Clinical Trials Register

Summary
EudraCT Number:	2021-002563-22
Sponsor's Protocol Code Number:	2020/538
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:	2021-05-19
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

2021-002563-22

A.3

Full title of the trial

Spartalizumab, mDCF (docetaxel, cisplatin and 5-fluorouracil) and radiotherapy in patients with metastatic squamous cell anal carcinoma.
A Phase IIA study

Spartalizumab, mDCF (docetaxel, cisplatine et 5-fluorouracil) et radiothérapie dans le traitement du cancer du canal anal métastatique. Etude de phase IIA.

A.3.1

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

Spartalizumab, mDCF (docetaxel, cisplatin and 5-fluorouracil) and radiotherapy in patients with metastatic squamous cell anal carcinoma.
A Phase IIA study

Spartalizumab, mDCF (docetaxel, cisplatine et 5-fluorouracil) et radiothérapie dans le traitement du cancer du canal anal métastatique. Etude de phase IIA.

A.3.2

Name or abbreviated title of the trial where available

SPARTANA

A.4.1

Sponsor's protocol code number

2020/538

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	CHU de Besançon
B.1.3.4	Country	France
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	INCa CLIP²
B.4.2	Country	France
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation
B.5.2	Functional name of contact point

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.2.1.2	Country which granted the Marketing Authorisation	France
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	spartalizumab
D.3.2	Product code	PDR001
D.3.4	Pharmaceutical form	Solution for injection
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	SPARTALIZUMAB
D.3.9.1	CAS number	1935694-88-4
D.3.9.3	Other descriptive name	PDR001
D.3.9.4	EV Substance Code	SUB191185
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: 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.2.1.1.1	Trade name	DOCETAXEL
D.2.1.1.2	Name of the Marketing Authorisation holder	PFIZER France
D.2.1.2	Country which granted the Marketing Authorisation	France
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	DOCETAXEL
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	DOCETAXEL
D.3.9.1	CAS number	114977-28-5
D.3.9.4	EV Substance Code	SUB12492MIG
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Information not present in EudraCT
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Information not present in EudraCT
	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.2.1.1.1	Trade name	CISPLATINE
D.2.1.1.2	Name of the Marketing Authorisation holder	TEVA SANTE
D.2.1.2	Country which granted the Marketing Authorisation	France
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	CISPLATINE
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	Cisplatin
D.3.9.1	CAS number	15663-27-1
D.3.9.4	EV Substance Code	SUB07483MIG
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Information not present in EudraCT
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	No
D.2.1.1.1	Trade name	5-Fluorouracile
D.2.1.1.2	Name of the Marketing Authorisation holder	PFIZER HOLDING FRANCE
D.2.1.2	Country which granted the Marketing Authorisation	France
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	5-Fluorouracile
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.3.9.1	CAS number	51-21-8
D.3.9.3	Other descriptive name	FLUOROURACIL
D.3.9.4	EV Substance Code	SUB07721MIG
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Information not present in EudraCT
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

metastatic anal canal cancer

cancer du canal anal métastatique

E.1.1.1

Medical condition in easily understood language

metastatic anal canal cancer

cancer du canal anal métastatique

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

The primary objective of this clinical trial is to evaluate the Progression-Free Survival (PFS) rate at 1 year.

Evaluation du taux de survie sans progression (PFS) à 12 mois.

E.2.2

Secondary objectives of the trial

•the objective response rate
•the overall survival
•the Progression Free Survival median
•the complete response rate
•To assess the impact of this combination treatment on patient’s health related quality of life
•To assess the patient’s health related quality of life treated by this combination
•To evaluate the safety of this combination of treatment
•To evaluate the pharmacodynamics of the combination treatment: HPV-specific and telomerase-specific T cell responses before and after treatment in peripheral blood mononuclear cells
•To analyse the tumor genotyping for HPV, p53 and PD-1 expression and to study the correlation of these biomarkers with treatment efficacy
•To characterize the tumor-infiltrating lymphocytes and PD-L1 expression in tumors
•To explore the correlation of both peripheral CD4 anti-telomerase immunity and PD-L1 immunohistochemistry with progression-free survival
•To characterize the prognostic value of circulating HPV DNA on oncological outcomes

Evaluer le taux de réponse objective
-Evaluer la survie globale
-Evaluer la médiane de survie sans progression
-Evaluer le taux de réponse complète
-Evaluer l’impact de cette combinaison de traitement sur la qualité de vie du patient relative à la santé
-Evaluer la toxicité de cette combinaison de traitement
-Evaluer la pharmacodynamie de la combinaison de traitement, par les réponses des cellules T spécifiques anti-HPV et anti-télomérase avant et après traitement dans le sang périphérique
-Analyser le génotypage des tumeurs pour l'expression d’HPV, p53 et PD-1 et étudier la corrélation de ces biomarqueurs avec l'efficacité du traitement
-Caractériser les lymphocytes infiltrant la tumeur et l'expression de PD-L1 dans les tumeurs
-Explorer la corrélation entre l'immunité anti-télomérase CD4 périphérique et de l'immunohistochimie PD-L1 avec la survie sans progression
-Caractériser la valeur pronostique de l'ADN tumoral circulant d’HPV et la réponse au traitement

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Homme ou femme âgé de 18 ans ou plus
2. Statut ECOG ≤ 1
3. Carcinome épidermoïde du canal anal métastatique histologiquement prouvé
4. Présence d'une lésion évaluable par CT-scan/IRM évaluée selon les critères RECIST v1.1
5. Patient éligible à un traitement par DCFm
6. CT scan réalisé dans les 30 jours précédant l’inclusion
7. PET-Scan réalisé dans les 30 jours précédant l’inclusion
8. Espérance de vie ≥ 12 mois
9. Fonction hématologique et fonctionnelle adéquate des organes terminaux : définie par les résultats des tests de laboratoire suivants obtenus dans les 14 jours précédant le début du traitement à l'étude :
10. Consentement éclairé signé
11. Patient affilié ou bénéficiaire de la sécurité sociale française d'assurance maladie (PUMA; La protection Universelle Maladie)
12. Capacité de se conformer au protocole de l’étude, selon l’investigateur

E.4

Principal exclusion criteria

Patient HIV positif avec taux de CD4 < 400 cells/mm3 (le test VIH est obligatoire avant l'inclusion)
2. Antécédent d’une autre tumeur maligne dans les 2 ans précédant l'inclusion, à l'exception des cancers cutanés superficiels ou des tumeurs localisées de bas grade dites guéries et non traitées par un traitement systémique,
3. Tout état/maladie médical ou maladie psychiatrique compromettant la compréhension de l’information ou la réalisation de l’étude,
4. Sujets inclus dans une autre étude interventionnelle avec produit de santé ou étant dans la période d’exclusion d’une autre étude,
5. Patient ayant un reçu un traitement anticancéreux cytotoxique, biologique ou systémique (y compris expérimental) dans les 4 semaines précédant la première dose du traitement à l'étude,
6. Radiothérapie pour les métastases osseuses dans les 2 semaines, toute autre radiothérapie dans les 4 semaines avant la première dose du traitement à l'étude. Traitement systémique par radionucléides dans les 6 semaines précédant la première dose du traitement à l'étude. Les sujets présentant des complications cliniquement pertinentes en cours suite à une radiothérapie antérieure ne sont pas éligibles,
7. Grossesse, allaitement ou absence/refus de contraception adéquate chez les patientes fertiles pendant la période de traitement et pendant 6 mois à compter de la dernière administration de traitement,
8. Patient sous tutelle, curatelle ou sous la protection de la justice,
9. Patient ayant déjà reçu une immunothérapie,
10. Patient ayant déjà reçu une chimiothérapie,
11. Récidive locale ou locorégionale

E.5 End points

E.5.1

Primary end point(s)

12 mois

E.5.1.1

Timepoint(s) of evaluation of this end point

12 mois

E.5.2

Secondary end point(s)

E.5.2.1

Timepoint(s) of evaluation of this end point

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

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

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.8.5.1

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

E.8.6.2

Trial being conducted completely outside of the EEA

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

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	No
F.1.1.1	In Utero	No
F.1.1.2	Preterm newborn infants (up to gestational age < 37 weeks)	No
F.1.1.3	Newborns (0-27 days)	No
F.1.1.4	Infants and toddlers (28 days-23 months)	No
F.1.1.5	Children (2-11years)	No
F.1.1.6	Adolescents (12-17 years)	No
F.1.2	Adults (18-64 years)	No
F.1.3	Elderly (>=65 years)	No
F.2 Gender
F.2.1	Female	No
F.2.2	Male	No
F.3 Group of trial subjects
F.3.1	Healthy volunteers	No
F.3.2	Patients	No
F.3.3	Specific vulnerable populations	No
F.3.3.1	Women of childbearing potential not using contraception	No
F.3.3.2	Women of child-bearing potential using contraception	No
F.3.3.3	Pregnant women	No
F.3.3.4	Nursing women	No
F.3.3.5	Emergency situation	No
F.3.3.6	Subjects incapable of giving consent personally	No
F.3.3.7	Others	No
F.4 Planned number of subjects to be included
F.4.1	In the member state

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

2021-09-13

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2021-06-29

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

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