Clinical Trials Register

Summary
EudraCT Number:	2017-003038-98
Sponsor's Protocol Code Number:	BeyPro2
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
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

Expand All Collapse All

A. Protocol Information

A.1

Member State Concerned

Italy - Italian Medicines Agency

A.2

EudraCT number

2017-003038-98

A.3

Full title of the trial

An evaluation of the efficacy beyond progression of vemurafenib combined with cobimetinib associated with local treatment compared to second-line treatment in patients with BRAFV600 mutation-positive metastatic melanoma in focal progression with first-line combined vemurafenib and cobimetinib.

Valutazione dell’efficacia oltre la progressione di malattia di vemurafenib in combinazione con cobimetinib associati al trattamento locale rispetto ad un trattamento di seconda linea in pazienti con melanoma metastatico positivo per mutazione di BRAFV600 in progressione focale con vemurafenib e cobimetinib in combinazione in prima linea.

A.3.1

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

To evaluate the efficacy beyond progression of vemurafenib combined with cobimetinib associated with local treatment compared to second-line treatment in patients with BRAFV600 mutation-positive metastatic melanoma in focal progression with first-line combined vemurafenib and cobimetinib.

Studio per valutare l’efficacia oltre la progressione di malattia di vemurafenib in combinazione con cobimetinib associati al trattamento locale rispetto ad un trattamento di seconda linea in pazienti con melanoma metastatico positivo per mutazione di BRAFV600 in progressione focale con vemurafenib e cobimetinib in combinazione in prima linea.

A.3.2

Name or abbreviated title of the trial where available

A.4.1

Sponsor's protocol code number

BeyPro2

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	INTERGRUPPO MELANOMA ITALIANO
B.1.3.4	Country	Italy
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Roche S.p.A.
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	OPIS s.r.l.
B.5.2	Functional name of contact point	Dipartimento Medico
B.5.3	Address:
B.5.3.1	Street Address	Palazzo Aliprandi, Via Matteotti 10
B.5.3.2	Town/ city	Desio (MB)
B.5.3.3	Post code	20832
B.5.3.4	Country	Italy
B.5.4	Telephone number	003903626331
B.5.5	Fax number	00390362633633
B.5.6	E-mail	osservatorio@opis.it

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	ZELBORAF - 240 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - BLISTER (ALU/ALU) 56 COMPRESSE
D.2.1.1.2	Name of the Marketing Authorisation holder	ROCHE REGISTRATION GmbH
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	-
D.3.2	Product code	[-]
D.3.4	Pharmaceutical form	Film-coated tablet
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	VEMURAFENIB
D.3.9.1	CAS number	918504-65-1
D.3.9.2	Current sponsor code	RO5185426
D.3.9.4	EV Substance Code	SUB32161
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	240
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	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	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	COTELLIC
D.2.1.1.2	Name of the Marketing Authorisation holder	ROCHE REGISTRATION GmbH
D.2.1.2	Country which granted the Marketing Authorisation	European Union
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	-
D.3.2	Product code	[-]
D.3.4	Pharmaceutical form	Film-coated tablet
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	COBIMETINIB
D.3.9.1	CAS number	934660-93-2
D.3.9.2	Current sponsor code	RO5514041
D.3.9.4	EV Substance Code	SUB122319
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	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	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	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	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	OPDIVO - 10 MG/ML- CONCENTRATO PER SOLUZIONE PER INFUSIONE- USO ENDOVENOSO- FLACONCINO (VETRO)- 10 ML- 1 FLACONCINO
D.2.1.1.2	Name of the Marketing Authorisation holder	BRISTOL-MYERS SQUIBB PHARMA EEIG
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	-
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	nivolumab
D.3.9.2	Current sponsor code	nivolumab
D.3.9.3	Other descriptive name	nivolumab
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	10
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: 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	KEYTRUDA - 50 MG- POLVERE PER CONCENTRATO PER SOLUZIONE PER INFUSIONE- USO ENDOVENOSO- FLACONCINO (VETRO) 1 FLACONCINO
D.2.1.1.2	Name of the Marketing Authorisation holder	MERCK SHARP & DOHME LIMITED
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	-
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	pembrolizumab
D.3.9.2	Current sponsor code	pembrolizumab
D.3.9.3	Other descriptive name	pembrolizumab
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

BRAFV600 mutation-positive metastatic melanoma in focal progression

Melanoma metastatico positivo per mutazione di BRAFV600 in progressione focale

E.1.1.1

Medical condition in easily understood language

Metastatic melanoma

Melanoma metastatico

E.1.1.2

Therapeutic area

Diseases [C] - Cancer [C04]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	21.1
E.1.2	Level	LLT
E.1.2	Classification code	10053571
E.1.2	Term	Melanoma
E.1.2	System Organ Class	100000004864

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

The primary objective of the study is to evaluate the efficacy, in terms of overall survival, of vemurafenib combined with cobimetinib associated with local treatment compared with second-line therapy in patients with BRAFV600 mutation-positive metastatic melanoma in focal progression with first-line combined vemurafenib and cobimetinib.

L’obiettivo primario dello studio è di valutare l’efficacia, in termini di sopravvivenza globale, di vemurafenib in combinazione con cobimetinib associati al trattamento locale rispetto alla terapia di seconda linea in pazienti con melanoma metastatico positivo per mutazione di BRAFV600 in progressione focale con vemurafenib e cobimetinib in combinazione in prima linea.

E.2.2

Secondary objectives of the trial

- To compare progression-free survival of patients receiving treatment beyond focal progression vs second-line treatment;
- To compare the adverse event profiles in patients receiving treatment beyond progression vs. second-line treatment;
- To evaluate the prognostic role of focal versus non-focal progressive disease.

- Confrontare la sopravvivenza libera da progressione (Progression Free Survival - PFS) per i pazienti che hanno ricevuto il trattamento oltre la progressione focale rispetto al trattamento di seconda linea;
- Confrontare i profili degli eventi avversi nei pazienti che hanno ricevuto il trattamento oltre la progressione rispetto al trattamento di seconda linea;
- Valutare il ruolo prognostico di malattia progressiva focale rispetto a non focale.

E.2.3

Trial contains a sub-study

Yes

E.2.3.1

Full title, date and version of each sub-study and their related objectives

Other types of substudies
Specify title, date and version of each substudy with relative objectives: Ancillary biomarker study, version 2.0 date 15th november 2017
Objective: to provide more information on how bloodstream proteins and/or genes affect the possible response or lack of response to treatment, so that new therapeutic options can be identified or developed for patients.

Altre tipologie di sottostudi
specificare il titolo, la data e la versione di ogni sottostudio con i relativi obiettivi: Sottostudio sui biomarkers, versione 2.0 del 15.11.2017.
Obiettivo: fornire ulteriori informazioni sul modo in cui le proteine e o i geni presenti nel sangue influiscono sulla possibile riposta o mancata risposta al trattamento in studio, in modo da poter individuare o sviluppare nuove opzioni terapeutiche per i pazienti.

E.3

Principal inclusion criteria

- Patients with histologically confirmed melanoma, either unresectable Stage IIIc or Stage IV metastatic melanoma, as defined by the American Joint Committee on Cancer 7th edition;
- Patients previously untreated for metastatic melanoma;
- Documentation of BRAFV600 mutation-positive status in melanoma tumor tissue (archival or newly obtained tumor samples) by a validated mutational test;
- Adequate performance status to receive vemurafenib and cobimetinib therapy as determined by treating physician.

- Pazienti con melanoma confermato istologicamente, Stadio IIIc non resecabile o Stadio IV, come definito dall’American Joint Committee on Cancer 7° edizione;
- Pazienti non trattati precedentemente per melanoma metastatico;
- Documentazione di stato mutazionale positivo per BRAFV600 nel tessuto tumorale del melanoma (di archivio oppure ottenuto ex-novo) tramite test mutazionale validato;
- Performance status adeguato a ricevere la terapia con vemurafenib o cobimetinib a giudizio del medico che ha in cura il paziente.

E.4

Principal exclusion criteria

Cancer-related exclusion criteria:
1. Palliative radiotherapy within 7 days prior to the first dose of program treatment.
2. Patients with active malignancy (other than BRAF-mutated melanoma) or a previous malignancy within the past 3 years except for patients with resected melanoma, resected BCC, resected cutaneous SCC, resected melanoma in situ, resected carcinoma in situ of the cervix, and resected carcinoma in situ of the breast.
Exclusion criteria based on organ function:
Ocular:
3. Evidence of retinal pathology on ophthalmologic examination that is considered a risk factor for neurosensory retinal detachment / central serous chorioretinopathy (CSCR), retinal vein occlusion (RVO), or neovascular macular degeneration.
4. Systemic risk factor for RVO including uncontrolled glaucoma, uncontrolled hypercholesterolemia, hypertriglyceridemia or hyperglycemia.
Cardiac:
5. History of clinically significant cardiac dysfunction, including the following:
a) Current unstable angina.
b) Symptomatic congestive heart failure of New York Heart Association class 2 or higher.
c) History of congenital long QT syndrome or mean (average of triplicate measurements) QTcF = 450 msec at baseline; presence of clinically significant ventricular or atrial dysrhythmias = Grade 2.
d) Uncontrolled hypertension = Grade 2 (patients with a history hypertension controlled with anti-hypertensives to = Grade 1 are eligible).
e) Left ventricular ejection fraction (LVEF) below institutional lower limit of normal (LLN) or below 50%, whichever is lower.
General exclusion criteria:
6. Current severe, uncontrolled systemic disease.
7. Major surgery or traumatic injury within 14 days prior to first dose of program treatment.
8. History of malabsorption or other condition that would interfere with absorption of program drugs.
9. Hypersensitivity to the active substance or to any of the excipients.
10. Pregnant or breastfeeding women.

Criteri di esclusione correlati al tumore:
1.Radioterapia palliative nei 7 giorni precedenti la somministrazione della prima dose di trattamento in studio.
2. Pazienti con patologia maligna attiva (diversa dal melanoma con mutazione di BRAF) o pregressa patologia maligna nei 3 anni precedenti ad eccezione dei pazienti con melanoma resecato, BCC resecato, SCC cutaneo resecato, melanoma in situ resecato, carcinoma in situ della cervice resecato e carcinoma mammario in situ resecato.
Criteri di esclusione basati sulla funzionalità d’organo:
Oculari:
3. Evidenza di patologia retinica all’esame oftalmologico che sia considerata come un fattore di rischio per distacco della retina neurosensoriale / corioretinopatia sierosa centrale (Central Serous Chorioretinopathy - CSCR) / occlusione venosa retinica (Retinal Vein Occlusion - RVO), o degenerazione maculare neovascolare.
4. Fattore di rischio sistemico per RVO compresi glaucoma non controllato, ipercolesterolemia non controllata, ipertrigliceridemia o iperglicemia.
Cardiaci:
5. Anamnesi di disfunzione cardiaca clinicamente significativa, compresi i seguenti:
a) Attuale angina instabile
b) Scompenso cardiaco congestizio sintomatico di classe New York Heart Association 2 o superiore
c) Anamnesi di sindrome congenita del QT lungo o QTcF medio (media di triplice misurazione) = 450 msec al basale; presenza di aritmie ventricolari o atriali clinicamente significative = Grado 2
d) Ipertensione non controllata = Grado 2 (i pazienti con anamnesi di ipertensione controllata con anti-ipertensivi a = Grado 1 sono eleggibili)
e) Frazione di eiezione ventricolare sinistra (Left Ventricular Ejection Fraction – LVEF) al di sotto del limite di normalità inferiore (Lower Limit of Normal – LLN) istituzionale o inferiore al 50%, a seconda di quale dei due sia più basso
Criteri di esclusione generali:
6. Attuale patologia sistemica severa non controllata
7. Intervento chirurgico maggiore o danno traumatico nei 14 giorni precedenti la somministrazione della prima dose di trattamento in studio.
8. Anamnesi di malassorbimento o altra condizione che può interferire con l’assorbimento dei trattamenti in studio.
9. Ipersensibilità alla sostanza attiva o ad uno qualsiasi dei suoi eccipienti.
10. Donne in gravidanza o allattamento.

E.5 End points

E.5.1

Primary end point(s)

The primary endpoint is Overall Survival (OS) for patients with focal progression.

L’endpoint primario è la sopravvivenza globale (Overall Survival – OS) per i pazienti con progressione focale.

E.5.1.1

Timepoint(s) of evaluation of this end point

From the day of randomization to the day of death from any cause.

Dal giorno della randomizzazione al giorno della morte per qualsiasi causa.

E.5.2

Secondary end point(s)

Progression Free Survival (PFS) for patients with focal progression. ; OS for patients with non-focal progression.; Prognostic role in terms of OS of focal compared with non-focal progressive disease. ; Safety based on the following variables: Nature, frequency, severity, and timing of adverse events and serious adverse events; Changes in vital signs, physical findings and clinical laboratory results during and following vemurafenib + cobimetinib administration.

Sopravvivenza libera da progressione (Progression Free Survival - PFS) per i pazienti con progressione focale.; OS per i pazienti con progressione non focale.; Ruolo prognostico in termini di OS di malattia progressiva focale rispetto a non focale ; Sicurezza basata sulle seguenti variabili: Natura, frequenza, severità e tempistiche degli eventi avversi e degli eventi avversi seri; variazioni nei segni vitali, negli esiti fisici e nei risultati di laboratorio clinico durante e dopo la somministrazione di vemurafenib + cobimetinib.

E.5.2.1

Timepoint(s) of evaluation of this end point

From the day of randomization to the day of disease progression or death from any cause.; During the study; During the study; During the study

Dal giorno della randomizzazione al giorno della progressione della malattia o della morte per qualsiasi causa.; Durante lo studio; Durante lo studio; Durante lo studio

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

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

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

Yes

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

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 the study will occur when all patients have been followed up for survival for 24 months after the last patient has been randomized, or after the last dose of vemurafenib and cobimetinib (for non-randomized patients).

La fine dello studio si verificherà quando tutti i pazienti saranno stati osservati per la sopravvivenza per 24 mesi dopo la randomizzazione dell’ultimo paziente o dopo l’ultima dose di vemurafenib e cobimetinib (per i pazienti non randomizzati).

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

120

F.4.2

For a multinational trial

F.4.2.1

In the EEA

120

F.4.2.2

In the whole clinical trial

120

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)

Immunotherapy and other treatments for metastatic melanoma; best supportive care.

Immunoterapia e altri trattamenti per il melanoma metastatico; best supportive care.

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

2017-10-03

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2017-11-23

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2023-12-12

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