Clinical Trials Register

Summary
EudraCT Number:	2020-004834-39
Sponsor's Protocol Code Number:	IRST162.14
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Trial now transitioned
Date on which this record was first entered in the EudraCT database:	2022-09-14
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

2020-004834-39

A.3

Full title of the trial

Phase 2 trial of Translational approach to first line cHemo-immunotherapy followed by maintenance with pembrOlizumab and olaparib in Extensive-Stage Small-Cell Lung CanceR

Studio di fase 2 sull'approccio Traslazionale alla cHemoimmunoterapia di prima linea seguito da mantenimento con pembrOlizumab e olaparib nel caRcinoma polmonare a piccole cellule in stadio esteso

A.3.1

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

Treatment of extensive small cell lung cancer (ES-SCLC) with chemo-immunotherapy followed by a maintenance phase with Pembrolizumab and Olaparib.

Trattamento del carcinoma polmonare a piccole cellule in stadio esteso (ES-SCLC) con chemio-immunoterapia seguita da una fase di mantenimento con Pembrolizumab e Olaparib.

A.3.2

Name or abbreviated title of the trial where available

THOR

A.4.1

Sponsor's protocol code number

IRST162.14

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	ISTITUTO SCIENTIFICO ROMAGNOLO PER LO STUDIO E LA CURA DEI TUMORI (IRST) S.R.L. IRCCS
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	Merck Sharp & Dohme (MSD)
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	IRST IRCCS
B.5.2	Functional name of contact point	Centro di Coordinamento studi IRST
B.5.3	Address:
B.5.3.1	Street Address	via P. Maroncelli 40
B.5.3.2	Town/ city	Meldola (FC)
B.5.3.3	Post code	47014
B.5.3.4	Country	Italy
B.5.4	Telephone number	0544287168
B.5.6	E-mail	cc.ubsc@irst.emr.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	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	Olaparib
D.3.2	Product code	[MK-7339]
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.3.9.1	CAS number	763113-22-0
D.3.9.2	Current sponsor code	MK-7339
D.3.9.4	EV Substance Code	SUB32234
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	100
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	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	Olaparib
D.3.2	Product code	[MK-7339]
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.3.9.1	CAS number	763113-22-0
D.3.9.2	Current sponsor code	MK-7339
D.3.9.4	EV Substance Code	SUB32234
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	150
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	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	Keytruda (pembrolizumab, MK-3475)
D.2.1.1.2	Name of the Marketing Authorisation holder	Merck Sharp & Doheme B.V. EU/1/15/1024/002
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	Pembrolizumab
D.3.2	Product code	[MK-3475]
D.3.4	Pharmaceutical form	Solution for injection/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.3.9.1	CAS number	1374853-91-4
D.3.9.2	Current sponsor code	MK-3475
D.3.9.4	EV Substance Code	SUB167136
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)	Yes
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

Extensive-Stage Small-Cell Lung Cancer (ES SCLC)

Carcinoma polmonare a piccole cellule in stadio esteso (ES SCLC)

E.1.1.1

Medical condition in easily understood language

Extensive-Stage Small-Cell Lung Cancer (ES SCLC)

Carcinoma polmonare a piccole cellule in stadio esteso (ES SCLC)

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	10029882
E.1.2	Term	Oat cell carcinoma
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 chemo-immunotherapy induction followed by maintenance with pembrolizumab and olaparib in terms of Progression-free Survival (PFS) from registration.

Valutare l'efficacia dell'induzione della chemio-immunoterapia seguita dal mantenimento con pembrolizumab e olaparib in termini di sopravvivenza libera da progressione (PFS) dalla registrazione.

E.2.2

Secondary objectives of the trial

1. To evaluate the clinical activity as assessed by the overall objective response rate (ORR) and the Immune-related objective response rate (irORR);
2. To evaluate 6, 12 and 24 months Progression-free survival from registration;
3. To evaluate the Overall Survival (OS) from registration;
4. To determine the safety and tolerability of pembrolizumab in combination with chemotherapy and olaparib.
5. Exploratory objectives:to evaluate the PD-L1 expression, DDR alterations, TMB and MSI on biopsy and blood samples collected before, during and after the treatment, and analyse their association with study drugs response, including efficacy and/or adverse events.

1. Valutare l'attività clinica in base al tasso di risposta obiettiva globale (ORR) e al tasso di risposta obiettiva immuno-correlata (irORR);
2. Valutare la sopravvivenza libera da progressione a 6, 12 e 24 mesi dalla registrazione;
3. Valutare la sopravvivenza globale (OS) dalla registrazione;
4. Determinare la sicurezza e la tollerabilità di pembrolizumab in combinazione con la chemioterapia e olaparib.
5. Obiettivi esplorativi: valutare l'espressione di PD-L1, le alterazioni DDR, TMB e MSI su campioni bioptici e di sangue raccolti prima, durante e dopo il trattamento, e analizzare la loro associazione con la risposta ai farmaci in studio, compresa l'efficacia e/o gli eventi avversi.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

• Cytologically/histologically confirmed diagnosis of SCLC per the Veterans Administration Lung Study Group (VALG) staging system will be enrolled in this study. Patients must have extensive stage (ES) SCLC defined as Stage IV (T any, N any, M 1a/b) by the American Joint Committee on Cancer, Eighth Edition.
• Possibility of obtaining sufficient tissue sample, via a biopsy of the primary tumour or metastatic tumour tissue, within the 6 weeks prior to study entry.
• No prior systemic treatment for ES-SCLC.
• ECOG performance status 0-1.
• Adequate organ function
• Negative human immunodeficiency virus (HIV) test at screening.
• Negative total hepatitis B core antibody (HBcAb) test at screening, or positive total HBcAb test followed by a negative hepatitis B virus (HBV) DNA test at screening. The HBV DNA test will be performed only for patients who have a positive total HBcAb test.
• Negative hepatitis C virus (HCV) antibody test at screening, or positive HCV antibody test followed by a negative HCV RNA test at screening. The HCV RNA test will be performed

• Diagnosi di SCLC confermata citologicamente/istologicamente secondo il sistema di stadiazione del Veterans Administration Lung Study Group (VALG). I pazienti devono avere SCLC in stadio esteso (ES) definito come stadio IV (T qualsiasi, N qualsiasi, M 1a/b) dall'American Joint Committee on Cancer, ottava edizione.
• Possibilità di ottenere un campione di tessuto tumorale sufficiente, attraverso una biopsia del tumore primario o del tessuto tumorale metastatico, nelle 6 settimane precedenti l'ingresso nello studio.
• Nessun trattamento sistemico precedente per ES-SCLC.
• ECOG performance status 0-1.
• Funzione d'organo adeguata
• Test del virus dell'immunodeficienza umana (HIV) negativo allo screening.
• Test degli anticorpi totali dell'epatite B (HBcAb) negativo allo screening, oppure test HBcAb totale positivo seguito da un test del DNA del virus dell'epatite B (HBV) negativo allo screening. Il test HBV DNA sarà eseguito solo per i pazienti che hanno un test HBcAb totale positivo.
• Test degli anticorpi del virus dell'epatite C (HCV) negativo allo screening, oppure test degli anticorpi dell'HCV positivo seguito da un test HCV RNA negativo allo screening. Il test HCV RNA sarà eseguito solo per i pazienti che hanno un test anticorpale HCV positivo

E.4

Principal exclusion criteria

• Known active CNS metastases and/or carcinomatous meningitis.
• Active or history of autoimmune disease or immune deficiency which has required systemic treatment in the past 2 years (exceptions listed in the study protocol).
• evidence of active pneumonitis on screening chest CT scan.
• Prior radiotherapy within 2 weeks of start of study intervention.
• Live vaccine within 30 days prior to the first dose of study drug.
• Case of significant cardiovascular disease.
• Major surgical procedure within 4 weeks prior to initiation of study treatment, or anticipation of need for a major surgical procedure during the study.
• History of malignancy other than SCLC within 5 years prior to screening.
• Patient who has received prior therapy with an agent directed to another stimulatory or coinhibitory T-cell receptor (eg, anti-CTLA-4, anti-OX 40, anti-CD137, anti-CD27).
• Treatment with systemic immunostimulatory agents (including, but not limited to, interferon and interleukin 2 [IL-2]) within 4 weeks or 5 drug elimination half-lives (whichever is longer) prior to initiation of study treatment.
• Any previous treatment with a PARP inhibitor, including Olaparib.
• Concomitant use of known strong or moderateCYP3A inhibitors and strong or moderate CYP3A inducers.
• severe hypersensitivity (=Grade 3) to pembrolizumab, olaparib and/or any of their excipients. Known allergy or hypersensitivity to carboplatin or etoposide.

• Metastasi del SNC attive note e/o meningite carcinomatosa.
• Malattia autoimmune attiva o storia di immunodeficienza che ha richiesto un trattamento sistemico negli ultimi 2 anni (eccezioni elencate nel protocollo dello studio).
• Evidenza di polmonite attiva sulla TAC toracica di screening.
• Radioterapia precedente entro 2 settimane dall'inizio del trattamento sperimentale.
• Somministrazione di vaccino vivo entro 30 giorni prima della prima dose di farmaco sperimentale.
• pazienti con storia di malattia cardiovascolare significativa.
• Intervento chirurgico maggiore entro 4 settimane prima dell'inizio del trattamento dello studio, o previsione di intervento chirurgico durante lo studio.
• Storia di tumore maligno diverso dal SCLC nei 5 anni precedenti lo screening.
• Paziente che ha ricevuto una terapia precedente con un agente diretto ad un altro recettore delle cellule T stimolatorio o coinibitorio (es. anti-CTLA-4, anti-OX 40, anti-CD137, anti-CD27).
• Trattamento con agenti immunostimolatori sistemici (inclusi, ma non limitati a, interferone e interleuchina 2 [IL-2]) entro 4 settimane o 5 emivite di eliminazione del farmaco (qualunque sia il più lungo) prima dell'inizio del trattamento dello studio.
• Qualsiasi trattamento precedente con un inibitore PARP, incluso Olaparib.
• Uso concomitante di noti inibitori e induttori forti o moderati del CYP3A .
• Ipersensibilità grave (=grado 3) a pembrolizumab, olaparib e/o a uno qualsiasi dei loro eccipienti. Allergia o ipersensibilità nota al carboplatino o all'etoposide.

E.5 End points

E.5.1

Primary end point(s)

Evaluation of median PFS following the maintenance phase with pembrolizumab and olaparib after first-line treatment with immuno-chemotherapy.

Valutazione della PFS mediana in seguito alla fase di mantenimento con pembrolizumab ed olaparib dopo la prima linea di trattamento con immuno-chemioterapia.

E.5.1.1

Timepoint(s) of evaluation of this end point

About 44 months

Circa 44 mesi

E.5.2

Secondary end point(s)

Evaluation of the percentage of patients who are alive and progression free at 6, 12 (24) months from registration.; Evaluation of safety and toxicity of pebrolizumab in combination with chemotherapy and olaparib. Safety will be eavaluate as the number of participants discontinuing study drugs due to AEs. The toxicity rate will be evaluate as the percentage of patients experiencing a specific adverse event of grade 3-5, according to CTCAE (version 5.0); Evaluation of ORR and ORR according to Immuno-RECIST 1.1 criteria since registration; OS evaluation

Valutazione della percentuale dei pazienti liberi da progressione a 6-12-24 mesi dalla registrazione.; Valutazione della sicurezza e della tossicità di pebrolizumab in combinazione con chemioterapia e olaparib. Il profilo di sicurezza sarà valutata come il numero di partecipanti che discontinuano il trattamento sperimentale a causa di eventi avversi. Il tasso di tossicità sarà valutato come la percentuale di pazienti che sperimentano un evento avverso specifico di grado 3-5, secondo CTCAE (versione 5.0); Valutazione della ORR e della ORR secondo i criteri Immuno-RECIST 1.1 dalla registrazione; Valutazione della sopravvivenza globale (OS)

E.5.2.1

Timepoint(s) of evaluation of this end point

About at 30-36-48 months; About 44 months; About 36 months; About 44 months

A circa 30-36-48 mesi; Circa 44 mesi; Circa 36 mesi; Circa 44 mesi

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

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

studio in aperto, a singolo braccio

open label, 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 trial will be 12 months after the last data capture performed during the last follow up visit.

La conclusione della sperimentazione corrisponde a 12 mesi dopo l'ultima raccolta dati durante l'ultima visita di follow-up .

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

F.4.2

For a multinational trial

F.4.2.1

In the EEA

F.4.2.2

In the whole clinical trial

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)

Patients who discontinue treatment for reasons other than disease progression will enter follow-up phase (clinical, laboratory, and instrumental checks will be performed every 6 weeks until week 48 and every 9 weeks thereafter).
After disease progression or initiation of a new anticancer therapy, patients will be followed up with telephone contacts every 12 weeks until death, withdrawal of consent, or end of study.

I pazienti che discontinuano il trattamento per motivi diversi dalla progressione entreranno in follow-up (controlli clinici, laboratoristici e strumentali ogni 6 settimane fino alla 48ma settimana e successivamente ogni 9 settimane).
Dopo progressione di malattia o inizio di una nuova terapia oncologica i pazienti saranno seguiti con contatti telefonici ogni 12 settimane fino a decesso, ritiro del consenso o fine dello studio.

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2022-10-19

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2022-10-07

P. End of Trial
P.	End of Trial Status	Trial now transitioned

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