Clinical Trials Register

Summary
EudraCT Number:	2020-004876-16
Sponsor's Protocol Code Number:	SURE-02
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:	2021-08-30
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

2020-004876-16

A.3

Full title of the trial

SURE-02_An open label, single-arm, phase 2 study of perioperative pembrolizumab plus sacituzumab govitecan for patients with muscle-invasive bladder cancer who cannot receive or refuse cisplatin-based chemotherapy

SURE-02: Studio di Fase 2, in aperto, a singolo braccio, con anticorpo immunoconiugato sacituzumab govitecan, in associazione a pembrolizumab, in pazienti con carcinoma uroteliale della vescica muscolo-infiltrante che non possono ricevere o che rifiutano la chemioterapia con cisplatino.

A.3.1

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

A.3.2

Name or abbreviated title of the trial where available

SURE-02

A.4.1

Sponsor's protocol code number

SURE-02

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	OSPEDALE SAN RAFFAELE
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 Corp.
B.4.2	Country	United States
B.4.1	Name of organisation providing support	Immunomedics, 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	Fullcro S.r.l.
B.5.2	Functional name of contact point	Clinical Operations
B.5.3	Address:
B.5.3.1	Street Address	Via Ignazio Guidi 3
B.5.3.2	Town/ city	Roma
B.5.3.3	Post code	00147
B.5.3.4	Country	Italy
B.5.4	Telephone number	0658300326
B.5.5	Fax number	0658300309
B.5.6	E-mail	valentina.granelli@fullcro.org

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.2.1.1.1	Trade name	KEYTRUDA (Pembrolizumab, MK-3475)
D.2.1.1.2	Name of the Marketing Authorisation holder	Merck, Sharp & Dohme 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	[NA]
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	PEMBROLIZUMAB
D.3.9.1	CAS number	1374853-91-4
D.3.9.2	Current sponsor code	NA
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.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	Sacituzumab Govitecan
D.3.2	Product code	[IMMU-132]
D.3.4	Pharmaceutical form	Lyophilisate 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	1491917-83-9
D.3.9.2	Current sponsor code	IMMU-132
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	180
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)	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	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

Carcinoma uroteliale della vescica muscolo infiltrante

E.1.1.1

Medical condition in easily understood language

muscle-invasive bladder cancer

Carcinoma uroteliale della vescica muscolo infiltrante

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	10046714
E.1.2	Term	Urothelial carcinoma bladder
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	10046714
E.1.2	Term	Urothelial carcinoma bladder
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 assess whether sacituzumab govitecan plus pembrolizumab results in pathological complete response (herein referred to as either “pT0” or “pCR”) in patients with clinical T2-4aN0M0 MIBC who cannot receive or refuse to receive cisplatin-based chemotherapy

Valutare l’attività del trattamento neoadiuvante con sacituzumab govitecan+pembrolizumab in pazienti affetti da carcinoma uroteliale della vescica muscolo-infiltrante.

E.2.2

Secondary objectives of the trial

To evaluate the safety and tolerability of sacituzumab govitecan+pembrolizumab in patients with high-risk organ-confined cancer

Valutare la sicurezza e la tollerabilità di sacituzumab govitecan+pembrolizumab somministrato ad una popolazione di pazienti con neoplasia organo-confinata ad alto rischio.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

written informed consent
>18 years of age
Histopathologically confirmed urothelial carcinoma.
Fit and planned for RC
ECOG performance status score of 0 or 1
Adequate hematologic counts , hepatic and renal function.
Negative pregnancy test and Effective contraception during the study, unless evidence of infertility exists
Clinical stage T2-T4aN0M0 MIBC, assessed by CT + PET/CT + mpMRI.
Ineligibility to receive cisplatin-based neoadjuvant chemotherapy based on Galsky’s criteria OR refusal to receive neoadjuvant cisplatin-based chemotherapy

Consenso informato scritto.
Età = 18 anni.
Diagnosi istologicamente confermata (TURB) di carcinoma uroteliale.
Eleggibilità per l’intervento chirurgico di cistectomia radicale accettato dal paziente.
ECOG performance status di 0 o 1.
Adeguata funzione midollare, epatica e renale.
Test di gravidanza negativo e Effettiva contraccezione durante lo studio, a meno che esista documentazione di infertilità
Stadio clinico T2-4N0M0 confermato alla TURB e alle indagini radiologiche.
Rifiuto della chemioterapia neoadiuvante contenente cisplatino oppure ineleggibilità alla stessa in base ai criteri di Galsky.

E.4

Principal exclusion criteria

prior systemic anti-cancer therapy including investigational agents and immunotherapy, prior radiotherapy on the bladder tumor, partial cystectomy. Refusal to undergo RC.
live vaccine, antibiotics within 30 days prior to the first dose of study drug.
Partecipation in a study of an investigational agent or device, additional known malignancy , severe hypersensitivity to study drugs and/or any of their excipients, active autoimmune disease that required systemic treatment.
history of (non-infectious) pneumonitis that required steroids or current pneumonitis.
active chronic inflammatory bowel disease, any condition that is not in the best interest of the subject to participate, in the opinion of the treating investigator.
active cardiac disease, defined as:
Myocardial infarction or unstable angina pectoris within 6 months of C1D1
History of serious ventricular arrhythmia, high-grade atrioventricular block, or other cardiac arrhythmias requiring anti-arrhythmic medications; history of QT interval prolongation
NYHA Class III or greater congestive heart failure or left ventricular ejection fraction of < 40%
known history of HIV-1/2 infection, known history of Hepatitis B or known active Hepatitis C virus infection.
other concurrent medical or psychiatric conditions that, in the Investigator’s opinion, may be likely to confound study interpretation or prevent completion of study procedures and follow-up examinations.
High dose systemic corticosteroids are not allowed within 2 weeks of C1D1.
Have received or are currently receiving (within the previous 2 weeks) antibiotics.

precedente terapia antitumorale sistemica inclusi agenti sperimentali e immunoterapia, precedente radioterapia sul tumore della vescica, cistectomia parziale. Rifiuto di sottoporsi a RC.
vaccino vivo e antibiotici somministrati nei 30 giorni precedenti la prima dose del farmaco in studio.
Partecipazione a studi con farmaci o device sperimentali, neoplasia aggiuntiva nota, grave ipersensibilità ai trattamenti e / o ad uno qualsiasi degli eccipienti, malattia autoimmune attiva che ha richiesto un trattamento,
storia di polmonite (non infettiva) o in corso , malattia intestinale infiammatoria cronica attiva, la partecipazione non è nel migliore interesse del soggetto, secondo il parere dello sperimentatore curante.
malattia cardiaca attiva, definita come:
Infarto miocardico o angina pectoris instabile entro 6 mesi da C1D1, Storia di aritmia ventricolare grave, blocco atrioventricolare di alto grado o altre aritmie cardiache che richiedono farmaci antiaritmici,storia di prolungamento dell'intervallo QT, Insufficienza cardiaca congestizia di classe NYHA III o superiore o frazione di eiezione ventricolare sinistra <40%, storia di infezione da HIV-1/2, storia nota di epatite B o di epatite C attiva

E.5 End points

E.5.1

Primary end point(s)

Number of complete pathological responses, defined as the absence of viable tumor cells on the histological examination of the cystectomy.

Numero di risposte patologiche complete, definite come assenza di cellule tumorali vitali all’esame istologico della cistectomia.

E.5.1.1

Timepoint(s) of evaluation of this end point

to the cystectomy

alla cistectomia

E.5.2

Secondary end point(s)

Safety and tolerability evaluation of the treatment:
Number of patients who experienced adverse events.
Type, frequency, severity and correlation to treatment of adverse events, assessed according to the Common Toxicity Criteria for adverse events (CTCAE) v 5.0.
Progression-free survival (PFS).
Overall survival (OS).

Valutazione della sicurezza e della tollerabilità del trattamento:
Numero di pazienti che hanno avuto eventi avversi.
Tipo, frequenza, severità e correlazione al trattamento degli eventi avversi, valutati secondo i Common Toxicity Criteria for adverse events (CTCAE) v 5.0.
Sopravvivenza libera da progressione (PFS).
Sopravvivenza globale (OS).

E.5.2.1

Timepoint(s) of evaluation of this end point

until 12 months post adiuvant Pembrolizumab treatment

fino a 12 mesi post adiuvant Pembrolizumab treatment

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

Yes

E.8.1.7.1

Other trial design description

in aperto, singolo braccio, non controllato

uncontrolled, single arm, open label study

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

Yes

E.8.4

The trial involves multiple sites in the Member State concerned

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

LVLS

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

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

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)

They will be followed according to clinical practice

Verranno seguito secondo pratica clinica

G. Investigator Networks to be involved in the Trial

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

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2021-10-07

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2021-11-10

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

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