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    Summary
    EudraCT Number:2017-003413-25
    Sponsor's Protocol Code Number:GCT1015-04
    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:2018-03-13
    Trial results View 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 number2017-003413-25
    A.3Full title of the trial
    A single arm, multicenter, international trial of tisotumab vedotin (HuMax®-TF-ADC) in previously treated, recurrent or metastatic cervical cancer
    Sperimentazione internazionale, a braccio singolo, multicentrica di tisotumab vedotin (HuMax® TF ADC) nel carcinoma della cervice recidivante o metastatico precedentemente trattato.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Trial of efficacy and safety of tisotumab vedotin (HuMax®-TF-ADC) in patients with previously treated, advanced cervical cancer
    Sperimentazione sull'efficacia e la sicurezza di tisotumab-vedotin (HuMax®-TF-ADC) in pazienti affette da carcinoma della cervice in stadio avanzato precedentemente trattato
    A.3.2Name or abbreviated title of the trial where available
    NA
    NA
    A.4.1Sponsor's protocol code numberGCT1015-04
    A.5.4Other Identifiers
    Name:INDNumber:135476
    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 SponsorGenmab A/S
    B.1.3.4CountryDenmark
    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 supportGenmab A/S
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGenmab A/S
    B.5.2Functional name of contact pointClinical Trial Information
    B.5.3 Address:
    B.5.3.1Street AddressKalvebod Brygge 43
    B.5.3.2Town/ cityCopenhagen V
    B.5.3.3Post code1560
    B.5.3.4CountryDenmark
    B.5.4Telephone number+457020 2728
    B.5.6E-mailregulatory@genmab.com
    D. IMP Identification
    D.IMP: 1
    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 nameTisotumab vedotin
    D.3.2Product code HuMax®-TF-ADC
    D.3.4Pharmaceutical form Powder for 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 INNtisotumab vedotin
    D.3.9.1CAS number 1418731-10-1
    D.3.9.2Current sponsor codeIgG1-1015-011-1006
    D.3.9.3Other descriptive nameHUMAX-TF-ADC
    D.3.9.4EV Substance CodeSUB127266
    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) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    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 typeAntibody Drug Conjugate (ADC)
    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
    recurrent or metastatic cervical cancer
    carcinoma della cervice ricorrente o metastatico
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10008342
    E.1.2Term Cervix carcinoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    • Determine the anti-tumor efficacy in patients with cervical cancer
    Determinare l'efficacia antitumorale in pazienti con carcinoma della cervice
    E.2.2Secondary objectives of the trial
    • Evaluate durability
    • Evaluate other clinical outcomes
    • Assess safety and tolerability
    Valutare la durata
    Valutare altri esiti clinici
    Valutare la sicurezza e la tollerabilità
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Patients with extra-pelvic metastatic or recurrent cervical cancer including squamous cell, adenocarcinoma or adenosquamous histology, that:
    1. Have experienced disease progression during or after treatment with:
    - Paclitaxel+cisplatin or carboplatin OR
    - Paclitaxel+topotecan,
    in combination with bevacizumab unless patients are ineligible for bevacizumab treatment according to local standards.
    2. Have received no more than 2 prior systemic treatment regimens for recurrent or metastatic cervical cancer. Chemotherapy administered in combination with radiation therapy is not considered a prior systemic regimen.
    3. Are not candidates for curative therapy, including but not limited to, radiotherapy or exenterative surgery.
    • Age ≥ 18 years
    • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
    • Life expectancy of at least three months
    • A negative serum pregnancy test for patients of reproductive potential
    • Patients of reproductive potential must agree to use adequate contraception during and for 6 months after the last IMP administration
    • Following receipt of verbal and written information about the trial, patients must provide signed informed consent before any trial-related activity is carried out
    • Acceptable coagulation status:
    o International normalized ratio (INR) ≤ 1.2 (without anti-coagulation therapy).
    o Activated partial thromboplastin time (aPTT) ≤ 1.25 ULN.
    o Patients on anti-coagulation therapy (e.g., warfarin) must be on a steady dose (no active titration) for at least 4 weeks prior to screening and must have an INR ≤ 2.5 for eligibility. Concurrent use of prophylactic AcetylSalicylic Acid (ASA, e.g., aspirin) for patients on anti-coagulation therapy (e.g., warfarin) is prohibited.
    •Pazienti con carcinoma della cervice extra-pelvico metastatico o recidivante, compresi quelli a istologia squamocellulare, di adenocarcinoma o adenosquamosa, che:
    1. Abbiano manifestato progressione della malattia durante o dopo il trattamento con:
    -paclitaxel + cisplatino o carboplatino
    OPPURE
    -paclitaxel + topotecan,
    in combinazione con bevacizumab, salvo che le pazienti non siano idonee al trattamento con bevacizumab secondo gli standard locali.
    2. Abbiano ricevuto non più di 2 precedenti regimi terapeutici sistemici per il carcinoma della cervice recidivante o metastatico. La chemioterapia somministrata in combinazione con la radioterapia non è considerata un precedente regime sistemico.
    3. Non siano candidate per la terapia curativa, compresa, senza limitazione, la radioterapia o chirurgia exenterativa.
    •Età ≥18 anni.
    •Stato di validità secondo il Gruppo cooperativo orientale di oncologia (ECOG) pari a 0 o 1
    •Aspettativa di vita di almeno tre mesi.
    •Negatività al test di gravidanza su siero per le pazienti in età fertile.
    •Le pazienti in età fertile devono acconsentire all’uso di contraccezione adeguata durante e per 6 mesi dopo l’ultima somministrazione dell’IMP.
    •Una volta ricevute informazioni verbali e scritte sulla sperimentazione, le pazienti devono fornire il consenso informato scritto prima di sottoporsi a qualsiasi attività correlata alla sperimentazione.
    •Stato di coagulazione accettabile:
    o International normalized ratio (INR) ≤ 1.2 (senza anti-coagulazione terapia).

    •Tempo di tromboplastina parziale attivato (aPTT) ≤ 1,25 ULN.
    •Le pazienti in terapia anticoagulante (ad es. Warfarin) devono essere su una dose costante (nessuna titolazione attiva) per almeno 4 settimane prima dello screening e devono avere un INR ≤ 2.5 per essere considerate idonee. Uso concomitante di acido acetilsalicilico profilattico (ASA, ad es., aspirina) per pazienti in terapia anticoagulante la terapia (ad es. warfarin) è proibita.
    E.4Principal exclusion criteria
    • Known past or current coagulation defects
    • Ongoing major bleeding
    • Clinically significant cardiac disease
    • Other cancer: Known past or current malignancy other than inclusion diagnosis



    • Difetti di coagulazione noti pregressi o attuali
    • sanguinamento maggiore in corso
    • Malattia cardiaca clinicamente significativa
    • Altri tumori: tumore maligno noto pregresso o attuale che non rientri nella diagnosi di inclusione
    E.5 End points
    E.5.1Primary end point(s)
    • Confirmed objective response rate based upon RECIST v1.1 assessed by the independent review committee
    Tasso di risposta obiettiva confermato in base alla versione 1.1 dei Criteri di valutazione della risposta nei tumori solidi (RECIST), valutato da un comitato di revisione indipendente
    E.5.1.1Timepoint(s) of evaluation of this end point
    • During the trial, see protocol
    durante lo studio, fare riferimento al protocollo
    E.5.2Secondary end point(s)
    • Duration of response (DOR) based upon RECIST v1.1
    • Confirmed objective response rate based upon RECIST v1.1 assessed by the investigator
    • Time to response based upon RECIST v1.1
    • Progression free survival based upon RECIST v1.1
    • Overall survival
    • Adverse events and safety laboratory parameters
    • Pharmacokinetics (PK)
    • Immunogenicity
    • Durata della risposta (DOR) in base ai criteri RECIST v1.1
    • Tasso di risposta obiettiva confermato valutato dallo sperimentatore in base ai criteri RECIST v1.1
    • Tempo alla risposta in base ai criteri RECIST v1.1
    • Sopravvivenza libera da progressione in base ai criteri RECIST v1.1
    • Sopravvivenza complessiva
    • Eventi avversi e parametri di laboratorio di sicurezza.
    • Farmacocinetica (PK)
    • Immunogenicità
    E.5.2.1Timepoint(s) of evaluation of this end point
    • During the trial, see protocol
    durante lo studio, fare riferimento al protocollo
    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 No
    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 No
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA33
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Belgium
    Czech Republic
    Denmark
    Germany
    Italy
    Spain
    Sweden
    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
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    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: 10
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 90
    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 state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 92
    F.4.2.2In the whole clinical trial 100
    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
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2018-07-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-06-27
    P. End of Trial
    P.End of Trial StatusCompleted
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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