Clinical Trials Register

Summary
EudraCT Number:	2017-000794-37
Sponsor's Protocol Code Number:	WO39760
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2019-09-04
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

2017-000794-37

A.3

Full title of the trial

A PHASE II, OPEN-LABEL, MULTICENTER, MULTI-COHORT STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF COBIMETINIB PLUS ATEZOLIZUMAB IN PATIENTS WITH SOLID TUMORS

ESTUDIO DE FASE II ABIERTO, MULTICÉNTRICO Y CON VARIAS COHORTES PARA INVESTIGAR LA EFICACIA Y SEGURIDAD DE COBIMETINIB CON ATEZOLIZUMAB EN PACIENTES CON TUMORES SÓLIDOS

A.3.1

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

A Study to Investigate the Efficacy and Safety of Cobimetinib plus Atezolizumab in Patients with Solid Tumors

Estudio para investigar la eficacia y seguridad de Cobimetinib con Atezolizumab en pacientes con tumores sólidos

A.4.1

Sponsor's protocol code number

WO39760

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. Hoffman-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	+34913257300
B.5.6	E-mail	spain.start_up_unit@roche.com

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Cobimetinib (GDC-0973)
D.3.2	Product code	RO5514041/F04
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 (GDC-0973)
D.3.9.1	CAS number	934660-93-2
D.3.9.2	Current sponsor code	RO5514041
D.3.9.3	Other descriptive name	COBIMETINIB, GDC-0973/XL518
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	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 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	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	RO5541267/F03
D.3.4	Pharmaceutical form	Solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	ATEZOLIZUMAB
D.3.9.2	Current sponsor code	RO5541267
D.3.9.3	Other descriptive name	MPDL3280A
D.3.9.4	EV Substance Code	SUB178312
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	60
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 3
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	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	Cobimetinib (GDC-0973)
D.3.2	Product code	RO5514041/F09
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 (GDC-0973)
D.3.9.1	CAS number	934660-93-2
D.3.9.2	Current sponsor code	RO5514041
D.3.9.3	Other descriptive name	COBIMETINIB, GDC-0973/XL518
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	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 4
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 Limited
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 and solvent for solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	ATEZOLIZUMAB
D.3.9.2	Current sponsor code	RO5541267
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	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.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

Solid tumors

Tumores sólidos

E.1.1.1

Medical condition in easily understood language

Solid tumors are masses of abnormal tissue growth that originate in organs or soft tissues and do not include fluid areas and cysts

Los tumores sólidos son masas de tejido de crecimiento anormal originados en órganos o téjidos blandos y no incluide en áreas líquidas y quistes

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	10065252
E.1.2	Term	Solid tumor
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 cobimetinib plus atezolizumab by objective response rate (ORR)

Evaluar la eficacia de cobimetinib con atezolizumab según la Tasa de respusta Objetiva (TRO)

E.2.2

Secondary objectives of the trial

To evaluate the efficacy of cobimetinib plus atezolizumab by OS, PFS, DOR and DCR
To evaluate the safety of cobimetinib plus atezolizumab
To characterize cobimetinib and atezolizumab pharmacokinetics
To evaluate the immune response to atezolizumab

-Evaluar la eficacia de cobimetinib con atezolizumab según Supervivencia global (SG), Supervivencia sin progresión (SSP), Duración de la respuesta (DdR) y tasa de control de la enfermedad (TCE)
-Evaluar la seguridad de cobimetinib con atezolizumab
-Describir la farmacocinética de cobimetinib y atezolizumab
-Evaluar la respuesta inmunitaria a atezolizumab

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

General Inclusion Criteria:
- Age >=18 years
- Ability to comply with the study protocol, in the investigator's judgment
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
- Life expectancy >=3 months, as determined by the investigator
- Adequate hematologic and end-organ function
Cancer-Related Inclusion Criteria:
- Patients must have measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) scan per RECIST v1.1.
- Availability to provide a representative tumor specimen biopsy. For patients with SCCHN or RCC, histologic samples are required. For patients with UC, cytological or histologic samples are acceptable.
- Evidence of tumor progression on or after the last treatment regimen received and within 6 months prior to study enrollment
- For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use a non-hormonal contraceptive method with a failure rate of < 1% per year during the treatment period and for at least 5 months after the last dose of atezolizumab and within 3 months after the last dose of cobimetinib. Women must refrain from donating eggs during this same period.
- For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm during the treatment period and for at least 3 months after the last dose of cobimetinib

Criterios de Inclusión generales:
- Edad >=18 años
-Capacidad para cumplir con el protocolo del estudio a juicio del investigador
-ECOG de 0 o 1
- Esperanza de vida >= 3 meses según lo determinado por el investigador
-Función hemática y del órgano afectado adecuada
Criterios de inclusión relacionados con el cáncer:
-Los pacientes deben presentar enfermedad cuantificable por TAC o RM conforme a los Criterios de evaluación de la respuesta en tumores sólidos (RECIST v. 1.1).
-Disponibilidad para facilitar una biopsia tumoral representativa.En los pacientes con CECC o CCR, se necesitan muestras histológicas. En los pacientes con CU, se aceptan muestras citológicas o histológicas.
-Indicios de progresión tumoral durante el último régimen de tratamiento recibido o después en los 6 meses anteriores a la inclusión en el estudio
-En las mujeres en edad fértil: acceder a practicar la abstinencia (evitar las relaciones sexuales con varones) o utilizar un método anticonceptivo no hormonal con una tasa de fallos < 1 % anual durante el período de tratamiento y durante al menos 5 meses tras la última dosis de atezolizumab y 3 meses tras la última dosis de cobimetinib. Las mujeres deben abstenerse de donar óvulos durante dicho periodo
-Para los hombres: acceder a mantener la abstinencia (evitar las relaciones heterosexuales completas) o a utilizar métodos anticonceptivos y acceder a no donar semen durante el periodo de tratamiento y en los 3 meses posteriores a la última dosis de cobimetinib

E.4

Principal exclusion criteria

General Exclusion Criteria:
- Inability to swallow medications
- Malabsorption condition that would alter the absorption of orally administered medications
- Poor peripheral venous access
- Prior treatment with cobimetinib or a MEK inhibitor
- For patients in Cohorts 1, 2, and 3 only: prior treatment with T-cell co-stimulating or immune checkpoint blockade therapies, including anti−CTLA-4, anti−PD-1, and anti−PD-L1 therapeutic antibodies
- Treatment with investigational therapy within 14 days prior to initiation of study treatment
- Any anti-cancer therapy, including chemotherapy or hormonal therapy, within 2 weeks prior to initiation of study treatment
- History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
- Known hypersensitivity to biopharmaceutical agents produced in Chinese hamster ovary cells or any component of the atezolizumab formulation, or any component of the cobimetinib formulation or hypersensitivity to any anti–PD-1/PD-L1 therapy
- History of serous retinopathy, retinal vein occlusion (RVO), or evidence of ongoing serous retinopathy or RVO at baseline
- 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
- Uncontrolled tumor-related pain
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage more than once every 28 days
- Uncontrolled hypercalcemia (ionized calcium > 1.5 mmol/L, calcium > 12 mg/dL, or corrected calcium greater than the ULN) or symptomatic hypercalcemia requiring continued use of bisphosphonate therapy
- Active or untreated CNS metastases
- Pregnancy or breastfeeding, or intending to become pregnant during the study
Exclusion Criteria based on Organ Function or Medical History Cardiovascular
Patients who meet the following cardiovascular exclusion criterion will be excluded from study entry:
•Left ventricular ejection fraction (LVEF) below the institutional lower limit of normal or < 50%, whichever is lower Infections
Patients who meet any of the following infection exclusion criteria will be excluded from study entry:
•Positive HIV test at screening
•Active hepatitis B virus (HBV) infection (chronic or acute)
•Active hepatitis C virus (HCV) infection
•Active tuberculosis
•Severe infection within 4 weeks prior to initiation of study treatment, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia
•Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study treatment

Criterios de exclusión generales
• Incapacidad de tragar medicamentos. Podrán permitirse otros medios de ingestión tras la obtención de la aprobación del supervisor médico.
• Problemas de absorción que alterarían la absorción de los medicamentos administrados por vía oral
• Mal acceso venoso periférico
• Tratamiento anterior con cobimetinib o un inhibidor de MEK
• En los pacientes de las cohortes 1, 2 y 3 solamente: tratamiento anterior con bloqueo de puntos de control inmunitario o coestimuladores de linfocitos T, incluidos los anticuerpos terapéuticos anti-CTLA-4, anti-PD-1 y anti-PD-L1
• Tratamiento con fármacos experimentales en los 14 días anteriores al inicio del tratamiento del estudio
• Cualquier tratamiento antineoplásico, incluidas la quimioterapia y la hormonoterapia, en las 2 semanas anteriores al inicio del tratamiento del estudio
• Antecedentes de reacciones alérgicas, anafilácticas u otras reacciones de hipersensibilidad graves a anticuerpos híbridos o humanizados o proteínas de fusión
• Hipersensibilidad conocida a los fármacos biológicos producidos en células de ovario de hámster chino, a cualquier componente de la formulación de atezolizumab ó a cualquier componente de la formulación de cobimetinib o hipersensibilidad conocida al cualquier tratamiento anti-PD-1/PD-L1
• Antecedentes de retinopatía serosa grave, oclusión de las venas retinianas (OVR) o evidencias de retinopatía serosa en curso u OVR en el momento basal
• Procedimiento quirúrgico importante para fines distintos al diagnóstico en las 4 semanas anteriores al inicio del tratamiento del estudio o previsión de necesitar un procedimiento quirúrgico importante durante el transcurso del estudio
• Dolor no controlado relacionado con el tumor
• Derrame pleural incontrolado, derrame pericárdico o ascitis que requieran procedimientos de drenaje recurrentes más de una vez cada 28 días
• Hipercalcemia no controlada (calcio ionizado > 1,5 mmol/l, calcio > 12 mg/dl o calcio corregido superior al LSN) o hipercalcemia sintomática que requiera el uso continuado de tratamiento con bifosfonatos.
• Metástasis en el SNC activas o sin tratar
• Embarazo o lactancia, o intención de quedarse embarazada durante el estudio
*Criterios de exclusión basados en la función orgánica o el historial clínico,
Los pacientes que cumplan estos criterios cadiovasculares de exlucusión deben ser excluidos del estudio:
• Fracción de eyección ventricular izquierda (FEVI) por debajo del límite inferior de la normalidad del centro o < 50 %, el valor que sea más bajo
Infecciones:
• Prueba del VIH positiva en la selección
• Infección por virus de la hepatitis B (VHB) activa (crónica o aguda)
• Infección por el virus de la hepatitis C (VHC) activa
• Tuberculosis activa
• Infección grave en las 4 semanas anteriores al inicio del tratamiento del estudio, incluidas, entre otras, la hospitalización por complicaciones de una infección, bacteriemia o neumonía grave
• Tratamiento con antibióticos terapéuticos por vía oral o i.v. en las 2 semanas anteriores al inicio del tratamiento del estudio

E.5 End points

E.5.1

Primary end point(s)

1. Objective response

1. Respuesta Objetiva

E.5.1.1

Timepoint(s) of evaluation of this end point

1. Up to 3 years

1. hasta 3 años

E.5.2

Secondary end point(s)

1. Overall survival
2. Progression-free survival
3. Duration of response (DOR)
4. Disease control rate (DCR)
5. Occurrence and severity of adverse events, with severity determined according to the NCI CTCAE v4.0
6. Change from baseline in targeted vital signs
7. Change from baseline in targeted clinical laboratory test results
8. Plasma concentration of cobimetinib at specified timepoints
9. Serum concentration of atezolizumab at specified timepoints
10. Presence of ADAs during the study relative to the presence of ADAs at baseline

1. SUpervivencia Global
2. Supervivencia libre de progresión
3. Duración de la respuesta (DdR)
4. Tasa de control de la enfermedad (TCE)
5. Aparición de acontecimientos adversos y su intensidad, con la intensidad determinada mediante los criterios CTCAE del NCI v4.0
6. Alteraciones desde el momento basal en constantes vitales específicas
7. Alteraciones desde el momento basal en resultados analíticos clínicos específicos
8. Concentración plasmática de cobimetinib en puntos temporales específicos
9. Concentración sérica de atezolizumab en puntos temporales específicos
10. Presencia de AAF durante el estudio en relación con la prevalencia de AAF en el momento basal

E.5.2.1

Timepoint(s) of evaluation of this end point

1-7. Up to 3 years
8. Day 15 of Cycle 3
9-10. Day 1 (Cohorts 1-6 only), Day 15 (Cohort 7 only) of Cycle 1; Day 1 of Cycles 2, 4, 8, 12, and 16; Day 15 of Cycle 3; at atezolizumab treatment discontinuation visit, and <90 days after last atezolizumab infusion

1-7 Hasta 3 años
8. Día 15 de ciclo 3
9-10 Día 1 (solo Cohortes 1-6), Día 15 (solo Cohorte 7) de Ciclo 1, Día 1 de ciclos 2,4,8,12 y 16; Día 15 de Ciclo 3; en la visita de discontinuación de Atezolizumab y <90 días después de la última infusión de atezolizumab

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

Yes

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

E.8.1.1

Randomised

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

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

Belgium

Germany

Greece

Hungary

Korea, Republic of

Spain

United Kingdom

United States

E.8.7

Trial has a data monitoring committee

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

The study will end when all patients enrolled have been followed until death, withdrawal of consent, loss to follow-up, or the Sponsor decides to end the trial, whichever occurs first. Patients may continue study treatment until the development of progressive
disease, unacceptable toxicity, and/or withdrawal of consent.

El estudio concluirá cuando todos los pacientes incluidos hayan sido sometidos a seguimiento hasta su muerte, la revocación del consentimiento, la pérdida durante el seguimiento o la decisión del promotor de poner fin al ensayo, lo que suceda primero. Los pacientes podrán continuar con el tratamiento del estudio hasta la aparición de enfermedad progresiva, toxicidad inaceptable o la retirada del consentimiento

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:

166

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

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

F.4.2.2

In the whole clinical trial

250

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)

Currently, the Sponsor does not have any plans to provide cobimetinib, atezolizumab or any other study treatments or interventions to patients who have completed the study. The Sponsor may evaluate whether to continue providing treatment in accordance with the Roche Global Policy on Continued Access to Investigational Medicinal Product, available at the following Web site: http://www.roche.com/policy_continued_access_to_investigational_medicines.pdf

Actualmente, el Promotor no tiene palnes de porporcionar cobimetinib, Atezolizumab o cualquier otro tratamiento del estudio o intervenciones a pacientes que han completado el estudio. El promotor puede evaluar si continuar roporcionando tratamiento de acuerdo con la Política global de Roche sobre acceso continuo a productos medicinales en investigación, disponible en la siguiente web:
http://www.roche.com/policy_continued_access_to_investigational_medicines.pdf

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

2019-09-02

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2019-07-12

P. End of Trial
P.	End of Trial Status	Completed

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IMP with orphan designation in the indication
Orphan Designation Number:
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