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    Summary
    EudraCT Number:2020-001856-16
    Sponsor's Protocol Code Number:35RC17_9804_REVOLUMHOD
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-07-10
    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 ConcernedFrance - ANSM
    A.2EudraCT number2020-001856-16
    A.3Full title of the trial
    Evaluation of the Relationship Between Anti-PD-1 Exposure and Tumor VOLUME in Patients Treated for Conventional HODgkin's Lymphoma
    Evaluation de la RElation entre exposition aux anti-PD-1 et VOLUme tumoral chez le patient traité pour un lyMphome de HODgkin classique
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluation of the Relationship Between Therapeutical Antibody Exposure and Tumor VOLUME in Patients Treated for Conventional HODgkin's Lymphoma
    Evaluation de la RElation entre exposition à un anticorps thérapeutique et VOLUme tumoral chez le patient traité pour un lyMphome de HODgkin classique
    A.3.2Name or abbreviated title of the trial where available
    REVOLUMHOD
    REVOLUMHOD
    A.4.1Sponsor's protocol code number35RC17_9804_REVOLUMHOD
    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 SponsorRennes University Hospital
    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 supportCancer Translational Research Program
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRennes University Hospital
    B.5.2Functional name of contact pointSponsor
    B.5.3 Address:
    B.5.3.1Street Address2 avenue Henri Le Guilloux
    B.5.3.2Town/ cityRennes
    B.5.3.3Post code35000
    B.5.3.4CountryFrance
    B.5.6E-maildri@chu-rennes.fr
    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 Pharma EEIG
    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.3.2Product code BMS-936558
    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.3.11 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 KEYTRUDA
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Sharp & Dohme BV
    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 nameKEYTRUDA
    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.3.11 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.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
    Refractory Hodgkin Lymphoma
    Lymphome de Hodgkin réfractaire
    E.1.1.1Medical condition in easily understood language
    Hodgkin Lymphoma
    Lymphome de Hodgkin
    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 HLGT
    E.1.2Classification code 10025319
    E.1.2Term Lymphomas Hodgkin's disease
    E.1.2System Organ Class 10005329 - Blood and lymphatic system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluate the correlation between pre-treatment tumor volume and early exposure to anti-PD-1 in patients treated for Hodgkin Lymphoma.
    L’objectif principal de l’étude est d’évaluer la corrélation entre le volume tumoral avant traitement et l’exposition précoce aux anti-PD-1 chez les patients traités pour un Lymphome de Hodgkin
    E.2.2Secondary objectives of the trial
    a. Assess the correlation between anti-PD-1 exposure during treatment and initial tumour volume (TMTV).
    b. Evaluate the correlation between anti-PD-1 exposure and tumor volume (TMTV) at 3 months (for Deauville 4-5)
    c. Assess the correlation between anti-PD-1 exposure and metabolic response at 3 months of treatment initiation.
    d. Assess the correlation between anti-PD-1 exposure and residual tumour disease (ctDNA) at 3 months from the start of treatment (12).
    e. Determine the relationship between anti-PD-1 exposure and the expression of target molecules (PD-1, PDL-1 and PDL-2) in tumour and plasma at 3 months from the start of treatment.
    f. Determine the relationship between anti-PD-1 exposure and the occurrence of immunological adverse events (irAE) at 3 months from the start of treatment.
    g. Assess the relationship between anti-PD-1 exposure and medium- and long-term therapeutic efficacy (PFS and OS).
    a. Evaluer la corrélation entre l’exposition aux anti-PD-1 au cours du traitement et le volume tumoral initial (TMTV).
    b. Evaluer la corrélation entre l’exposition aux anti-PD-1 et le volume tumoral (TMTV) à 3 mois (pour les Deauville 4-5)
    c. Evaluer la corrélation entre l’exposition aux anti-PD-1 et la réponse métabolique à 3 mois du début du traitement.
    d. Evaluer la corrélation entre l’exposition aux anti-PD-1 et la maladie tumorale résiduelle (ctDNA) à 3 mois du début du traitement (12).
    e. Déterminer la relation entre l’exposition aux anti-PD-1 et l’expression des molécules cibles (PD-1, PDL-1 et PDL-2) dans la tumeur et le plasma à 3 mois du début du traitement.
    f. Déterminer la relation entre l’exposition aux anti-PD-1 et la survenue d’’évènements indésirables immunologiques (irAE) à 3 mois du début du traitement.
    g. Evaluer la relation entre l’exposition aux anti-PD-1 et l’efficacité thérapeutique à moyen et long terme (PFS et OS).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - More than 18 years old
    - Patient for whom treatment with anti-PD-1 antibodies (nivolumab or pembrolizumab) is administered as monotherapy for relapsed or refractory classical Hodgkin's lymphoma within the scope of the WMA
    - Patient for whom a PET/CT scan for evaluation of TMTV is available within 30 days prior to the first dose of treatment without intercurrent antitumor therapy between the last PET-CT and the start of anti-PD1 therapy
    - Signed consent form
    - Patient with a Health insurance
    - Patient majeur
    - Patient pour lequel un traitement par anticorps anti-PD-1 (nivolumab ou pembrolizumab) est administré en monothérapie pour un lymphome de Hodgkin classique en rechute ou réfractaire dans le cadre de l’AMM
    - Patient pour lequel un TEP-TDM permettant l’évaluation du TMTV est disponible dans les 30 jours précédant la 1e prise de traitement sans traitement antitumoral intercurrent entre le dernier TEP-TDM et le début du traitement par anti-PD1
    - Patient ayant signé un consentement libre, éclairé et écrit
    - Patient affilié à un régime de sécurité sociale
    E.4Principal exclusion criteria
    - Persons of full age subject to legal protection (safeguard of justice, guardianship, trusteeship), persons deprived of their liberty, pregnant or breastfeeding women, minors, persons unable to give their consent
    - Patient with a contraindication to treatment with OPDIVO or KEYTRUDA
    - Patient treated with anti-PD1 in combination with other antitumor therapy
    - Patient included in another interventional clinical study
    - Personnes majeures faisant l’objet d’une protection légale (sauvegarde de justice, curatelle, tutelle), les personnes privées de liberté, femmes enceintes ou allaitantes, mineurs, personnes hors d’état d’exprimer son consentement
    - Patient présentant une contre-indication au traitement par NIV ou PEM
    - Patient traité par anti-PD1 en association avec un autre traitement antitumoral
    - Patient participant à une autre étude clinique interventionnelle
    E.5 End points
    E.5.1Primary end point(s)
    Linear relationship, using Pearson's correlation, between the initial TMTV evaluated according to Meignan et al. (13) and the area under the curve (AUC) of anti-PD-1 at the first treatment.
    Le critère de jugement principal est défini par la relation linéaire en utilisant la corrélation de Pearson, entre le TMTV initial évalué selon Meignan et al. (13) et l’aire sous la courbe (AUC) d’anti-PD-1 lors de la première cure.
    E.5.1.1Timepoint(s) of evaluation of this end point
    3 months
    3 mois
    E.5.2Secondary end point(s)
    a. Assess the correlation between anti-PD-1 exposure during treatment and initial tumour volume (TMTV).
    b. Evaluate the correlation between anti-PD-1 exposure and tumor volume (TMTV) at 3 months (for Deauville 4-5)
    c. Assess the correlation between anti-PD-1 exposure and metabolic response at 3 months of treatment initiation.
    d. Assess the correlation between anti-PD-1 exposure and residual tumour disease (cfDNA) at 3 months from the start of treatment (14).
    e. Determine the relationship between anti-PD-1 exposure and the expression of the target molecules (PD-1, PDL-1 and PDL-2) in the tumour prior to treatment and in the plasma prior to treatment and during the first 3 months of treatment.
    f. Determine the relationship between anti-PD-1 exposure and the occurrence of immunological adverse events (irAE) within 3 months of treatment initiation.
    g. Assess the relationship between anti-PD-1 exposure and survival (PFS and OS).
    a. Evaluer la corrélation entre l’exposition aux anti-PD-1 au cours du traitement et le volume tumoral initial (TMTV).
    b. Evaluer la corrélation entre l’exposition aux anti-PD-1 et le volume tumoral (TMTV) à 3 mois (pour les Deauville 4-5)
    c. Evaluer la corrélation entre l’exposition aux anti-PD-1 et la réponse métabolique à 3 mois du début du traitement.
    d. Evaluer la corrélation entre l’exposition aux anti-PD-1 et la maladie tumorale résiduelle (cfDNA) à 3 mois du début du traitement (14).
    e. Déterminer la relation entre l’exposition aux anti-PD-1 et l’expression des molécules cibles (PD-1, PDL-1 et PDL-2) dans la tumeur avant traitement et dans le plasma avant traitement et au cours des 3 premiers mois de traitement.
    f. Déterminer la relation entre l’exposition aux anti-PD-1 et la survenue d’évènements indésirables immunologiques (irAE) dans les 3 mois suivant le début du traitement.
    g. Evaluer la relation entre l’exposition aux anti-PD-1 et la survie (PFS et OS).
    E.5.2.1Timepoint(s) of evaluation of this end point
    a. 3 months
    b. 3 months
    c. 3 months
    d. 3 months
    e. 3 months
    f. 3 months
    g. 12 months
    a. 3 mois
    b. 3 mois
    c. 3 mois
    d. 3 mois
    e. 3 mois
    f. 3 mois
    g. 12 mois
    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 No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic Yes
    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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 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 concerned17
    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 No
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned 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: 50
    F.1.3Elderly (>=65 years) No
    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 state50
    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
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2020-08-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-09-08
    P. End of Trial
    P.End of Trial StatusOngoing
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