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    Summary
    EudraCT Number:2017-003739-12
    Sponsor's Protocol Code Number:NICOLE
    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:2021-01-07
    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 number2017-003739-12
    A.3Full title of the trial
    Preoperative Nivolumab in patients with locally advanced colon cancer (T3 or T4): a window-of-opportunity study
    Nivolumab preoperatorio in pazienti con cancro al colon localmente avanzato (T3 o T4): uno studio window-of-opportunity
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Preoperative Nivolumab in patients with locally advanced colon cancer (T3 or T4): a window-of-opportunity study
    Nivolumab preoperatorio in pazienti con cancro al colon localmente avanzato (T3 o T4): uno studio window-of-opportunity
    A.3.2Name or abbreviated title of the trial where available
    NICOLE - NIvolumab in locally advanced COLon cancEr
    NICOLE ¿ NIvolumab in localmente avanzato COLon cancEr
    A.4.1Sponsor's protocol code numberNICOLE
    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 SponsorSOCIETà CAMPANA DI IMMUNOTERAPIA ONCOLOGICA
    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 supportBRISTOL-MYERS SQUIBB
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationClinical Research Technology Srl
    B.5.2Functional name of contact point CRO
    B.5.3 Address:
    B.5.3.1Street Addressvia San Leonardo trav. Migliaro
    B.5.3.2Town/ citySalerno
    B.5.3.3Post code84131
    B.5.3.4CountryItaly
    B.5.4Telephone number089301545
    B.5.5Fax number0897724155
    B.5.6E-mailnicole@cr-technology.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 Yes
    D.2.1.1.1Trade name OPDIVO - 10 MG/ML- CONCENTRATO PER SOLUZIONE PER INFUSIONE- USO ENDOVENOSO- FLACONCINO (VETRO)- 10 ML- 1 FLACONCINO
    D.2.1.1.2Name of the Marketing Authorisation holderBRISTOL-MYERS SQUIBB PHARMA EEIG
    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 name nivolumab
    D.3.2Product code BMS-936558
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.11 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) Yes
    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
    colon cancer: a window-of-opportunity study
    cancro al colon localmente avanzato (T3 o T4)
    E.1.1.1Medical condition in easily understood language
    colon cancer: a window-of-opportunity study
    cancro al colon localmente avanzato (T3 o T4)
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10009944
    E.1.2Term Colon cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10009944
    E.1.2Term Colon cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10009989
    E.1.2Term Colonic cancer
    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
    o determine the feasibility of Nivolumab in the preoperative setting in patients with T3-T4 colon cancer: delay in surgery resection > 21 days after last administration of nivolumab; severe adverse events-NCI CTC-AE Version 4.03 criteria.

    -To determine the degree of pathologic regression: percentage of patients achieving a pathological complete tumor regression (TRG1).

    -To determine molecular and immunophenotypic changes in tumor and peripheral blood evaluating several biomarkers.
    Determinare la fattibilit¿ della somministrazione di Nivolumab in sede preoperatoria in pazienti con carcinoma al colon T3-T4: ritardo nella resezione chirurgica >21 giorni dopo l¿ultima somministrazione di Nivolumab; eventi avversi severi secondo NCI CTC-AE versione 4.03.

    - Determinare il grado di regressione patologica: percentuale di pazienti che raggiungono una regressione patologica completa del tumore (TRG1).

    - Determinare i cambiamenti molecolari e immunofenotipici nel tumore e nel sangue periferico valutando diversi biomarcatori.
    E.2.2Secondary objectives of the trial
    ¿ Objective Tumor Response Rate (ORR) as defined by Response Evaluation Criteria In Solid Tumors (RECIST)
    ¿ Metabolic Response by FDG-Positron emission tomography¿computed tomography (PET-CT) scan prior to surgery compared to the baseline test.
    ¿ Postoperative complications (occurring within 60 days from surgery)
    ¿ Relapse-Free Survival
    ¿ Overall Survival
    ¿ Tasso di Risposta Obiettiva del Tumore (ORR) cos¿ come definito dai Criteri di Valutazione della Risposta nei Tumori Solidi (RECIST)
    ¿ Risposta Metabolica mediante scansioni di tomografia ad emissione di FDG-positroni ¿ tomografia computerizzata (PET-CT)
    ¿ Complicazioni postoperatorie (che si verificano entro 60 giorni dalla chirurgia)
    ¿ Sopravvivenza Libera da Ricaduta
    ¿ Sopravvivenza Globale
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives

    Other types of substudies
    Specify title, date and version of each substudy with relative objectives: To determine molecular and immunophenotypic changes in tumor and peripheral blood evaluating several biomarkers.

    Altre tipologie di sottostudi
    specificare il titolo, la data e la versione di ogni sottostudio con i relativi obiettivi: Determinazione dei cambiamenti molecolari e immunofenotipici nel tumore e nel sangue periferico valutando diversi biomarcatori. Versione 1.0 del 27 ottobre 2017
    E.3Principal inclusion criteria
    1) Patients diagnosed with histologically confirmed adenocarcinoma of colon with staging of locally advanced (T3 or T4)
    2) No prior treatments (chemotherapy, radiation or surgery) for colon cancer
    3) Either sex aged = 18 years
    4) Colon lesion determined and measured preoperatively by either spiral or multidetector CT scan
    5) ECOG Performance Status =1 at study entry
    6) Adequate bone marrow haematological function: absolute neutrophil count (ANC) = 1.5 x 109/L AND platelet count = 100 x 109/L AND haemoglobin = 9 g/dL
    7) Adequate liver function: total bilirubin = 1.5 x upper limit of normal (ULN) AND aspartate aminotransferase (AST)/alanine aminotransferase (ALT) = 2.5 X ULN
    8) Adequate renal function: serum creatinine = 1.5 mg/dL OR creatinine clearance = 60 mL/min in males and =50 mL/min in females (calculated according to Cockroft-Gault formula)
    9) Serum calcium levels, international normalised ratio (INR) and partial thromboplastin time were within normal limits
    10) Female subjects of childbearing potential must have a negative urine pregnancy test result at baseline and practice a reliable method of contraception throughout the study
    11) Availability of tumor tissue from basal biopsy for immunoscore and biomarker analysis.
    12) Ability to understand study-related patient information and provision of written informed consent for participation in the study
    1) Pazienti con diagnosi di adenocarcinoma del colon istologicamente confermato con uno stadio localmente avanzato (T3 or T4).
    2) Nessun precedente trattamento (chemioterapia, radioterapia o chirurgia) per cancro al colon.
    3) Età = 18 anni per entrrambi i sessi.
    4) Lesione al colon determinata e misurata in fase preoperatoria mediante TAC spirale o multidetettore.
    5) ECOG Performance Status =1 all’ingresso nello studio.
    6) Adeguata funzionalità ematologica del midollo osseo: conta assoluta dei neutrofili (ANC) ) =1.5 x 109/L e conta piastrinica =100 x 109/L ED emoglobina =9 g/dL.
    7) Adeguata funzionalità epatica: bilirubina totale =1.5 volte il limite superiore di normalità (ULN) e aspartato aminotrasferasi (AST)/alanina aminostrasferasi (ALT) =2.5 volte l’ULN.
    8) Adeguata funzionalità renale: creatinina sierica =1.5 mg/dL OPPURE clearance della creatinina =60 mL/min nei maschi e =50 mL/min nelle femmine (calcolate in accordo alla formula di Cockroft-Gault).
    9) Livelli sierici di calcio, international normalised ratio (INR) e tempo di tromboplastina parziale entro i limiti di normalità.
    10) Donne in età fertile devono avere al baseline un risultato negativo del test di gravidanza sulle urine e praticare un metodo contraccettivo affidabile per tutta la durata dello studio.
    11) Disponibilità di tessuto tumorale da biopsia basale per l’immunoscore e l’analisi dei biomarcatori.
    12) Capacità di comprendere le informazioni sul paziente correlate allo studio e di fornire il consenso informato scritto per la partecipazione allo studio.
    E.4Principal exclusion criteria
    1) Evidence of metastatic disease
    2) Prior malignancy within the prior 5 years. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer
    3) Subjects with active, known or suspected autoimmune disease
    4) Subjects with a condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of treatment
    5) Prior treatment with an anti-PD-1, anti-Programmed Death 1 ligand (PD-L1), anti-PD-L2, or anti-cytotoxic T lymphocyte associated antigen-4 (anti-CTLA-4) antibody
    6) Female subjects who are pregnant (positive urine pregnancy test), breast-feeding, or who are of childbearing potential and not practicing a reliable method of birth control
    7) Evidence of severe or uncontrolled systemic disease or any concurrent condition which in the investigator’s opinion makes it undesirable for the patient to participate in the study, or which would jeopardize compliance with the protocol, or would interfere with the results of the study
    8) Patients with a history of cardiovascular or interstitial lung disease and evidence or risk of retinal vein occlusion or central serous retinopathy
    9) Inability to regularly access center facilities for logistical or other reasons
    10) History of poor co-operation, non-compliance with medical treatment, or unreliability
    11) Participation in any interventional drug or medical device study within 30 days prior to treatment start
    12) Positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C (HCV antibody) with virus ribonucleic acid indicating acute or chronic infection;
    13) Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)
    1) Evidenza di malattia metastatica.
    2) Malattia precedente entro i 5 anni precedenti. Eccezioni includono carcinoma delle cellule basali della pelle o carcinoma delle cellule squamose della pelle sottoposti a terapia potenzialmente curativa o carcinoma cervicale in situ.
    3) Soggetti con malattia autoimmune attiva, nota o sospetta.
    4) Soggetti con una condizione che richiede un trattamento sistemico con corticosteroidi (>10 mg equivalenti di prednisone al giorno) o con altri farmaci immunosoppressivi entro 14 giorni dal trattamento.
    5) Trattamento precedente con un anticorpo anti-PD-1, anti-ligando al recettore di morte programmato (PD-L1), anti-PD-L2 o anti-linforcita T citotossico associato all’antigene 4 (anti-CTLA-4).
    6) Donne in stato di gravidanza (test di gravidanza sulle urine positivo), che allattano o potenzialmente fertili e che non praticano un metodo affidabile sul controllo delle nascite.
    7) Evidenza di malattia sistemica grave o incontrollata o di qualsiasi altra condizione concomitante che secondo lo sperimentatore rende indesiderabile la partecipazione del paziente allo studio o che metterebbe a repentaglio la conformità al protocollo o che potrebbe interferire con i risultati dello studio.
    8) Pazienti con storia di malattia cardiovascolare o malattia polmonare interstiziale ed evidenza o rischio di occlusione della vena retinica o retinopatia sierosa centrale.
    9) Impossibilità ad accedere regolarmente alle strutture centrali per ragioni logistiche o di altro tipo.
    10) Storia di scarsa cooperazione, di non conformità alle cure mediche o di inaffidabilità.
    11) Partecipazione a qualsiasi studio con un farmaco interventistico o con dispositivo medico entro i 30 giorni precedenti all’inizio del trattamento.
    12) Test positivo per l’antigene di superficie del virus dell’epatite B (HBVsAg) o dell’epatire C (anti-HCV) con acido ribonucleico virale che indica un’infezione acuta o cronica.
    13) Storia nota di test positivi per il virus dell’immunodeficienza umana (HIV) o per la sindrome da immunodeficienza acquisita (AIDS).
    E.5 End points
    E.5.1Primary end point(s)
    Safety Assessments
    Efficacy Assessments
    Biomarker study
    Valutazioni della Sicurezza:
    Valutazioni sull’Efficacia
    Studio dei biomarcatori
    E.5.1.1Timepoint(s) of evaluation of this end point
    Safety Assessments: Toxicities will be evaluated throughout the study treatment and up to 30 days after surgery. Toxicity will be graded according to the NCI Common Toxicity Criteria.
    The National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTC-AE) Version 4.03 will be used to evaluate the clinical safety of the treatment in this study. Patients will be assessed for AEs at each clinical visit and as necessary throughout the study. Grade =3 hematological and non-hematological toxicities will be recorded.
    Efficacy Assessments: Pathological tumor regression will be evaluated according to Mandard modified scoring system [Mandard 1994].
    Biomarker study: The Immunoscore evaluation will be assessed using standardized Immunoscore assays and software (HalioDx).
    Safety Assessments: Toxicities will be evaluated throughout the study treatment and up to 30 days after surgery. Toxicity will be graded according to the NCI Common Toxicity Criteria.
    The National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTC-AE) Version 4.03 will be used to evaluate the clinical safety of the treatment in this study. Patients will be assessed for AEs at each clinical visit and as necessary throughout the study. Grade =3 hematological and non-hematological toxicities will be recorded.
    Efficacy Assessments: Pathological tumor regression will be evaluated according to Mandard modified scoring system [Mandard 1994].
    Biomarker study: The Immunoscore evaluation will be assessed using standardized Immunoscore assays and software (HalioDx).
    E.5.2Secondary end point(s)
    The clinical response is a secondary objective of the study and will be evaluated through repetition of either spiral or multidetector CT scan prior to surgery (within 3 days before surgery) and defined according to the RECIST (Response Evaluation Criteria In Solid Tumours) guidelines version 1.1.; Metabolic response evaluated by FDG-PET is a secondary objective. Therefore PET-CT scans are planned at baseline (before treatment) and prior to surgery (within 3 days before surgery).; Postoperative complications; Relapse-Free Survival; Overall Survival
    La risposta clinica ¿ un obiettivo secondario dello studio e sar¿ valutata attraverso la ripetizione di una TAC prima dell'intervento (entro 3 giorni prima dell'intervento chirurgico) e definita secondo le linee guida RECIST versione 1.1 .;
    La risposta metabolica valutata mediante FDG-PET ¿ un obiettivo secondario. Pertanto le scansioni PET-CT sono pianificate al basale (prima del trattamento) e prima dell'intervento (entro 3 giorni prima dell'intervento chirurgico).; valutazione Complicazioni postoperatorie; Sopravvivenza Libera da Ricaduta; Sopravvivenza Globale
    E.5.2.1Timepoint(s) of evaluation of this end point
    within 3 days before surgery (7 weeks after signing the consent); Metabolic response evaluated by FDG-PET is a secondary objective. Therefore PET-CT scans are planned at baseline (before treatment) and prior to surgery (within 3 days before surgery).; 60 days from surgery; Patients will have follow-up evaluation every six months for five years.; Patients will have follow-up evaluation every six months for five years.
    entro 3 giorni prima dell'intervento chirurgico (7 settimane dalla firma del consenso);
    La risposta metabolica valutata mediante FDG-PET ¿ un obiettivo secondario. Pertanto le scansioni PET-CT sono pianificate al basale (prima del trattamento) e prima dell'intervento (entro 3 giorni prima dell'intervento chirurgico).; 60 giorni dalla chirurgia; I pazienti effettueranno un follow up di valutazione ogni sei mesi per cinque anni succesivi alla chirurgia; I pazienti effettueranno un follow up di valutazione ogni sei mesi per cinque anni succesivi alla chirurgia
    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 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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    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
    The study will end 90 days after the last patient's surgery
    Lo studio finir¿ dopo 90 giorni dall'intervento chirurgico dell'ultimo paziente arruolato
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months15
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months15
    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: 11
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 11
    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 state22
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 22
    F.4.2.2In the whole clinical trial 22
    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)
    Postoperatively, standard adjuvant chemotherapy will be administered in pathological III-stage and at investigator discretion in pathological II-stage at high risk.
    Dopo l¿intervento, la chemioterapia standard adiuvante sar¿ somministrata nel III stadio patologico e a discrezione dello sperimentatore nel II stadio patologico ad alto rischio.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2018-01-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-12-20
    P. End of Trial
    P.End of Trial StatusOngoing
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