Clinical Trials Register

Summary
EudraCT Number:	2014-003106-33
Sponsor's Protocol Code Number:	GO29342
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Prematurely Ended
Date on which this record was first entered in the EudraCT database:	2018-12-10
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

Italy - Italian Medicines Agency

A.2

EudraCT number

2014-003106-33

A.3

Full title of the trial

A PHASE III, OPEN-LABEL, RANDOMIZED STUDY OF MPDL3280A (ANTI−
PDL1 ANTIBODY) COMPARED WITH GEMCITABINE+CISPLATIN OR CARBOPLATIN FOR PD-L1−SELECTED, CHEMOTHERAPY NAIVE PATIENTS WITH STAGE IV SQUAMOUS NON−SMALL CELL LUNG CANCER

Studio di Fase III, in aperto, randomizzato di confronto tra il trattamento con MPDL3280A (Anticorpo-Anti-PD-L1) rispetto a Gemcitabina + Cisplatino o Carboplatino, in pazienti con epressione PD-L1 e non precedentemente trattati con chemioterapia, affetti da carcinoma polmonare non a piccole cellule, squamoso, di stadio IV

A.3.1

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

Safety and efficacy of MPDL3280A (anti-PDL1 antibody) compared to gemcitabine + platinum-based chemotherapy in previously untreated patients with metastatic, squamous, PD-L1-selected, non-small cell lung cancer

Sicurezza ed efficacia di MPDL3280A (anticorpo anti-PD-L1) rispetto a gemcitabina + chemioterapia a base di platino in pazienti non precedentemente trattati, selezionati in base al PD-L1, affetti da carcinoma polmonare non a piccole cellule, squamoso, metastatico

A.3.2

Name or abbreviated title of the trial where available

A.4.1

Sponsor's protocol code number

GO29342

A.5.1

ISRCTN (International Standard Randomised Controlled Trial) Number

ISRCTN00000000

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT00000000

A.5.3

WHO Universal Trial Reference Number (UTRN)

U0000-0000-0000

A.5.4

Other Identifiers

Name:

Number:

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	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	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	-
B.5.5	Fax number	-
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
D.3.2	Product code	-
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
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
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	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
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

Previously untreated Stage IV, Squamous, Non-Small Cell Lung Cancer

Carcinoma polmonare non a piccole cellule, squamoso, di stadio IV, non precedentemente trattato

E.1.1.1

Medical condition in easily understood language

Lung cancer that has spread to areas near the lungs or other organs and has not yet been treated by chemotherapy

Carcinoma polmonare diffusosi nelle aree adiacenti ai polmoni o ad altri organi e che non è ancora stato trattato con chemioterapia

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	PT
E.1.2	Classification code	10025125
E.1.2	Term	Lung squamous cell carcinoma stage IV
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

The primary objective for this study is to evaluate the efficacy of MPDL3280A compared with carboplatin or cisplatin + gemcitabine in chemotherapy-naive patients with Stage IV squamous NSCLC, as measured by investigator-assessed PFS according to RECIST v1.1

L'obiettivo primario di questo studio consiste nel valutare l'efficacia di MPDL3280A rispetto a carboplatino o cisplatino + gemcitabina nei pazienti naive alla chemioterapia, affetti da NSCLC squamoso di stadio IV, misurato in base alla PFS valutata dallo sperimentatore secondo i criteri RECIST v1.1

E.2.2

Secondary objectives of the trial

To evaluate the efficacy of MPDL3280A compared with carboplatin or cisplatin +gemcitabine as measured by ORR according to RECIST v1.1 assessed by investigator;To evaluate the efficacy of MPDL3280A compared with carboplatin or cisplatin +gemcitabine as measured by OS;To determine the impact of MPDL3280A compared with carboplatin or cisplatin +gemcitabine as measured by time to deterioration (TTD) in patient reported lung cancer symptom (cough, dyspnea, chest pain) score;To evaluate the efficacy of MPDL3280A compared with carboplatin or cisplatin +gemcitabine as measured by Independent Review Facility (IRF)-assessed PFS according to RECIST v1.1;To evaluate the efficacy of MPDL3280A as measured by investigator- assessed DOR according to RECIST v1.1;To evaluate the efficacy of MPDL3280A as measured by investigator- assessed time in response (TIR) according to RECIST v1.1;To evaluate the OS rate at 1 and 2 years in each treatment arm

Valutare l'effic di MPDL3280A risp a carboplatino o cisplatino+gemcitabina misurata in base all'ORR valut dallo sperimentatore secondo i criteri RECIST v1.1;Valutare l'effic di MPDL3280A risp a carboplatino o cisplatino+gemcitabina misurata in base all'OS;Stabilire l'impatto di MPDL3280A risp a carboplatino o cisplatino+gemcitabina misurato in base al punteggio relativo al tempo trascorso prima del deterioram (TTD) dei sintomi dovuti al carcinoma polmonare riferiti dal paz (tosse, dispnea, dolore toracico);Valutare l'effic di MPDL3280A risp a carboplatino o cisplatino+gemcitabina misurata in base alla PFS valutata dalla Struttura di revisione indipendente (IRF) secondo i criteri RECIST v1.1;Valutare l'effic di MPDL3280A misurata in base al DOR valut dallo sperimentatore secondo i criteri RECIST v1.1;Valutare l'effic di MPDL3280A misurata in base al tempo di risposta (TIR) valut dallo sperimentatore secondo i criteri RECIST v1.1;Valutare il tasso di OS a 1 e 2 anni in ciascun braccio

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

•ECOG performance status of 0 or 1
•Histologically or cytologically confirmed, Stage IV squamous NSCLC
•Tumor PD-L1 expression as determined by an IHC assay performed by a central laboratory on previously obtained archival tumor tissue or tissue obtained from a biopsy at screening
•Measurable disease, as defined by RECIST v1.1
•Adequate hematologic and end-organ function
•Patient with a history of treated asymptomatic CNS metastases are eligible, provided they meet all of the following criteria:
Measurable disease outside CNS
Only supratentorial metastases allowed (i.e., no metastases to midbrain, pons, medulla or spinal cord)
No ongoing requirement for corticosteroids as therapy for CNS disease;
anticonvulsants at a stable dose allowed
No stereotactic radiation within 7 days or whole-brain radiation within
14 days prior to randomization
No evidence of interim progression between the completion of CNS- directed therapy and the screening radiographic study
•Patients with new asymptomatic CNS metastases detected at the screening scan must receive radiation therapy and/or surgery for CNS metastases. Following treatment, these patients may then be eligible without the need for an additional brain scan prior to enrollment, if all other criteria are met.
•For female patients of childbearing potential and male patients with partners of childbearing potential, agreement (by patient and/or partner) to use a highly effective form(s) of contraception and to continue its use for 90 days after the last dose of MPDL3280A
•Women 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.

• Stato di performance ECOG 0 o 1
• NSCLC squamoso di stadio IV confermato istologicamente o citologicamente
• Espressione tumorale di PD-L1 come stabilito da un'analisi IHC eseguita da un laboratorio centrale su tessuto tumorale d'archivio o tessuto ottenuto con una biopsia allo screening
• Malattia misurabile, come definita secondo i criteri RECIST v1.1
• Funzione ematica e degli organi principali adeguata
• I pazienti con anamnesi di metastasi del SNC asintomatiche e trattate sono eleggibili, a condizione che siano soddisfatti i seguenti criteri:
Malattia misurabile al di fuori del SNC
Sono ammesse solo metastasi sovratentoriali (ossia nessuna metastasi a mesencefalo, ponte, midollo o midollo spinale)
Nessuna necessità in atto di corticosteroidi come terapia per malattia del SNC;
sono consentiti anticonvulsivanti a una dose stabile
Nessuna radioterapia stereotassica nei 7 giorni o radioterapia panencefalica nei
14 giorni precedenti la randomizzazione
Nessuna evidenza di progressione temporanea tra il completamento della terapia diretta al SNC e lo studio radiografico di screening
• I pazienti con nuove metastasi del SNC asintomatiche rilevate alla scansione di screening devono ricevere radioterapia e/o chirurgia per le metastasi del SNC. Successivamente al trattamento, tali pazienti potrebbero essere eleggibili senza necessità di un'ulteriore scansione cerebrale prima dell'arruolamento, se fossero soddisfatti tutti gli altri criteri.
• Per pazienti di sesso femminile in età fertile e pazienti di sesso maschile con partner in età fertile, consenso (da parte del paziente e/o partner) all’utilizzo di metodi contraccettivi altamente efficaci e alla prosecuzione dell'utilizzo per 90 giorni dopo l'ultima dose di MPDL3280A
• Le donne non in stato di post-menopausa (12 mesi di amenorrea non indotta da terapia) o chirurgicamente sterili devono avere un test di gravidanza su siero negativo nei 14 giorni precedenti l'inizio del trattamento con il farmaco in studio.

E.4

Principal exclusion criteria

•Active or untreated CNS metastases as determined by CT or magnetic resonance imaging (MRI) evaluation during screening and prior radiographic assessments
•Leptomeningeal disease
•Uncontrolled tumor-related pain
•Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
•Uncontrolled or symptomatic hypercalcemia
•Malignancies other than NSCLC within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death
•History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
•Known hypersensitivity to biopharmaceuticals produced in Chinese hamster ovary cells or any component of the MPDL3280A formulation
•History of autoimmune disease, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis
•History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan
•Positive test for HIV
•Patients with active hepatitis B or hepatitis C
•Active tuberculosis
•Severe infections within 4 weeks prior to randomization, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia
•Significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or greater), myocardial infarction within 3
months prior to randomization, unstable arrhythmias, or unstable angina
•Administration of a live, attenuated vaccine within 4 weeks before randomization or anticipation that such a live attenuated vaccine will be required during the study
Influenza vaccination should be given during influenza season. Patients must not receive live, attenuated influenza vaccine (e.g., FluMist) within 4 weeks prior to randomization or at any time during the study.
•Any approved anti-cancer therapy, including chemotherapy, or hormonal therapy within 3 weeks prior to initiation of study treatment
•Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 28 days prior to randomization

• Metastasi del SNC attive o non trattate come stabilito mediante valutazione con TC o risonanza magnetica per immagini (RMI) durante lo screening e con valutazioni radiografiche precedenti
• Malattia leptomeningea
• Dolore non controllato correlato al tumore
• Effusione pleurica non controllata, effusione pericardica o asciti che richiedono ricorrenti procedure di drenaggio
• Ipercalcemia non controllata o sintomatica
• Tumori maligni diversi dall'NSCLC nei 5 anni precedenti la randomizzazione, con l'eccezione di quelli con un rischio trascurabile di metastasi o decesso
• Anamnesi di reazione allergica grave, reazione anafilattica o altra reazione di ipersensibilità agli anticorpi chimerici o umanizzati o alle proteine di fusione
• Ipersensibilità nota ad agenti biofarmaceutici prodotti in cellule di ovaio di criceto cinese o a uno qualsiasi dei componenti della formulazione di MPDL3280A
• Anamnesi di malattia autoimmune, compresi a titolo esemplificativo miastenia grave, miosite, epatite autoimmune, lupus eritematoso sistemico, artrite reumatoide, malattia infiammatoria intestinale, trombosi vascolare associata a sindrome antifosfolipidica, granulomatosi di Wegener, sindrome di Sjögren, sindrome di Guillain-Barré, sclerosi multipla, vasculite o glomerulonefrite
• Anamnesi di fibrosi polmonare idiopatica, polmonite organizzativa (ad es. bronchiolite obliterante), polmonite indotta da farmaci, polmonite idiopatica o evidenza di polmonite attiva rilevata con TC del torace allo screening
• Test positivo per l'HIV
• Pazienti con epatite B o C attiva
• Tubercolosi attiva
• Gravi infezioni nelle 4 settimane precedenti la randomizzazione, compresi a titolo esemplificativo ricovero per complicanze dell'infezione, batteriemia o polmonite grave
• Patologia cardiovascolare significativa, ad esempio cardiopatia secondo la classificazione della New York Heart Association (Classe II o superiore), infarto miocardico nei 3 mesi precedenti la randomizzazione, aritmia instabile o angina instabile
• Somministrazione di vaccino vivo attenuato nelle 4 settimane precedenti la randomizzazione o previsione di necessità di somministrare un vaccino vivo attenuato durante lo studio
Nella stagione influenzale è opportuno somministrare il vaccino antinfluenzale. Ai pazienti non deve essere somministrato un vaccino influenzale vivo attenuato (ad es. FluMist•) nelle 4 settimane precedenti la randomizzazione o in qualsiasi momento durante lo studio.
• Eventuali terapie antitumorali approvate, comprese chemioterapia o terapia ormonale nelle 3 settimane precedenti l'inizio del trattamento in studio
• Trattamento con qualsiasi altro agente sperimentale o partecipazione ad altra sperimentazione clinica a scopo terapeutico nei 28 giorni precedenti la randomizzazione

E.5 End points

E.5.1

Primary end point(s)

PFS, defined as the time from randomization to the first occurrence of disease progression as determined by the investigator with use of RECIST v1.1 or death from any cause, whichever occurs first

• PFS, definita come il tempo intercorso tra la randomizzazione e la prima manifestazione di progressione della malattia come stabilito dallo sperimentatore secondo i criteri RECIST v1.1 o il decesso per qualsiasi causa, a seconda dell'evento che si verifica per primo

E.5.1.1

Timepoint(s) of evaluation of this end point

Please refer to E.5.1

Si faccia riferimento a E.5.1

E.5.2

Secondary end point(s)

•Objective response, defined as PR plus CR as determined by the investigator according to RECIST v1.1
•OS, defined as the time from randomization to death from any cause
•TTD in patient reported lung cancer symptoms (cough, dyspnea, or chest pain, whichever occurs first) with use of the SILC scale symptom score, defined as time from randomization to the first deterioration maintained for two assessments or one assessment followed by death from any cause within 1 week
•PFS, defined as the time from randomization to the first occurrence of disease progression as determined by IRF using RECIST v1.1 or death from any cause, whichever occurs first
•DOR, defined as the time from the first occurrence of a documented objective response to the time of disease progression, as determined by the investigator with use of RECIST v1.1, or death from any cause, whichever occurs first
•TIR, defined as the same as DOR for responders. For non-responders, TIR is defined as date of randomization plus 1 day.
•1-year OS and 2-year OS
•TTD in patient reported lung cancer symptoms, defined as time from randomization to deterioration (10 point change) on each of the EORTC QLQ-C30 and EORTC QLQ-LC13 symptom subscales (cough, dyspnea [single item and multi item subscales], chest pain, arm/shoulder pain, or fatigue) maintained for two assessments or one assessment followed by death from any cause within 3 weeks
•Change from baseline in patient-reported lung cancer symptoms (chest pain, dyspnea, and cough) on the symptom severity score of the SILC scale

• Risposta obiettiva, definita come PR più CR come stabilito dallo sperimentatore secondo i criteri RECIST v1.1
• OS, definita come il tempo intercorso tra la randomizzazione e il decesso per qualsiasi causa
• TTD dei sintomi di carcinoma polmonare riferiti dal paziente (tosse, dispnea, o dolore toracico, a seconda dell'evento che si verifica per primo) usando il punteggio di gravità dei sintomi della scala SILC, definito come il tempo intercorso tra la randomizzazione e il primo deterioramento mantenuto per due valutazioni o per una valutazione seguita da decesso per qualsiasi causa entro 1 settimana
• PFS, definita come il tempo intercorso tra la randomizzazione e la prima manifestazione di progressione della malattia come stabilito dall'IRF secondo i criteri RECIST v1.1 o il decesso per qualsiasi causa, a seconda dell'evento che si verifica per primo
• DOR, definita come il tempo intercorso tra la prima manifestazione di una risposta obiettiva documentata e la progressione della malattia come stabilito dallo sperimentatore secondo i criteri RECIST v1.1 o il decesso per qualsiasi causa, a seconda dell'evento che si verifica per primo
• TIR, definito come DOR per i responder. Per i non responder, TIR definito come la data di randomizzazione più un giorno.
• OS di un anno e OS di due anni
• TTD dei sintomi di carcinoma polmonare riferiti dal paziente, definito come il tempo intercorso tra la randomizzazione e il deterioramento (variazione di 10 punti) in ciascuna delle sottoscale dei sintomi EORTC QLQ-C30 e EORTC QLQ-LC13 (tosse, dispnea [sottoscale a elemento singolo e a più elementi], dolore toracico, dolore a braccio/spalla o affaticamento) mantenuto per due valutazioni o una valutazione seguita da decesso per qualsiasi causa entro 3 settimane
• Variazione dalla baseline dei sintomi di carcinoma polmonare riferiti dal paziente (dolore toracico, dispnea e tosse) con il punteggio di gravità dei sintomi della scala SILC

E.5.2.1

Timepoint(s) of evaluation of this end point

Please refer to E.5.2

Si faccia riferimento a E.5.2

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

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)

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

Information not present in EudraCT

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

Brazil

China

Czech Republic

France

Germany

Greece

Hungary

Italy

Korea, Republic of

Poland

Romania

Russian Federation

Serbia

Spain

Thailand

Turkey

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 study is when approximately 291 deaths in the ITT population have been observed.

Lo studio termina quando si sono osservati circa 291 decessi nella popolazione ITT.

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

Number of subjects for this age range:

F.1.1.1

In Utero

Information not present in EudraCT

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

Information not present in EudraCT

F.1.1.3

Newborns (0-27 days)

Information not present in EudraCT

F.1.1.4

Infants and toddlers (28 days-23 months)

Information not present in EudraCT

F.1.1.5

Children (2-11years)

Information not present in EudraCT

F.1.1.6

Adolescents (12-17 years)

Information not present in EudraCT

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

280

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

120

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

Yes

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

110

F.4.2

For a multinational trial

F.4.2.1

In the EEA

222

F.4.2.2

In the whole clinical trial

400

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

Lo Sponsor valuterà se sia opportuno proseguire la somministrazione di MPDL3280A ai pazienti assegnati a tale trattamento dopo la valutazione delle misure degli esiti di efficacia primari e secondari e dei dati sulla sicurezza raccolti nello studio.

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

2015-05-21

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2015-06-10

P. End of Trial
P.	End of Trial Status	Prematurely Ended

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IMP with orphan designation in the indication
Orphan Designation Number:
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