and/or unresectable) with measurable
disease
_Have at least 1 lesion accessible for biopsy;
_Eastern Cooperative Oncology Group Performance Status of 0 or 1;
_Participants must have received, and then progressed, relapsed, or
been intolerant to, at least 1 standard treatment regimen in the
advanced or metastatic setting according to solid tumor histologies.

• I partecipanti devono avere almeno 18 anni;
• avere conferma istologica o citologica di tumore solido in stadio avanzato (metastatico, recidivo e/o inoperabile) con malattia misurabile
• avere almeno una lesione accessibile per la biopsia
• ECOG status pari a 0 oppure 1
• I partecipanti devono aver ricevuto, e dopo aver progredito, aver avuto una recidiva o essere risultati intolleranti, almeno un trattamento standard nel setting avanzato o metastatico in accordo alle istologie del tumore solido.

E.4

Principal exclusion criteria

-Participants with primary CNS malignancies, tumors with CNS
metastases as the only site of disease, active brain metastases, or
leptomeningeal metastasis will be excluded;
-Active, known, or suspected autoimmune disease;
-Participants with other active malignancy requiring concurrent
intervention.
-Prior organ allograft.
Other protocol defined exclusion criteria could apply.

o Saranno esclusi partecipanti con tumori primari del SNC, con tumori con metastasi al SNC come unico sito di malattia, con metastasi cerebrali attive o con metastasi leptomeningee;
o Malattia autoimmune attiva, nota o sospetta;
o Partecipanti con altre neoplasie attive che richiedono interventi concomitanti.
o Precedente allotrapianto di organo.
Potrebbero essere applicati altri criteri di esclusione definiti dal protocollo.

E.5 End points

E.5.1

Primary end point(s)

_Incidence of AEs, SAEs, AEs meeting protocol-defined DLT criteria, _AEs
leading to discontinuation, death, and laboratory abnormalities

Incidenza di AE, SAE, AE che corrispondono ai criteri definiti dal protocollo di DLT, AE che portano all’interruzione del trattamento, decesso, e anomalie di laboratorio

E.5.1.1

Timepoint(s) of evaluation of this end point

Up to 4 years

fino a 4 anni

E.5.2

Secondary end point(s)

_Summary measures of PK parameters of BMS-986249;
_Summary measures of PK parameters of BMS-986249 in combination
with nivolumab;
_OOR, DOR, PFS, and TTR per RECIST v1.1 or PCWG3 (for prostate
cancer);
_Incidence of AEs, SAEs, death, laboratory abnormalities, AEs leading to
discontinuation;
_TTD.

o Riassunto delle misure dei parametri PK di BMS-986249;
o Riassunto delle misure dei parametri PK di BMS-986249 in combinazione con nivolumab;
o OOR, DOR, PFS e TTR per RECIST v1.1 o PCWG3 (per cancro alla prostata);
o Incidenza di eventi avversi, eventi avversi gravi, decesso, anomalie di laboratorio, eventi avversi che portano alla sospensione del trattamento;
o TTD.

E.5.2.1

Timepoint(s) of evaluation of this end point

Up to 4 years

Fino a 4 anni

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

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

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

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

Yes

E.8.4

The trial involves multiple sites in the Member State concerned

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

Information not present in EudraCT

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

Australia

Canada

United States

Germany

Italy

Netherlands

Spain

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

Ultima visita dell’ultimo soggetto

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:

338

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

112

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

140

F.4.2.2

In the whole clinical trial

450

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. BMS reserves the right to terminate access to BMSsupplied
study treatment under conditions, see protocol section 7.9.

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

2018-10-04

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2018-09-26

P. End of Trial
P.	End of Trial Status	Ongoing

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