Clinical Trials Register

Summary
EudraCT Number:	2018-000416-21
Sponsor's Protocol Code Number:	CA030-001
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Restarted
Date on which this record was first entered in the EudraCT database:	2018-08-10
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

Spain - AEMPS

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

Primer estudio en seres humanos, fase 1/2 de BMS-986249 en monoterapia y en combinación con nivolumab en tumores sólidos avanzados

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

Primer estudio en seres humanos, fase 1/2 de BMS-986249 en monoterapia y en combinación con nivolumab en tumores sólidos avanzados

A.4.1

Sponsor's protocol code number

CA030-001

A.5.3

WHO Universal Trial Reference Number (UTRN)

U1111-1208-7059

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	a-CTLA-4 Probody mAb
D.3.2	Product code	BMS-986249-01
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-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	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.3.9.3	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.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

Tumores sólidos avanzados

E.1.1.1

Medical condition in easily understood language

Advanced Solid Tumors

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, 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).

- Caracterizar la seguridad, la tolerabilidad y la TLD y determinar la DMT/DRF2 de BMS-986249 administrado en monoterapia y en combinación con nivolumab en pacientes con tumores sólidos avanzados (Partes 1A y 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).

- Caracterizar la FC de BMS-986249 cuando se administra en monoterapia y en combinación con nivolumab;
- Evaluar la eficacia preliminar de BMS-986249 en monoterapia y en combinación con nivolumab en tumores sólidos avanzados (Partes 1A y 1B) usando los RECIST v1.1 o los criterios del PCWG3 (para el cáncer de próstata)

E.2.3

Trial contains a sub-study

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.

_Participantes con al menos 18 años de edad;
_Tener confirmación citológico o histológica de un tumor sólido avanzado (metastásico, recurrente y/o irresecable) con enfermedad medible;
_Tener al menos una lesión accesible para biopsia;
_Estatus Eastern Cooperative Oncology Group Performance de 0 or 1;
_Los participantes deben haber recibido, y haber progresado, recurrido, o ser intolerantes al menos a 1 régimen de tratamiento estándar en la fase avanzada o metastásica, de acuerdo con los histologías de tumores sólidos.

E.4

Principal exclusion criteria

_Participants with primary CNS malignancies or tumors with CNS metastases as the only site of disease;
_Participants with other active malignancy requiring concurrent intervention;

_Participantes con malignidades primarios del SNC o tumores con metástasis en el SNC como único sitio de enfermedad;
_Participantes con otras malignidades activas que requieran intervención simultánea;

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

- Incidencia de AA, AAG, AA que cumplan los criterios de TLD definidos por el protocolo, AA que conduzcan a suspensión, muerte y anomalías de laboratorio

E.5.1.1

Timepoint(s) of evaluation of this end point

Up to 4 years

- Hasta 4 años

E.5.2

Secondary end point(s)

_Summary measures of PK parameters of BMS-986249 up to 2 years;
_BOR, DOR, PFS, and TTR per RECIST v1.1 or PCWG3 (for prostate cancer) up to 4 years

- Medidas resumen de los parámetros FC de BMS-986249 hasta 2 años;
- MRG, DdR, SLP y THR según los RECIST v1.1 o los criterios PCWG3 (en el cáncer de próstata) hasta 4 años

E.5.2.1

Timepoint(s) of evaluation of this end point

Up to 2 years or up to 4 years

Hasta 2 años o hasta 4 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

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

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

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

Australia

Canada

Italy

Netherlands

Spain

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

Último visita del último sujeto

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:

225

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

140

F.4.2.2

In the whole clinical trial

300

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 BMS-supplied study treatment under conditions, see protocol section 7.9.

Al finalizar el estudio,los participantes que continúen demostrando beneficio clínico serán elegibles para recibir el tto de estudio proporcionado por BMS.El tratamiento de estudio será proporcionado a través de una extensión del estudio,un estudio "rollover" autorizado por la autoridad sanitaria y comité ético correspondientes,u otro mecanismo a discreción de BMS.BMS se reserva el derecho de finalizar el suministro al tto de estudio en determinadas condiciones (sección 7.9 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

2019-01-31

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2019-01-21

P. End of Trial
P.	End of Trial Status	Restarted

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