Clinical Trials Register

Summary
EudraCT Number:	2016-004744-11
Sponsor's Protocol Code Number:	PERFECT
National Competent Authority:	Netherlands - Competent Authority
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2017-02-27
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

Netherlands - Competent Authority

A.2

EudraCT number

2016-004744-11

A.3

Full title of the trial

PDL-1 targeting in resectable oesophageal cancer: a phase IB feasibility study of Atezolizumab and chemoradiation (PERFECT)

Haalbaarheidsonderzoek naar de behandeling van preoperatieve chemoradiotherapie en atezolizumab gevolgd door operatie bij patiënten met slokdarmkanker

A.3.1

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

PDL-1 targeting in resectable oesophageal cancer: a phase IB feasibility study of Atezolizumab and chemoradiation (PERFECT)

Haalbaarheidsonderzoek naar de behandeling van preoperatieve chemoradiotherapie en atezolizumab gevolgd door operatie bij patiënten met slokdarmkanker

A.3.2

Name or abbreviated title of the trial where available

PERFECT

A.4.1

Sponsor's protocol code number

PERFECT

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	Academic Medical Center
B.1.3.4	Country	Netherlands
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	University of Amsterdam
B.4.2	Country	Netherlands
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Academic Medical Center
B.5.2	Functional name of contact point	Laurien Verkleij
B.5.3	Address:
B.5.3.1	Street Address	Meibergdreef 9
B.5.3.2	Town/ city	Amsterdam
B.5.3.3	Post code	1105 AZ
B.5.3.4	Country	Netherlands
B.5.6	E-mail	trialmedonc@amc.uva.nl

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	tecentriq
D.2.1.1.2	Name of the Marketing Authorisation holder	FDA
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	Tecentriq
D.3.4	Pharmaceutical form	Concentrate and solvent 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	ATEZOLIZUMAB
D.3.9.1	CAS number	1380723-44-3
D.3.9.3	Other descriptive name	Tecentriq
D.3.9.4	EV Substance Code	SUB178312
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	1200
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.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

oesophageal cancer

slokdarmkanker

E.1.1.1

Medical condition in easily understood language

oesophageal cancer

slokdarmkanker

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

Possibly, outcomes of treatment can be further improved by adding atezolizumab to neoadjuvant chemoradiation. As a first step we aim to know whether the addition of atezolizumab feasible. That is, we want to know how the treatment is tolerated and whether the treatment can be given as scheduled.

Mogelijk kunnen de uitkomsten van de behandeling verder verbeterd worden door voorafgaand aan de operatie een nieuw middel – atezolizumab - aan de behandeling toe te voegen. Als eerste stap in het onderzoek hiernaar willen we weten of de toevoeging van atezolizumab aan de behandeling haalbaar is. Dat wil zeggen: we willen weten hoe de behandeling wordt verdragen en of de behandeling volgens planning kan worden gegeven.

E.2.2

Secondary objectives of the trial

Secondary endpoints are:
• Incidence and severity of toxicity defined according to CTCAE v4.03 and Radiation Oncology Group (RTOG) criteria.
• Percentage completion of chemotherapy and radiation treatment
• Percentage withdrawal rate from surgery
• Incidence and severity of post-operative complications according to the Dindo classification.
• Pathological response according to the Mandard criteria.
• R0 resection rate.
• Progression free survival
• Overall survival

Exploratory endpoints are:
• Potential biomarker development based on assessment of tumour biopsies, faeces and blood samples and the proposed mechanism of action of study drugs.

Secundaire eindpunten zijn:
• De incidentie en ernst van de toxiciteit gedefinieerd volgens CTCAE v4.03 en Radiation Oncology Group (RTOG) criteria.
• Percentage voltooiing van chemotherapie en bestraling
• Percentage terugtrekking een operatie
• De incidentie en ernst van postoperatieve complicaties volgens de Dindo classificatie.
• Pathologische reactie volgens de Mandard criteria.
• Percentage R0 resectie.
• Progressievrije overleving
• Algemene overleving

Verkennende eindpunten zijn:
• Potentiële biomarker ontwikkeling op basis van de beoordeling van de tumor biopten, uitwerpselen en bloedmonsters en het voorgestelde werkingsmechanisme van de studie medicijnen

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Histologically proven adenocarcinoma of the esophagus or gastro esophageal junc
2. The tumor is surgically resectable
3. Patient is fit for surgery

1. Histologische bewezen adenocarcinoom van de slokdarm of slokdarm-maag-overgang
2. De tumor is chirurgisch te verwijderen.
3. De patiënt is fit genoeg om een operatie te ondergaan.

E.4

Principal exclusion criteria

Past or current history of malignancy other than entry diagnosis interfering with prognosis of esophageal cancer

Een andere maligniteit die interfereert met de prognose van slokdarmkanker

E.5 End points

E.5.1

Primary end point(s)

The primary endpoint is feasibility defined as percentage completion of treatment with atezolizumab. Patients that do not complete treatment with atezolizumab for reasons other than toxicity will be replaced and not included in the analysis of the primary end point

Het primaire eindpunt is haalbaarheid gedefinieerd als percentage voltooiing van de behandeling met atezolizumab. Patiënten die de behandeling met atezolizumab niet afmaken voor andere redenen dan toxiciteit, worden vervangen en niet opgenomen in de analyse van het primaire eindpunt.

E.5.1.1

Timepoint(s) of evaluation of this end point

At surgery

Bij de operatie

E.5.2

Secondary end point(s)

E.5.2.1

Timepoint(s) of evaluation of this end point

At resection and during follow-up

Bij de operatie en gedurende follow-up.

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

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.8.3

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

E.8.7

Trial has a data monitoring committee

Yes

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

last visit of the last subject

Laatste bezoek van de laatste patiënt

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

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.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

Geen

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

2017-02-27

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2017-02-17

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

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