Clinical Trials Register

Summary
EudraCT Number:	2016-005189-75
Sponsor's Protocol Code Number:	BO39633
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:	2017-07-04
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

2016-005189-75

A.3

Full title of the trial

AN OPEN-LABEL, MULTICENTER EXTENSION STUDY IN PATIENTS PREVIOUSLY ENROLLED IN A GENENTECH- AND/OR F. HOFFMANN LA ROCHE LTD-SPONSORED ATEZOLIZUMAB STUDY

ESTUDIO DE EXTENSIÓN MULTICÉNTRICO, ABIERTO EN PACIENTES INCLUIDOS PREVIAMENTE EN UN ESTUDIO CLÍNICO DE ATEZOLIZUMAB PROMOCIONADO POR GENENTECH Y/O F. HOFFMANN-LA ROCHE LTD.

A.3.1

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

An Extension Study in Patients Previously Enrolled in a Genentech− and/or F. Hoffmann-La Roche Ltd−Sponsored Atezolizumab Study

Un estudio de extensión en pacientes previamente incluidos en un estudio de Atezolizumab promocionado por Genentech y / o F. Hoffmann-La Roche Ltd

A.4.1

Sponsor's protocol code number

BO39633

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(Soc.Unipersonal) que realiza el ensayo en España y que actúa como representante de F.Hoffmann-La Roche
B.1.3.4	Country	Switzerland
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	F. Hoffmann-La Roche Ltd
B.4.2	Country	Switzerland
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	F. Hoffmann-La Roche Ltd
B.5.2	Functional name of contact point	Trial Information Support Line-TISL
B.5.3	Address:
B.5.3.1	Street Address	Grenzacherstrasse 124
B.5.3.2	Town/ city	Basel
B.5.3.3	Post code	4070
B.5.3.4	Country	Switzerland
B.5.4	Telephone number	34913257300
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	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	Atezolizumab (MPDL3280A)
D.3.2	Product code	RO5541267
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	ATEZOLIZUMAB
D.3.9.2	Current sponsor code	RO5541267
D.3.9.3	Other descriptive name	MPDL3280A
D.3.9.4	EV Substance Code	SUB178312
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.3.8 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.3.9.3	Other descriptive name	MPDL3280A
D.3.9.4	EV Substance Code	SUB178312
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	125
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	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	Docetaxel
D.2.1.1.2	Name of the Marketing Authorisation holder	Accord Healthcare Limited, UK
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 and solvent for 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	DOCETAXEL
D.3.9.3	Other descriptive name	DOCETAXEL
D.3.9.4	EV Substance Code	SUB12492MIG
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	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: 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	Avastin
D.2.1.1.2	Name of the Marketing Authorisation holder	Roche Registration Ltd
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	Bevacizumab
D.3.2	Product code	RO4876646
D.3.4	Pharmaceutical form	Concentrate and solvent 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	BEVACIZUMAB
D.3.9.1	CAS number	216974-75-3
D.3.9.2	Current sponsor code	RO4876646
D.3.9.4	EV Substance Code	SUB16402MIG
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	25
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	SUTENT
D.2.1.1.2	Name of the Marketing Authorisation holder	Pfizer
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	Sunitinib
D.3.2	Product code	RO4632993
D.3.4	Pharmaceutical form	Capsule, hard
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	SUNITINIB
D.3.9.1	CAS number	557795-19-4
D.3.9.2	Current sponsor code	RO4632993
D.3.9.4	EV Substance Code	SUB22321
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	12.5 to 50
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	Javlor
D.2.1.1.2	Name of the Marketing Authorisation holder	Pierre-Fabre Médicament
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	vinflunine
D.3.2	Product code	RO7059926
D.3.4	Pharmaceutical form	Concentrate and solvent 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	VINFLUNINE
D.3.9.1	CAS number	162652-95-1
D.3.9.4	EV Substance Code	SUB00063MIG
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	25
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	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

Cancer
(Future parent protocols may include other cancer that are not included in this section)

Cáncer
(Los futuros protocolos originales pueden incluir otros tipos de cáncer que no se incluyen en esta sección)

E.1.1.1

Medical condition in easily understood language

Cancer is a disease with an uncontrolled growth of malignant cells in the body and ability of these cells to spread from original site to distant site

El cáncer es una enfermedad con un crecimiento incontrolado de células malignas en el cuerpo y la capacidad de estas células para propagarse desde el sitio original a un sitio distante

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	10046721
E.1.2	Term	Urothelial carcinoma bladder stage III
E.1.2	System Organ Class	100000017505

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	10029514
E.1.2	Term	Non-small cell lung cancer NOS
E.1.2	System Organ Class	100000015833

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	PT
E.1.2	Classification code	10061873
E.1.2	Term	Non-small cell lung 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	10023400
E.1.2	Term	Kidney cancer
E.1.2	System Organ Class	100000056053

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 provide continued access to atezolizumab-based therapy and/or comparator agent(s) for eligible patients still on study treatment at the time of the parent-study closure

Proporcionar acceso continuado al tratamiento basado en atezolizumab y/o con el o los fármacos comparadores a los pacientes elegibles que sigan recibiendo el tratamiento del estudio en el momento de terminar el estudio original

E.2.2

Secondary objectives of the trial

- To evaluate the safety of atezolizumab monotherapy or atezolizumab administered with combined agent(s) or comparator agent(s)
- To evaluate overall survival data with regard to administration of atezolizumab monotherapy or atezolizumab administered in combination with other agent(s) or comparator agent(s)

-Evaluar la seguridad de atezolizumab administrado en monoterapia o en combinación con otro(s) agente(s) o fármaco(s) comparador(es)
-Evaluar los datos de la supervivencia global con respecto a la administración de atezolizumab en monoterapia o en combinación con otro(s) agente(s) o fármaco(s) comparador(es)

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

- Eligible for continuing or crossing over to atezolizumab-based therapy at the time of the parent-study closure as per the parent study or
Eligible for continuing the comparator agent(s) in a Genentech- or Roche-sponsored study at the time of the parent-study closure as per the parent study
- First dose of study treatment in the extension study will be received within the treatment interruption period allowed by the parent study
- Continue to benefit from atezolizumab-based study treatment or from the comparator at the time of parent-study closure as assessed by the investigator
- Able to comply with the extension study, in the investigator's judgment
- Will comply with contraception criteria detailed in the designated Reference Safety Information (RSI)
- Negative serum pregnancy test within 7 days prior to start of study treatment in women of childbearing potential

-Ser elegibles para continuar recibiendo o ser transferidos a tratamiento basado en atezolizumab en el momento de terminar el estudio original, de acuerdo con los criterios establecidos en ese estudio o
- Ser elegibles para continuar recibiendo el agente o los agentes comparadores administrados en un estudio promocionado por Genentech o Roche en el momento de terminar el estudio original, de acuerdo con los criterios establecidos en ese estudio
-La primera dosis del tratamiento del estudio en el estudio de extensión se administrará dentro del período de interrupción del tratamiento permitido en el estudio original
-Continuar obteniendo beneficio clínico del tratamiento del estudio basado en atezolizumab o del comparador en el momento de terminar el estudio original, lo que será determinado por el investigador
-Capacidad para cumplir los requisitos del estudio de extensión, de acuerdo con el criterio del investigador
- Comprometerse a cumplir las medidas anticonceptivas detalladas en el Reference Safety Information (RSI)
-Prueba de embarazo en suero negativa en los 7 días previos al inicio del tratamiento del estudio, en las mujeres potencialmente fértiles

E.4

Principal exclusion criteria

- Meet of any of the study treatment discontinuation criteria specified in the parent study at the time of enrollment in the extension study
- Time between the last dose of treatment received in parent study and first dose in extension study is longer than the interruption period allowed in the parent study. If the interruption period is beyond the period allowed by the parent study, the acceptable length of interruption will depend on an agreement between the investigator and the Medical
Monitor of the extension study.
- Treatment with any anti-cancer treatment (other than treatment permitted in the parent study) during the time between last treatment in the parent study and the first dose of study treatment in the extension study
- Permanent discontinuation of study treatment for any reason during the parent study or during the time between last treatment in the parent study and the first dose of study treatment in the extension study
- Any unresolved or irreversible toxicities during the parent study that required permanent discontinuation of study treatment, in accordance to the parent study or local prescribing information
- Ongoing serious adverse event(s) that has not resolved to baseline level or Grade <= 1 from the parent study or during the time between last treatment in the parent study and the first dose of study treatment in the extension study
- Any serious uncontrolled concomitant disease that would contraindicate the use of study treatment at the time of the extension study or that would place the patient at high risk for treatment-related complications
- Concurrent participation in any therapeutic clinical trial (other than the parent study)
- Pregnant or lactating, or intending to become pregnant during the extension study

-Cumplir cualquiera de los criterios para la suspensión del tratamiento del estudio especificados en el estudio original en el momento de la inclusión en el estudio de extensión
- El tiempo transcurrido desde la administración de la última dosis del tratamiento en el estudio original y la administración de la primera dosis en el estudio de extensión es superior al permitido en el estudio original para la interrupción del tratamiento. Si el período durante el cual se ha interrumpido el tratamiento es superior al permitido en el estudio original, la duración aceptable de la interrupción dependerá de lo acordado conjuntamente por el investigador y el monitor médico del estudio de extensión

-Tratamiento con cualquier fármaco anticanceroso (que no sea el permitido en el estudio original) durante el tiempo transcurrido desde la administración de la última dosis en el estudio original y la primera dosis del tratamiento del estudio en el estudio de extensión
- Suspensión permanente del tratamiento del estudio, por el motivo que sea, durante el estudio original o durante el tiempo transcurrido desde la administración de la última dosis en el estudio original y la primera dosis del tratamiento del estudio en el estudio de extensión

-Toxicidades no resueltas o irreversibles durante el estudio original que han requerido la suspensión permanente del tratamiento del estudio, de acuerdo con lo establecido en el estudio original o en la ficha técnica local
- Acontecimientos adversos graves en curso que no hayan remitido al valor basal o a grado  1 desde el estudio original o durante el tiempo transcurrido desde la administración de la última dosis en el estudio original y la primera dosis del tratamiento del estudio en el estudio de extensión

-Cualquier enfermedad concomitante grave no controlada para la cual estaría contraindicado el uso del tratamiento del estudio en el momento de la inclusión en el estudio de extensión o que pudiera implicar para el paciente un riesgo alto de complicaciones relacionadas con el tratamiento
-Participación simultánea en cualquier ensayo clínico terapéutico (que no sea el estudio original)
-Pacientes embarazadas o en período de lactancia o que tengan intención de quedarse embarazadas durante el estudio de extensión

E.5 End points

E.5.1

Primary end point(s)

Not applicable

No aplica

E.5.1.1

Timepoint(s) of evaluation of this end point

Not applicable

No aplica

E.5.2

Secondary end point(s)

1. Incidence and severity of serious adverse events, with severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v4.0
2. Incidence and severity of adverse events of special interest, with severity determined according to NCI CTCAE, v4.0
3. Time to death due to any cause

1-Incidencia y severidad (determinada de acuerdo con los criterios NCI CTCAE, v4.0) de los acontecimientos adversos graves
2-Incidencia y severidad (determinada de acuerdo con los criterios NCI CTCAE, v4.0) de los acontecimientos adversos de especial interés
3.Tiempo hasta la muerte por cualquier causa

E.5.2.1

Timepoint(s) of evaluation of this end point

1-3. Throughout the study

1-3.A lo largo 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

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)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

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

164

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

Belgium

Bosnia and Herzegovina

Brazil

Canada

Chile

Czech Republic

El Salvador

France

Georgia

Greece

Guatemala

Hong Kong

Hungary

Israel

Italy

Japan

Korea, Republic of

Mexico

Netherlands

New Zealand

Panama

Peru

Poland

Romania

Russian Federation

Serbia

Singapore

Slovenia

Spain

Switzerland

Taiwan

Thailand

Ukraine

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

The end of this study is defined as the date when the last patient, last visit (LPLV) occurs, safety follow-up is received from the last patient, or if the Sponsor decides to terminate the study, whichever occurs first.

La terminación del estudio se define como la fecha en la que tenga lugar la última visita del último paciente (UVUP), se reciba información sobre el seguimiento de seguridad del último paciente o cuando el promotor decida terminar el estudio, dependiendo de lo que ocurra primero.

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:

278

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

278

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

237

F.4.2.2

In the whole clinical trial

556

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)

This trial aims at providing continued access to atezolizumab-based therapy and/or comparator agent(s) for eligible patients still on study treatment at the time of the parent-study closure.

El objetivo del estudio es proporcionar acceso continuado al tratamiento basado en atezolizumab y/o con el o los fármacos comparadores a los pacientes elegibles que sigan recibiendo el tratamiento del estudio en el momento de terminar el estudio original

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

2017-07-06

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2017-06-27

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