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    Summary
    EudraCT Number:2016-002272-27
    Sponsor's Protocol Code Number:DSHNHL2015-1
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2018-02-27
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2016-002272-27
    A.3Full title of the trial
    Improvement of Outcome in Elderly Patients or Patients not eligible for high-dose chemotherapy with Aggressive Non-Hodgkin Lymphoma in first Relapse or Progression by adding Nivolumab to Gemcitabine, Oxaliplatin plus Rituximab in case of B-cell lymphoma
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Improvement of Outcome in Elderly Patients or Patients not eligible for high-dose chemotherapy with Aggressive Non-Hodgkin Lymphoma in first Relapse or Progression by adding Nivolumab to a standard chemotherapy.
    A.3.2Name or abbreviated title of the trial where available
    NIVEAU
    A.4.1Sponsor's protocol code numberDSHNHL2015-1
    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 SponsorSaarland University
    B.1.3.4CountryGermany
    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.4.2CountryUnited States
    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 Management
    B.5.3 Address:
    B.5.3.1Street AddressCHU Lyon Sud - Pav 6D
    B.5.3.2Town/ cityPierre Bénite
    B.5.3.3Post code69495
    B.5.3.4CountryFrance
    B.5.4Telephone number+33472 66 93 33
    B.5.5Fax number+334 26 07 40 55
    B.5.6E-mailniveau@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.3.9.3Other 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 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.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 with first relapse or progression of aggressive Non-Hodgkin’s Lymphoma who are not eligible neither for autologous nor allogeneic stem cell transplantation
    E.1.1.1Medical condition in easily understood language
    Patients with first relapse or progression of aggressive Non-Hodgkin’s Lymphoma who are not eligible neither for autologous nor allogeneic stem cell transplantation
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 22.0
    E.1.2Level PT
    E.1.2Classification code 10029547
    E.1.2Term Non-Hodgkin's lymphoma
    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
    Improvement of 1-yr PFS by nivolumab plus (R)-GemOx followed by nivolumab consolidation instead of (R)-GemOx alone in patients with progressed or relapsed aggressive NHLs not eligible neither for autologous nor allogeneic stem cell transplantation
    E.2.2Secondary objectives of the trial
    - To determine whether survival can be increased by adding nivolumab to standard (R)-GemOx.
    - To determine whether outcome can be improved by adding nivolumab to standard (R)-GemOx.
    - To determine toxicity and protocol adherence of standard (R)-GemOx with or without nivolumab.
    - To evaluate quality of life of patients with relapsed or refractory aggressive Non-Hodgkin’s Lymphoma treated with (R)-GemOx with or without Nivolumab.
    - To analyze outcome according to biological parameters.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - all patient >65 years of age or older than 18 years if if not eligible for neither autologous nor allogeneic stem cell transplantation
    - Ineligibility for neither autologous nor allogeneic stem cell Transplantation
    -Diagnosis of aggressive Non-Hodgkin's lymphoma, based on an excisional biopsy of a lymph node or on an appropriate sample of a lymph node or of an extranodal involvement at initial diagnosis or relapse or progression. The entities treated in the study will be based on the WHO 2017 classification
    -Performance status ECOG 0 – 2
    -Patients must have only one prior chemotherapy regimen including an anthracycline. The last cytotoxic drug must be given at least four weeks prior randomization. Rituximab must be part of the first-line regimen in case of a B-cell lymphoma (except for primary CD20-
    negative lymphoma). Patients may have received prior radiation therapy as part of their first-line therapy
    - Men who are sexually active with women of childbearing potential (WOCBP) must use any contraceptive method with a failure rate of less than 1% per year
    - Written informed consent of the patient
    E.4Principal exclusion criteria
    -Already initiated lymphoma therapy after first relapse or progression (except for the prephase Treatment)
    -Serious accompanying disorder or impaired organ function (except when due to lymphoma involvement)
    -WBC < 2.5 G/l, Neutrophils < 2 G/l, Platelets < 100 G/l (does not apply if cytopenia is caused by lymphoma)
    -Prolongation of QTc interval > 450 ms, demonstrated in one electrocardiogram (done as triplicate). This does not apply for patients with a block of the right and/or left bundle branch.
    -Family history for Long QT-syndrome
    -Patients with an active, known or suspected autoimmune disease
    -no requirement for immunosuppressive doses of systemic corticosteroids (except for treatment of lymphoma)
    -Chronic active hepatitis B or C
    - HIV-infection
    - Patients with a severe immunodeficiency
    - Previous therapy with Nivolumab, Gemcitabine or Oxaliplatin
    - Patients with a “currently active” second malignancy other than non-melanoma skin cancer
    - CNS involvement of lymphoma (intracerebral, meningeal, intraspinal intradural) or primary CNS lymphoma
    - Persistent neuropathy grade >2 (NCI CTC-AE v4.03) (unless due to lymphoma involvement)
    -Pregnancy or breast-feeding women
    - Women of childbearing potential (WOCBP)
    -Active serious infections not controlled by oral and/or intravenous antibiotics or anti-fungal medication
    - Any medical condition which in the opinion of the investigator places the subject at an
    unacceptably high risk for toxicities.
    - Lymphomas other than those listed in the inclusion criteria notably indolent lymphoma,
    Mantle cell lymphoma, Burkitt lymphoma, adult T-cell
    leukemia/lymphoma
    - Persons not able to understand the impact, nature, risks and consequences of the trial
    (including language barrier)
    - Persons not agreeing to the transmission of their pseudonymous data
    - Persons depending on sponsor or investigator
    - Persons from highly protected groups
    - Allergies and Adverse Drug Reaction History of allergy to study drug components.
    - Participation in another clinical trial with drug intervention within 4 weeks prior to start of the first cycle and during the study. However, participation in a clinical trial of firstline therapy of lymphoma is allowed.
    E.5 End points
    E.5.1Primary end point(s)
    Progression-free survival
    E.5.1.1Timepoint(s) of evaluation of this end point
    1 year
    (data collected during the restagings and the follow-up assessments as planned in the protocol (cf. chapter 8.9 in the protocol))
    E.5.2Secondary end point(s)
    •complete response rate
    •partial response rate
    •overall response rate
    •duration of response
    •progression rate
    •rate of treatment-related deaths
    •relapse rate
    •Event-free survival
    •Overall survival
    •Toxicity
    •Protocol adherence
    •quality of life as assessed by the EQ-5D-5L.
    •outcome according to PD-L1 and PD-1 expression, cell of origin, 9p24.1 alterations
    E.5.2.1Timepoint(s) of evaluation of this end point
    •complete response rate , partial response rate, overall response rate : (data collected during the restagings and the follow-up assessments as planned in the protocol (cf. chapter 8.9 in the protocol))
    •duration of response : end of study
    •progression rate : end of study
    •rate of treatment-related deaths : end of study
    •relapse rate : end of study
    •Event-free survival : end of study
    •Overall survival : end of study
    •Toxicity : end of study
    •Protocol adherence : end of study
    •quality of life as assessed by the EQ-5D-5L : end of study
    •outcome according to PD-L1 and PD-1 expression, cell of origin, 9p24.1 alterations : end of study

    (data collected during the restagings and the follow-up assessments as planned in the protocol (cf. chapter 8.9 in the protocol))
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    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) 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 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 Yes
    E.8.2.3.1Comparator description
    Standard chemotherapy with Gemcitabine, Oxaliplatin and rituximab in case of B-cell lymphoma
    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 concerned18
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA76
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Israel
    Austria
    Belgium
    France
    Germany
    Netherlands
    Poland
    Portugal
    Czechia
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years7
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years7
    E.8.9.2In all countries concerned by the trial months0
    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: 350
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 378
    F.4.2.2In the whole clinical trial 388
    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
    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 Decision2017-12-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-12-15
    P. End of Trial
    P.End of Trial StatusOngoing
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