Clinical Trials Register

Summary
EudraCT Number:	2021-000336-55
Sponsor's Protocol Code Number:	D5086C00001
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2021-06-23
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

Spain - AEMPS

A.2

EudraCT number

2021-000336-55

A.3

Full title of the trial

A Phase III, Open Label, Randomised, 3 Arm, Multi Centre Study of Savolitinib plus Durvalumab versus Sunitinib and Durvalumab Monotherapy in Participants with MET Driven, Unresectable and Locally Advanced or Metastatic Papillary Renal Cell Carcinoma (PRCC) (SAMETA)

Estudio fase III, abierto, aleatorizado y multicentrico con 3 grupos de tratamiento de savolitinib más durvalumab frente a sunitinib y durvalumab en monoterapia en participantes con carcinoma de células renales papilares (CCRP) irresecable y localmente avanzado o metastásico causado por mutación en MET (SAMETA)

A.3.1

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

A clinical trial to compare the effectiveness of savolitinib plus durvalumab relative to sunitinib for the treatment of renal cell cancer.

Ensayo clínico para comparar la eficacia de savolitinib más durvalumab en relación con sunitinib para el tratamiento del carcinoma de células renales.

A.3.2

Name or abbreviated title of the trial where available

SAMETA

A.4.1

Sponsor's protocol code number

D5086C00001

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	AstraZeneca AB
B.1.3.4	Country	Sweden
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	AstraZeneca AB
B.4.2	Country	Sweden
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	AstraZeneca
B.5.2	Functional name of contact point	Information Center
B.5.3	Address:
B.5.3.1	Street Address	N/A
B.5.3.2	Town/ city	N/A
B.5.3.3	Post code	N/A
B.5.3.4	Country	United States
B.5.6	E-mail	information.center@astrazeneca.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	Savolitinib
D.3.2	Product code	AZD6094, HMPL-504
D.3.4	Pharmaceutical form	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	savolitinib
D.3.9.1	CAS number	1313725-88-0
D.3.9.2	Current sponsor code	AZD6094
D.3.9.3	Other descriptive name	1-[(S)-1-(imidazo[1,2-a]pyridin-6-yl)ethyl]-6-(1-methyl-1H-pyrazol-4-yl)-1H-[1,2,3]-triazolo[4,5-b]pyrazine
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	200
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	Durvalumab
D.3.2	Product code	MEDI4736
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	durvalumab
D.3.9.1	CAS number	1428935-60-7
D.3.9.2	Current sponsor code	MEDI4736
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	50
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	Yes
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 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	Sutent 25 mg hard capsules
D.2.1.1.2	Name of the Marketing Authorisation holder	Pfizer Europe MA EEIG
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.3.4	Pharmaceutical form	Capsule, hard
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	sunitinib malate
D.3.9.1	CAS number	341031-54-7
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	25
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	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	Sutent 12.5 mg hard capsules
D.2.1.1.2	Name of the Marketing Authorisation holder	Pfizer Europe MA EEIG
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.3.4	Pharmaceutical form	Capsule, hard
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	sunitinib malate
D.3.9.1	CAS number	341031-54-7
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	12.5
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

MET-driven, unresectable and locally advanced or metastatic Papillary Renal Cell Carcinoma

Carcinoma de células renales papilares (CCRP) irresecable y localmente avanzado o metastásico causado por mutación en MET

E.1.1.1

Medical condition in easily understood language

unresectable and locally advanced or metastatic renal cell cancer

carcinoma de células renales irresecable y localmente avanzado o metastásico

E.1.1.2

Therapeutic area

Diseases [C] - Cancer [C04]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	PT
E.1.2	Classification code	10078493
E.1.2	Term	Papillary renal cell carcinoma
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

To demonstrate the effectiveness of savolitinib plus durvalumab relative to sunitinib by assessment of progression-free survival (PFS) in participants with MET-driven, unresectable and locally advanced or metastatic PRCC.

Demostrar la eficacia de savolitinib más durvalumab en relación con sunitinib mediante la evaluación de la SSP en participantes con CCRP irresecable y localmente avanzado o metastásico causado por mutación en MET.

E.2.2

Secondary objectives of the trial

a. To demonstrate the effectiveness of savolitinib plus durvalumab relative to sunitinib in participants with MET-driven, unresectable and locally advanced or metastatic PRCC by the assessment of :
- overall survival (OS)
- objective response rate (ORR)
- duration of response (DoR)
- disease control rate (DCR) at 24 and 48 weeks
- time from randomisation to second progression or death (PFS2)

b. To demonstrate the effectiveness of savolitinib plus durvalumab relative to durvalumab monotherapy in participants with MET-driven, unresectable and locally advanced or metastatic PRCC by assessment of :
- ORR
- DoR
- PFS

c. To assess patient-reported symptoms, functioning, and HRQoL in participants with MET-driven, unresectable and locally advanced or metastatic PRCC treated with savolitinib plus durvalumab relative to sunitinib

d. To evaluate the PK of savolitinib and durvalumab in participants with MET-driven, unresectable and locally advanced or metastatic PRCC.

a.Demostrar la eficacia de savolitinib más durvalumab en relación con sunitinib mediante la evaluación de la:
-SG
-TRO
-DR
-TCE a las 24 y 48 semanas
-SSP2
b.Demostrar la eficacia de savolitinib más durvalumab en relación con durvalumab en monoterapia mediante la evaluación de:
-TRO
-SSP
-DR
c. Evaluar los síntomas notificados por el paciente, el funcionamiento y la CdVRS en participantes con CCRP irresecable y localmente avanzado o metastásico causado por mutación en MET tratados con savolitinib más durvalumab en relación con sunitinib.
d. Evaluar la FC de savolitinib y durvalumab en participantes con CCRP irresecable y localmente avanzado o metastásico causado por mutación en MET.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

• Histologically confirmed unresectable and locally advanced or metastatic PRCC
• PRCC must be centrally confirmed as MET-driven using a sponsor-designated central laboratory validated NGS assay
• No prior systemic anti-cancer treatment in the metastatic setting; no prior exposure to MET inhibitors, Durvalumab or Sunitinib in any setting
• Karnofsky Score >70
• At least one lesion, not previously irradiated, that can be accurately measured at baseline
• Adequate organ and bone marrow function
• Life expectancy ≥12weeks at Day 1

- CCRP irresecable y localmente avanzado o metastásico, confirmado histológicamente
- Entrega obligatoria de una muestra tumoral FFIP para evaluar el CCRP causado por mutación en MET sin mutación de FH concomitante utilizando el análisis de NGS validado por el laboratorio central designado por el promotor
- Participantes que no han recibido previamente ningún tratamiento antineoplásico sistémico en el contexto metastásico, ni exposición previa a inhibidores de MET, durvalumab o sunitinib en ningún contexto
- Estado funcional de Karnofsky ≥70
- Al menos una lesión, no irradiada previamente, que se pueda medir con precisión al inicio
- Función adecuada de los órganos y de la médula
- Esperanza de vida de 12 semanas

E.4

Principal exclusion criteria

• History of serious liver disease, with or without, normal LFTs, such as cirrhosis or Wilson’s disease
• Spinal cord compression or brain metastases, unless asymptomatic and stable on treatment for at least 14 days prior to study intervention
• Active or prior cardiac disease (within past 6 months) or clinically significant ECG abnormalities and/or factors/medications that may affect QT and/or QTc intervals
• Active infection including HIV, TB, HBV and HCV
• Active or prior documented autoimmune or inflammatory disorders
• Receipt of live attenuated vaccine within 30 days prior to the first dose of study intervention

- Antecedentes de hepatopatía grave, con o sin PFH normales, como cirrosis o enfermedad de Wilson
- Compresión de la médula espinal o metástasis cerebrales, a menos que sean asintomáticas y estén estables con tratamiento al menos 14 días antes del inicio de la intervención del estudio
- Enfermedades cardíacas en la actualidad o en los últimos 6 meses
- Infección activa por VHB, VHC, tuberculosis o VIH
- Antecedentes de inmunodeficiencia primaria activa
- Administración de vacunas atenuadas de microorganismos vivos en los 30 días anteriores a la primera dosis de la intervención del estudio

E.5 End points

E.5.1

Primary end point(s)

PFS is defined as time from randomisation until disease progression per RECIST 1.1 as assessed by blinded independent central review (BICR), or death due to any cause.

La supervivencia sin progresión se define como el tiempo transcurrido desde la aleatorización hasta la progresión según los criterios RECIST 1.1, según lo evaluado mediante RCIE, o la muerte por cualquier causa.

E.5.1.1

Timepoint(s) of evaluation of this end point

PFS: disease progression or death
PFS is planned to be analyzed at approximately 28 months after the first patient randomized (DCO1).

SSP: progresión o muerte de la enfermedad
SSP: se prevé analizar aproximadamente 28 meses después de la aleatorización del primer paciente.

E.5.2

Secondary end point(s)

a. and b. :
- OS is defined as time from randomisation until the date of death due to any cause.
- ORR is defined as the proportion of participants who have a complete response (CR) or partial response (PR) as determined by BICR per RECIST 1.1.
- DoR will be defined as the time from the date of first documented response until date of documented progression per RECIST 1.1 as assessed by BICR or death due to any cause.
- DCR at 24 or 48 weeks is defined as the percentage of participants who have a CR or PR or who have stable disease (SD) per RECIST 1.1 as assessed by BICR for at least 23 or 47 weeks, respectively after randomisation.
- PFS2 will be defined as time from randomisation to the earliest of the progression event (following the initial progression), subsequent to the first subsequent therapy or death.
- PFS is defined as time from randomisation until disease progression per RECIST 1.1 as assessed by blinded independent central review (BICR), or death due to any cause.

c. Time to deterioration and change from baseline in symptoms, functioning, and HRQoL as measured by FKSI-19.

d. The measures of interest are as follows:
- participants randomised to savolitinib plus durvalumab : plasma concentration of savolitinib and its metabolites pre-dose (Ctrough) and post-dose (C1h and C3h), serum concentration of durvalumab pre-dose (Ctrough) and at the end of infusion (Cmax)
- participants randomised to durvalumab monotherapy : serum concentration of durvalumab pre-dose (Ctrough) and at the end of infusion (Cmax)

a y b:
- SG La supervivencia global se define como el tiempo transcurrido desde la fecha de aleatorización hasta la fecha de la muerte por cualquier causa.
-TRO La tasa de respuesta objetiva se define como la proporción de participantes que presentan una RC o RP según lo determinado mediante RCIE en base a los criterios RECIST 1.1.
- La duración de la respuesta se definirá como el tiempo transcurrido desde la fecha de la primera respuesta documentada hasta la fecha de la progresión documentada según los criterios RECIST 1.1, según lo evaluado mediante RCIE o la muerte por cualquier causa.
- La tasa de control de la enfermedad a las 24 o 48 semanas se define como el porcentaje de participantes que presentan una RC o RP o que presentan EE según los criterios RECIST 1.1 según lo evaluado mediante RCIE durante al menos 23 o 47 semanas, respectivamente, después de la aleatorización.
- El tiempo desde la aleatorización hasta la segunda progresión o la muerte se define como el tiempo transcurrido desde la fecha de aleatorización hasta la fecha más temprana del acontecimiento de progresión (tras la progresión inicial), después del primer tratamiento posterior o la muerte.
- La tasa de respuesta objetiva y su medida de interés se definen como se indicó anteriormente.
c. Tiempo hasta el deterioro y cambio desde el inicio en los síntomas, el funcionamiento y la CdVRS según lo medido por el FKSI‐19.
d. Las medidas de interés son las siguientes:
Concentración plasmática de savolitinib y sus metabolitos antes de la dosis (Cmín.) y después de la dosis (C1h y C3h) en los participantes aleatorizados a savolitinib más durvalumab.
Concentración sérica de durvalumab antes de la dosis (Cmín.) y al final de la infusión (Cmáx.) en los participantes aleatorizados a savolitinib más durvalumab o durvalumab en monoterapia.

E.5.2.1

Timepoint(s) of evaluation of this end point

a. and b. :
- OS: date of death
- ORR: first objective response (complete or partial)
- DoR: first documented response until date of documented progression or death
- DCR : 24 or 48 weeks after randomization
- PFS2: the earliest of progression event subsequent to first subsequent therapy or death
- PFS: disease progression or death
These are planned to be analyzed at approximately 28 months after the first patient randomized (DCO1). In addition, for OS secondly once OS data has reached planned, approximately 42 months post first subject randomized (DCO2).

c. Day 1 of each cycle
d. Please refer to the schedule of activities in the study protocol
"c" and "d" are planned to be analyzed at approximately 28 months after the first patient randomized (DCO1).

a. y b. :
-SG: fecha de muerte
-TRO: primera respuesta objetiva (completa o parcial)
-DR: primera respuesta documentada hasta la fecha de progresión documentada o muerte
-TC: 24 o 48 semanas después de la aleatorización
-TA2P: el primero de los eventos de progresión después de la primera terapia posterior o la muerte
-TAP: progresión de la enfermedad o muerte

c. día 1 de cada ciclo
d. Consulte el calendario de actividades del protocolo de estudio
Se prevé que "c" y "d" se analicen aproximadamente 28 meses después de la aleatorización del primer paciente

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

Yes

E.6.11

Pharmacogenomic

Yes

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

Yes

E.8.1.6

Cross over

Yes

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

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

Australia

Brazil

Canada

Chile

China

Hong Kong

India

Israel

Korea, Republic of

Mexico

Russian Federation

Singapore

Taiwan

Turkey

Ukraine

United States

France

Germany

Italy

Netherlands

Poland

Romania

Spain

United Kingdom

Czechia

Argentina

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

last visit of the last participant in the study

última visita del último paciente en el estudio

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:

120

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

Yes

F.3.3.6.1

Details of subjects incapable of giving consent

Adult participant with authorised legal representative

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

200

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)

After the final DCO for this trial (DCO2), Sponsor will be able to continue to supply trial intervention (ie, savolitinib plus durvalumab, durvalumab monotherapy, sunitinib, or savolitinib monotherapy [if durvalumab was stopped earlier]) to subjects who are ongoing on those treatments at DCO2 as long as, in the opinion of the investigator, they are still receiving clinical benefit or until meeting any other discontinuation criteria. They will be monitored according to routine clinical practice.

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

2021-10-05

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2021-07-12

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

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IMP with orphan designation in the indication
Orphan Designation Number:
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