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    Summary
    EudraCT Number:2022-002841-17
    Sponsor's Protocol Code Number:ASST-FARM_ONCO_TEPMEETCET-2022
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-11-28
    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 number2022-002841-17
    A.3Full title of the trial
    Phase 2, open-label, multicentre, single-arm study to evaluate the activity of the combination of EGFR inhibitors and c-MET inhibitors in patients with platinum-resistant head and neck squamous cell carcinoma after relapse to immunotherapy
    Phase 2, open-label, multicentre, single-arm study to evaluate the activity of the combination of EGFR inhibitors and c-MET inhibitors in patients with platinum-resistant head and neck squamous cell carcinoma after relapse to immunotherapy
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase 2, open-label, multicentre, single-arm study to evaluate the activity of the combination of EGFR inhibitors and c-MET inhibitors in patients with platinum-resistant head and neck squamous cell carcinoma after relapse to immunotherapy
    Phase 2, open-label, multicentre, single-arm study to evaluate the activity of the combination of EGFR inhibitors and c-MET inhibitors in patients with platinum-resistant head and neck squamous cell carcinoma after relapse to immunotherapy
    A.3.2Name or abbreviated title of the trial where available
    TEPMEETCET
    TEPMEETCET
    A.4.1Sponsor's protocol code numberASST-FARM_ONCO_TEPMEETCET-2022
    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 SponsorAZIENDA SOCIO SANITARIA TERRITORIALE DEGLI SPEDALI CIVILI DI BRESCIA
    B.1.3.4CountryItaly
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportMerck Healthcare KGaA
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationasst degli Spedali Civili di Brescia
    B.5.2Functional name of contact pointcoordinamento ricerca
    B.5.3 Address:
    B.5.3.1Street Addressp.le Spedali Civili 1
    B.5.3.2Town/ citybrescia
    B.5.3.3Post code25123
    B.5.3.4CountryItaly
    B.5.6E-mailcoordinamento.ricerca@asst-spedalicivili.it
    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 Yes
    D.2.1.1.1Trade name TEPMETKO
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Europe
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameTEPMETKO
    D.3.2Product code [TEPMETKO]
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNtepotinib
    D.3.9.2Current sponsor codetepotinib
    D.3.9.3Other descriptive nametepotinib
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    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 Yes
    D.2.1.1.1Trade name ERBITUX - 5 MG/ML SOLUZIONE PER INFUSIONE - USO ENDOVENOSO- FLACONCINO(VETRO) 20 ML 1 FLACONCINO
    D.2.1.1.2Name of the Marketing Authorisation holderMERCK KGAA
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 namecetuximab
    D.3.2Product code [cetuximab]
    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 INNCETUXIMAB
    D.3.9.2Current sponsor codecetuximab
    D.3.9.3Other descriptive namecetuximab
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number400
    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
    in patients with platinum-resistant head and neck squamous cell carcinoma after relapse to immunotherapy “
    in pazienti affetti da carcinoma squamoso del distretto testa-collo, platino resistenti in progressione ad immunoterapia
    E.1.1.1Medical condition in easily understood language
    in patients with platinum-resistant head and neck squamous cell carcinoma after relapse to immunotherapy “
    in pazienti affetti da carcinoma squamoso del distretto testa-collo, platino resistenti in progressione ad immunoterapia
    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 PT
    E.1.2Classification code 10028997
    E.1.2Term Neoplasm malignant
    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
    To evaluate the activity of tepotinib in combination with cetuximab in terms of tumor response
    Valutare l’attività di tepotinib + cetuximab
    E.2.2Secondary objectives of the trial
    To further evaluate the activity of the combination of tepotinib and cetuximab in terms of:
    * duration of response (DoR) and disease control rate (DCR)
    * progression-free survival (PFS)
    * overall survival (OS)
    To evaluate the safety and tolerability of tepotinib in combination with cetuximab
    Impact on Quality of Life (QoL)
    Valutazioni aggiuntive sull’attività di tepotinib + cetuximab in termini di:
    * duration of response (DoR) e disease control rate (DCR)
    * progression-free survival (PFS)
    * overall survival (OS)
    Valutare la tolleranza di tepotinib + cetuximab
    Impatto sulla Quality of Life (QoL)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Adults > 18 years old
    - Patients must have histologically confirmed HNSCC from any primary site; nasopharyngeal carcinoma and paranasal sinus, will be included; squamous cell carcinoma of unknown primary, clearly related to the head and neck, will be included
    - Recurrent/metastatic disease, fulfilling at least one of the criteria defined below:
    a) Incurable disease as assessed by surgical or radiation oncology
    b) Metastatic (M1) disease
    c) Persistent or progressive disease following curative-intent radiation, and not a candidate for surgical salvage due to incurability or morbidity; patients who decline radical surgery are eligible
    - For patients with oropharyngeal primary site or unknown primary site only: tumoral human papillomavirus (HPV) status must be negative, as established; acceptable standards include p16 immunohistochemistry (where a tumor is classified as p16-positive when showing diffuse nuclear and cytoplasmic staining in at least 70% of tumor cells) and/or assessment of HPV deoxyribonucleic acid (DNA)
    For patients with nasopharyngeal cancer only or unknown primary site only: tumoral Epstein- Barr Virus (EBV) status must be negative.
    - Adulti > 18 anni
    - I pazienti devono avere HNSCC confermato istologicamente da qualsiasi sito primario; saranno inclusi carcinoma nasofaringeo e seno paranasale; Sarà incluso il carcinoma a cellule squamose di origine sconosciuta, chiaramente correlato alla testa e al collo.
    - Malattia ricorrente/metastatica, che soddisfi almeno uno dei criteri definiti di seguito:
    a) Malattia incurabile valutata mediante oncologia chirurgica o radiologica
    b) Malattia metastatica (M1)
    c) malattia persistente o progressiva a seguito di radiazioni curative e non candidata per il salvataggio chirurgico a causa di incurabilità o morbilità; I pazienti che rifiutano la chirurgia radicale sono eleggibili
    - Per i pazienti con sito primario orofaringeo o solo sito primario sconosciuto: lo stato del papillomavirus umano tumorale (HPV) deve essere negativo, come stabilito; Gli standard accettabili includono l'immunoistochimica p16 (dove un tumore è classificato come p16-positivo quando mostra colorazione nucleare e citoplasmatica diffusa in almeno il 70% delle cellule tumorali) e/o valutazione dell'acido desossiribonucleico (DNA) HPV)
    Per i pazienti con solo carcinoma nasofaringeo o solo sito primario sconosciuto: lo stato del virus di Epstein-Barr (EBV) tumorale deve essere negativo.
    E.4Principal exclusion criteria
    - History of severe allergic or anaphylactic reactions or hypersensitivity to recombinant proteins or excipients in the investigational agent;
    - Prior treatment with a hepatocyte growth factor (HGF)/cMet inhibitor such as rilotumumab, crizotinib, MetMAb, or ARQ197;
    - Uncontrolled central nervous system (CNS) metastases, including leptomeningeal metastases, are not allowed; subjects with previously treated brain metastases will be allowed if the brain metastases have been stable without steroid treatment for at least 2 weeks (radiotherapy or surgery);
    - Failure to recover to grade 1 or baseline from all toxic effects of previous chemotherapy, radiation therapy, biologic therapy, immunotherapy, and/or experimental therapy, with the exception of: alopecia, grade =< 2 peripheral neuropathy, grade =< 2 cetuximab-related rash or other skin changes, hypomagnesemia (acceptable values detailed below), hypokalemia (acceptable values detailed below), and the acceptable hematologic values summarized above; a washout period of 3 weeks from any prior cytotoxic chemotherapy, targeted therapy, immunotherapy or investigational drug is required;
    - Previous treatment with cetuximab for RM disease. Use of cetuximab is allowed if given concurrently with radiation;
    - Significant pulmonary disease, including pulmonary hypertension or interstitial pneumonitis;
    - Peripheral edema >= grade 2 per National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version 5.0;
    - Anamnesi di gravi reazioni allergiche o anafilattiche o ipersensibilità alle proteine ricombinanti o agli eccipienti nell'agente sperimentale;
    - Trattamento precedente con un fattore di crescita degli epatociti (HGF)/inibitore cMet come rilotumumab, crizotinib, MetMAb o ARQ197;
    -Le metastasi incontrollate del sistema nervoso centrale (SNC), comprese le metastasi leptomeningee, non sono consentite; I soggetti con metastasi cerebrali precedentemente trattate saranno ammessi se le metastasi cerebrali sono rimaste stabili senza trattamento steroideo per almeno 2 settimane (radioterapia o chirurgia)
    -Mancato recupero al grado 1 o basale da tutti gli effetti tossici di precedenti chemioterapia, radioterapia, terapia biologica, immunoterapia e/o terapia sperimentale, ad eccezione di: alopecia, grado = < 2 neuropatia periferica, grado = < 2 eruzione cutanea correlata a cetuximab o altri cambiamenti cutanei, ipomagnesemia (valori accettabili dettagliati di seguito), ipokaliemia;(valori accettabili dettagliati di seguito) e i valori ematologici accettabili riassunti sopra; è richiesto un periodo di washout di 3 settimane da qualsiasi precedente chemioterapia citotossica, terapia mirata, immunoterapia o farmaco sperimentale;
    -Precedente trattamento con cetuximab per la malattia di RM. L'uso di cetuximab è consentito se somministrato in concomitanza con le radiazioni;
    - Malattia polmonare significativa, inclusa ipertensione polmonare o polmonite interstiziale;
    - Edema periferico >= grado 2 per National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) versione 5.0;
    E.5 End points
    E.5.1Primary end point(s)
    Objective response (OR, confirmed complete response [CR] or partial response [PR]) determined according to RECIST Version 1.1 assessed by the Investigators
    Risposta obiettiva (OR, risposta completa confermata [CR] o risposta parziale [PR]) determinata secondo RECIST Versione 1.1 valutata dagli sperimentatori
    E.5.1.1Timepoint(s) of evaluation of this end point
    Complete Response (CR) defined as at least two determinations of CR at least 4 weeks apart (with no PD in between)
    Partial Response (PR) defined as at least two determinations of PR or better (PRfollowed by PR or PR followed by CR) at least 4 weeks apart (and not qualifying for a CR), with no PD in between
    Stable Disease (SD) defined as at least one SD assessment (or better)[= 6 weeks] after start date (and not qualifying for confirmed CR or PR.
    Non-CR/non-PD (applicable only to participants with non- measurable disease at Baseline) = at least one non-CR/non-PD assessment (or better) [= 6 weeks] afterstart date (and not qualifying for CR or PR).
    PD = PD = 12 weeks after start date (and not qualifying for CR, PR,
    Risposta completa (CR) definita come almeno due determinazioni di CR a distanza di almeno 4 settimane (senza PD in mezzo)
    Risposta parziale (PR) definita come almeno due determinazioni di PR o migliore (PR seguita da PR o PR seguita da CR) a distanza di almeno 4 settimane (e non qualificanti per una CR), senza PD in mezzo
    Malattia stabile (DS) definita come almeno una valutazione SD (o migliore) [= 6 settimane] dopo la data di inizio (e non qualificante per CR o PR confermate.
    Non CR/non PD (applicabile solo ai partecipanti con malattia non misurabile al basale) = almeno una valutazione non CR/non PD (o migliore) [= 6 settimane] dopo la data di inizio (e non idoneo per CR o PR).
    PD = PD = 12 settimane dopo la data di inizio (e non qualificanti per CR, PR,
    E.5.2Secondary end point(s)
    DoR and DCR according to RECIST
    1.1 as assessed by the Investigators.
    ° PFS
    ° OS; To evaluate the safety and tolerability of tepotinib incombination with cetuximab; Impact on Quality of Life (QoL)
    DoR e DCR secondo RECIST
    1.1 come valutato dagli sperimentatori.
    ° PFS
    ° OS; To evaluate the safety and tolerability of tepotinib incombination with cetuximab; Impact on Quality of Life (QoL)
    E.5.2.1Timepoint(s) of evaluation of this end point
    3, 6, 9, 12,15, and 18 months; every time; Pre- study (within 2 weeks of study registration) and Week 9, Cycle 3 of Intervention]
    3, 6, 9, 12,15, 18 mesi; in qualsiasi momento; Pre- study (within 2 weeks of study registration) and Week 9, Cycle 3 of Intervention]
    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 No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    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 No
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    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 No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    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 years3
    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 years3
    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: 18
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 7
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    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 state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 25
    F.4.2.2In the whole clinical trial 25
    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 will be treated according to the standards of the National Health System
    I pazienti saranno trattati secondo gli standard del SSN
    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 Decision2023-04-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-01-10
    P. End of Trial
    P.End of Trial StatusOngoing
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