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    Summary
    EudraCT Number:2020-002964-29
    Sponsor's Protocol Code Number:IMMU-132-13
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2021-06-07
    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 number2020-002964-29
    A.3Full title of the trial
    A Randomized Open-Label Phase III Study of Sacituzumab Govitecan Versus Treatment of Physician's Choice in Subjects with Metastatic or
    Locally Advanced Unresectable Urothelial Cancer
    Studio randomizzato di fase III in aperto che valuta sacituzumab govitecan rispetto al trattamento di scelta del medico in soggetti con carcinoma uroteliale non resecabile metastatico o localmente avanzato
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to compare study medication Sacituzumab Govitecan with Standard of Care medications (Paclitaxel, Docetaxel or Vinflunine) in Metastatic (spread to other locations in the body) or Locally Advanced Unresectable (cannot be removed surgically) Urothelial (urinary system) Cancer which has progressed or returned after prior treatments with platinum containing chemotherapy and immunotherapy
    Studio volto a confrontare il farmaco in studio sacituzumab govitecan con i farmaci della terapia standard (paclitaxel, docetaxel o vinflunina) nel tumore uroteliale (del sistema urinario) metastatico (diffuso in altre sedi del corpo) o localmente avanzato non resecabile (che non può essere rimosso chirurgicamente) che è progredito o si è ripresentato dopo un precedente trattameno con chemioterapia al platino e immunoterapia.
    A.3.2Name or abbreviated title of the trial where available
    NA
    NA
    A.4.1Sponsor's protocol code numberIMMU-132-13
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04527991
    A.5.4Other Identifiers
    Name:INDNumber:140084
    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 SponsorIMMUNOMEDICS, 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 supportImmunomedics, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationImmunomedics, Inc.
    B.5.2Functional name of contact pointImmunomedics Medical Information
    B.5.3 Address:
    B.5.3.1Street Address300 The American Road
    B.5.3.2Town/ cityMorris Plains
    B.5.3.3Post codeNJ 07950
    B.5.3.4CountryUnited States
    B.5.4Telephone number001889834668
    B.5.5Fax number000000000000
    B.5.6E-mailMedinfo@immunomedics.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.2.1.1.1Trade name Javlor
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameVinflunina
    D.3.2Product code [NA]
    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 INNVINFLUNINA DITARTRATO
    D.3.9.1CAS number 162652-95-1
    D.3.9.2Current sponsor codeVinflunina
    D.3.9.4EV Substance CodeSUB00063MIG
    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.2.1.1.1Trade name NA
    D.2.1.1.2Name of the Marketing Authorisation holderNA
    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 nameSacituzumab govitecan
    D.3.2Product code [IMMU-132, hRS7-SN38]
    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 INNSACITUZUMAB GOVITECAN
    D.3.9.1CAS number 1491917-83-9
    D.3.9.2Current sponsor codeSacituzumab govitecan
    D.3.9.3Other descriptive nameIMMU-132, hRS7-SN38
    D.3.9.4EV Substance CodeSUB191213
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number180
    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 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 No
    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 namePaclitaxel
    D.3.2Product code [NA]
    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 INNPACLITAXEL
    D.3.9.1CAS number 33069-62-4
    D.3.9.2Current sponsor codePAclitaxel
    D.3.9.4EV Substance CodeSUB09583MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number6
    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.2.1.1.1Trade name Docetaxel
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameDocetaxel
    D.3.2Product code [NA]
    D.3.4Pharmaceutical form Concentrate and solvent 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 INNDOCETAXEL
    D.3.9.1CAS number 114977-28-5
    D.3.9.2Current sponsor codeDocetaxel
    D.3.9.4EV Substance CodeSUB12492MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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.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
    Metastatic or Locally Advanced Unresectable Urothelial Cancer.
    Carcinoma uroteliale non resecabile metastatico o localmente avanzato.
    E.1.1.1Medical condition in easily understood language
    Urothelial Cancer not possible of being surgically removed which has grown outside the area it started in and has either spread or not yet
    spread to distant parts of the body.
    Tumore uroteliale che non può essere rimosso chirurgicamente, che è cresciuto al di fuori dell'area dove ha avuto inizio e che si è diffuso o meno in parti distanti del corpo.
    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 LLT
    E.1.2Classification code 10046728
    E.1.2Term Urothelial carcinoma urethra
    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 10077840
    E.1.2Term Urothelial cancer of renal pelvis
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10046714
    E.1.2Term Urothelial carcinoma bladder
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10046723
    E.1.2Term Urothelial carcinoma ureter
    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
    The primary objective is to assess Overall Survival with sacituzumab govitecan in comparison with treatment of physician's choice (TPC) in subjects with metastatic or locally advanced unresectable UC.
    L'obiettivo primario è valutare la sopravvivenza complessiva con sacituzumab govitecan rispetto a quella ottenuta con il trattamento di scelta del medico (TPC) in soggetti con carcinoma uroteliale (UC) metastatico o localmente avanzato non resecabile.
    E.2.2Secondary objectives of the trial
    1. To assess PFS with sacituzumab govitecan in comparison with TPC by investigator assessment and blinded independent central review (BICR) using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
    2. To assess ORR, clinical benefit rate (CBR), and duration of objective tumor response (DOR) with sacituzumab govitecan in comparison with TPC by investigator assessment and BICR using RECIST v1.1.
    3. To assess safety and tolerability of sacituzumab govitecan in comparison with TPC.
    4. To assess Quality of Life (QOL) with sacituzumab govitecan in comparison with TPC.
    1. Valutare la sopravvivenza libera da progressione (PFS) con sacituzumab govitecan rispetto a quella ottenuta con il TPC in base alla valutazione dello sperimentatore e alla revisione centrale e indipendente in cieco (BICR) secondo i criteri di valutazione della risposta nei tumori solidi (RECIST) v1.1.
    2. Valutare il tasso di risposta obiettiva (ORR), il tasso di beneficio clinico (CBR) e la durata della risposta obiettiva del tumore (DOR) con sacituzumab govitecan rispetto al TPC in base alla valutazione dello sperimentatore e alla BICR secondo i criteri RECIST v1.1.
    3. Valutare la sicurezza e la tollerabilità di sacituzumab govitecan rispetto al TPC.
    4. Valutare la qualità della vita (QOL) con sacituzumab govitecan rispetto al TPC.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Female or male subjects, >or= 18 years of age, able to understand and give written informed consent.
    2. Subjects with histologically documented metastatic or locally advanced unresectable UC defined as:
    • Tumor (T) 4b, any node (N) or • Any T, N 2-3 Tumors of upper and lower urinary tract are permitted. Mixed histologic types are allowed if urothelial is the predominant histology.
    3. ECOG PS score of 0 or 1.
    4. Subjects with progression or recurrence following receipt of platinumcontaining regimen and anti PD-1/PD-L1 therapy for metastatic or locally advanced unresectable disease will be enrolled.
    a. Subjects with recurrence or progression <or= 12 months following completion of cisplatin-containing chemotherapy given in the neoadjuvant/ adjuvant setting may utilize that line of therapy to be eligible for the study. The 12-month period is counted from completion of surgical intervention or platinum therapy, respectively. These subjects must receive anti PD-1/PD-L1 therapy in the metastatic or locally
    advanced unresectable setting to be eligible.
    b. Subjects who received either carboplatin or anti PD-1/PD-L1 therapy in the neoadjuvant/ adjuvant setting will not be able to count that line of therapy towards eligibility for the study.
    c. Cisplatin ineligible subjects who meet one of the below criteria and who were treated with carboplatin in the metastatic or locally advanced unresectable settings may count that line of therapy towards eligibility.
    They must then have received anti PD-1/PDL1 therapy in metastatic or locally advanced unresectable setting to be eligible for the study.
    Cisplatin ineligibility is defined as meeting one of the following criteria:
    1. Creatinine Clearance <60 mL/min
    2. Grade >or=2 Audiometric Hearing Loss
    3. Grade >or=2 Peripheral Neuropathy
    4. New York Heart Association (NYHA) Class III heart failure
    5. ECOG PS >or=2
    d. Anti PD-1/PD-L1 therapy administered as part of maintenance therapy may be counted towards eligibility for the study
    e. Subjects who received only concurrent chemoradiation for bladder preservation without further systemic therapy are not eligible to enroll in the study. The substitution of carboplatin for cisplatin does not constitute a new regimen provided no new chemotherapeutic agents were added to the regimen and no progression was noted prior to the change in platinum.
    5. Subjects with previously treated brain metastases may participate in the study provided they have stable CNS disease for at least 4 weeks prior to the first dose of study drug and stabilization of all neurologic symptoms, have no evidence of new or enlarging brain metastases, and are not using steroids > 20 mg of prednisone (or equivalent) daily for brain metastases for at least 7 days prior to first dose of the study drug.
    6. Adequate hematologic counts without transfusion or growth factor support within 1 week of study drug initiation (hemoglobin >or= 9 g/dL, absolute neutrophil count [ANC] >or= 1,500/mm3, and platelets >or= 100,000/µL).
    7. Adequate hepatic function (bilirubin <or= 1.5x institutional upper limit of normal [IULN], aspartate aminotransferase [AST] and alanine aminotransferase [ALT] <or= 2.5 x IULN or <or= 5 x IULN if known liver metastases and serum albumin > 3 g/dL).
    Docetaxel will only be an option in TPC arm for subjects with a total bilirubin <or=1 x IULN, and an AST and/or ALT = 1.5x IULN if alkaline phosphatase is also > 2.5 x IULN.
    8. Creatinine clearance >or= 30 mL/min as assessed by the Cockcroft-Gault equation or other validated instruments (e.g. Modification of Diet in Renal Disease [MDRD] equation.
    1. Soggetti maschi o femmine di età >or=18 anni, in grado di comprendere e fornire consenso informato scritto.
    2. Soggetti con UC non resecabile, metastatico o localmente avanzato, definito come

    Sono consentiti tumori delle vie urinarie superiori e inferiori, tipi istologici misti se quella uroteliale è l’istologia predominante.
    3. Punteggio dello stato di validità (PS) ECOG di 0 o 1.
    4. I soggetti con progressione o recidiva dopo aver assunto regime contenente platino e terapia anti-PD-1/PD-L1 per malattia metastatica o localmente avanzata non resecabile saranno arruolati.
    a. I soggetti con recidiva o progressione <or=12 mesi dopo il completamento della chemioterapia contenente cisplatino e/o la terapia somministrata in contesto neoadiuvante/adiuvante possono utilizzare tale linea di terapia per essere idonei allo studio. Il periodo di 12 mesi è conteggiato dal completamento della terapia a base di platino o dall’intervento chirurgico o della terapia a base di platino, rispettivamente. Questi soggetti devono ricevere terapia anti PD-1/PD-L1 nel contesto metastatico o localmente avanzato non resecabile per essere idonei.
    b. I soggetti che hanno ricevuto terapia a base di carboplatino o anti PD-1/PD-L1 nel contesto neo-adiuvante/adiuvante non potranno conteggiare tale linea di terapia ai fini dell’idoneità allo studio.
    c. I soggetti non idonei al cisplatino che soddisfano uno dei criteri di cui sotto e che erano stati trattati con carboplatino nel contesto metastatico o localmente avanzato possono conteggiare tale linea di terapia ai fini dell’idoneità. Devono quindi aver ricevuto terapia anti PD- 1/PD-L1 nel contesto metastatico o localmente avanzato per essere idonei allo studio.
    La non idoneità al cisplatino è definita come:
    1. Clearance della creatinina <60 ml/min
    2. Perdita dell'udito di grado >or=2 da esame audiometrico
    3. Neuropatia periferica di grado >or=2
    4. Insufficienza cardiaca di Classe III secondo la New York Heart Association (NYHA)
    5. PS ECOG >or=2
    d. La terapia anti PD-1/PD-L1 somministrata nell’ambito della terapia di mantenimento può essere conteggiata ai fini dell’idoneità allo studio
    e. I soggetti che hanno ricevuto solo la chemioradioterapia concomitante per la conservazione della vescica senza ulteriore terapia sistemica non sono idonei all’arruolamento nello studio. L’adozione del carboplatino in sostituzione del cisplatino non costituisce un nuovo regime a condizione che non sia stato aggiunto alcun nuovo farmaco chemioterapico al regime e che non sia stata osservata progressione prima di cambiare il tipo di platino.
    5. I soggetti con metastasi cerebrali precedentemente trattate possono partecipare allo studio, purché presentino malattia del SNC stabile almeno nelle 4 settimane che precedono la prima dose del farmaco dello studio e una stabilizzazione di tutti i sintomi neurologici, che non presentino evidenza di nuove metastasi cerebrali o di ampliamento delle metastasi esistenti, che non assumano steroidi >20 mg di prednisone (o equivalente) al giorno per metastasi cerebrali per almeno 7 giorni prima della prima dose di farmaco dello studio.
    6. Conte ematologiche adeguate senza trasfusione o supporto del fattore della crescita entro 1 settimana dall’avvio della terapia con il farmaco dello studio (emoglobina >or=9 g/dl, conta assoluta dei neutrofili [ANC] >or=1.500/mm3 e piastrine >or=100.000/µl).
    7. Adeguata funzionalità epatica (bilirubina <or=1,5 xIULN, AST e ALT <or=2,5 x IULN o <or=5 x IULN se vi sono metastasi epatiche note e albumina sierica >3 g/dl).
    Docetaxel sarà disponibile solo nel braccio del TPC per i soggetti con bilirubina totale <or=1 x IULN e valore di AST e/o ALT <or=1,5 x IULN se la fosfatasi alcalina è anch’essa >2,5 x IULN.
    8. Clearance della creatinina >or=30 ml/min, valutata mediante l’equazione di Cockcroft-Gault o altri strumenti validati.
    E.4Principal exclusion criteria
    Have had a prior anti-cancer mAb/ADC within 4 weeks prior to C1D1 or have had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to C1D1. Subjects participating in observational studies are eligible.
    - Have received prior chemotherapy for urothelial cancer with all available SOC therapies in the control arm (i.e., both prior paclitaxel and docetaxel in regions where vinflunine is not an approved therapy, or
    prior paclitaxel, docetaxel and vinflunine in regions where vinflunine is an approved therapy).
    - Have not recovered (i.e., = Grade 1) from AEs due to previously administered chemotherapeutic agent.
    • Note: Subjects with = Grade 2 neuropathy or any grade of alopecia are an exception to this criterion and will qualify for the study.
    • Note: If subjects received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting study therapy.
    - Have previously received topoisomerase 1 inhibitors.
    - Have an active second malignancy.
    • Note: Subjects with a history of malignancy that have been completely treated and with no evidence of active cancer for 3 years prior to enrollment, or subjects with surgically cured tumors with low risk of
    recurrence are allowed to enroll in the study after discussion with the medical monitor.
    - Have an active serious infection requiring anti-infective therapy (Contact medical monitor for clarification).
    - Have inability to tolerate or are allergic to any potential TPC agent or sacituzumab govitecan or unable or unwilling to receive the doses specified in the protocol.
    - Precedente mAb/ADC antitumorale nelle 4 settimane precedenti il C1G1 o precedente chemioterapia, terapia mirata micromolecolare o radioterapia nelle 2 settimane precedenti il C1G1. I soggetti che partecipano a studi osservazionali sono idonei..
    - Precedente chemioterapia per UC con tutte le terapie SOC disponibili nel braccio di controllo (ovvero, sia paclitaxel che docetaxel precedenti nelle regioni in cui la vinflunina non è una terapia approvata, oppure paclitaxel, docetaxel e vinflunina in regioni in cui la vinflunina è una terapia approvata).
    - Non essersi ripresi (ovvero, grado <or=1) da AE causati da agenti chemioterapici somministrati in precedenza.
    • Nota: i soggetti con neuropatia di grado <or=2 o alopecia di qualsiasi grado sono un’eccezione a questo criterio e saranno idonei allo studio.
    • Nota: qualora un soggetto sia stato sottoposto a un intervento di chirurgia maggiore, questo deve essersi ripreso adeguatamente dalla tossicità e/o dalle complicanze derivanti dall’intervento prima di avviare la terapia dello studio.
    - Aver ricevuto in precedenza inibitori della topoisomerasi 1.
    - Avere un secondo tumore maligno attivo.
    • Nota: i soggetti con anamnesi di tumore maligno completamente trattato e senza evidenza di tumore attivo per 3 anni prima dell’arruolamento o i soggetti con tumori curati chirurgicamente a basso rischio di recidiva possono arruolarsi nello studio dopo averne parlato con il responsabile del monitoraggio medico.
    - Infezione attiva grave che richieda una terapia antinfettiva (contattare il responsabile del monitoraggio medico per chiarimenti).
    - Incapacità di tollerare o allergia a qualsiasi potenziale agente TPC o sacituzumab govitecan, oppure incapacità o riluttanza a ricevere le dosi specificate nel protocollo.
    E.5 End points
    E.5.1Primary end point(s)
    Overall Survival (OS): OS is defined as the time from the date of randomization to the date of death, regardless of cause. If a subject is not known to have died, OS will be censored at the date the subject is last known to be alive.
    Sopravvivenza complessiva (OS): OS è definita come il tempo dalla data di randomizazione alla data del decesso, indipendentemente dalla causa. Se di un soggetto non è noti il decesso, si considererà come OS la data in cui si ha avuto l'ultima notizia che il paziente fosse vivo.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Monitored throughout the study and OS will be captured q8 weeks once patients discontinue treatment.
    Monitorato dutante il corso dello studio, con OS registrata ogni 8 settimane una volta che il paziente ha interrotto il trattamento.
    E.5.2Secondary end point(s)
    1. Progression-free Survival (PFS) by investigator assessment and Blinded Independent Central Review (BICR) using RECIST v1.1
    2. Objective Response Rate (ORR), Clinical Benefit Rate (CBR) and Duration of Objective Tumor Response (DOR) by investigator assessment and BICR using RECIST v1.1.
    3. Safety and tolerability evaluated by AEs, SAEs, and laboratory changes.
    4. European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) score and European Quality of Life 5-dimensions 5-levels (EuroQOL EQ-5D-5L) score.
    1. PFS in base alla valutazione dello sperimentatore e alla BICR secondo i criteri RECIST v1.1.
    2. ORR, CBR e DOR in base alla valutazione dello sperimentatore e alla BICR secondo i criteri RECIST v1.1.
    3. Sicurezza e tollerabilità valutate in base a AE, SAE e variazioni dei valori di laboratorio.
    4. Punteggio EORTC QLQ-C30 e punteggio EuroQOL EQ-5D-5L.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Monitored throughout the study.
    Monitorato dutante il corso dello studio.
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 concerned12
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA56
    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
    Canada
    China
    United States
    Austria
    Belgium
    France
    Germany
    Italy
    Portugal
    Spain
    Sweden
    United Kingdom
    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
    The study will be completed after all events are collected for the primary analysis with appropriate follow-up as designated.
    Lo studio sarà completato dopo che sono stati raccolti tutti gli eventi per l'analisi primaria con appropriato follow-up, come previsto.
    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 months8
    E.8.9.1In the Member State concerned days7
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months6
    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: 426
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 174
    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 state61
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 240
    F.4.2.2In the whole clinical trial 600
    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)
    At the completion of the study, subjects who are deriving benefit from sacituzumab govitecan may continue to receive treatment in a rollover study.
    Al completamento dello studio, i soggetti che stanno traendo beneficio da sacituzumab govitecan potranno continuare a ricevee il trattamento in uno studio di rollover.
    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 Decision2021-07-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-07-14
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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