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    Summary
    EudraCT Number:2016-000105-36
    Sponsor's Protocol Code Number:R2810-ONC-1540
    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:2021-01-28
    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 number2016-000105-36
    A.3Full title of the trial
    A PHASE 2 STUDY OF REGN2810, A FULLY HUMAN MONOCLONAL ANTIBODY TO PROGRAMMED DEATH – 1 (PD-1), IN PATIENTS WITH ADVANCED CUTANEOUS SQUAMOUS CELL CARCINOMA
    Studio di fase 2 su REGN2810, un anticorpo monoclonale interamente umano anti Programmed Death-1 (PD-1, proteina 1 di morte cellulare programmata), in pazienti con carcinoma cutaneo a cellule squamose in stato avanzato
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of Cemiplimab (REGN2810 (Anti-PD-1) in Patients With Advanced Malignancies
    Studio su Cemiplimab (REGN2810 (Anti-PD-1), in pazienti con tumori maligni avanzati
    A.3.2Name or abbreviated title of the trial where available
    R2810-ONC-1540
    R2810-ONC-1540
    A.4.1Sponsor's protocol code numberR2810-ONC-1540
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02760498
    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 pointClinical Trial Management
    B.5.3 Address:
    B.5.3.1Street Address777 Old Saw Mill River Road
    B.5.3.2Town/ cityTarrytown
    B.5.3.3Post code10591
    B.5.3.4CountryUnited States
    B.5.6E-mailclinicaltrials@regeneron.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 nameREGN2810
    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.3.9.3Other descriptive nameanti-PD-1 mAb
    D.3.9.4EV Substance CodeSUB179369
    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 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 nameREGN2810
    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.3.9.3Other descriptive nameanti-PD-1 mAb
    D.3.9.4EV Substance CodeSUB179369
    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 No
    D.IMP: 3
    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 nameREGN2810
    D.3.2Product code [REGN2810]
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous 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.3.9.3Other descriptive nameanti-PD-1 mAb
    D.3.9.4EV Substance CodeSUB179369
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number175
    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 No
    D.IMP: 4
    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 nameREGN2810
    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.3.9.3Other descriptive nameanti-PD-1 mAb
    D.3.9.4EV Substance CodeSUB179369
    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 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
    Advanced cutaneous squamous cell carcinoma
    Carcinoma cutaneo a cellule squamose in stato avanzato
    E.1.1.1Medical condition in easily understood language
    Advanced cancerous growth
    Crescita tumorale in stadio avanzato
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level PT
    E.1.2Classification code 10041823
    E.1.2Term Squamous cell 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
    For Groups 1 to 4, the primary objective of this study is to estimate the clinical benefit of cemiplimab monotherapy for patients with: metastatic (nodal or distant) CSCC, or unresectable locally advanced CSCC. Group 1consists of patients with metastatic (nodal or distant) CSCC treated with cemiplimab 3 mg/kg IV Q2W. Group 2 consists of patients with unresectable locally advanced CSCC, treated with cemiplimab 3 mg/kg IV Q2W. Group 3 consists of patients with metastatic (nodal or distant) CSCC treated with cemiplimab 350 mg IV Q3W. Group 4 consists of patients with advanced CSCC (metastatic [nodal or distal] or unresectable locally advanced) treated with cemiplimab 600 mg IV Q4W. Clinical benefit is measured by ORR according to central review in each group. For Group 6, the primary objective is to provide additional efficacy and safety data for cemiplimab monotherapy in patients with advanced CSCC (metastatic [nodal or distant] or locally advanced) treated with cemiplimab 350 mg IV Q3W.
    Gruppi da 1 a 4: stimare il beneficio clinico di cemiplimab in monoterapia per i pz con CSCC metastatico (nodale o distante) o CSCC localmente avanzato non resecabile. Gruppo1: pz con CSCC metastatico (nodale o distante) trattati con cemiplimab 3mg/kg EV Q2W. Gruppo2: pz con CSCC localmente avanzato non resecabile, trattati con cemiplimab 3mg/kg EV Q2W. Gruppo3: pz con CSCC metastatico (nodale o distante) trattati con cemiplimab 350mg EV Q3W. Gruppo 4: pz con CSCC avanzato (metastatico [nodale o distale] o non resecabile localmente avanzato) trattati con cemiplimab 600 mg EV Q4W. Beneficio clinico misurato in base a ORR secondo revisione centrale in ciascun gruppo. Gruppo6: obiettivo primario è fornire ulteriori dati di efficacia e sicurezza su cemiplimab in monoterapia per i pz con CSCC avanzato (metastatico [nodale o distante] o localmente avanzato) trattati con cemiplimab 35 mg EV Q3W.
    E.2.2Secondary objectives of the trial
    Secondary objectives for Groups 1 to 4 , and Group 6 are:
    -To estimate ORR according to investigator review;
    -To estimate the duration of response (DOR), progression free survival (PFS) and overall survival (OS) by central and investigator review;
    -To estimate the complete response (CR) rate by central review;
    -To assess the safety and tolerability of cemiplimab;
    -To assess the PK of cemiplimab
    -To assess the immunogenicity of cemiplimab
    For Groups 1 to 5 only:
    -To assess the impact of cemiplimab on quality of life using European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
    Group 6 only: To assess relationships between PD-L1 status (by immunohistochemistry [IHC]) and efficacy measures (ORR, DOR, PFS).
    Gli obiettivi secondari per i Gruppi da 1 a 4 e per il Gruppo 6 sono:
    • Stimare la ORR in base alla revisione da parte dello sperimentatore
    • Stimare la durata della risposta (DOR), la sopravvivenza libera da progressione (PFS) e la sopravvivenza globale (OS) in base alla revisione centrale e dello sperimentatore
    • Stimare il tasso di risposta completa (CR) in base alla revisione centrale
    • Valutare la sicurezza e la tollerabilità di cemiplimab
    • Valutare il PK di cemiplimab
    • Valutare l'immunogenicità di cemiplimab
    Solo per i Gruppi da 1 a 5:
    • Valutare l’impatto di cemiplimab sulla qualità della vita utilizzando il questionario principale a 30 domande per la misurazione della qualità della vita redatto dall'Organizzazione europea per la ricerca e il trattamento del cancro (EORTC QLQ-C30)
    Solo Gruppo 6: Valutare le relazioni tra lo stato di PD-L1 (mediante immunoistochimica [IHC]) e le misure di efficacia (ORR, DOR, PFS).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -At least 1 measurable lesion
    -Eastern Cooperative Oncology Group (ECOG) performance status =1
    - Adequate bone marrow function
    -Adequate renal function
    - Adequate hepatic function
    -Archived or newly obtained tumor material
    -Patients must consent to undergo biopsies of externally visible CSCC lesions (Group 2 only)
    - Almeno 1 lesione misurabile secondo i criteri dello studio
    - Performance status secondo ECOG (Eastern Cooperative Oncology Group) =1
    - Funzionalità del midollo osseo adeguata
    - Funzionalità renale adeguata
    - Funzionalità epatica adeguata
    - Materiale tumorale di archivio o appena ottenuto
    - I pazienti devono acconsentire a sottoporsi a biopsie delle lesioni CSCC visibili esternamente al basale (solo Gruppo 2)
    E.4Principal exclusion criteria
    A patient who meets any of the following criteria will be excluded from the study:
    1.Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk for immune-related adverse events (irAEs).
    2.Prior treatment with an agent that blocks the PD-1/PD-L1 pathway.
    3.Prior treatment with other immune modulating agents that was
    (a) within fewer than 4 weeks (28 days) prior to the first dose of cemiplimab, or
    (b) associated with immunemediated adverse events that were = grade 1 within 90 days prior to the first dose of cemiplimab, or
    (c) associated with toxicity that resulted in discontinuation of the immune-modulating agent.
    4.Untreated brain metastasis(es) that may be considered active. Patients with previously treated brain metastases may participate provided that the lesion(s) is (are) stable (without evidence of progression for at least 6 weeks on imaging obtained in the screening period), and there is no evidence of new or enlarging brain metastases, and the patient does not require any immunosuppressive doses of systemic corticosteroids for management of brain metastasis(es) within 4 weeks of first dose of cemiplimab.
    5.Immunosuppressive corticosteroid doses (>10 mg prednisone daily or equivalent) within 4 weeks prior to the first dose of cemiplimab.
    6.Active infection requiring therapy, including infection with human immunodeficiency virus, or active infection with hepatitis B virus or hepatitis C virus.
    7.History of non-infective pneumonitis within the last 5 years
    8.History of documented allergic reactions or acute hypersensitivity reaction attributed to antibody treatments.
    9.Patients with a history of solid organ transplant .
    10.Prior treatment with a BRAF inhibitor
    Un paziente che soddisfa uno dei seguenti criteri sarà escluso dallo studio:
    1. Evidenza in corso o recente (entro 5 anni) di malattia autoimmune significativa necessitante di terapia immunosoppressiva sistemica, che potenzialmente suggesrisce un rischio di eventi avversi immuno-correlati (irAE)
    2. Precedente trattamento con un agente bloccante la via PD-1/PD-L1
    3. Precedente trattamento con altri agenti con azione modulante sul sistema immunitario
    (a) somministrato entro meno di 4 settimane (28 giorni) prima della prima dose di cemiplimab o
    (b) associato a eventi avversi immuno mediati di grado = 1 entro 90 giorni prima della prima dose di cemiplimab o
    (c) associato a tossicità determinante l'interruzione del trattamento immuno-modulante
    4. Metastasi cerebrale/i non trattata/e che può/possono essere considerata/e attiva/e. I pazienti con metastasi cerebrali precedentemente trattate possono partecipare a condizione che la(e) lesione(i) sia(siano) stabile(i) (senza evidenza di progressione per almeno 6 settimane sulle immagini ottenute nel periodo di screening) e non vi siano evidenze di metastasi cerebrali nuove o ingrandite e il paziente non richieda dosi immunosoppressive di corticosteroidi sistemici per la gestione della(e) metastasi cerebrale(i) entro 4 settimane dalla prima dose di cemiplimab
    5. Dosi immunosoppressive di corticosteroidi (> 10 mg di prednisone al giorno o equivalente) entro 4 settimane prima della prima dose di cemiplimab
    6. Infezione attiva che richiede terapia, inclusa infezione da virus dell'immunodeficienza umana, infezione attiva da virus dell’epatite B o virus dell’epatite C
    7. Anamnesi di polmonite non infettiva negli ultimi 5 anni
    8. Anamnesi di reazioni allergiche documentate o reazione di ipersensibilità acuta attribuita a trattamenti con anticorpi
    9. Pazienti con anamnesi di trapianto di organo solido
    10. Precedente trattamento con farmaci inibitori di BRAF
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint for this study is ORR according to central review during the 12 treatment cycles (Group 1, 2 and 6) or 6 treatment cycles (Groups 3 and 4), that will be assessed separately for patients with metastatic CSCC or unresectable locally advanced CSCC
    L'endpoint di efficatica primaria per questo studio è l'ORR (Overall response rate) secondo la revisione centrale nei 12 cicli di trattamento (Gruppi 1, 2 e 6) o 6 cicli di trattamento (Gruppi 3 e 4). Il tasso di risposta globale sarà valutata separatamente per i pazienti con CSCC metastatico o CSCC localmente avanzato non resecabile
    E.5.1.1Timepoint(s) of evaluation of this end point
    96 weeks (Group 1 and 2), 54 weeks (Group 3 and 5), 48 weeks (Group 4) and up to 108 weeks (Group 6)
    96 settimane (Gruppo 1 e 2), 54 settimane (Gruppo 3 e 5), 48 settimane (Gruppi 4) e fino a 108 settimane (Gruppo 6)
    E.5.2Secondary end point(s)
    The secondary efficacy outcome measures are:
    - ORR for Group 1 through 6 by investigator assessments
    - DOR – measured from the time measurement criteria are first met for CR/PR, whichever is recorded first, until the first date of recurrent or progressive disease or death due to any cause in patients with best overall response (BOR) of CR or PR
    - PFS – measured from time of enrollment until the first date of recurrent or progressive disease, or death due to any cause
    - OS – measured from time of enrollment until death due to any cause
    - CR rate
    - Change in scores of patient-reported outcomes on EORTC QLQ-C30
    (except Group 6)
    - Anti-drug antibodies (ADA)
    - For Group 6 only: To assess relationships between PD-L1 status (by
    IHC) and efficacy measures (ORR, DOR, PFS).
    I parametri di valutazione di efficacia secondari sono:
    ORR per i Gruppi da 1 a 6 in base alle valutazioni dello sperimentatore
    Durata della risposta (DOR)
    PFS - misurata dal momento dell'arruolamento fino alla prima data di malattia ricorrente o progressiva, o decesso per qualsiasi causa
    OS - misurata dal momento dell'arruolamento fino al decesso per qualsiasi causa
    Tasso di CR
    Variazione dei punteggi degli esiti riferiti dal paziente nel questionario EORTC QLQ C30 (tranne il Gruppo 6)
    Anticorpi anti-farmaco (ADA)
    Solo Gruppo 6: Valutare le relazioni tra stato di PD L1 (in base a IHC) e misure di efficacia (ORR, DOR, PFS).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Patients should receive response assessments according to the treatment schedule of their cohort.
    I pazienti riceveranno le valutazioni della risposta in accordo al programma di trattamento della propria coorte.
    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 No
    E.6.11Pharmacogenomic Yes
    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 concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA75
    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
    Brazil
    New Zealand
    United States
    France
    Germany
    Greece
    Italy
    Spain
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The end of study for all groups is approximately 1.5 years after completion of the treatment at the end of extended follow-up.
    For Group 6, end of study is approximately 6 months after completion of the follow-up period.
    La fine dello studio per tutti i gruppi è circa 1.5 anni dopo il completamento del trattamento alla fine del "extended follow-up". Per il gruppo 6, la fine dello studio è circa 6 mesi dopo il completamento del periodo di follow-up.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days21
    E.8.9.2In all countries concerned by the trial years10
    E.8.9.2In all countries concerned by the trial months2
    E.8.9.2In all countries concerned by the trial days2
    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: 216
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 217
    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 state130
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 249
    F.4.2.2In the whole clinical trial 433
    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)
    After treatment, retreatment, and follow-up are completed or if patients prematurely discontinue from treatment, patients will receive extended follow-up every 4 months for 1 year
    Una volta completati il trattamento, la ripetizione del trattamento e il follow-up o se i pazienti interrompono anticipatamente il trattamento, i pazienti saranno sottoposti al follow-up esteso ogni 4 mesi per 1 anno
    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 Decision2020-04-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-02-26
    P. End of Trial
    P.End of Trial StatusCompleted
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