Clinical Trials Register

Summary
EudraCT Number:	2020-004027-17
Sponsor's Protocol Code Number:	SGN35-027
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2021-08-02
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

Italy - Italian Medicines Agency

A.2

EudraCT number

2020-004027-17

A.3

Full title of the trial

Multiple Part Clinical Trial of Brentuximab Vedotin in Classical Hodgkin Lymphoma Subjects

Sperimentazione clinica in più parti su brentuximab vedotin in soggetti con linfoma di Hodgkin classico

A.3.1

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

Clinical Trial of Brentuximab Vedotin in Classical Hodgkin Lymphoma

Studio clinico di brentuximab vedotin nel linfoma di Hodgkin classico

A.3.2

Name or abbreviated title of the trial where available

A.4.1

Sponsor's protocol code number

SGN35-027

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT03646123

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	SEAGEN INC.
B.1.3.4	Country	United States
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	Seagen Inc.
B.4.2	Country	United States
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Seagen Inc
B.5.2	Functional name of contact point	Seagen Clinical Trial Information
B.5.3	Address:
B.5.3.1	Street Address	21621- 30th Drive SE, Building 4
B.5.3.2	Town/ city	Bothell
B.5.3.3	Post code	98021
B.5.3.4	Country	United States
B.5.4	Telephone number	000000
B.5.5	Fax number	000000
B.5.6	E-mail	clinicaltrials@seagen.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	Yes
D.2.1.2	Country which granted the Marketing Authorisation	Italy
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	Dacarbazine
D.3.2	Product code	[-]
D.3.4	Pharmaceutical form	Powder for 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.3.8	INN - Proposed INN	DACARBAZINE
D.3.9.1	CAS number	4342-03-4
D.3.9.2	Current sponsor code	Dacarbazine
D.3.9.4	EV Substance Code	SUB06882MIG
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	Yes
D.2.1.2	Country which granted the Marketing Authorisation	Italy
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	Dacarbazine
D.3.2	Product code	[-]
D.3.4	Pharmaceutical form	Powder for 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.3.8	INN - Proposed INN	DACARBAZINE
D.3.9.1	CAS number	4342-03-4
D.3.9.2	Current sponsor code	Dacarbazine
D.3.9.4	EV Substance Code	SUB06882MIG
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	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.2.1.2	Country which granted the Marketing Authorisation	Italy
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	Dacarbazine
D.3.2	Product code	[-]
D.3.4	Pharmaceutical form	Powder for 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.3.8	INN - Proposed INN	DACARBAZINE
D.3.9.1	CAS number	4342-03-4
D.3.9.2	Current sponsor code	Dacarbazine
D.3.9.4	EV Substance Code	SUB06882MIG
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	500
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: 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.2.1.2	Country which granted the Marketing Authorisation	Italy
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	Dacarbazine
D.3.2	Product code	[-]
D.3.4	Pharmaceutical form	Powder for 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.3.8	INN - Proposed INN	DACARBAZINE
D.3.9.1	CAS number	4342-03-4
D.3.9.2	Current sponsor code	Dacarbazine
D.3.9.4	EV Substance Code	SUB06882MIG
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	1000
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: 5
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	ADCETRIS®
D.2.1.1.2	Name of the Marketing Authorisation holder	Seattle Genetics, 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	Yes
D.2.5.1	Orphan drug designation number	EU/3/08/596; EU/3/08/595
D.3 Description of the IMP
D.3.1	Product name	Brentuximab vedotin
D.3.2	Product code	[SGN-35]
D.3.4	Pharmaceutical form	Powder for 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	BRENTUXIMAB VEDOTIN
D.3.9.1	CAS number	914088-09-8
D.3.9.2	Current sponsor code	SGN-35
D.3.9.4	EV Substance Code	SUB32397
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	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	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	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: 6
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	OPDIVO
D.2.1.1.2	Name of the Marketing Authorisation holder	Bristol-Myers Squibb Pharma 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.3.1	Product name	Nivolumab
D.3.2	Product code	[-]
D.3.4	Pharmaceutical form	Concentrate for 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.3.8	INN - Proposed INN	Nivolumab
D.3.9.2	Current sponsor code	-
D.3.9.3	Other descriptive name	NIVOLUMAB
D.3.9.4	EV Substance Code	SUB122750
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	10
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)	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: 7
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.2.1.2	Country which granted the Marketing Authorisation	Italy
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	Doxorubicin
D.3.2	Product code	[Doxorubicin]
D.3.4	Pharmaceutical form	Concentrate for 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.3.8	INN - Proposed INN	Doxorubicin Hydrochloride
D.3.9.2	Current sponsor code	Doxorubicin
D.3.9.4	EV Substance Code	SUB01827MIG
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	2
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.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

Classical Hodgkin Lymphoma

Linfoma di Hodgkin classico

E.1.1.1

Medical condition in easily understood language

Hodgkin Lymphoma

Linfoma di Hodgkin

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	LLT
E.1.2	Classification code	10020328
E.1.2	Term	Hodgkin's lymphoma
E.1.2	System Organ Class	100000004864

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	LLT
E.1.2	Classification code	10020328
E.1.2	Term	Hodgkin's lymphoma
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

Parts B and C: To assess the complete response (CR) rate at EOT with AN+AD in subjects with previously untreated cHL

Parti B e C: Valutare il tasso di risposta completa (CR) a fine trattamento (EOT) con AN+AD in soggetti con linfoma di Hodgkin classico (cHL) precedentemente non trattato

E.2.2

Secondary objectives of the trial

Parts B and C:
To assess the safety and tolerability of AN+AD
- To assess the overall response rate (ORR)
- To assess the duration of response (DOR)
- To assess the duration of complete response (DOCR)
- To assess the event-free survival (EFS)
- To assess the progression-free survival (PFS)
- To assess the overall survival (OS)

Parti B e C:
- Valutare la sicurezza e la tollerabilità di AN+AD
- Valutare il tasso di risposta complessiva (ORR)
- Valutare la durata della risposta (DOR)
- Valutare la durata della risposta completa (DOCR)
- Valutare la sopravvivenza libera da eventi (EFS)
- Valutare la sopravvivenza libera da progressione (PFS)
- Valutare la sopravvivenza complessiva (OS)

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

• Treatment-naïve, cHL subjects:
a. Subjects enrolling in Part B of the study must have Ann Arbor Stage I or II cHL with bulky mediastinal disease, or Stage III or IV disease.
b. Subjects enrolling in Part C of the study must have Ann Arbor Stage I or II cHL without bulky mediastinal disease.
• Histologically confirmed cHL according to the current World Health
Organization Classification.
• Bidimensional measurable disease as documented by PET/CT or CT imaging.
• Age 12 years or older in the United States. For regions outside of the United States, subjects must be age 18 years or older.
• An Eastern Cooperative Oncology Group (ECOG) performance status < = 2.
Other protocol defined inclusion criteria may apply.

• Soggetti con cHL naïve al trattamento:
a. I soggetti che si arruolano nella Parte B dello studio devono presentare cHL allo stadio di Ann Arbor I o II, con malattia massiva del mediastino o malattia allo stadio III o IV.
b. I soggetti che si arruolano nella Parte C dello studio devono presentare cHL allo stadio di Ann Arbor I o II senza malattia massiva del mediastino.
• cHL istologicamente confermato secondo l’attuale Classificazione dell’Organizzazione Mondiale della Sanità.
• Malattia misurabile bidimensionale documentata mediante PET/TC o TC.
• Età pari o superiore a 12 anni negli Stati Uniti. Per le regioni al di fuori degli Stati Uniti, i soggetti devono avere un’età pari o superiore a 18 anni.
• Stato di performance secondo l’Eastern Cooperative Oncology Group (ECOG) <= 2.
Potrebbero applicarsi criteri di inclusione aggiuntivi definiti dal protocollo.

E.4

Principal exclusion criteria

• Nodular lymphocyte predominant HL
• History of another malignancy within 3 years before the first dose of study drug or any evidence of residual disease from a previously
diagnosed malignancy. Exceptions are malignancies with a negligible risk of metastasis or death. Subjects with nonmelanoma skin cancer,
localized prostate cancer, or carcinoma in situ of any type are not excluded if they have undergone complete resection.
• Prior immunosuppressive chemotherapy, therapeutic radiation, or any immunotherapy within 4 weeks of first study drug dose.
• Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, or antiCTLA-4 antibody, or any other antibody or drug specifically targeting Tcell
co-stimulation or checkpoint pathways.
• Active cerebral/meningeal disease related to the underlying malignancy.
• Any active Grade 3 or higher (per the National Cancer Institute's Common Terminology Criteria for Adverse Events [NCI CTCAE] Version
4.03) viral, bacterial, or fungal infection within 2 weeks prior to the first dose of study drug.
• Current therapy with other systemic anti-neoplastic or investigational agents.
• Planned consolidative radiotherapy during the study treatment period (Parts B and C only).
• Active interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary
toxicity (Parts B and C only).
• Grade 3 or higher pulmonary disease unrelated to underlying malignancy.
• Idiopathic interstitial pneumonia or diffusing capacity of the lung for carbon monoxide <50% predicted.
• Documented history of a cerebral vascular event within 6 months prior to their first dose of brentuximab vedotin.
• Subjects with Child-Pugh B or C hepatic impairment.
• Grade 2 or higher peripheral sensory or motor neuropathy at baseline.
• Subjects with acute or chronic graft-versus-host-disease (GvHD) or receiving immunosuppressive therapy as treatment for or prophylaxis
agent against GvHD.
• Previous treatment with brentuximab vedotin.
• Subjects who are pregnant or breastfeeding.
Other protocol defined exclusion criteria may apply.

• LH predominante dei linfociti nodulari:
• Anamnesi di altra malignità nei 3 anni precedenti la prima dose del farmaco in studio o qualsiasi evidenza di malattia residua da una malignità precedentemente diagnosticata. Costituiscono eccezioni le malignità con un rischio trascurabile di metastasi o decesso. I soggetti con carcinoma cutaneo non melanoma, carcinoma prostatico localizzato o carcinoma in situ di qualsiasi tipo non sono esclusi se sono stati sottoposti a resezione completa.
• Precedente chemioterapia immunosoppressiva, radiazione terapeutica o qualsiasi immunoterapia entro 4 settimane dalla prima dose di farmaco dello studio
• Precedente trattamento con un anticorpo anti-proteina di morte programmata-1 (anti-PD-1), anti-ligando 1 della proteina di morte cellulare programmata (anti-PD-L1), anti-ligando 2 della proteina di morte cellulare programmata (anti-PD-L2) o anti-proteina 4 associata ai linfociti T citotossici (anti-CTLA-4) o qualsiasi altro anticorpo o farmaco specificamente mirato alla co-stimolazione delle cellule T o ai pathway del checkpoint
• Malattia cerebrale/meningea attiva correlata alla malignità sottostante.
• Qualsiasi infezione virale, batterica o fungina attiva di Grado 3 o superiore (secondo i Criteri terminologici comuni per gli eventi avversi del National Cancer Institute [NCI CTCAE] versione 4.03) entro le 2 settimane precedenti la prima dose di farmaco dello studio.
• Attuale terapia con altri agenti antineoplastici sistemici o sperimentali.
• Radioterapia consolidativa programmata durante il periodo di trattamento dello studio (solo Parti B e C).
• Malattia polmonare interstiziale attiva sintomatica o che può interferire con il rilevamento o la gestione di sospetta tossicità polmonare correlata al farmaco (solo Parti B e C).
• Malattia polmonare di Grado 3 o superiore non correlata a malignità sottostante.
• Polmonite interstiziale idiopatica o capacità di diffusione del polmone per il monossido di carbonio <50% prevista.
• Anamnesi documentata di evento cerebrovascolare nei 6 mesi precedenti la prima dose di brentuximab vedotin.
• Soggetti con compromissione epatica secondo Child-Pugh B o C.
• Neuropatia sensoriale periferica o motoria di Grado 2 o superiore al basale.
• Soggetti con malattia da trapianto contro l’ospite (GvHD) cronica o acuta o che ricevono una terapia immunosoppressiva come trattamento o un agente di profilassi contro la GvHD.
• Precedente trattamento con brentuximab vedotin.
• Soggetti in gravidanza o in fase di allattamento al seno.
Potrebbero applicarsi criteri di esclusione aggiuntivi definiti dal protocollo.

E.5 End points

E.5.1

Primary end point(s)

CR rate at EOT

Percentuale della CR all’EOT

E.5.1.1

Timepoint(s) of evaluation of this end point

Fino a 6 mesi

Up to 6 months

E.5.2

Secondary end point(s)

- Incidence, severity, seriousness, and relatedness of AEs; incidence and severity of lab abnormalities
- Estimate the ORR
- DOR
- DOCR
- EFS
- PFS

- Incidenza, gravità, serietà e correlazione degli eventi avversi (EA); incidenza e gravità delle anomalie di laboratorio
- Stimare l’ORR
- DOR
- DOCR
- EFS
- PFS

E.5.2.1

Timepoint(s) of evaluation of this end point

- Up to 7 months
- Up to 6 months
- Up to 5 years
- Up to 5 years
- Up to 5 years
- Up to 5 years
- Up to 5 years

- Fino a 7 mesi
- Fino a 6 mesi
- Fino a 5 anni
- Fino a 5 anni
- Fino a 5 anni
- Fino a 5 anni
- Fino a 5 anni

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

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

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

Information not present in EudraCT

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

Canada

United States

Italy

Spain

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 be closed approximately 5 years after the last subject receives the last dose, or when no subjects remain in follow-up, whichever occurs first

Lo studio verrà chiuso circa 5 anni dopo che l'ultimo soggetto ha ricevuto l'ultima dose, o quando nessun soggetto rimane nel follow-up, a seconda di quale condizione si verifica per prima

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:

150

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

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)

Subjects will revert to the care of their physician after participation in the study

I soggetti torneranno alle cure del proprio medico dopo la partecipazione allo 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

2021-03-30

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2021-02-23

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

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