Clinical Trials Register

Summary
EudraCT Number:	2021-003990-74
Sponsor's Protocol Code Number:	CA022-009
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2022-07-11
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

Expand All Collapse All

A. Protocol Information

A.1

Member State Concerned

Spain - AEMPS

A.2

EudraCT number

2021-003990-74

A.3

Full title of the trial

A Phase 2, Open-label, Randomized Controlled Trial of BMS-986218 or BMS-986218 Plus Nivolumab in Combination with Docetaxel in Participants with Metastatic Castration-resistant Prostate Cancer

Ensayo en fase II, abierto, aleatorizado y controlado de BMS-986218 o BMS-986218 más nivolumab en combinación con docetaxel en participantes con cáncer de próstata metastásico resistente a la castración

A.3.1

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

A Phase 2 Trial of BMS-986218 or BMS-986218/Nivolumab in Combination with Docetaxel in Metastatic Castration-resistant Prostate Cancer

Ensayo en fase II de BMS-986218 o BMS-986218/nivolumab en combinación con docetaxel en cáncer de próstata metastásico resistente a la castración

A.4.1

Sponsor's protocol code number

CA022-009

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	GSM-CT
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-CTLA4-NF mAb
D.3.2	Product code	BMS-986218
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	BMS-986218
D.3.9.3	Other descriptive name	BMS986218, BMS-986218-01
D.3.9.4	EV Substance Code	SUB189021
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	20
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	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	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

Metastatic Castration-resistant Prostate Cancer

Cáncer de próstata metastásico resistente a la castración

E.1.1.1

Medical condition in easily understood language

Cancer that has spread (metastasized) beyond the prostate gland and for which hormone therapy is no longer effective in stopping or slowing the disease.

Cáncer que se ha diseminado (metastatizado) más allá de la próstata y para el que la terapia hormonal ya no es eficaz para detener o ralentizar la enfermedad.

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	PT
E.1.2	Classification code	10036909
E.1.2	Term	Prostate cancer metastatic
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

1. To assess the safety, tolerability, and DLTs of docetaxel in combination with BMS-986218 or in combination with BMS-986218 plus nivolumab in participants with mCRPC (Part 1).
2. To compare the rPFS in mCRPC participants treated with docetaxel and either docetaxel in combination with BMS-986218 or docetaxel in combination with BMS-986218 and nivolumab (Part 2).

1. Evaluar la seguridad, la tolerabilidad y las TLD de docetaxel en combinación con BMS-986218 o en combinación con BMS-986218 más nivolumab en participantes con CPmRC (parte 1).
2. Comparar la SSPr en participantes con CPmRC tratados con docetaxel y docetaxel en combinación con BMS-986218 o docetaxel en combinación con BMS-986218 y nivolumab (parte 2).

E.2.2

Secondary objectives of the trial

1. To assess the antitumor activity of the combination of docetaxel with BMS-986218 or BMS-986218 and nivolumab in mCRPC participants, based on ORR, TTR, and DOR (Part 2).
2. To assess PSA response rate (PSA-RR) and time to PSA progression (TTP-PSA; limited to participants with measurable PSA [defined as ≥ 2 ng/ml] at baseline) (Part 2).
3. To assess overall survival (OS) (Part 2).
4. To characterize safety of BMS-986218 in combination with docetaxel, and with nivolumab and docetaxel in Part 2.

1. Evaluar la actividad antitumoral de la combinación de docetaxel con BMS-986218 o BMS-986218 y nivolumab en participantes con CPmRC, en función de la TRO, el tiempo en margen terapéutico (TMT) y la DR (parte 2).
2. Evaluar la tasa de respuesta del PSA (TR-PSA) y el tiempo hasta la progresión del PSA (THPPSA; limitado a participantes con PSA medible [definido como ≥ 2 ng/ml] al inicio) (Parte 2).
3. Evaluar la supervivencia global (SG) (parte 2).
4. Caracterizar la seguridad de BMS-986218 en combinación con docetaxel, y con nivolumab y docetaxel en la parte 2.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

• Histologic confirmation of carcinoma of the prostate without small cell features.
• Documented prostate cancer progression by Prostate Cancer Working Group 3 (PCWG3) criteria while castrate.
• Evidence of metastatic disease documented by either bone lesions on radionuclide bone scan and/or soft tissue lesions on computed tomography (CT)/magnetic resonance imaging (MRI).
• Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1.
• Ongoing androgen deprivation therapy (ADT) with a gonadotropin-releasing hormone (GnRH) agonist/antagonist or bilateral orchiectomy (i.e., surgical or medical castration) confirmed by testosterone level ≤ 1.73 nmol/L (50 ng/dL) at the screening visit.
• Chemotherapy-naive for metastatic castration-resistant prostate cancer (mCRPC) and have received at least one novel antiandrogen therapy (NAT).

Other protocol-defined inclusion criteria apply.

• Confirmación histológica del carcinoma de próstata sin características microcíticas.
• Progresión documentada del cáncer de próstata según los criterios del Grupo de Trabajo sobre el Cáncer de Próstata 3 (PCWG3).
• Indicios actuales de enfermedad metastásica documentada por lesiones óseas en la gammagrafía ósea y/o lesiones de partes blandas en tomografía axial computarizada (TAC)/resonancia magnética (RM).
• Estado funcional según el Grupo Oncológico Cooperativo del Este (ECOG) de 0 a 1.
• Terapia de privación de andrógenos (ADT) en curso con un agonista/antagonista de la hormona liberadora de gonadotropina (GnRH) o una orquiectomía bilateral (es decir, castración quirúrgica o médica) confirmada por un nivel de testosterona ≤1,73 nmol/l (50 ng/dl) en la visita de selección.
• Los participantes sin tratamiento previo con quimioterapia para el CPmRC y que han recibido al menos un tratamiento hormonal de segunda generación (NTA).

Se aplican otros criterios de exclusión definidos en el protocolo.

E.4

Principal exclusion criteria

• Concurrent malignancy (present during screening) requiring treatment or history of prior malignancy active within 2 years prior to treatment assignment in Part 1 or randomization in Part 2.
• Untreated central nervous system (CNS) metastases.
• Leptomeningeal metastases.
• Active, known or suspected autoimmune disease.

Other protocol-defined exclusion criteria apply.

• Neoplasia maligna simultánea (presente durante la selección) que requiera tratamiento o antecedentes de neoplasia maligna previa activa en los 2 años anteriores a la asignación del tratamiento en la parte 1 o la aleatorización en la parte 2.
• Metástasis en el sistema nervioso central (SNC) sin tratar.
• Metástasis leptomeníngea.
• Presencia o sospecha de enfermedad autoinmunitaria activa.

Se aplican otros criterios de exclusión definidos en el protocolo.

E.5 End points

E.5.1

Primary end point(s)

1. Incidence of AEs, SAEs, AEs meeting protocol-defined DLT criteria, TRAEs, AEs leading to discontinuation, and deaths.
2. rPFS for randomized participants is the time between randomization date and the first date of documented radiographic progression, or death due to any cause, whichever occurs first. The radiographic progression will be assessed by blinded independent central review (BICR) per PCWG3.

1. Incidencia de AA, AAG, AA que cumplen los criterios de TLD definidos en el protocolo, AART, AA que provocan la interrupción del tratamiento y muertes.
2. La SSPr para los participantes aleatorizados es el tiempo transcurrido entre la fecha de aleatorización y la primera fecha de progresión radiográfica documentada o la muerte por cualquier causa, lo que ocurra primero. La progresión radiográfica se evaluará mediante revisión central independiente ciega (RCIC) según el PCWG3.

E.5.1.1

Timepoint(s) of evaluation of this end point

1. Any time in Part 1.
2. First date of documented radiographic progression, or death due to any cause, whichever occurs first.

1. En cualquier momento en la parte 1.
2. Primera fecha de progresión radiográfica documentada o muerte por cualquier causa, lo que ocurra primero.

E.5.2

Secondary end point(s)

1. a) Objective response rate per PCWG3 (ORR-PCWG3) is the proportion of participants who have a confirmed complete or partial best overall response (BOR) per PCWG3 among randomized participants who have measurable disease at baseline. The BOR is defined as the best response designation, as determined by the BICR, recorded between the date of randomization and the date of objectively documented radiographic progression, or last tumor measurement, whichever occurs first.
b) Time to response per PCWG3 (TTR-PCWG3) is the time from randomization date to the date of the first documented CR or PR per PCWG3, as determined by BICR.
c) Duration of response per PCWG3 (DOR-PCWG3) is the time between the date of first response (CR/PR per PCWG3) to the date of first documented radiographic progression per PCWG.

2. a) PSA-RR is the proportion of randomized participants with a 50% or greater decrease in PSA from baseline to any post-baseline PSA result. A second consecutive value obtained 3 or more weeks later is required to confirm the PSA response.
b) TTP-PSA is the time between randomization date to the date of PSA progression per PCWG3 in randomized participants.

3. OS for all randomized participants is the time between randomization date and the date of death from any cause.

4. Overall safety and tolerability will be measured by the incidence of AEs, TRAEs, SAEs, AEs leading to discontinuation, and deaths.

1. a) La tasa de respuesta objetiva según el PCWG3 (TROPCWG3) es la proporción de participantes que tienen una mejor respuesta global (MRG) completa o parcial confirmada según el PCWG3 entre los participantes aleatorizados que presentan enfermedad medible al inicio. La MRG se define como la mejor designación de respuesta, determinada mediante la RCIC, registrada entre la fecha de aleatorización y la fecha de progresión
radiográfica documentada objetivamente, o la última medición del tumor, lo que ocurra primero.
b) El tiempo en margen terapéutico según el PCWG3 (TMT-PCWG3) es el tiempo transcurrido desde la fecha de la aleatorización hasta la fecha de la primera RC o RP documentada según el PCWG3, según lo determinado por la RCIC.
c) La duración de la respuesta según el PCWG3 (DRPCWG3) es el tiempo transcurrido entre la fecha de la primera respuesta (RC/RP según el PCWG3) y la fecha de la primera progresión radiográfica documentada según el PCWG3.

2. a) La TR-PSA es la proporción de participantes aleatorizados con una reducción del PSA del 50 % o superior desde el inicio hasta cualquier resultado del PSA posterior al inicio. Se requiere un segundo valor consecutivo obtenido 3 o más semanas después para confirmar la respuesta del PSA.
b) El THP-PSA es el tiempo transcurrido entre la fecha de aleatorización y la fecha de progresión del PSA según el PCWG3 en los participantes aleatorizados.

3. La SG de todos los participantes aleatorizados es el tiempo transcurrido entre la fecha de aleatorización y la fecha de la muerte por cualquier causa.

4. La seguridad global y la tolerabilidad se medirán por la incidencia de AA, AART, AAG, AA que provocan la interrupción y muertes.

E.5.2.1

Timepoint(s) of evaluation of this end point

1. a) Date of objectively documented radiographic progression, or last tumor measurement, whichever occurs first.
b) Date of the first documented CR or PR per PCWG3.
c) Date of first documented radiographic progression per PCWG3 (as determined by BICR), or death due to any cause.

2. a) Date when 50% or greater decrease in PSA occurs compared to baseline.
b) Date of PSA progression per PCWG3.

3. End of study.

4. End of study.

1. a) Fecha de progresión radiográfica documentada objetivamente o última medición del tumor, lo que ocurra primero.
b) Fecha de la primera RC o RP documentada según el PCWG3.
c) Fecha de la primera progresión radiográfica documentada según el PCWG3 (según lo determinado por la RCIE) o muerte por cualquier causa.

2. a) Fecha en la que se produce una disminución del PSA del 50 % o superior en comparación con el inicio.
b) Fecha de progresión del PSA según el PCWG3.

3. Fin del estudio.

4. Fin del estudio.

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

E.6.8

Bioequivalence

E.6.9

Dose response

Yes

E.6.10

Pharmacogenetic

Yes

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)

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

E.8.1.6

Cross over

E.8.1.7

Other

Yes

E.8.1.7.1

Other trial design description

Tratamiento cruzado opcional (grupo 2d) para los participantes aleatorizados al grupo 2a de la parte

Optional Crossover Treatment (Arm 2d) for Participants Randomized to Part 2 Arm 2a.

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

Canada

United States

France

Netherlands

Spain

Greece

Italy

United Kingdom

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

End of trial is defined as the last participant last visit or scheduled procedure shown in the Schedule of Activities for the last participant.

El final del ensayo se define como la última visita del último participante o el procedimiento programado que se muestra en el calendario de actividades del último participante.

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:

163

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

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

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

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

204

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, Sponsor will not continue to provide Sponsor-supplied study intervention to participants/investigators unless Sponsor chooses to extend the study. The investigator should ensure that the participant receives appropriate standard of care to treat the condition under study.

Al final del estudio, el promotor no seguirá proporcionando intervención del estudio a los participantes/investigadores a menos que el promotor decida ampliar el estudio. El investigador debe asegurarse que el participante reciba el tratamiento estándar adecuado para tratar el afección en estudio.

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

2022-09-21

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2022-09-19

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

Select Country:	Select Age Range:
Select Trial Status:	Select Trial Phase:
Select Gender:
Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
Clear advanced search filters

Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom
Outside EU/EEA

Clinical trials