Clinical Trials Register

Summary
EudraCT Number:	2014-005490-37
Sponsor's Protocol Code Number:	WO29522
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:	2016-02-02
Trial results	View 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

2014-005490-37

A.3

Full title of the trial

A PHASE III, MULTICENTER, RANDOMIZED, PLACEBO-CONTROLLED STUDY OF ATEZOLIZUMAB (ANTI?PD-L1 ANTIBODY) IN COMBINATION WITH NAB-PACLITAXEL COMPARED WITH PLACEBO WITH NAB-PACLITAXEL FOR PATIENTS WITH PREVIOUSLY UNTREATED METASTATIC TRIPLE-NEGATIVE BREAST CANCER

ESTUDIO EN FASE III, MULTICÉNTRICO, ALEATORIZADO Y CONTROLADO CON PLACEBO DE ATEZOLIZUMAB (ANTICUERPO ANTI-PD-L1) COMBINADO CON NAB-PACLITAXEL EN COMPARACIÓN CON PLACEBO CON NAB-PACLITAXEL EN PACIENTES CON CÁNCER DE MAMA TRIPLE NEGATIVO METASTÁSICO NO TRATADO PREVIAMENTE

A.3.1

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

A trial of MPDL3280A and nab-Paclitaxel in metastatic triple negative breast cancer

Ensayo con MPDL3280A y nab-Paclitaxel en cáncer de mama triple negativo metastásico.

A.4.1

Sponsor's protocol code number

WO29522

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. que representa en España a F. Hoffmann-La Roche Ltd
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	Genentech Inc. c/o 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	global.rochegenentechtrials@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	MPDL3280A-RO5541267-F-03
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	SUB126162
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.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	Abraxane
D.2.1.1.2	Name of the Marketing Authorisation holder	Celgene
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	nab-paclitaxel
D.3.2	Product code	RO024-7506
D.3.4	Pharmaceutical form	Powder 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	PACLITAXEL
D.3.9.1	CAS number	33069-62-4
D.3.9.4	EV Substance Code	SUB09583MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	5
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	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.8 Information on Placebo
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Solution for infusion
D.8.4	Route of administration of the placebo	Intravenous use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Previously untreated metastatic triple negative breast cancer

Cáncer de mama triple negativo metastásico no tratado previamente

E.1.1.1

Medical condition in easily understood language

Metastatic breast cancer

Cáncer de mama metastásico

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	18.1
E.1.2	Level	LLT
E.1.2	Classification code	10027475
E.1.2	Term	Metastatic breast cancer
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 evaluate the efficacy of MPDL3280A + nab-paclitaxel compared with placebo + nab-paclitaxel as measured by progression-free survival (PFS; per investigator assessment using Response Evaluation Criteria in Solid Tumors [RECIST] v1.1)
? To evaluate the efficacy of atezolizumab + nab-paclitaxel compared with
placebo + nab-paclitaxel as measured by overall survival (OS)

? Evaluar la eficacia de atezolizumab (MPDL3280A) + nab-paclitaxel en comparación con placebo + nab-paclitaxel, medida mediante la supervivencia sin progresión (SSP; conforme a la evaluación del investigador aplicando los Criterios de evaluación de la respuesta en tumores sólidos [RECIST] v1.1)
? Evaluar la eficacia de atezolizumab + nab-paclitaxel en comparación con placebo + nab-paclitaxel, medida mediante la supervivencia global (SG)

E.2.2

Secondary objectives of the trial

? To evaluate the efficacy of atezolizumab + nab-paclitaxel compared with
placebo + nab-paclitaxel as measured by objective response rate (ORR; per
investigator assessment using RECIST v1.1)
? To evaluate the efficacy of atezolizumab + nab-paclitaxel compared with
placebo + nab-paclitaxel as measured by duration of objective response (DOR; per
investigator using RECIST v1.1) among patients with an objective response
? To evaluate patient-reported outcomes (PROs) of health status/health-related
quality of life (HRQoL) associated with atezolizumab + nab-paclitaxel compared with
placebo + nab-paclitaxel, as measured by the time to deterioration (TTD) in
Items 29 and 30 of the European Organisation for Research and Treatment of
Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30)

? Evaluar la eficacia de atezolizumab + nab-paclitaxel en comparación con placebo + nab-paclitaxel, medida mediante la tasa de respuestas objetivas (TRO; conforme a la evaluación del investigador aplicando los criterios RECIST v1.1)
? Evaluar la eficacia de atezolizumab + nab-paclitaxel en comparación con placebo + nab-paclitaxel, medida mediante la duración de la respuesta objetiva (DRO; conforme al investigador aplicando los criterios RECIST v1.1) en las pacientes con una respuesta objetiva
? Evaluar los resultados comunicados por las pacientes (RCP) del estado de salud/calidad de vida relacionada con la salud (CVRS) asociados a atezolizumab + nab-paclitaxel en comparación con placebo + nab-paclitaxel, medidos mediante el tiempo transcurrido hasta el deterioro (TTD) en los ítems 29 y 30 del Cuestionario de calidad de vida esencial 30 (QLQ-C30) de la European Organisation for Research and Treatment of Cancer

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

? Women aged ? 18 years
? Metastatic or locally advanced, histologically documented TNBC (absence of HER2, ER, and PR expression)
? No prior chemotherapy or targeted systemic therapy for inoperable locally advanced or metastatic TNBC
? Representative FFPE tumor specimens in paraffin blocks (preferred) or at least
15 unstained slides, with an associated pathology report documenting ER, PR, and HER2 negativity
?A tumor specimen obtained from metastatic or locally advanced disease (if applicable) must be submitted if clinically feasible
? ECOG performance status of 0 or 1
? Life expectancy ? 12 weeks
? Measurable disease, as defined by RECIST v1.1
?Adequate hematologic and end-organ function defined by laboratory results obtained within 2 weeks prior to first study treatment.
?Women of child bearing potential must agree to use adequate contraception (double barrier
methods of birth control or abstinence) prior to study entry, for the duration of study treatment, and for 90 days after the last dose of study treatment.
? Patients who are not postmenopausal (? 12 months of non?therapy-induced amenorrhea) or surgically sterile must have a negative serum pregnancy test result within 14 days prior to initiation of study drug

? Mujeres o varones de ? 18 años de edad
? CMTN metastásico o localmente avanzado, documentado mediante examen histológico (ausencia de expresión de HER2, RE y RP)
? Ausencia de quimioterapia o tratamiento sistémico dirigido previos para CMTN localmente avanzado o metastásico inoperable
? Muestras tumorales FFIP representativas (una muestra de archivo o tejido reciente de la recidiva tumoral antes del tratamiento) en bloques de parafina (preferido) o al menos 15 cortes no teñidos, con un informe de anatomía patológica adjunto que documente negatividad de RE, RP y HER2
? También se debe enviar (si procede) una muestra tumoral obtenida de enfermedad metastásica o localmente avanzada recidivante, si es clínicamente factible.
? Estado funcional de 0 o 1 del ECOG
? Esperanza de vida ? 12 semanas
? Enfermedad mensurable, definida según los criterios RECIST v1.1
? Función hematológica y orgánica adecuada, definida por los resultados analíticos siguientes obtenidos en las dos semanas previas a la administración de la primera dosis del tratamiento del estudio
? Mujeres en edad fértil deben comprometerse a usar métodos anticonceptivos adecuados (métodos de control de natalidad de doble barrera o abstinencia) antes de la primera dosis del estudio, durante el periodo de tratamiento y durante al menos 90 días después de la última dosis.
? Las mujeres que no sean posmenopáusicas (? 12 meses de amenorrea no inducida por tratamiento) ni quirúrgicamente estériles deben tener un resultado negativo en una prueba de embarazo en suero en los 14 días previos al inicio del fármaco del estudio.

E.4

Principal exclusion criteria

? Spinal cord compression not definitively treated with surgery and/or radiation, or previously
diagnosed and treated spinal cord compression without evidence that disease has been
clinically stable for > 2 weeks prior to randomization
? Known CNS disease, except for treated asymptomatic CNS metastases
? Leptomeningeal disease
? Uncontrolled pleural effusion, pericardial effusion, or ascites (indwelling drainage catheters are permitted)
? Uncontrolled tumor-related pain
? Uncontrolled hypercalcemia
?Pregnancy or lactation
? Evidence of significant uncontrolled concomitant disease that could affect compliance with
the protocol or interpretation of results, including significant liver disease (such as cirrhosis,
uncontrolled major seizure disorder, or superior vena cava syndrome)
? Significant cardiovascular disease
? Severe infection within 4 weeks prior to randomization, including but not limited to
hospitalization for complications of infection, bacteremia, or severe pneumonia
? History of autoimmune disease (Autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone and Type 1 diabetes mellitus on an stable insulin regimen may be eligible for this study)
? Prior allogeneic stem cell or solid organ transplantation
? History of idiopathic pulmonary fibrosis (including pneumonitis), drug-induced pneumonitis,
organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia), or
evidence of active pneumonitis on screening chest CT scan.
History of radiation pneumonitis in the radiation field (fibrosis) is permitted.
? Positive test for HIV
? Active hepatitis B or hepatitis C
?Active tuberculosis
?Treatment with systemic corticosteroids or other systemic immunosuppressive medications (including but not limited to prednisone, dexamethasone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor [TNF] agents) within 2 weeks prior to randomization, or anticipated requirement for systemic immunosuppressive medications during the trial.
Low dose steroids for nausea, adrenocortical insufficiency or orthostatic hypotension, IV contrast allergic reactions and inhaled corticosteroids are permitted.

? Compresión de médula espinal no tratada definitivamente con cirugía o radioterapia o diagnosticada y tratada previamente sin signos de estabilización clínica de la enfermedad durante > 2 semanas previas a la aleatorización.
? Enfermedad confirmada en el SNC, salvo las metástasis asintomáticas en el SNC tratadas
? Afectación leptomeníngea
? Derrame pleural, derrame pericárdico o ascitis no controlados (Las pacientes con catéteres permanentes podrán participar)
? Dolor no controlado relacionado con el tumor.
? Hipercalcemia no controlada
? Embarazo o lactancia
? Signos de enfermedades concomitantes importantes no controladas que podrían afectar al cumplimiento del protocolo o a la interpretación de los resultados, como hepatopatías importantes (por ejemplo, cirrosis, trastorno convulsivo importante no controlado o síndrome de la vena cava superior).
? Enfermedades cardiovasculares importantes
? Infecciones graves en las 4 semanas previas a la aleatorización, entre ellas, infecciones complicadas que requieran hospitalización, bacteriemia o neumonía grave
? Antecedentes de enfermedades autoinmunitarias (podrán participar pacientes con antecedentes de hipotiroidismo autoinmunitario que estén recibiendo dosis estables de tratamiento hormonal sustitutivo y pacientes con con diabetes mellitus de tipo 1 controlada que estén recibiendo dosis estables de insulina)
? Alotrasplante previo de células progenitoras u órganos sólidos
? Antecedentes de fibrosis pulmonar idiopática (incluida la neumonitis), neumonitis inducida por fármacos, neumonía organizada (p. ej., bronquiolitis obliterante, neumonía organizada criptogénica) o signos de neumonitis activa en la TC de tórax de la selección. Están permitidos los antecedentes de neumonitis inducida por radiación en el campo irradiado (fibrosis).
? Resultado positivo en el análisis del VIH
? Hepatitis B o Hepatitis C
? Tuberculosis activa
? Tratamiento sistémico con corticosteroides u otros inmunodepresores (entre ellos, prednisona, dexametasona, ciclofosfamida, azatioprina, metotrexato, talidomida y antagonistas del factor de necrosis tumoral [TNF]) en las 2 semanas previas a la aleatorización o pacientes que previsiblemente requieran tratamiento sistémico con inmunodepresores durante el estudio. Las pacientes que hayan recibido inmunodepresores sistémicos en dosis bajas y durante períodos breves (por ejemplo, una sola dosis de dexametasona por náuseas), con antecedente de reacción alérgica al contraste IV y al uso de corticosteroides inhalados podrán participar en el estudio.

E.5 End points

E.5.1

Primary end point(s)

Progression free survival (PFS)

Supervivencia sin progresión (SSP)

E.5.1.1

Timepoint(s) of evaluation of this end point

Tumor assessments will be performed every 8 weeks for the first 12 months and every 12 weeks thereafter until disease progression or treatment discontinuation, whichever is later

Las evaluaciones del tumor llevarán a cabo cada 8 semanas durante los 12 primeros meses y luego cada 12 semanas hasta la progresión de la enfermedad o la suspensión del tratamiento, lo que ocurra más tarde.

E.5.2

Secondary end point(s)

Overall survival (OS), Objective response rate (ORR) and duration of objective response (DOR), Patient reported outcomes (PRO) of health status and health quality of life (HRQoL)

Supervivencia global (SG), Tasa de respuestas objetiva (TRO), Duración de la respuesta objetiva (DRO), resultados comunicados por las pacientes (RCP) del estado de salud/calidad de vida relacionada con la salud (CVRS).

E.5.2.1

Timepoint(s) of evaluation of this end point

OS - every 3 months until death, withdrawal of consent, loss to follow-up, or study
termination by the Sponsor
ORR and DOR ? tumor assessments will be performed every 8 weeks for the first 12 months and every 12 weeks thereafter until disease progression or treatment discontinuation, whichever is later
PRO and HRQoL - at baseline (Cycle 1,Day 1); at Day 1 of each subsequent cycle; and at the treatment discontinuation visit. In
addition, all patients will complete the PRO questionnaires every 28 days for 1 year after
treatment discontinuation, regardless of whether the patient is receiving subsequent
anti-cancer therapy.

SG - cada 3 meses hasta el fallecimiento, retirada del consentimiento, pérdida del seguimiento o finalización del estudio por parte del promotor.
TRO y DRO - Las evaluaciones del tumor llevarán a cabo cada 8 semanas durante los 12 primeros meses y luego cada 12 semanas hasta la progresión de la enfermedad o la suspensión del tratamiento, lo que ocurra más tarde.
RCP y CVRS - en la visita basal (Ciclo 1, Día 1); al Día 1 de cada ciclo posterior y hasta la visita de discontinuación. Adicionalmente, todos los pacientes completarán el cuestionario RCP cada 28 días durante un año tras la discontinuación del tratamiento, independientemente de si el paciente está recibiendo tratamiento contra el cáncer.

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

Yes

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

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

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

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

Yes

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

Austria

Belgium

Canada

Czech Republic

Denmark

Estonia

Finland

France

Germany

Greece

Hungary

Italy

Korea, Republic of

Latvia

Norway

Poland

Portugal

Romania

Slovenia

Spain

United Kingdom

United States

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

The end of the study is expected to occur about 53 months after FPI when
approximately the pre-planned number of deaths will have been observed

Está previsto que el estudio termine alrededor de 53 meses después de la inclusión de la primera paciente (IPP) cuando se haya observado aproximadamente la cifra prevista de muertes

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

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:

228

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

122

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

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

120

F.4.2.2

In the whole clinical trial

350

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)

The Sponsor will evaluate the appropriateness of continuing to provide MPDL3280A to
patients assigned to this treatment after evaluating the primary and secondary efficacy
outcome measures and safety data gathered in the study. These analyses may be
conducted prior to completion of the study.

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

2016-03-16

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2016-03-08

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:
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Clinical trials