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    Summary
    EudraCT Number:2020-004844-27
    Sponsor's Protocol Code Number:SURE-01
    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: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 number2020-004844-27
    A.3Full title of the trial
    SURE-01_An open label, single-arm, phase 2 study of neoadjuvant sacituzumab govitecan, before radical cystectomy, for patients with muscle-invasive bladder cancer who cannot receive or refuse cisplatin-based chemotherapy
    SURE-01_An open label, single-arm, phase 2 study of neoadjuvant sacituzumab govitecan, before radical cystectomy, for patients with muscle-invasive bladder cancer who cannot receive or refuse cisplatin-based chemotherapy
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Neoadjuvant sacituzumab govitecan to treat muscle-invasive bladder cancer
    Terapia neoadiuvante con sacituzumab govitecan per trattare cancro della vescica muscolo-infiltrante
    A.3.2Name or abbreviated title of the trial where available
    SURE-01
    SURE-01
    A.4.1Sponsor's protocol code numberSURE-01
    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 SponsorOSPEDALE SAN RAFFAELE
    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 supportImmunomedics, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOspedale San Raffaele
    B.5.2Functional name of contact pointGenitourinary Medical Oncology
    B.5.3 Address:
    B.5.3.1Street AddressVia Olgettina 60
    B.5.3.2Town/ cityMilano
    B.5.3.3Post code20132
    B.5.3.4CountryItaly
    B.5.6E-mailnecchi.andrea@hsr.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 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 namesacituzumab govitecan
    D.3.2Product code [IMMU-132]
    D.3.4Pharmaceutical form Lyophilisate 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 codeIMMU-32
    D.3.9.3Other descriptive namesacituzumab govitecan
    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 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 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
    Muscle-invasive bladder cancer
    Cancro della vescica muscolo-infiltrante
    E.1.1.1Medical condition in easily understood language
    Bladder cancer
    Cancro della vescica
    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 LLT
    E.1.2Classification code 10007293
    E.1.2Term Carcinoma bladder
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess whether sacituzumab govitecan results in pathological complete response (herein referred to as either “pT0” or “pCR”) in patients with MIBC who cannot receive or refuse cisplatin-based chemotherapy.
    Valutare l’attività del trattamento neoadiuvante con sacituzumab govitecan in pazienti affetti da carcinoma uroteliale della vescica muscolo-infiltrante.
    E.2.2Secondary objectives of the trial
    • To evaluate radiological response on those patients with measurable disease.
    • To evaluate the surgical and medical safety of neoadjuvant therapy.
    • To assess survival outcomes (event-free survival and overall survival).
    • Valutare la risposta radiologica nei pazienti con malattia misurabile.
    • Valutare la sicurezza chirurgica e medica della terapia neoadiuvante.
    • Valutare la sopravvivenza (sopravvivenza libera da progressione e globale).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    ¿ Female or male subjects, >18 years of age, able to understand and give written informed consent
    ¿ Histopathologically confirmed urothelial carcinoma. Patients with mixed histologies are required to have a dominant (i.e. 50% at least) transitional cell pattern.
    ¿ Fit and planned for RC (according to local guidelines).
    ¿ ECOG performance status score of 0 or 1
    ¿ Adequate hematologic counts without transfusional or growth factor support within 2 weeks of study drug initiation (Hemoglobin = 9 g/dL, ANC = 1,500/ mm3, and Platelets
    = 100,000/ µL)
    ¿ Adequate hepatic function (Bilirubin = 1.5 IULN, AST and ALT = 2.5 x IULN or = 5 x IULN if known liver metastases and serum albumin >3 g/dl)
    ¿ Creatinine clearance =30 mL/min as assessed by the Cockcroft-Gault equation
    ¿ Female subjects of childbearing potential must have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study medication, and must not be lactating. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
    ¿ Female subjects of childbearing potential must be willing to use 2 methods of birthcontrol or be surgically sterile or abstain from heterosexual activity for the course of the
    study through 6 months after the last dose of study medication. Subjects of childbearing potential are those who have not been surgically sterilized or have not been free from
    menses for >2 years
    ¿ Male subjects must agree to use an adequate method of contraception starting with the first dose of study therapy through 3 months after the last dose of study therapy.
    ¿ Clinical stage defining clinical T2-T4N0M0 disease by CT (or MRI) + PET/CT (within 4 weeks of randomization by RECIST v1.1).
    ¿ The patient accepts to undergo radical cystectomy.
    ¿ Ineligibility to receive cisplatin-based neoadjuvant chemotherapy based on Galsky’s criteria OR refusal to receive neoadjuvant cisplatin-based chemotherapy.
    ¿ Consenso informato scritto.
    ¿ Età = 18 anni.
    ¿ Diagnosi istologicamente confermata (TURB) di carcinoma a cellule transizionali della vescica.
    ¿ Prevalente istologia uroteliale. La presenza di varianti istologiche non uroteliali è ammessa purché esse non rappresentino la componente maggioritaria del tumore.
    ¿ Stadio clinico T2-4N0M0 confermato alla TURB e alle indagini radiologiche.
    ¿ Nessuna precedente terapia sistemica (le pregresse instillazioni intravescicali di chemioterapia per malattia superficiale sono ammesse).
    ¿ Adeguata funzione midollare, epatica e renale.
    ¿ Eleggibilità per l’intervento chirurgico di cistectomia radicale.
    ¿ Rifiuto della chemioterapia neoadiuvante cisplatino-contenente oppure ineleggibilità alla stessa in base ai criteri di Galsky. Tali criteri includono almeno 1 dei seguenti elementi: filtrato glomerulare calcolato di <60 ml/min, ECOGperformance status >1, pregressa co-morbidità cardiologica classificata come cardiopatia classe NYHA III-IV, pregressa neuropatia o deficit audiometrico di grado 3-4.
    ¿ ECOG performance status di 0 o 1.
    ¿ Soggetti che accettino di praticare un’effettiva contraccezione durante l’intera durata dello studio, a meno che esista documentazione di infertilità (un test di gravidanza negativo eseguito entro 7 giorni precedenti l’inizio dello studio è necessario per tutte le donne in età fertile).
    ¿ Possibilità e disponibilità a seguire le procedure previste dal protocollo.
    E.4Principal exclusion criteria
    1. Has received prior systemic anti-cancer therapy including investigational agents and immunotherapy.
    2. Has received prior radiotherapy on the bladder tumor.
    3. Refusal to undergo RC.
    4. Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment.
    Note: Participants who have entered the follow-up phase of an investigational study may participate as long as it has been 4 weeks after the last dose of the previous investigational agent.
    5. Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.
    6. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (eg, breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded. Participants with low-risk early stage prostate cancer defined as follows are not excluded; Stage T1c or T2a with a Gleason score = 6 and prostatic-specific antigen (PSA) < 10 ng/mL either treated with
    definitive intent or untreated in active surveillance that has been stable for the past year prior to study allocation.Women who are pregnant or lactating
    7. Has severe hypersensitivity (=Grade 3) to sacituzumab govitecan and/or any of its excipients.
    8. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject’s participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
    9. Have active cardiac disease, defined as:
    • Myocardial infarction or unstable angina pectoris within 6 months of C1D1
    • History of serious ventricular arrhythmia (i.e., ventricular tachycardia or ventricular fibrillation), high-grade atrioventricular block, or other cardiac arrhythmias requiring anti-arrhythmic medications (except for atrial fibrillation that is well controlled with antiarrhythmic medication); history of QT interval prolongation
    • NYHA Class III or greater congestive heart failure or left ventricular ejection fraction of < 40%
    10. Have known history of HIV-1/2 with uncontrolled viral load.
    11. Have active HBV or HCV. In subjects with a history of HBV or HCV, subjects with detectable viral loads will be excluded.
    12. Have other concurrent medical or psychiatric conditions that, in the Investigator’s opinion, may be likely to confound study interpretation or prevent completion of study procedures and follow-up examinations.
    • Evidenza clinica e/o strumentale di adenopatie patologiche o di metastasi a distanza.
    • Co-morbidità escluse:
    • Importanti patologie cardiovascolari, quali:
    • Infarto miocardico (IM), angina instabile (l’IM a più di 6 mesi dall’ingresso nello studio è ammesso), scompenso cardiaco di grado = 2 secondo i criteri NYHA, aritmie di qualsiasi natura che richiedano l’uso di farmaci (betabloccanti o digossina sono permessi), ipertensione (PA media > 140/90 mm/Hg) non controllata, prolungamento dell’intervallo QT (QTc) > 450 msec.
    • Storia di infarti cerebro-vascolari, embolia polmonare o trombosi venosa profonda non trattata entro i 6 mesi che precedono l’inizio del protocollo.
    • Infezione da HIV o epatite cronica attiva di tipo B e C.
    • Diagnosi di immunodeficienza o sta ricevendo una terapia steroidea per via sistemica o qualsiasi altra forma di terapia immunosoppressiva nei 7 giorni precedenti la prima dose del trattamento sperimentale.
    • Infezioni clinicamente serie in fase attiva (di grado > 2 dei CTCAE v.5.0).
    • Seconda neoplasia pregressa o concomitante fatta eccezione per il carcinoma in situ della cervice, il carcinoma basocellulare o qualsiasi altra neoplasia trattata in modo radicale ad un tempo >5 anni rispetto alla data di ingresso nello studio.
    • Gravidanza e allattamento.
    • Presenza di infezione non controllata.
    • Nota ipersensibilità a farmaci chimicamente correlabili a sacituzumab govitecan.
    • Presenza di qualsiasi condizione medica, disfunzione metabolica o psichiatrica che possa limitare la piena osservanza delle procedure dello studio.
    E.5 End points
    E.5.1Primary end point(s)
    Number of complete pathological responses, defined as the absence of viable tumor cells on the histological examination of the cystectomy. Evidence of carcinoma in situ or non-muscle infiltrating disease does not define a complete pathological response.
    Numero di risposte patologiche complete, definite come assenza di cellule tumorali vitali all’esame istologico della cistectomia. L’evidenza di carcinoma in situ o malattia non muscolo-infiltrante non definisce una risposta patologica completa.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At cistectomy, about 4 months after inclusion
    Alla cistectomia, a circa 4 mesi dall'inclusione
    E.5.2Secondary end point(s)
    Evaluation of safety and tolerability of the treatment:
    Number of patients who experienced adverse events.
    Type, frequency, severity and relationship to the treatment of the adverse events, evaluated according the Common Toxicity Criteria for adverse events (CTCAE) v 5.0.
    Progression free survival
    Overall survival
    Valutazione della sicurezza e della tollerabilità del trattamento:
    Numero di pazienti che hanno avuto eventi avversi.
    Tipo, frequenza, severità e correlazione al trattamento degli eventi avversi, valutati secondo i Common Toxicity Criteria for adverse events (CTCAE) v 5.0.
    Sopravvivenza libera da progressione (PFS).
    Sopravvivenza globale (OS).
    E.5.2.1Timepoint(s) of evaluation of this end point
    During the course of the study
    Follow up every 12 weeks after final treatment
    In corso di studio
    Follow up ogni 12 settimane dopo l'ultimo trattamento
    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 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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    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 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
    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 months2
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months2
    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: 38
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 18
    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 state56
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 56
    F.4.2.2In the whole clinical trial 56
    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 local clinical practice
    I pazienti saranno trattai in accordo alla pratica clinica locale.
    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 Decision2021-06-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-04-14
    P. End of Trial
    P.End of Trial StatusOngoing
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