Clinical Trials Register

Summary
EudraCT Number:	2022-003708-33
Sponsor's Protocol Code Number:	ML43332
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:	2022-12-13
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

2022-003708-33

A.3

Full title of the trial

A PHASE II, OPEN LABEL, RANDOMIZED, NON-COMPARATIVE COHORTS STUDY OF ADJUVANT ATEZOLIZUMAB OR ATEZOLIZUMAB PLUS TIRAGOLUMAB IN SOLID TUMORS WITH RESECTABLE DISEASE WITH INTERMEDIATE-HIGH RISK OF RECURRENCE AND HIGH TUMOR MUTATIONAL BURDEN (TMB-H) OR MICROSATELLITE INSTABILITY (MSI-H)

ESTUDIO DE FASE II, ABIERTO, ALEATORIZADO, DE COHORTES NO COMPARATIVAS, DE ATEZOLIZUMAB O ATEZOLIZUMAB EN COMBINACIÓN CON TIRAGOLUMAB COMO TRATAMIENTO ADYUVANTE EN PACIENTES CON TUMORES SÓLIDOS RESECABLES CON RIESGO DE RECURRENCIA INTERMEDIO-ALTO Y ALTA CARGA MUTACIONAL TUMORAL (TMB-H) O INESTABILIDAD DE MICROSATÉLITES (MSI-H)

A.3.1

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

A PHASE II STUDY OF ADJUVANT ATEZOLIZUMAB OR ATEZOLIZUMAB PLUS TIRAGOLUMAB IN SOLID TUMORS WITH RESECTABLE DISEASE WITH INTERMEDIATE-HIGH RISK OF RECURRENCE AND HIGH TUMOR MUTATIONAL BURDEN OR MICROSATELLITE INSTABILITY.

ESTUDIO FASE II DE ATEZOLIZUMAB O ATEZOLIZUMAB EN COMBINACIÓN CON TIRAGOLUMAB COMO TRATAMIENTO ADYUVANTE EN PACIENTES CON TUMORES SÓLIDOS RESECABLES CON RIESGO DE RECURRENCIA INTERMEDIO-ALTO Y ALTA CARGA MUTACIONAL TUMORAL O INESTABILIDAD DE MICROSATÉLITES

A.4.1

Sponsor's protocol code number

ML43332

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	Roche Farma S.A.U.
B.1.3.4	Country	Spain
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	Roche Farma S.A.U.
B.4.2	Country	Spain
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Roche Farma S.A.U.
B.5.2	Functional name of contact point	Head of Spain
B.5.3	Address:
B.5.3.1	Street Address	Ribera del Loira 50
B.5.3.2	Town/ city	Madrid
B.5.3.3	Post code	28042
B.5.3.4	Country	Spain
B.5.4	Telephone number	+34913253700
B.5.6	E-mail	spain.start_up_unit@roche.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	Yes
D.2.1.1.1	Trade name	Tecentriq
D.2.1.1.2	Name of the Marketing Authorisation holder	Roche Registration GmbH
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	Atezolizumab
D.3.2	Product code	RO5541267
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	Atezolizumab
D.3.9.2	Current sponsor code	RO5541267
D.3.9.4	EV Substance Code	SUB178312
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	60
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.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	tiragolumab
D.3.2	Product code	RO7092284/F03-01
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	Tiragolumab
D.3.9.1	CAS number	1918185-84-8
D.3.9.2	Current sponsor code	RO7092284
D.3.9.3	Other descriptive name	MTIG7192A, anti-TIGIT, aTIGIT, PRO400402, 4.1D3
D.3.9.4	EV Substance Code	SUB197861
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	60
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

Solid tumors

Tumores sólidos

E.1.1.1

Medical condition in easily understood language

Solid tumors are abnormal mass of tissue that usually does not contain cysts or liquid areas. Solid tumors may be benign (not cancerous), or malignant (cancerous)

Los tumores sólidos son masas anormales de tejido que generalmente no contienen quistes o áreas líquidas. Los tumores sólidos pueden ser benignos (no cancerosos) o malignos (cancerosos)

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

The primary objective for this study is to evaluate the efficacy (DFS) of tiragolumab plus atezolizumab and atezolizumab alone in TMB =13 mut/MB or MSI-H selected patients with solid tumors in the adjuvant setting with intermediate-high risk of relapse.

El objetivo principal de este estudio es evaluar la eficacia (basándose en la SLE) de tiragolumab en combinación con atezolizumab y de atezolizumab como agente único en el contexto del tratamiento adyuvante en pacientes con tumores sólidos seleccionados por una TMB ≥13 mutaciones/MB o MSI alta (MSI-H) con riesgo de recurrencia de intermedio a alto.

E.2.2

Secondary objectives of the trial

To evaluate the efficacy of tiragolumab plus atezolizumab and atezolizumab alone.
To evaluate the safety and tolerability of atezolizumab and tiragolumab plus atezolizumab.
To evaluate the relationship between tumor and blood-based biomarkers (including but not limited to PD-L1, PD-1, ctDNA levels, somatic mutations, and others), as defined by IHC or quantitative ddPCR, next generation sequencing, and/or other methods and measures of efficacy.
To evaluate the correlation of F1 Tracker monitoring and imaging at the time of apparent recurrence of primary disease (i.e., primary disease recurrence, occurrence of new primary) in patients with confirmed recurrence of disease.

Evaluar la eficacia de tiragolumab en combinación con atezolizumab y atezolizumab como agente único.
Evaluar la seguridad y tolerabilidad de atezolizumab y tiragolumab en combinación con atezolizumab .
Evaluar la relación entre los biomarcadores tumorales y los biomarcadores en sangre (incluyendo, entre otros, PD-L1, PD-1, niveles de ADNtc o mutaciones somáticas y otros), definida mediante inmunohistoquímica (IHC) o ddPCR cuantitativa, secuenciación de nueva generación y/u otros métodos, y las variables de eficacia.
Evaluar la correlación de la monitorización mediante F1 Tracker y las imágenes radiológicas en el momento de la recurrencia aparente de la enfermedad primaria (es decir, recurrencia de la enfermedad primaria, desarrollo de un nuevo tumor primario) en pacientes con recurrencia confirmada de la enfermedad.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

-Signed Informed Consent Form (ICF).
-Male or female, 18 years of age or older.
-ECOG performance status of 0 to 1.
-Solid tumors considered to be resectable with a curative intent with known high TMB/ MSI-H.
-Patients must undergo standard treatment according to the stage of their disease.
-All patients must be disease free after standard therapy to be included in this study.
-TMB ≥ 13 mut/MB or MSI-H in tumor tissue biopsy.
-Patients must be at intermediate/high risk of recurrence.
-Adequate hematologic and organ function.
-For female patients of childbearing potential, agreement to use a highly effective form(s) of contraception that results in a low failure rate when used consistently and correctly.
-For male patients with female partners of childbearing potential, agreement to use a highly effective form(s) of contraception that results in a low failure rate when used consistently and correctly.
-Oral contraception should always be combined with an additional contraceptive method because of a potential interaction with the study drugs.
-Women not postmenopausal or surgically sterile must have a negative serum pregnancy test result.

-Firmar el formulario de consentimiento informado (FCI).
-Varones o mujeres de ≥ 18 años.
-Estado funcional del Eastern Cooperative Oncology Group (ECOG) de 0 a 1.
-Presentar cualquier tumor sólido que se considere resecable con intención curativa con TMB alta / MSI-H conocidas.
-Los pacientes deben recibir tratamiento estándar en función del estadio de la enfermedad.
-Todos los pacientes deben estar libres de enfermedad tras el tratamiento estándar para poder ser incluidos en este estudio.
-Presentar una TMB ≥ 13 mutaciones/MB o MSI-H en la muestra de tejido tumoral de la biopsia.
-Los pacientes deben presentar riesgo de recurrencia de intermedio a alto.
-Función hematológica y de órganos adecuada.
-Las mujeres en edad fértil deben comprometerse a utilizar uno o varios métodos anticonceptivos muy eficaces que tengan una tasa de fallos baja cuando se usan de manera constante y correcta.
-Los varones con pareja femenina en edad fértil deben comprometerse a utilizar uno o varios métodos anticonceptivos muy eficaces que tengan una tasa de fallos baja cuando se usan de manera constante y correcta.
-Los anticonceptivos orales se deben combinar siempre con otro método anticonceptivo debido a las posibles interacciones con los fármacos del estudio.
-Las mujeres que no sean postmenopáusicas o no estén esterilizadas quirúrgicamente deben presentar un resultado negativo en la prueba de embarazo en suero.

E.4

Principal exclusion criteria

-Previous malignancies within 3 years prior to enrollment, with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome.
-Patients with illnesses or conditions that interfere with their capacity to understand, follow, and/or comply with study procedures.
-Prior cancer immunotherapy.
-Any contraindication for surgery and/or systemic therapy and cancer immunotherapy.
-Known serine/threonine kinase 11 ligand alterations, mouse double minute 2 homolog amplifications.
-Women who are pregnant, lactating, or intending to become pregnant during the study.
-History of autoimmune disease.
-Positive test for human immunodeficiency virus.
-Patients with active hepatitis B (chronic or acute; defined as having a positive hepatitis B surface antigen test at screening) or hepatitis C.
-History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography scan.
-Severe infections within 4 weeks prior to be included in the study.
-Significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or greater), myocardial infarction, or cerebrovascular accident within 3 months prior to inclusion, unstable arrhythmias, or unstable angina.
-Treatment with systemic immunosuppressive medications within 2 weeks prior to inclusion.
-Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or renders the patient at high risk from treatment complications.
-Active tuberculosis.
-Major surgical procedure within 28 days prior to study treatment or anticipation of need for a major surgical procedure during the course of the study.
-Administration of a live, attenuated vaccine within 4 weeks prior to initiation of study treatment or anticipation that such a live attenuated vaccine will be required during the study.
-Treatment with systemic immunostimulatory agents within 4 weeks or 5 drug-elimination half-lives of the drug, whichever is longer, prior to randomization.

-Neoplasias malignas en los 3 años previos a la inclusión, exceptuando aquellas que tienen un riesgo insignificante de metástasis o muerte tratadas con intención curativa con el resultado esperado.
-Pacientes con enfermedades o condiciones que interfieran en su capacidad para entender, seguir y/o cumplir los procedimientos del estudio.
-Inmunoterapia previa para el cáncer.
-Cualquier contraindicación para la cirugía y/o el tratamiento sistémico y la inmunoterapia para el cáncer.
-Alteraciones del ligando STK-11, amplificaciones de MDM2 conocidas
-Mujeres embarazadas, en período de lactancia o que tengan intención de quedarse embarazadas durante el estudio.
-Antecedentes de enfermedades autoinmunes.
-Prueba de VIH positiva.
-Pacientes con infección activa por virus de hepatitis B (crónica o aguda; definida por un resultado positivo para anticuerpos contra el antígeno de superficie del virus de la hepatitis B en el período de selección) o hepatitis C.
-Antecedentes de fibrosis pulmonar idiopática, neumonía organizada, neumonitis inducida por fármacos, neumonitis idiopática o evidencia de neumonitis activa en la TC de tórax realizada en el período de selección.
-Infecciones graves en las 4 semanas previas a la inclusión en el estudio.
-Enfermedad cardiovascular significativa, como cardiopatías (de clase II o superior) de la New York Heart Association, infarto de miocardio o accidente cerebrovascular en los 3 meses previos a la inclusión en el estudio, arritmias inestables o angina de pecho inestable.
-Tratamiento con fármacos inmunosupresores sistémicos en las 2 semanas previas a la inclusión.
-Cualquier otra enfermedad, trastorno metabólico, hallazgo de la exploración física o de las pruebas de laboratorio clínico que proporcionen indicios razonables para sospechar la presencia de una enfermedad o trastorno para los cuales está contraindicado el uso de un fármaco en investigación, que puedan afectar a la interpretación de los resultados o que impliquen para el paciente un riesgo alto de sufrir complicaciones relacionadas con el tratamiento.
-Tuberculosis activa.
-Procedimientos de cirugía mayor en los 28 días previos al inicio del tratamiento del estudio o que sean previsiblemente necesarios en el transcurso del estudio.
-Administración de una vacuna de microorganismos vivos atenuados en las 4 semanas previas al inicio del tratamiento del estudio o que se requiera previsiblemente durante el estudio.
-Tratamiento con agentes inmunoestimuladores sistémicos en las 4 semanas previas a la aleatorización o durante el equivalente a 5 semividas de eliminación del fármaco en ese período, lo que sea más prolongado.

E.5 End points

E.5.1

Primary end point(s)

The primary endpoint is the Disease Free Survival (DFS) rate defined as the proportion of patients who have not suffered any of the following since the time of randomization: first documented recurrence of disease, new primary tumor or death due to any cause, whichever occurs first.

La variable principal es la tasa de Supervivencia libre de enfermedad (SLE), definida como el porcentaje de pacientes que no han manifestado ninguno de los acontecimientos siguientes desde el momento de la aleatorización: primer episodio documentado de recurrencia de la enfermedad, desarrollo de un nuevo tumor primario o muerte por cualquier causa, lo que ocurra primero.

E.5.1.1

Timepoint(s) of evaluation of this end point

At 24 months.

A los 24 meses

E.5.2

Secondary end point(s)

1. DFS rate
2. OS (Overall Survival) after randomization, defined as the time from randomization to death from any cause.
3. Incidence and severity of AEs, with severity determined according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events, Version 5.0 (CTCAE v5.0).
4. Change from baseline in targeted clinical laboratory test results.
5. Relationship between blood and tumor biomarkers and efficacy endpoints.
6. Relationship between imaging metrics and biomarkers in blood and recurrence of disease.

1. Tasa de Supervivencia libre de enfermedad (SLE)
2. SG (supervivencia global) después de la aleatorización, que se define como el tiempo transcurrido desde la aleatorización hasta la muerte por cualquier causa
3. Incidencia y severidad de los acontecimientos adversos, utilizando los Criterios de terminología común para acontecimientos adversos del National Cancer Institute (NCI), versión 5.0 (CTCAE v5.0) para determinar el grado de severidad.
4. Variación respecto a la situación basal en los resultados de las pruebas específicas de laboratorio clínico.
5. Relación entre los biomarcadores tumorales y de sangre y las variables de eficacia
6. Relación entre las imágenes radiológicas y los biomarcadores en sangre en le momento de la recurrencia aparente de la enfermedad primaria.

E.5.2.1

Timepoint(s) of evaluation of this end point

1. At 36, 48 and 60 months.
2. Up to approximatelly 8 years.
3-4. Up to approximatelly 3 years.
5-6. Up to approximatelly 5 years.
.

1. A los 36, 48 y 60 meses.
2. Hasta aproximadamente 8 años.
3-4. Hasta aproximadamente 3 años.
5-6. Hasta 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

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

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)

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

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

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

E.8.6.2

Trial being conducted completely outside of the EEA

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

UVUP

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

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:

F.1.3

Elderly (>=65 years)

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.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)

None

Ninguno

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

2023-03-15

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2023-02-23

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

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