Clinical Trials Register

Summary
EudraCT Number:	2020-001973-66
Sponsor's Protocol Code Number:	ML42243
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2021-06-17
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

Italy - Italian Medicines Agency

A.2

EudraCT number

2020-001973-66

A.3

Full title of the trial

A PHASE IIIB, SINGLE ARM, MULTICENTER STUDY OF ATEZOLIZUMAB (TECENTRIQ) IN COMBINATION WITH BEVACIZUMAB TO INVESTIGATE SAFETY AND EFFICACY IN PATIENTS WITH UNRESECTABLE HEPATOCELLULAR CARCINOMA NOT PREVIOUSLY TREATED WITH SYSTEMIC THERAPY - AMETHISTA

STUDIO DI FASE IIIB, A SINGOLO BRACCIO, MULTICENTRICO, SU ATEZOLIZUMAB (TECENTRIQ) IN ASSOCIAZIONE A BEVACIZUMAB PER VALUTARE LA SICUREZZA E L’EFFICACIA IN PAZIENTI AFFETTI DA CARCINOMA EPATOCELLULARE NON OPERABILE, NON PRECEDENTEMENTE TRATTATO CON TERAPIA SISTEMICA - AMETHISTA

A.3.1

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

STUDY TO EVALUATE SAFETY AND EFFICACY OF ATEZOLIZUMAB IN COMBINATION WITH BEVACIZUMAB IN PATIENTS WITH UNRESECTABLE HEPATOCELLULAR CARCINOMA NOT PREVIOUSLY TREATED WITH SYSTEMIC THERAPY

STUDIO PER VALUTARE LA SICUREZZA E L’EFFICACIA DI ATEZOLIZUMAB IN ASSOCIAZIONE A BEVACIZUMAB IN PAZIENTI AFFETTI DA CARCINOMA EPATOCELLULARE NON OPERABILE, NON PRECEDENTEMENTE TRATTATO CON TERAPIA SISTEMICA

A.3.2

Name or abbreviated title of the trial where available

AMETHISTA

A.4.1

Sponsor's protocol code number

ML42243

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 SPA
B.1.3.4	Country	Italy
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 SpA
B.4.2	Country	Italy
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Roche SpA
B.5.2	Functional name of contact point	Medical Affairs&Clinical Operations
B.5.3	Address:
B.5.3.1	Street Address	Viale G.B. Stucchi 110
B.5.3.2	Town/ city	Monza
B.5.3.3	Post code	20900
B.5.3.4	Country	Italy
B.5.4	Telephone number	0392475070
B.5.5	Fax number	0392474086
B.5.6	E-mail	italy.info_cta@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-EU/1/17/1220/001
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.3.9.1	CAS number	1380723-44-3
D.3.9.2	Current sponsor code	R05541267
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.3.11 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.IMP: 2
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Avastin
D.2.1.1.2	Name of the Marketing Authorisation holder	Roche Registration GmbH - EU/1/04/300/002
D.2.1.2	Country which granted the Marketing Authorisation	Italy
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	[-]
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	Bevacizumab
D.3.9.1	CAS number	216974-75-3
D.3.9.2	Current sponsor code	-
D.3.9.3	Other descriptive name	Bevacizumab
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	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

Unresectable hepatocellular carcinoma (HCC)

Carcinoma epatocellulare (HCC) non resecabile

E.1.1.1

Medical condition in easily understood language

Unresectable hepatocellular carcinoma (HCC)

Carcinoma epatocellulare (HCC) non resecabile

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	21.0
E.1.2	Level	LLT
E.1.2	Classification code	10019829
E.1.2	Term	Hepatocellular carcinoma recurrent
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 safety of atezolizumab + bevacizumab in terms of bleeding/haemorrhage

Valutare la sicurezza di atezolizumab + bevacizumab in termini di sanguinamento/emorragia

E.2.2

Secondary objectives of the trial

- To evaluate the efficacy of atezolizumab + bevacizumab
- To further evaluate the safety of atezolizumab + bevacizumab
- To evaluate Patient Reported Outcomes (PROs) and to describe the patient’s experience while receiving atezolizumab + bevacizumab
- To evaluate whether the patterns of tumor progression (growth versus new lesion, intrahepatic versus extrahepatic) have a different impact on OS and PPS
- To evaluate if post-study treatment have impact on OS
- To evaluate if reason of treatment withdrawal has impact on OS
- Gut Microbiome evaluation

- Valutare l'efficacia di atezolizumab + bevacizumab
- Valutare ulteriormente la sicurezza di atezolizumab + bevacizumab
- Valutare gli esiti riferiti dai pazienti (PRO) e descrivere l'esperienza dei pazienti durante il trattamento con atezolizumab + bevacizumab
- Valutare se gli andamenti della progressione del tumore (crescita rispetto a nuova lesione, lesione intraepatica rispetto a extraepatica) influiscono diversamente sulla OS e sulla PPS
- Valutare se il trattamento post-studio influisce sulla OS
- Valutare se il motivo del ritiro dal trattamento influisce sulla OS
- Valutazione del microbioma intestinale

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

• Signed Informed Consent Form;
• Age >=18 years at time of signing Informed Consent Form;
• Ability to comply with the study protocol, in the investigator's judgment;
• Unresectable HCC with diagnosis confirmed by histology, with a biopsy within 6 months from recruitment;
• Disease that is not amenable to curative surgical and/or locoregional therapies, or progressive disease after surgical and /or locoregional therapies;
• No prior systemic therapy (including systemic investigational agents) for HCC;
• At least one measurable (per RECIST 1.1) untreated lesion;
• Patients who received prior local therapy (e.g., radiofrequency ablation, percutaneous ethanol or acetic acid injection, cryoablation, high-intensity focused ultrasound, transarterial chemoembolization, transarterial embolization, SIRT etc.) are eligible provided the target lesion(s) have not been previously treated with local therapy or the target lesion(s) within the field of local therapy have subsequently progressed in accordance with RECIST version 1.1;
• ECOG Performance Status of 0 or 1 within 7 days prior to recruitment;
• Child-Pugh class A within 7 days prior to recruitment;

• Modulo di consenso informato firmato.
• Età >=18 anni alla data della firma del modulo di consenso informato.
• Capacità di rispettare il protocollo dello studio, secondo il giudizio dello sperimentatore.
• HCC non resecabile con diagnosi confermata istologicamente, con una biopsia nei 6 mesi precedenti all’arruolamento.
• Malattia non assoggettabile a terapie chirurgiche e/o locoregionali curative o malattia in progressione dopo le terapie chirurgiche e/o locoregionali.
• Nessuna terapia sistemica precedente (compresi farmaci sperimentali sistemici) per l'HCC.
• Almeno una lesione misurabile (secondo i criteri RECIST 1.1) non trattata.
• I pazienti che sono stati sottoposti a terapia locale precedente (per es. ablazione in radiofrequenza, iniezione percutanea di etanolo o acido acetico, crioablazione, ultrasuoni focalizzati ad alta intensità, chemioembolizzazione transarteriosa, embolizzazione transarteriosa, SIRT, ecc.) sono idonei purché la lesione o le lesioni bersaglio non siano state trattate in precedenza con terapia locale o purché la lesione o le lesioni bersaglio all'interno del campo della terapia locale abbiano successivamente mostrato progressione secondo la versione 1.1 dei criteri RECIST.
• Performance Status secondo l'ECOG di 0 o 1 nei 7 giorni precedenti al reclutamento.
• Classe Child-Pugh A nei 7 giorni precedenti all'arruolamento.

E.4

Principal exclusion criteria

• History of leptomeningeal disease or brain metastases;
• Active or history of autoimmune disease or immune deficiency, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain-Barré syndrome, or multiple sclerosis, with the following exceptions:
Patients with a history of autoimmune-related hypothyroidism who are on thyroid replacement hormone are eligible for the study.
Patients with controlled Type 1 diabetes mellitus who are on an insulin regimen are eligible for the study.
Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis are excluded) are eligible for the study provided all of following conditions are met:
- Rash must cover < 10% of body surface area;
- Disease is well controlled at baseline and requires only low-potency topical corticosteroids;
- No occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high potency or oral corticosteroids within the previous 12 months;
• History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan;
History of radiation pneumonitis in the radiation field (fibrosis) is permitted.
• Known active tuberculosis;
• Significant cardiovascular disease (such as New York Heart Association Class II or greater cardiac disease, myocardial infarction, or cerebrovascular accident) within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina;
• History of congenital long QT syndrome or corrected QT interval >500 ms (calculated with use of the Fridericia method) at screening;
• History of uncorrectable electrolyte disorder affecting serum levels of potassium, calcium, or magnesium;
• Major surgical procedure, other than for diagnosis, within 4 weeks prior to initiation of study treatment, or anticipation of need for a major surgical procedure during the study.

• Anamnesi di malattia leptomeningea o metastasi cerebrali.
• Presenza in atto o anamnesi di malattia autoimmune o immunodeficienza, comprese, ma non solo, miastenia grave, miosite, epatite autoimmune, lupus eritematoso sistemico, artrite reumatoide, malattia infiammatoria intestinale, sindrome da anticorpi antifosfolipidi, granulomatosi di Wegener, sindrome di Sjögren, sindrome di Guillain-Barré o sclerosi multipla, con le seguenti eccezioni:
I pazienti che presentano anamnesi di ipotiroidismo correlato a malattia autoimmune, trattati con una terapia sostitutiva a base di ormoni tiroidei, sono idonei allo studio.
I pazienti affetti da diabete di tipo 1 controllato, trattati con un regime insulinico, sono idonei allo studio.
I pazienti con eczema, psoriasi, lichen simplex cronico o vitiligine con manifestazioni solo dermatologiche (per es. i pazienti con artrite psoriasica sono esclusi) sono idonei allo studio purché soddisfino tutte le seguenti condizioni:
- L'eruzione cutanea deve coprire <10% della superficie corporea.
- La malattia è ben controllata al basale e necessita solo di corticosteroidi topici a bassa potenza.
- Nessuna esacerbazione acuta della condizione pre-esistente, che necessiti di psoralen più radiazioni con raggi ultravioletti A, metotrexato, retinoidi, farmaci biologici, inibitori orali della calcineurina oppure corticosteroidi ad alta potenza o orali negli ultimi 12 mesi.
• Anamnesi di fibrosi polmonare idiopatica, polmonite organizzativa (per es. bronchiolite obliterante), polmonite indotta da farmaco o polmonite idiopatica oppure evidenza di polmonite attiva rilevabile con la tomografia computerizzata (TAC) al torace eseguita allo screening.
È ammessa l'anamnesi di polmonite da radioterapia nel campo irradiato (fibrosi).
• Tubercolosi attiva accertata.
• Malattia cardiovascolare significativa (quale malattia cardiaca di classe II o più elevata secondo la New York Heart Association, infarto miocardico o accidente cerebrovascolare) nei 3 mesi precedenti all'inizio del trattamento in studio, aritmia instabile o angina instabile.
• Anamnesi di sindrome congenita del QT lungo o intervallo QT corretto >500 ms (calcolato con il metodo di Fridericia) allo screening.
• Anamnesi di disturbo elettrolitico non correggibile, che altera i livelli sierici di potassio, calcio o magnesio.
• Procedura chirurgica maggiore non diagnostica nelle 4 settimane precedenti all'inizio del trattamento in studio o previsione di necessità di una procedura chirurgica maggiore durante lo studio.

E.5 End points

E.5.1

Primary end point(s)

Incidence of Grade 3-5 NCI CTCAE v.5 bleeding/haemorrhage

Incidenza di sanguinamento/emorragia di grado 3-5 secondo NCI CTCAE v.5.0

E.5.1.1

Timepoint(s) of evaluation of this end point

An interim analysis of safety will be performed at the time of 50 recruited patients, estimated to occur at approximately 6 months after FPI.
The primary analysis of the safety endpoints and secondary endpoints will be undertaken once all patients have completed the study treatment phase and safety follow-up.

Sarà eseguita un'analisi ad interim sulla sicurezza quando saranno stati reclutati 50 pazienti, che si stima corrisponderà a circa 6 mesi dopo l'arruolamento del primo paziente (first patient in, FPI).
L'analisi primaria degli endpoint sulla sicurezza e degli endpoints secondari sarà eseguita quando tutti i pazienti avranno completato la fase di trattamento dello studio e il follow-up della sicurezza.

E.5.2

Secondary end point(s)

- Overall survival (OS), defined as the time from initiation of study treatment to death from any cause
- Incidence and severity of adverse events (AEs), with severity determined according to NCI CTCAE v5.0
- Vital signs
- Clinical laboratory test results
- Patient self-reported symptomatic Adverse Events (AEs) using National Cancer Institute's Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
- OS and PPS based on the following patterns of progression:
- >20% increase in tumor size against a known baseline lesion (intrahepatic growth [IHG] or extrahepatic growth [EHG])
- new intrahepatic tumor lesion (NIH) >10 mm
- new extrahepatic lesion (NEH) and/or vascular invasion
- OS based on type and duration of each post-study treatments
- OS based on the following reasons of treatment withdrawal:
-Progressive disease (PD) vs AEs vs deteriorating liver function/clinical conditions
- Relationship between the gut microbiome and antitumour responses following atezolizumab and bevacizumab

- Sopravvivenza globale (OS), definita come il periodo di tempo trascorso dall'inizio del trattamento in studio fino al decesso per qualsiasi causa
- Incidenza e gravità degli eventi avversi (EA), con la gravità determinata secondo NCI CTCAE v5.0
- Segni vitali
- Risultati delle analisi cliniche di laboratorio
- Eventi avversi (EA) sintomatici auto-riferiti dai pazienti utilizzando la versione dei Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) del National Cancer Institute.
- OS e PPS in base ai seguenti andamenti della progressione:
- >20% di aumento della dimensione del tumore rispetto a una lesione basale nota (crescita intraepatica [IHG] o crescita extraepatica [EHG])
- nuova lesione intraepatica (NIH)
- nuova lesione extraepatica (NEH) e/o invasione vascolare
- OS in base al tipo e alla durata di ciascun trattamento post-studio

- OS in base ai seguenti motivi di ritiro dal trattamento:
- Malattia in progressione (PD) rispetto a EA rispetto a deterioramento della funzionalità epatica/delle condizioni cliniche
- Correlazione tra il microbioma intestinale e le risposte antitumorali a seguito del trattamento con atezolizumab e bevacizumab

E.5.2.1

Timepoint(s) of evaluation of this end point

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

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

E.8.1.6

Cross over

E.8.1.7

Other

Yes

E.8.1.7.1

Other trial design description

a singolo braccio

single arm

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

Information not present in EudraCT

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 study will occur when all enrolled patients have either died, withdrawn consent, are lost to follow up, or have been followed for 36 months since the last study patient is enrolled, whichever occurs first.

Lo studio terminerà quando tutti i pazienti arruolati saranno deceduti, avranno ritirato in consenso, saranno persi al follow-up o saranno stati seguiti per 36 mesi dall'arruolamento dell'ultimo paziente dello studio, a seconda di quale termine venga raggiunto per primo.

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:

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

F.2 Gender

F.2.1

Female

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

150

F.4.2

For a multinational trial

F.4.2.1

In the EEA

150

F.4.2.2

In the whole clinical trial

150

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 offer continued access to Roche IMP (atezolizumab and bevacizumab) free of charge to eligible patients in accordance with the Roche Global Policy

Lo Sponsor continuerà a fornire gratuitamente atezolizumab e bevacizumab a tutti i pazienti eleggibili in accordo alla Policy Roche

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

2020-07-16

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2020-06-24

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

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IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
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