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    Summary
    EudraCT Number:2017-000350-19
    Sponsor's Protocol Code Number:R2810-ONC-1676
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-06-17
    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.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2017-000350-19
    A.3Full title of the trial
    An open-label, randomized, phase 3 clinical trial of REGN2810 versus investigator's choice of chemotherapy in recurrent or metastatic cervical carcinoma
    Studio clinico di fase 3, in aperto, randomizzato su REGN2810 rispetto alla terapia chemioterapica scelta dallo sperimentatore nel carcinoma della cervice ricorrente o metastatico
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of REGN2810 in Adults With Cervical Cancer
    Studio su REGN2810 in adulti con carcinoma della cervice
    A.3.2Name or abbreviated title of the trial where available
    NA
    NA
    A.4.1Sponsor's protocol code numberR2810-ONC-1676
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03257267
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorREGENERON PHARMACEUTICALS, INC.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportRegeneron Pharmaceuticals, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRegeneron Pharmaceuticals, Inc.
    B.5.2Functional name of contact pointMatthew Fury
    B.5.3 Address:
    B.5.3.1Street Address777 Old Saw Mill River Road
    B.5.3.2Town/ cityTarrytown
    B.5.3.3Post codeNY 10591
    B.5.3.4CountryUnited States
    B.5.4Telephone number9148473741
    B.5.5Fax number9148477735
    B.5.6E-mailclinicaltrials@regeneron.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product namePEMETREXED
    D.3.2Product code [PEMETREXED]
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPEMETREXED DISODIUM
    D.3.9.1CAS number 150399-23-8
    D.3.9.2Current sponsor code.
    D.3.9.4EV Substance CodeSUB03669MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameCemiplimab
    D.3.2Product code [REGN2810]
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCemiplimab
    D.3.9.1CAS number 1801342-60-8
    D.3.9.2Current sponsor codeREGN2810
    D.3.9.4EV Substance CodeSUB130944
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product Yes
    D.3.11.13.1Other medicinal product typea recombinant human antibody
    D.IMP: 3
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameTOPOTECAN
    D.3.2Product code [TOPOTECAN]
    D.3.4Pharmaceutical form Powder for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTOPOTECAN HYDROCHLORIDE
    D.3.9.1CAS number 119413-54-6
    D.3.9.2Current sponsor code.
    D.3.9.4EV Substance CodeSUB04921MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 4
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameIrinotecan
    D.3.2Product code [Irinotecan]
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNIrinotecan hydrochloride
    D.3.9.2Current sponsor codeNA
    D.3.9.4EV Substance CodeSUB02772MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 5
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameGemcitabina
    D.3.2Product code [Gemcitabina]
    D.3.4Pharmaceutical form Powder for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNgemcitabine hydrochloride
    D.3.9.2Current sponsor code.
    D.3.9.4EV Substance CodeSUB02324MIG
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 6
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameVINORELBIN
    D.3.2Product code [VINORELBINE]
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNVINORELBINE TARTRATE
    D.3.9.2Current sponsor code.
    D.3.9.4EV Substance CodeSUB20777
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 7
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameTOPOTECAN
    D.3.2Product code [TOPOTECAN]
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTOPOTECAN HYDROCHLORIDE
    D.3.9.1CAS number 119413-54-6
    D.3.9.2Current sponsor code.
    D.3.9.4EV Substance CodeSUB04921MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 8
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameGemcitabina
    D.3.2Product code [Gemcitabina]
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNgemcitabine hydrochloride
    D.3.9.2Current sponsor code.
    D.3.9.4EV Substance CodeSUB02324MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number38
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another 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.1.1Medical condition(s) being investigated
    recurrent or metastatic, cervical cancer
    carcinoma della cervice ricorrente o metastatico
    E.1.1.1Medical condition in easily understood language
    cervical carcinoma
    carcinoma della cervice
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10008229
    E.1.2Term Cervical cancer
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10008229
    E.1.2Term Cervical cancer
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare overall survival (OS) for patients with recurrent or metastatic, cervical cancer treated with either REGN2810 (cemiplimab) or investigator’s choice (IC) chemotherapy.
    Confrontare la sopravvivenza globale (OS) di pazienti con carcinoma della cervice ricorrente o metastatico trattate con REGN2810 (cemiplimab) o con la chemioterapia scelta dallo sperimentatore (IC).
    E.2.2Secondary objectives of the trial
    ¿ To compare progression-free survival (PFS) of REGN2810 (cemiplimab) versus IC hemotherapy
    ¿ To compare overall response rate (ORR) (partial response [PR] + CR) of REGN2810 (cemiplimab) versus IC chemotherapy
    per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
    ¿ To compare the duration of response (DOR) of REGN2810 (cemiplimab) versus IC chemotherapy
    ¿ To compare the safety profiles of REGN2810 (cemiplimab) versus IC chemotherapy by describing adverse events (AE)
    ¿ To compare quality of life for patients treated with REGN2810 (cemiplimab)
    versus IC chemotherapy using European Organization for Research and Treatment of CancerQuality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
    • Confrontare la sopravvivenza libera da progressione (PFS) di REGN2810 (cemiplimab) rispetto alla chemioterapia IC
    • Confrontare il tasso di risposta complessiva (ORR) (risposta parziale + risposta completa [CR]) di REGN2810 (cemiplimab) rispetto alla chemioterapia IC secondo i Criteri di valutazione della risposta nei tumori solidi, versione 1.1
    • Confrontare la durata della risposta (DOR) di REGN2810 (cemiplimab) rispetto alla chemioterapia IC
    • Confrontare i profili di sicurezza di REGN2810 (cemiplimab) rispetto alla chemioterapia IC descrivendo gli eventi avversi (EA)
    • Confrontare la qualità della vita (QOL) di pazienti trattate con REGN2810 (cemiplimab) rispetto alla chemioterapia IC usando il Questionario per misurare la qualità della vita-Modulo principale a 30 voci dell’Organizzazione europea per la ricerca e il trattamento dei tumori (EORTC QLQ-C30)
    E.2.3Trial contains a sub-study No
    E.3Principal 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 after treatment with platinum therapy (must have been used to treat metastatic, persistent, or recurrent 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
    I criteri elencati di seguito non intendono contenere tutte le considerazioni rilevanti per la potenziale partecipazione di una paziente a questa sperimentazione clinica.
    1. Tumore cervicale ricorrente, persistente e / o metastatico, per il quale non esiste un'opzione curativa (chirurgia o radioterapia con o senza chemioterapia). Istologie accettabili sono carcinoma squamoso, adenocarcinoma e carcinoma adenosquamoso. Sarcomi e carcinomi neuroendocrini non sono Istologie idonee.
    2. Progressione o recidiva del tumore dopo trattamento con platino terapia (deve essere stata utilizzata per il trattamento del carcinoma cervicale metastatico, persistente o ricorrente).
    3. La paziente deve avere una malattia misurabile come definito da RECIST
    4. Stato di performance ECOG = 1
    5. = 18 anni
    6. Funzione adeguata di organi o midollo osseo
    7. Ha ricevuto una precedente terapia con bevacizumab o ha avuto un motivo clinicamente documentato per cui non è stato somministrato
    8. Ha ricevuto una precedente terapia con paclitaxel o ha avuto un motivo clinicamente documentato per cui non è stato somministrato
    E.4Principal 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).
    4. Active or untreated brain metastases.
    5. Immunosuppressive corticosteroid doses (>10 mg prednisone daily or equivalent) within 4 weeks prior to the first dose of study drug REGN2810 [cemiplimab] or IC chemo) .
    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. History of malignancy other than cervical cancer within 3 years of first planned dose of REGN2810, except for tumors with negligible risk of metastasis.
    10. Prior treatment with live vaccines within 30 days of initial administration of REGN2810. Patients must not be treated with live vaccines during the study and up to 5 half-lives following the last dose of study drug.
    11. Patients with prior treatment on any clinical trial within 30 days of the initial administration of study drug(excepts Non-interventional and observational trials).
    1. Evidenze continue o recenti (entro 5 anni) di una significativa malattia autoimmune che ha richiesto un trattamento con trattamenti immunosoppressivi sistemici.
    2. Trattamento precedente con un agente che blocca la via PD-1 / PD-L1.
    3. Trattamento precedente con agenti immunomodulanti (diversi dagli agenti anti-PD-1 / PD-L1) entro 28 giorni (entro 90 giorni se si è verificato un evento avverso correlato al sistema immunitario).
    4. Metastasi cerebrali attive o non trattate.
    5. Dosi di corticosteroidi immunosoppressori (> 10 mg di prednisone al giorno o equivalenti) entro 4 settimane prima della prima dose del farmaco in studio REGN2810 [cemiplimab] o chemio IC).
    6. Infezione attiva che richiede una terapia sistemica.
    7. Storia di polmonite negli ultimi 5 anni
    8. Reazione di ipersensibilità allergica o acuta documentata attribuita ai trattamenti anticorpali
    9. Anamnesi di neoplasia diversa dal cancro cervicale entro 3 anni dalla prima dose programmata di REGN2810, ad eccezione dei tumori con rischio trascurabile di metastasi.
    10. Trattamento precedente con vaccini vivi entro 30 giorni dalla somministrazione iniziale di REGN2810. I pazienti non devono essere trattati con vaccini vivi durante lo studio e fino a 5 emivite dopo l'ultima dose di farmaco in studio.
    11. Pazienti con precedente trattamento in qualsiasi studio clinico entro 30 giorni dalla somministrazione iniziale del farmaco in studio (ad eccezione degli studi non interventistici e osservazionali).
    E.5 End points
    E.5.1Primary 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.
    L’endpoint primario è l’OS, definita come il tempo che intercorre tra la randomizzazione e la data del decesso. Le pazienti non decedute saranno censurate all’ultima data nota di contatto
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary endpoint is OS, defined as the time from randomization to the date of death.
    L'endpoint primario è OS, definito come il tempo dalla randomizzazione alla data di morte.
    E.5.2Secondary end point(s)
    Compare progression-free survival (PFS) of REGN2810 (cemiplimab) versus ICchemotherapy
    -To compare overall response rate (ORR) (partial response + complete response [CR]) of cemiplimab versus IC chemotherapy per Response Evaluation Criteria in Solid Tumors 1.1
    - To compare the duration of response (DOR) of cemiplimab versus IC chemotherapy
    -To compare the safety profiles of cemiplimab versus IC chemotherapy by describing adverse events (AE)
    -To compare quality of life (QOL) for patients treated with cemiplimab versus IC chemotherapy using the European Organization for Research and Treatment of Cancer
    Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
    Confrontare la sopravvivenza libera da progressione (PFS) di cemiplimab rispetto alla chemioterapia IC
    Confrontare il tasso di risposta globale (ORR) (risposta parziale + risposta completa [CR]) di cemiplima) rispetto a chemioterapia IC per criteri di valutazione della risposta nei tumori solidi 1.1
    Confrontare la durata della risposta (DOR) di cemiplimab rispetto alla chemioterapia IC
    Confrontare i profili di sicurezza di cemiplimab rispetto alla chemioterapia IC descrivendo gli eventi avversi (AE)
    Confrontare la qualità della vita (QOL) per le pazienti trattate con cemiplimab rispetto alla chemioterapia IC utilizzando il Questionario sulla Qualità della vita Questionnaire-Core 30 (EORTC QLQ-C30).
    E.5.2.1Timepoint(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 sopravvivenza libera da progressione sarà definita come il tempo dalla randomizzazione alla data della prima progressione del tumore documentata usando RECIST 1.1, o morte dovuta a qualsiasi causa.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    confrontare REGN2810 contro chemioterapia scelta dallo sperimentatore
    comparing REGN2810 versus IC of chemotherapy
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA49
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Belgium
    Brazil
    Canada
    Greece
    Italy
    Korea, Republic of
    Poland
    Russian Federation
    Spain
    Taiwan
    United Kingdom
    United States
    E.8.7Trial 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
    LPLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years6
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 514
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 76
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state54
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 170
    F.4.2.2In the whole clinical trial 590
    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
    Le pazienti che completano 16 cicli di trattamento entrano nel periodo di follow-up. Se non hanno sofferto di PD (Progressive disease) durante lo studio, le valutazioni radiologiche continueranno fino a che non si verifichi PD. Se una paziente sperimenta PD durante il periodo di follow-up, il trattamento con lo stesso farmaco somministrato durante il periodo di trattamento è un'opzione . Le pazienti saranno trattate nel periodo di ritrattamento in base alla loro randomizzazione iniziale
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2019-05-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-03-21
    P. End of Trial
    P.End of Trial StatusCompleted
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