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    Summary
    EudraCT Number:2017-001939-38
    Sponsor's Protocol Code Number:NIVINIHO
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-05-24
    Trial results View 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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2017-001939-38
    A.3Full title of the trial
    A prospective phase II study of nivolumab alone, or in combination with vinblastin in patients aged 61 years and older, with classical Hodgkin Lymphoma and coexisting medical conditions
    Etude de phase II évaluant le nivolumab seul ou en association à la vinblastine chez des patients atteints d’un lymphome de Hodgkin classique, âgés de 61 ans et plus et présentant des co-morbidités
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study of nivolumab alone, or in combination with vinblastin in patients aged 61 years and older, with Hodgkin Lymphoma
    Etude évaluant le nivolumab seul ou en association à la vinblastine chez des patients atteints d’un lymphome de Hodgkin
    A.4.1Sponsor's protocol code numberNIVINIHO
    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 SponsorLYSARC
    B.1.3.4CountryFrance
    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.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLYSARC
    B.5.2Functional name of contact pointProject Manager Chloé Gourc Berthod
    B.5.3 Address:
    B.5.3.1Street AddressCH LYON SUD - Bâtiment 2D
    B.5.3.2Town/ cityPIERRE BENITE CEDEX
    B.5.3.3Post code69495
    B.5.3.4CountryFrance
    B.5.4Telephone number+33(0)472669333
    B.5.5Fax number+33(0)426074055
    B.5.6E-mailaffaires-reglementaires@lysarc.org
    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
    D.2.1.1.2Name of the Marketing Authorisation holderBristol-Myers Squibb
    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 nameOpdivo
    D.3.4Pharmaceutical form Solution for injection
    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 INNNIVOLUMAB
    D.3.9.1CAS number 946414-94-4
    D.3.9.3Other descriptive nameNIVOLUMAB
    D.3.9.4EV Substance CodeSUB122750
    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 No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name VELBE
    D.2.1.1.2Name of the Marketing Authorisation holderEG LABO - LABORATOIRES EUROGENERICS
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 namevinblastine
    D.3.2Product code vinblastine
    D.3.4Pharmaceutical form Solution for injection
    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 INNVINBLASTINE SULFATE
    D.3.9.1CAS number 143-67-9
    D.3.9.2Current sponsor codeVINBLASTINE
    D.3.9.4EV Substance CodeSUB05098MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 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 No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    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
    patients aged 61 years and older, with classical Hodgkin lymphoma and coexisting medical conditions
    patients atteints d’un lymphome de Hodgkin classique, âgés de 61 ans et plus et présentant des co-morbidités
    E.1.1.1Medical condition in easily understood language
    Patients with Lymphoma with coexisting medical conditions
    patients atteints d’un lymphome présentant des co-morbidités
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10080208
    E.1.2Term Classical Hodgkin lymphoma
    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 the Complete Metabolic Response (CMR) rate by the Lugano classification 2014 at the end of treatment.
    Evaluer le taux de réponse métabolique complète défini selon la classification de Lugano 2014 à la fin de traitement.
    E.2.2Secondary objectives of the trial
    • To assess the feasibility of the protocol, with adequate protocol adherence (adequate dose without excessive delay)
    • To assess the safety profile of Nivolumab alone or combined with Vinblastin including immediate toxicities and non tumor events
    • To assess progression-free survival (PFS), event-free survival (EFS), and overall survival (OS)
    • To assess Complete Metabolic Response (CMR) rate by the Lugano classification 2014 at the end of induction treatment
    • To perform a geriatric assessment program (G8, CIRS-G)
    - Evaluer la faisabilité du protocole, avec une adhésion adéquate au protocole (dose adéquate sans retard excessif)
    - Evaluer le profil de sécurité du Nivolumab seul ou combiné à la Vinblastine incluant les toxicités immédiates et les évènements non tumoraux.
    - Evaluer la survie sans progression (PFS), survie sans évènement (EFS) et survie globale (OS).
    - Evaluer le taux de réponse métabolique complète défini selon la classification de Lugano 2014, à la fin de l’induction.
    - Réaliser un programme d’évaluation gériatrique par les scores CIRS-G et G8
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Having a first diagnosis of classical Hodgkin lymphoma
    - Age 61 years or older
    - Unfit for polychemotherapy
    - No previous treatment for Hodgkin lymphoma
    - Ann Arbor stages: I-IV
    - Baseline 18-FDG PET-CT (PET0) performed before any treatment with at least one hypermetabolic lesion
    - A minimum life expectancy of 3 months
    - Premier diagnostic de lymphome Hodgkinien classique
    - Age ≥ 61 ans
    - Unfit pour chimiothérapie (CIRS-G ≥ 6)
    - Jamais traités pour lymphome de Hodgkin
    - Stade Ann Arbor I-IV
    - Au moins une lésion évaluable sur la TEP baseline
    - Espérance de vie > 3 mois
    E.4Principal exclusion criteria
    - Contra-indication to Nivolumab and /or vinblastin
    - Subjects with active interstitial pneumonitis
    - Subjects with active infectious disease
    - Subjects with active, known or suspected autoimmune disease
    - Any serious active disease, severe cardio-pulmonary, or metabolic disease interfering with normal application of protocol treatment (according to the investigator’s decision)
    - Any of the following abnormal laboratory values :
    a. Calculated creatinine clearance < 30 mL/min (MDRD formula)
    b. AST or ALT > 2.5 times the upper limit of normal (ULN)
    c. Serum total bilirubin > 30μmol/L
    d. Neutrophils<1G/L or Platelets<50G/L, (unless related to bone infiltration by lymphoma)
    - Any history of cancer evolution requiring therapy during the last 3 years with the exception of non-melanoma skin tumors or stage 0 (in situ) cervical carcinoma. Patients previously diagnosed with prostate cancer are eligible if :
    a. Their disease was T1-T2a, N0, M0, with a Gleason score ≤ 7, and a prostate specific antigen (PSA) ≤ 10 ng/mL prior to initial therapy,
    b. They had definitive curative therapy (ie, prostatectomy or radiotherapy) ≥ 2 years before Day 1 of Cycle 1,
    c. At a minimum 2 years following therapy they had no clinical evidence of prostate cancer, and their PSA was undetectable if they underwent prostatectomy or <1 ng/mL if they did not undergo prostatectomy.
    - Uncontrolled diabetes mellitus leading to impossibility to perform PET scan
    - Treatment with any investigational drug within 30 days before planned first cycle of chemotherapy and during the study
    - Treatment with any investigational drug within 30 days before planned first cycle of chemotherapy and during the study
    - Adult person under legal protection
    - Adult person unabled to provide informed consent because of intellectual impairment, any serious medical condition, laboratory abnormality or psychiatric illness
    - Documented infection with HIV
    - Subjects with known active hepatitis C infection (patients with positive HCV serology are eligible only if PCR is negative for known HCV RNA)
    or subjects with known Active hepatitis B :
    a. HBsAg positive
    b. HBsAg negative, Ac anti-HBs positive and/or Ac anti-HBc positive (Patients who are seropositive due to a history of hepatitis B vaccine are eligible. Patients with Ac anti-HBs positive and/or Ac anti-HBc positive and no history of hepatitis B vaccine are eligible only if PCR for VHB DNA is negative)
    - Subjects with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration except for adrenal replacement steroid doses > 10 mg daily prednisone equivalent in the absence of active autoimmune disease.
    - Contre-indication au Nivolumab et /ou à la vinblastine
    - Sujets atteints de pneumonie interstitielle active
    - Sujets atteints d'une maladie infectieuse active
    - Sujets atteints d'une maladie auto-immune active, connue ou suspectée
    - Toute maladie active grave, cardiopulmonaire sévère, ou maladie métabolique interférant avec l'administration normale du traitement du protocole (selon la décision de l'investigateur)
    - L'une des valeurs de laboratoire anormales suivantes :
    a. une. Clairance de la créatinine calculée <30 mL / min (formule MDRD)
    b. AST ou ALT> 2,5 fois la limite supérieure de la normale (LSN)
    c. Bilirubine totale sérique> 30μmol / L
    d. Neutrophiles <1G / L ou plaquettes <50G / L (sauf si elles sont liées à une infiltration osseuse par un lymphome)
    - Tout antécédent d'évolution du cancer nécessitant un traitement au cours des 3 dernières années, à l'exception des tumeurs cutanées autres que le mélanome ou du cancer du col utérin de stade 0 (in situ). Les patients ayant déjà reçu un diagnostic de cancer de la prostate sont admissibles si:
    a. Leur maladie était T1-T2a, N0, M0, avec un score de Gleason ≤ 7, et un antigène prostatique spécifique (PSA) ≤ 10 ng / mL avant la thérapie initiale,
    b. Ils avaient un traitement curatif définitif (c.-à-d. Prostatectomie ou radiothérapie) ≥ 2 ans avant le jour 1 du cycle 1,
    c. Au minimum 2 ans après la thérapie, ils n'avaient aucune preuve clinique de cancer de la prostate, et leur PSA était indétectable s'ils avaient subi une prostatectomie ou <1 ng / mL s'ils n'avaient pas subi de prostatectomie.
    - Diabète incontrôlé avec impossibilité de réaliser une TEP
    - Tout traitement avec médicament expérimental dans les 30 jours avant le premier cycle de chimiothérapie planifié et pendant l'étude
    - Adulte sous protection juridique
    - Personne adulte incapable de fournir un consentement éclairé en raison d'une déficience intellectuelle, d'un trouble médical grave, d'une anomalie de laboratoire ou d'une maladie psychiatrique
    - Infection révélée de VIH
    Les sujets ayant une infection active connue contre l'hépatite C (patients avec sérologie positive pour le VHC ne sont éligibles que si la PCR est négative pour l’ARN du VHC) ou Les sujets ayant une infection active connue contre l'hépatite B :
    a. Ag HBs positif
    b. HBsAg négatif, anti-HBs positif et/ou anti-HBc positif (les patients qui sont séropositifs en raison d’une précédente vaccination contre l’hépatite B sont éligibles. Les patients avec anti-HBs positif et/ou anti-HBc positif et sans antécédent de vaccination contre l’hépatite B sont éligibles seulement si l’ADN du VHB est indétectable)
    - Sujets ayant besoin d'un traitement systémique avec corticostéroïdes (> 10 mg d'équivalent prednisone par jour) ou d'autres médicaments immunosuppresseurs dans les 14 jours suivant l'administration du médicament à l'étude, à l'exception de corticostéroïdes> 10 mg de prednisone par jour en l'absence de maladie auto-immune active.
    E.5 End points
    E.5.1Primary end point(s)
    To assess the Complete Metabolic Response (CMR) rate by the Lugano classification 2014
    Evaluer le taux de réponse métabolique complète défini selon la classification de Lugano 2014
    E.5.1.1Timepoint(s) of evaluation of this end point
    at the end of treatment
    à la fin de traitement
    E.5.2Secondary end point(s)
    - Feasibility
    - Progression free survival
    - Event free Survival
    - Overall survival
    - Complete response rates at end of induction treatment
    - Safety endpoints
    - Geriatric assessment
    - Faisabilité
    - Survie sans progression
    - Survie sans événement
    - Survie globale
    - Taux de réponse complète à la fin du traitement d'induction
    - Critères de sécurité
    - Evaluation de gériatrie
    E.5.2.1Timepoint(s) of evaluation of this end point
    - Feasibility
    - Progression free survival: from first nivolumab dose into the study to the first observation of documented disease progression/relapse or death due to any cause
    - Event free Survival: from the date of first nivolumab dose to the date of first documented disease progression/relapse, initiation of new anti-lymphoma therapy or death from any cause.
    - Overall survival: from date of first nivolumab dose into the study to the date of death from any cause
    - Complete response rates at end of induction treatment: at end of induction treatment
    - Safety endpoints: throughout the study
    - Geriatric assessment: at baseline
    - Faisabilité
    - Survie sans progression: de la première dose de nivolumab dans l'étude à la première observation de progression de la maladie documentée / rechute ou de décès dus à une cause quelconque
    - Survie sans événement: de la date de la première dose de nivolumab à la date de la première progression documentée de la maladie / rechute, de l'instauration d'un nouveau traitement anti-lymphome ou de la mort pour une cause quelconque
    - Survie globale: de la date de la première dose de nivolumab dans l'étude à la date du décès pour une cause quelconque
    - Taux de réponse complète à la fin du traitement d'induction
    - Critères de sécurité: durant toute l'étude
    - Evaluation gériatrique à la baseline
    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.8.2.4Number 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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA50
    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 No
    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
    5 years after inclusion of first patient
    5 ans après l'inclusion du premier patient.
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years5
    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: 10
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 54
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 64
    F.4.2.2In the whole clinical trial 64
    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)
    None
    Aucun
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation LYSA
    G.4.3.4Network Country France
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2018-06-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-01-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-08-12
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