Clinical Trials Register

Summary
EudraCT Number:	2022-002586-15
Sponsor's Protocol Code Number:	SOGUG-2020-IEC(VEJ)-11
National Competent Authority:	France - ANSM
Clinical Trial Type:	EEA CTA
Trial Status:	Trial now transitioned
Date on which this record was first entered in the EudraCT database:	2022-11-24
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

France - ANSM

A.2

EudraCT number

2022-002586-15

A.3

Full title of the trial

A Phase 2, open-label, multi-centre, multi-national interventional trial to evaluate the efficacy and safety of erdafitinib (ERDA) monotherapy and erdafitinib (ERDA) and cetrelimab (CET) combination as neoadjuvant treatment in cisplatin-ineligible patients with muscle-invasive bladder cancer (MIBC) whose tumours express FGFR gene alterations.

Essai interventionnel de phase II, en ouvert, multicentrique et multinational destiné à évaluer l'efficacité et la sécurité de l'erdafitinib (ERDA) en monothérapie et de l'association erdafitinib (ERDA) et cétrélimab (CET) en tant que traitement néoadjuvant chez des patients inéligibles au cisplatine atteints de cancer de la vessie invasif sur le plan musculaire (CVIM) dont les tumeurs expriment des altérations du gène FGFR.

A.3.1

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

Erdafitinib (ERDA) alone or in combination with cetrelimab (CET) as neoadjuvant treatment (prior to surgery) in subjects with muscle-invasive bladder cancer (MIBC) whose tumours express FGFR gene alterations and are ineligible for receiving cisplatin treatment

Erdafitinib (ERDA) seul ou en association avec cetrelimab (CET) comme traitement néoadjuvant (avant la chirurgie) chez les sujets atteints d'un cancer de la vessie invasif sur le plan musculaire (MIBC) dont les tumeurs expriment des altérations du gène du FGFR et qui ne sont pas éligibles pour recevoir un traitement au cisplatine.

A.3.2

Name or abbreviated title of the trial where available

SOGUG-NEOWIN TRIAL

ESSAI SOGUG-NEOWIN

A.4.1

Sponsor's protocol code number

SOGUG-2020-IEC(VEJ)-11

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	Spanish Oncology Genito Urinary Group (SOGUG)
B.1.3.4	Country	Spain
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	Janssen Pharmaceutica NV
B.4.2	Country	Belgium
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Spanish Oncology Genito Urinary Group (SOGUG)
B.5.2	Functional name of contact point	Isabel Grau Miró
B.5.3	Address:
B.5.3.1	Street Address	Velázquez 7
B.5.3.2	Town/ city	Madrid
B.5.3.3	Post code	28001
B.5.3.4	Country	Spain
B.5.4	Telephone number	+34610286915
B.5.6	E-mail	trialmanager@sogug.es

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	Cetrelimab
D.3.2	Product code	JNJ-63723283
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	Cetrelimab
D.3.9.1	CAS number	2050478-92-5
D.3.9.2	Current sponsor code	JNJ-63723283
D.3.9.3	Other descriptive name	JNJ-63723283
D.3.9.4	EV Substance Code	SUB193853
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	30
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	Yes
D.3.11.13.1	Other medicinal product type	It is a fully human immunoglobulin G4(IgG4) kappa monoclonal antibody (mAb)
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	Balversa
D.2.1.1.2	Name of the Marketing Authorisation holder	Janssen Biotech Inc.
D.2.1.2	Country which granted the Marketing Authorisation	United States
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	Erdafitinib
D.3.2	Product code	JNJ-42756493
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	Erdafitinib
D.3.9.1	CAS number	1346242-81-6
D.3.9.2	Current sponsor code	JNJ-42756493
D.3.9.3	Other descriptive name	JNJ-42756493
D.3.9.4	EV Substance Code	SUB192453
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	up to
D.3.10.3	Concentration number	8
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

Muscle-invasive bladder cancer (MIBC)

Cancer de la vessie invasif sur le plan musculaire (MIBC)

E.1.1.1

Medical condition in easily understood language

Bladder cancer that spreads beyond the inner lining of the bladder and into the muscle layer

Cancer de la vessie qui se propage au-delà de la paroi interne de la vessie et dans la couche musculaire.

E.1.1.2

Therapeutic area

Diseases [C] - Cancer [C04]

MedDRA Classification

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 assess the antitumor activity measured as pT0N0 rate, defined as no evidence of residual disease based on pathological review of the surgical specimen
•To assess the percentage of pathological downstaging response

• Évaluer l'activité antitumorale mesurée en tant que taux de pT0N0, défini comme aucune preuve de maladie résiduelle basée sur l'examen pathologique de l'échantillon chirurgical.
• Évaluer le pourcentage de réponse de downstaging pathologique .

E.2.2

Secondary objectives of the trial

•To evaluate the percentage of tumour downstaging
•To estimate the event-free survival (EFS)
•To estimate the overall survival (OS).
•To evaluate the Objective Response Rate (ORR) after neoadjuvant treatment
•To assess the safety profile and tolerability of both schemes
•To calculate the rate of delay of surgery.

• Évaluer le pourcentage de downstaging tumoral, défini comme TNM pathologique inférieur au TNM clinique.
• Estimer le taux de survie sans événement (SSE), défini comme la progression de la maladie, le décès ou tout événement empêchant la réalisation de la CR, y compris l'initiation de tout traitement supplémentaire avant la CR.
• Estimer la survie globale (SG).
• Évaluer le taux de réponse objective (TRO) selon RECIST v1.1 chez les patients après traitement néoadjuvant (avant CR).
• Évaluer le profil de sécurité et la tolérabilité des deux schémas d'erdafitinib seul et en association avec le cétrélimab.
• Calculer le taux de retard de la chirurgie.

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

Biomarkers Analysis

Analyse des biomarqueurs

E.3

Principal inclusion criteria

1)Written informed consent stating that he or she understands the purpose of the study and the procedures involved and agrees to participate in the study.
2)Histologically confirmed diagnosis of MIBC (Stage T2-4a N0/N1 M0) obtained via a diagnostic or maximal TURBT performed no later than 3 months prior to start the screening visit.
3)Pure or predominant (≥50%) UC histology as determined at the local site.
4)Age ≥ 18 years.
5)Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
6)Decline or ineligible (“unfit”) for cisplatin-based chemotherapy
7)Presence of a selected FGFR alteration on analysis of tumour biopsy
8)Adequate organ function
9)No other malignancy
10)Willingness to avoid pregnancy or fathering children

1) Consentement éclairé écrit indiquant qu'il ou elle comprend le but de l'étude et les procédures impliquées et accepte de participer à l'étude.
2) Diagnostic histologiquement confirmé de CVIM (stade T2-4a N0/N1 M0) obtenu via une RTTV diagnostique ou maximale effectuée au plus tard 3 mois avant le début de la visite de sélection.
3) Histologie de CU pure ou prédominante (≥50 %) telle que déterminée sur le centre local.
4) Âge ≥ 18 ans.
5) Statut de 0 ou 1 du score de l'indice de performance ECOG (Eastern Cooperative Oncology Group).
6) Refus ou inéligibilité (« inapte ») à la chimiothérapie à base de cisplatine telle
7) Présence d'une altération sélectionnée du FGFR à l'analyse de la biopsie tumorale, montrant l'une des neuf aberrations basées sur le panel Qiagen Therascreen FGFR (Tableau 1). Les rapports locaux basés sur des tests validés peuvent être acceptés (avec confirmation ultérieure auprès de Qiagen Therascreen). Les patients ayant des tests locaux positifs n'auront pas à attendre la confirmation pour être inclus. Tous les patients doivent envoyer un échantillon de tumeur pour le test Qiagen Therascreen. En cas de divergences, la détermination locale prévaudra.
8) Fonction organique adéquate dans les 14 jours suivant le traitement et avant le Jour 1 du Cycle 1 (prise en charge médicale autorisée)
9) Aucune autre tumeur maligne (diagnostic au cours des 3 dernières années), à l'exception du cancer de la peau non mélanome traité (basal ou épidermoïde), du carcinome in situ du col de l'utérus et du cancer de la prostate à faible risque.
10) Volonté d'éviter une grossesse ou de concevoir un enfant

E.4

Principal exclusion criteria

1)Clinical evidence of N2-N3 tumours or metastatic bladder cancer.
2)Has tumour with any neuroendocrine or small cell component.
3)Patients who are not considered fit for cystectomy or reject cystectomy.
5)Prior FGFR-targeted or antiPD1/PDL1 systemic therapy.
6)Prior systemic therapy, radiation therapy, or surgery for bladder cancer

1) Preuve clinique de tumeurs N2-N3 ou de cancer de la vessie métastatique.
2) Présence d'une tumeur avec un composant neuroendocrinien ou à petites cellules.
3) Patients qui ne sont pas considérés comme aptes à la cystectomie ou qui refusent la cystectomie.
4) Patients présentant des comorbidités qui les empêcheront de bénéficier de l'intervention à l'essai.
5) Thérapie systémique antérieure ciblant le FGFR ciblé ou anti-PD1/PDL1.
6) La thérapie systémique, radiothérapie ou chirurgie antérieure pour le cancer de la vessie autre que la résection transurétrale de la tumeur de la vessie (RTTV) ou les biopsies ne sont pas autorisées. Un BCG antérieur ou un autre traitement intravésical non destiné au CVIM est autorisé s'il est terminé au moins 6 semaines avant le début du traitement à l'étude.

E.5 End points

E.5.1

Primary end point(s)

Primary endpoint(s)
•Pathological complete response (pCR).
•Pathological downstaging <ypT2.

Critère(s) d'évaluation principal(s)
-Réponse complète pathologique (RCP).
-Déclassement pathologique <ypT2.

E.5.1.1

Timepoint(s) of evaluation of this end point

After a maximum of 30 weeks from the start of treatment (First Follow- up visit ) on specimens obtained during radical cystectomy.

Après un maximum de 30 semaines à compter du début du traitement (première visite de suivi) sur des échantillons obtenus lors d'une cystectomie radicale.

E.5.2

Secondary end point(s)

Secondary endpoints
•Rate of pathological downstaging (pDS)
•Event-free Survival rate.
•OS.
•ORR according to RECIST, after neoadjuvant treatment.
•Adverse events.
•Rate of delay of surgery (classed as a delay event if performed > 6 weeks after last dose of treatment).

Critères d'évaluation secondaires
-Taux de déclassement pathologique (pDS)
Taux de survie sans événement
-Survie générale
Taux de réponse objective selon RECIST, après traitement néoadjuvant -Evénements indésirables
-Événements indésirables
-Taux d'intervention chirurgicale retardée (considérée comme retardée si l'intervention est effectuée >6 semaines après la dernière dose de traitement).

E.5.2.1

Timepoint(s) of evaluation of this end point

During treatment and follow-up period.

Pendant le traitement et la période de suivi.

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

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

France

Spain

Italy

United Kingdom

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

LVLS

Dernière visite du dernier sujet recruté

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

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)

None

Aucun

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

2023-03-31

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2023-02-03

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

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