Clinical Trials Register

Summary
EudraCT Number:	2019-001655-39
Sponsor's Protocol Code Number:	GCT1015-07
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2019-12-20
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

Spain - AEMPS

A.2

EudraCT number

2019-001655-39

A.3

Full title of the trial

A Randomized, Open-Label, Phase 3 Trial of Tisotumab Vedotin Versus Investigator’s Choice Chemotherapy in Second- or Third-Line Recurrent or Metastatic Cervical Cancer

Ensayo en fase III, aleatorizado y abierto de tisotumab vedotina en comparación con la quimioterapia de elección del investigador como tratamiento de segunda o tercera línea del cáncer de cuello uterino recurrente o metastásico

A.3.1

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

A RANDOMIZED, OPEN-LABEL TRIAL TO COMPARE TISOTUMAB VEDOTIN TO INVESTIGATOR'S CHOICE CHEMOTHERAPY IN PATIENTS WITH CERVICAL CANCER

UN ENSAYO ALETATORIZADO, ABIERTO PARA COMPARAR EL TISOTUMAB VEDOTINA CON LA QUIMIOTERAPIA DE ELECCIÓN DEL INVESTIGADOR EN PACIENTES CON CÁNCER CERVICAL

A.3.2

Name or abbreviated title of the trial where available

innovaTV 301

A.4.1

Sponsor's protocol code number

GCT1015-07

A.5.4

Other Identifiers

Name:

135476

Number:

IND

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	Genmab A/S
B.1.3.4	Country	Denmark
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	Genmab A/S
B.4.2	Country	Denmark
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Genmab A/S
B.5.2	Functional name of contact point	Clinical Trial Information
B.5.3	Address:
B.5.3.1	Street Address	Kalvebod Brygge 43
B.5.3.2	Town/ city	Copenhagen V
B.5.3.3	Post code	1560
B.5.3.4	Country	Denmark
B.5.6	E-mail	clinicaltrials@genmab.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	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	Tisotumab Vedotin
D.3.2	Product code	HuMax®-TF-ADC
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	Tisotumab Vedotin
D.3.9.1	CAS number	1418731-10-8
D.3.9.2	Current sponsor code	IgG1-1015-011-1006
D.3.9.3	Other descriptive name	HUMAX-TF-ADC
D.3.9.4	EV Substance Code	SUB127266
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	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	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	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	Yes
D.3.11.13.1	Other medicinal product type	Antibody Drug Conjugate (ADC)
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Comparator
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	Gemcitabine 1000 mg, powder for solution for infusion
D.2.1.1.2	Name of the Marketing Authorisation holder	Sun Pharmaceutical Industries Europe B.V.
D.2.1.2	Country which granted the Marketing Authorisation	United Kingdom
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.3.4	Pharmaceutical form	Powder 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	GEMCITABINE
D.3.9.1	CAS number	95058-81-4
D.3.9.4	EV Substance Code	SUB07892MIG
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	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	Comparator
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	Irinotecan hydrochloride 20 mg/ml concentrate for solution for infusion
D.2.1.1.2	Name of the Marketing Authorisation holder	Seacross Pharmaceuticals Limited
D.2.1.2	Country which granted the Marketing Authorisation	United Kingdom
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.3.4	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	IRINOTECAN
D.3.9.1	CAS number	97682-44-5
D.3.9.4	EV Substance Code	SUB08295MIG
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	20
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.IMP: 4
D.1.2 and D.1.3	IMP Role	Comparator
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	Potactasol (Topotecan Actavis)4 mg
D.2.1.1.2	Name of the Marketing Authorisation holder	Actavis Group PTC ehf
D.2.1.2	Country which granted the Marketing Authorisation	Germany
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.3.4	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	TOPOTECAN
D.3.9.1	CAS number	123948-87-8
D.3.9.4	EV Substance Code	SUB11191MIG
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	4
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.IMP: 5
D.1.2 and D.1.3	IMP Role	Comparator
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	Vinorelbin Aurobindo 10 mg/ml
D.2.1.1.2	Name of the Marketing Authorisation holder	PUREN Pharma GmbH & Co. KG
D.2.1.2	Country which granted the Marketing Authorisation	Germany
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.3.4	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	VINORELBINE
D.3.9.1	CAS number	71486-22-1
D.3.9.4	EV Substance Code	SUB00069MIG
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	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

Second- or Third-Line Recurrent or Metastatic Cervical Cancer

Cáncer de cuello uterino de segunda o tercera línea

E.1.1.1

Medical condition in easily understood language

Second- or Third-Line Cervical Cancer

Cáncer de cuello uterino de segunda o tercera línea

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	21.1
E.1.2	Level	PT
E.1.2	Classification code	10008342
E.1.2	Term	Cervix carcinoma
E.1.2	System Organ Class	10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

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 demonstrate improvement in clinical efficacy of tisotumab vedotin compared to chemotherapy in subjects with second- or third-line (2L-3L) cervical cancer

•Demostrar la mejoría en la eficacia clínica de tisotumab vedotina comparado con la quimioterapia en sujetos con cáncer de cuello uterino de segunda o tercera línea (2L-3L)

E.2.2

Secondary objectives of the trial

•To further demonstrate improvement in clinical efficacy of tisotumab vedotin compared to chemotherapy in subjects with 2L-3L cervical cancer
•To demonstrate improvement in antitumor activity of tisotumab vedotin compared to chemotherapy in subjects with 2L-3L cervical cancer
•To evaluate the safety and tolerability of tisotumab vedotin
•To assess health-related quality of life (HRQOL)

•Demostrar aún más la mejoría en la eficacia clínica de tisotumab vedotina comparado con la quimioterapia en sujetos con cáncer de cuello uterino de 2L-3L
•Demostrar la mejoría en la actividad antitumoral de tisotumab vedotina comparado con la quimioterapia en sujetos con cáncer de cuello uterino de 2L-3L
•Evaluar la seguridad y la tolerabilidad de tisotumab vedotina
•Evaluar la calidad de vida relacionada con la salud (CdVRS)

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1.Age ≥18 years (for subjects in Japan, age ≥20 years).
2.Must sign an informed consent form (ICF) indicating that they understand the purpose of and procedures required for the trial and are willing to participate in the trial prior to any other trial-related assessments or procedures.
3.Has recurrent or metastatic cervical cancer with squamous cell, adenocarcinoma, or adenosquamous histology, and:
a.Has experienced disease progression during or after treatment with standard of care systemic therapy defined as either:
- paclitaxel+cisplatin+bevacizumab, or
- paclitaxel+carboplatin+bevacizumab, or
- paclitaxel+topotecan/nogitecan+bevacizumab
b.Has received 1 or 2 prior systemic therapy regimens for recurrent and/or metastatic cervical cancer.
c.Is not a candidate for curative therapy, including but not limited to radiotherapy or exenterative surgery.
5.Acceptable renal function
6.Acceptable liver function
7.Acceptable hematological status
8.Has ECOG PS of 0 or 1 prior to randomization.
10.Has a negative serum pregnancy test for female subjects of reproductive potential. Subjects that are postmenopausal or permanently sterilized (refer to Section 10.1.4) can be considered as not having reproductive potential.
11.Subjects of reproductive potential must agree to use adequate contraception during and for 6 months after the last trial treatment administration.
13.Where required by local health authorities, has negative serology for hepatitis B surface antigen (HBsAg)/HBV DNA, or hepatitis C antibody (HCVAb) or RNA. Active hepatitis C is defined by a known positive HCVAb result and known quantitative HCV RNA results greater than the lower limits of detection of the assay.
14.Must provide a fresh or archival biopsy prior to the first planned administration of trial treatment, unless determined it is unfeasible after sponsor medical review.

1. Edad ≥18 años (para las sujetos en Japón, edad ≥20 años).
2. Debe firmar un formulario de consentimiento informado (FCI) en el que indique que entiende la finalidad y los procedimientos necesarios para el ensayo y que está dispuesta a participar en el ensayo antes de que tenga lugar cualquier otra evaluación o procedimiento relacionado con el ensayo.
3. Padece cáncer de cuello uterino recurrente o metastásico con histología epidermoide, de adenocarcinoma o de carcinoma adenoescamoso y:
a. Ha experimentado progresión de la enfermedad durante o después del tratamiento sistémico de la práctica clínica habitual, que se define como:
- paclitaxel + cisplatino + bevacizumab o
- paclitaxel + carboplatino + bevacizumab o
- paclitaxel + topotecán/nogitecán + bevacizumab.
b. Ha recibido 1 o 2 pautas posológicas previas de tratamiento sistémico para el cáncer de cuello uterino recurrente y/o metastásico.
c. No es candidata para un tratamiento curativo, incluidos, entre otros, la radioterapia o la cirugía resectiva.
5. Función renal aceptable.
6. Función hepática aceptable.
7. Estado hematológico aceptable.
8. Presenta un EG ECOG de 0 o 1 antes de la aleatorización.
10. Presenta un resultado negativo en la prueba de embarazo en suero para las mujeres en edad fértil. Se puede considerar que las sujetos que son posmenopáusicas o que se hayan esterilizado de manera permanente (consulte la sección 10.1.4) no se encuentran en edad fértil.
11. Las sujetos en edad fértil deben aceptar el uso de métodos anticonceptivos adecuados durante la administración del tratamiento del ensayo y hasta 6 meses después de su última administración.
13. Presenta una serología negativa para el antígeno de superficie del virus la hepatitis B (HBsAg)/ADN del VHB o del anticuerpo contra el virus de la hepatitis C (HCVAb) o ARN del VHC, cuando así lo exijan las autoridades sanitarias locales. La hepatitis C activa se define mediante un resultado positivo conocido para el HCVAb y resultados del ARN del VHC cuantitativos conocidos superiores a los límites inferiores de la detección de la prueba.
14. Debe proporcionar una biopsia en fresco o de archivo antes de la primera administración programada del tratamiento del ensayo, a menos que tras la revisión médica del promotor se determine que es inviable.

E.4

Principal exclusion criteria

1.Has primary neuroendocrine, lymphoid, sarcomatoid, or other histologies not mentioned in inclusion criterion 3
2.Has clinically significant bleeding issues or risks
3. Clinically significant cardiac disease
5.Ocular surface disease Common Terminology Criteria for Adverse Events (CTCAE) grade 2 or above, any prior episode of cicatricial conjunctivitis, or any prior episode of Stevens-Johnson syndrome.
6.Other cancer: known past or current malignancy other than inclusion diagnosis, except for: non-invasive basal cell or squamous cell skin carcinoma; non-invasive, superficial bladder cancer; any curable cancer with a complete response (CR) of ≥5 years duration.
8.Surgery/procedures: major surgery within 4 weeks or minor surgery within 7 days prior to the first trial treatment administration. Subjects must have recovered adequately from the toxicity or complications from the intervention prior to starting trial treatment. Subjects who have planned major surgery during the treatment period must be excluded from the trial.
9.Peripheral neuropathy ≥grade 2.
10.Prior anti-cancer therapy:
a.Any prior treatment with MMAE-derived drugs.
b.Radiotherapy within 21 days prior to the first administration of trial treatment. Subjects must have recovered from all clinically significant radiation-related toxicities. At least 42 days must have elapsed from the last administration of chemo radiotherapy.
c.Is currently participating in or has participated in a trial of an investigational agent or device and received active treatment within 28 days prior to the first dose of trial treatment.

1. Presenta una histología primaria neuroendocrina, linfocítica, sarcomatoide u otras histologías no mencionadas en el criterio de inclusión 3.
2. Presenta riesgos o problemas hemorrágicos clínicamente significativos.
3. Cardiopatía clínicamente significativa.
5. Enfermedad de la superficie ocular de grado 2 o superior según los Criterios terminológicos comunes para acontecimientos adversos (CTCAE), cualquier episodio previo de conjuntivitis cicatricial o cualquier episodio previo de síndrome de Stevens-Johnson.
6. Otros tipos de cáncer: neoplasia maligna conocida previa o actual distinta del diagnóstico de inclusión, excepto: carcinoma epidermoide o basocelular no invasivo; cáncer de vejiga superficial no invasivo; cualquier cáncer curable con una respuesta completa (RC) de ≥5 años de duración.
8. Cirugía/operaciones: cirugía mayor en las 4 semanas o cirugía menor en los 7 días anteriores a la primera administración del tratamiento del ensayo. Las sujetos deben haberse recuperado de manera adecuada de la toxicidad o las complicaciones de la intervención antes de comenzar el tratamiento del ensayo. Se debe excluir del ensayo a las sujetos que tengan programada una cirugía mayor durante el período de tratamiento.
9. Neuropatía periférica de grado ≥2.
10. Tratamiento antineoplásico previo:
a. Cualquier tratamiento previo con fármacos derivados de MMAE.
b. Radioterapia en los 21 días previos a la primera administración del tratamiento del ensayo. Las sujetos deben haberse recuperado de todas las toxicidades clínicamente significativas relacionadas con la radiación. Deben haber transcurrido al menos 42 días desde la última administración de la quimio o radioterapia.
c. Está participando o ha participado en un ensayo de un fármaco o producto en investigación y ha recibido tratamiento activo en los 28 días previos a la primera dosis del tratamiento del ensayo.

E.5 End points

E.5.1

Primary end point(s)

•Overall survival (OS)

•Supervivencia general (SG)

E.5.1.1

Timepoint(s) of evaluation of this end point

During the trial, see protocol

Durante el ensayo, vease el protocolo

E.5.2

Secondary end point(s)

•Progression-free survival (PFS) based on Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 as assessed by the investigator
•Confirmed overall response rate (ORR) based on RECIST v1.1 as assessed by the investigator
•Incidence of adverse events (AEs)
•EQ-5D-3L index
•EQ-5D visual analog scale (VAS)
•EORTC-QLQ-C30
•EORTC-QLQ-CX24

•Supervivencia sin progresión (SSP) basada en los Criterios de evaluación de la respuesta en tumores sólidos (RECIST) v1.1 evaluados por el investigador
•Tasa de respuesta global confirmada (TRG) basada en RECIST v1.1 evaluada por el investigador
•Índice EQ-5D-3L
•Escala visual analógica (VAS) EQ-5D
•EORTC-QLQ-C30
•EORTC-QLQ-CX24

E.5.2.1

Timepoint(s) of evaluation of this end point

During the trial, see protocol

Durante el ensayo, vease el protocolo

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

Yes

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

Yes

E.6.13.1

Other scope of the trial description

Immunogenicity

Imunogenicidad

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)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

Yes

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

Yes

E.8.2.3.1

Comparator description

Investigators choice chemotherapy

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

Argentina

Austria

Belgium

Brazil

Canada

Croatia

Czech Republic

Denmark

Estonia

France

Germany

Greece

Ireland

Israel

Italy

Japan

Korea, Republic of

Lithuania

Netherlands

Norway

Singapore

Spain

Sweden

Taiwan

Ukraine

United Kingdom

United States

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

The trial is considered completed when the last survival follow-up visit is completed or 5 years after randomization of the last subject participating in the trial, whichever occurs first.

El ensayo se considera completado cuando se completa la última visita de seguimiento de supervivencia o 5 años después de la aleatorización del último sujeto que participó en el ensayo, lo que ocurra primero.

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:

386

F.1.3

Elderly (>=65 years)

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

236

F.4.2.2

In the whole clinical trial

482

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)

Provided in the protocol

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

2021-08-17

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2021-05-11

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

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