Clinical Trials Register

Summary
EudraCT Number:	2017-000350-19
Sponsor's Protocol Code Number:	R2810-ONC-1676
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2017-09-18
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

2017-000350-19

A.3

Full title of the trial

An open-label, randomized, phase 3 clinical trial of REGN2810 versus therapy of investigator's choice chemotherapy in recurrent or metastatic platinum-refractory cervical carcinoma

Ensayo clínico en fase III abierto y aleatorizado de REGN2810 en comparación con el tratamiento de quimioterapia a elección del investigador para el carcinoma cervicouterino resistente a platino recurrente o metastásico

A.3.1

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

Study of REGN2810 in Adults With Cervical Cancer

Ensayo clinico de REGN2810 en adultos con cancer cervicouterino

A.4.1

Sponsor's protocol code number

R2810-ONC-1676

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	Regeneron Pharmaceuticals, 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	Regeneron Pharmaceuticals, 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	Regeneron Pharmaceuticals, Inc.
B.5.2	Functional name of contact point	Matthew Fury
B.5.3	Address:
B.5.3.1	Street Address	777 Old Saw Mill River Road
B.5.3.2	Town/ city	Tarrytown
B.5.3.3	Post code	NY 10591
B.5.3.4	Country	United States
B.5.4	Telephone number	9148473741
B.5.5	Fax number	9148477735
B.5.6	E-mail	clinicaltrials@regeneron.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	REGN2810
D.3.2	Product code	REGN2810
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	N/A
D.3.9.1	CAS number	1801342-60-8
D.3.9.2	Current sponsor code	REGN2810
D.3.9.3	Other descriptive name	HUMAN IGG4 ISOTYPE MONOCLONAL (GDF8) ANTIBODY
D.3.9.4	EV Substance Code	SUB130944
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	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	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	a recombinant human antibody
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.2.5	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	PEMETREXED DISODIUM
D.3.9.1	CAS number	150399-23-8
D.3.9.3	Other descriptive name	PEMETREXED DISODIUM
D.3.9.4	EV Substance Code	SUB03669MIG
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	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.2.5	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 HYDROCHLORIDE
D.3.9.1	CAS number	119413-54-6
D.3.9.3	Other descriptive name	TOPOTECAN HYDROCHLORIDE
D.3.9.4	EV Substance Code	SUB04921MIG
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: 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.2.5	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
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 hydrochloride
D.3.9.3	Other descriptive name	IRINOTECAN HYDROCHLORIDE
D.3.9.4	EV Substance Code	SUB02772MIG
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: 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.2.5	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	Gemcitabine
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 hydrochloride
D.3.9.3	Other descriptive name	GEMCITABINE HYDROCHLORIDE
D.3.9.4	EV Substance Code	SUB02324MIG
D.3.10	Strength
D.3.10.1	Concentration unit	g gram(s)
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	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: 6
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.2.5	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	Vinorelbine
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 TARTRATE
D.3.9.3	Other descriptive name	VINORELBINE TARTRATE
D.3.9.4	EV Substance Code	SUB20777
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

recurrent or metastatic, platinum-refractory cervical cancer

carcinoma cervicouterino resistente a platino recurrente o metastásico

E.1.1.1

Medical condition in easily understood language

cervical carcinoma

carcinoma cervicouterino

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

To compare overall survival (OS) for patients with recurrent or metastatic, platinum-refractory cervical cancer
treated with either REGN2810 or investigator’s choice (IC) chemotherapy.

Comparar la supervivencia general (SG) de las pacientes con cáncer cervicouterino resistente a platino recurrente o metastásico tratado con REGN2810 o la quimioterapia a elección del investigador

E.2.2

Secondary objectives of the trial

 To compare progression-free survival (PFS) of REGN2810 versus IC chemotherapy
 To compare overall response rate (ORR) (partial response [PR] + CR) of REGN2810 versus IC chemotherapy
per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
 To compare the duration of response (DOR) of REGN2810 versus IC chemotherapy
 To compare the safety profiles of REGN2810 versus IC chemotherapy by describing adverse events (AE)
 To compare quality of life for patients treated with REGN2810 versus IC chemotherapy using European Organization for Research and Treatment of CancerQuality of Life Questionnaire-Core 30 (EORTC QLQ-C30)

• Comparar la supervivencia sin progresión (SSP) de REGN2810 en comparación con la quimioterapia a elección del investigador.
• Comparar la tasa de respuesta global (TRG) (respuesta parcial + respuesta completa [RC]) de REGN2810 en comparación con la quimioterapia a elección del investigador según los Criterios de evaluación de la respuesta en tumores sólidos 1.1.
• Comparar la duración de la respuesta (DR) de REGN2810 en comparación con la quimioterapia a elección del investigador.
• Comparar los perfiles de seguridad de REGN2810 en comparación con la quimioterapia a elección del investigador mediante la descripción de los acontecimientos adversos (AA).
• Comparar la calidad de vida (CdV) de las pacientes tratadas con REGN2810 en comparación con la quimioterapia a elección del investigador mediante el Cuestionario de calidad de vida de 30 ítems de la Organización Europea de Investigación y Tratamiento del Cáncer (QLQ-C30 de la EORTC)

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

The criteria listed below are not intended to contain all considerations relevant to a patient’s potential participation in this clinical trial.
1. Recurrent, persistent, and/or metastatic cervical cancer, for which there is not a curativeintent option (surgery or radiation therapy with or without chemotherapy). Acceptable histologies are squamous carcinoma, adenocarcinoma, and adenosquamous carcinoma. Sarcomas and neuro-endocrine carcinomas are not eligible histologies.
2. Tumor progression or recurrence within 6 months of last dose of platinum therapy that was used to treat metastatic, persistent or current cervical cancer
3. Patient must have measurable disease as defined by RECIST
4. Eastern Cooperative Oncology Group (ECOG) performance status ≤1
5. ≥18 years old
6. Adequate organ or bone marrow function
7. Received prior bevacizumab therapy or had clinically documented reason why not administered
8. Received prior paclitaxel therapy or had clinically documented reason why not administered

Los criterios listados a continuación no pretenden contener todas las consideraciones relevantes para una posible participación del paciente en este ensayo clínico.
1. Cáncer de cuello de útero recurrente, persistente y/o metastásico para el que no existe una opción con intención curativa (cirugía o radioterapia con o sin quimioterapia). Las histologías aceptables son carcinoma epidermoide, adenocarcinoma y carcinoma adeno-epidermoide. Los sarcomas y los carcinomas neuroendocrinos no son histologías aptas.
2. Progresión o recurrencia tumoral en los 6 meses posteriores a la última dosis de tratamiento con platino que se empleó para tratar el cáncer de cuello de útero metastásico, persistente o recurrente.
3. La paciente debe presentar enfermedad medible de acuerdo con los criterios.
4. Estado general ≤1 conforme a la escala ECOG (Eastern Cooperative Oncology Group).
5. ≥18 años de edad.
6. Función de la médula ósea adecuada.
7. Haber recibido anteriormente un tratamiento que contuviera bevacizumab o haber existido razones clínicas documentadas por las que no se administró.
8. Haber recibido anteriormente un tratamiento que contuviera paclitaxel o haber existido razones clínicas documentadas por las que no se administró.

E.4

Principal exclusion criteria

1. Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments.
2. Prior treatment with an agent that blocks the PD-1/PD-L1 pathway.
3. Prior treatment with immune modulating agents (other than anti-PD-1/PD-L1 agents) within 28 days (within 90 days if there was an immune-related adverse event)prior to enrollment date.
4. KActive or untreated brain metastases.
5. Immunosuppressive corticosteroid doses (>10 mg prednisone daily or equivalent) within 4 weeks prior to the first dose of REGN2810.
6. Active infection requiring systemic therapy.
7. History of pneumonitis within the last 5 years
8. Documented allergic or acute hypersensitivity reaction attributed to antibody treatments
9. Known allergy to doxycycline or other tetracycline antibiotics
10. History of malignancy other than cervical cancer within 3 years of first planned dose of REGN2810, except for tumors with negligible risk of metastasis

1. Indicios actuales o recientes (en el plazo de 5 años) de enfermedad autoinmune significativa que requirió tratamiento con inmunosupresores sistémicos.
2.Tratamiento previo con un agente que bloquea la vía PD-1/PD-L1.
3. Tratamiento previo con otros agentes inmunomoduladores (diferentes a agentes anti PD-1/PD-L1) administrados en los 28 dias antes de la fecha de inscripción(90 dias si hubo algún acontecimiento adverso relacionado con el sistema inmunitario).
4. Metástasis cerebrales activas o sin tratamiento.
5.Dosis inmunosupresoras de corticosteroides (>10 mg diarios de prednisona o equivalente) en las 4 semanas anteriores a la primera dosis de REGN2810.
6.Infección activa que requiera terapia sistémica.
7. Antecedentes de neumonitis en los últimos 5 años.
8. Reacciones alérgicas o reacciones de hipersensibilidad agudas documentadas que se atribuyan a tratamientos con anticuerpos.
09. Alergia conocida a la doxiciclina u otros antibióticos del grupo tetraciclina.
10. Antecedentes de neoplasia maligna diferente del cáncer de cuello de útero en los 3 años anteriores a la fecha de la primera dosis planificada de REGN2810, excepto para tumores con riesgo insignificante de metástasis.

E.5 End points

E.5.1

Primary end point(s)

The primary endpoint is OS, defined as the time from randomization to the date of death. A patient who has not died will be censored at the last known date of contact.

El criterio de valoración principal es la SG, definida como el tiempo desde la aleatorización hasta la fecha de la muerte. A las pacientes que no fallezcan, se les censurará en la última fecha de contacto que se conozca.

E.5.1.1

Timepoint(s) of evaluation of this end point

The primary endpoint is OS, defined as the time from randomization to the date of death.

El criterio de valoración principal es la SG, definida como el tiempo desde la aleatorización hasta la fecha de la muerte.

E.5.2

Secondary end point(s)

 Compare progression-free survival (PFS) of REGN2810 versus IC chemotherapy

 To compare overall response rate (ORR) (partial response + complete response [CR]) of REGN2810 versus IC chemotherapy per Response Evaluation Criteria in Solid Tumors 1.1
 To compare the duration of response (DOR) of REGN2810 versus IC chemotherapy
 To compare the safety profiles of REGN2810 versus IC chemotherapy by describing adverse events (AE)
 To compare quality of life (QOL) for patients treated with REGN2810 versus IC chemotherapy using the European Organization for Research and Treatment of Cancer Quality of Life
Questionnaire-Core 30 (EORTC QLQ-C30)

•Comparar la supervivencia sin progresión (SSP) del REGN2810 en comparación con el tratamiento de quimioterapia a elección del investigador
•Comparar la tasa de respuesta global (TRG) (respuesta parcial + respuesta completa [RC]) de REGN2810 en comparación con la quimioterapia a elección del investigador según los Criterios de evaluación de la respuesta en tumores sólidos 1.1.
• Comparar la duración de la respuesta (DR) de REGN2810 en comparación con la quimioterapia a elección del investigador.
• Comparar los perfiles de seguridad de REGN2810 en comparación con la quimioterapia a elección del investigador mediante la descripción de los acontecimientos adversos (AA).
• Comparar la calidad de vida (CdV) de las pacientes tratadas con REGN2810 en comparación con la quimioterapia a elección del investigador mediante el Cuestionario de calidad de vida de 30 ítems de la Organización Europea de Investigación y Tratamiento del Cáncer (QLQ-C30 de la EORTC)

E.5.2.1

Timepoint(s) of evaluation of this end point

Progression-free survival will be defined as the time from randomization to the date of the first documented tumor progression using RECIST 1.1, or death due to any cause.

La supervivencia sin progresión se definirá como el tiempo desde la aleatorización hasta la fecha de la primera progresión tumoral documentada empleando los criterios RECIST 1.1, o la muerte por cualquier causa.

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

Yes

E.6.6

Pharmacokinetic

Yes

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

Yes

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)

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

Yes

E.8.1.7.1

Other trial design description

Quimioterapia

Chemotherapy

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

comparar REGN2810 REGN2810 con el tratamiento de quimioterapia a elección del investigador

comparing REGN2810 versus IC of 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

Australia

Brazil

Canada

Korea, Republic of

Poland

Russian Federation

Spain

Taiwan

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

LPLV

Última visita del último paciente

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:

349

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

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

436

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)

Patients who complete 16 cycles of treatment enter the follow up period . If they have not experienced PD (Progressive disease) during the study, radiologic assessments will continue until PD is occurred.If a patient experiences PD during the follow-up period, retreatment with the same drug that was given during the treatment period is an option. The patients will be treated in the retreatment period in accordance with their initial randomization

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

2017-11-23

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2017-11-15

P. End of Trial
P.	End of Trial Status	Completed

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Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
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