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    Summary
    EudraCT Number:2021-001707-32
    Sponsor's Protocol Code Number:NIVOPTIMIZE-trial
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-04-22
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2021-001707-32
    A.3Full title of the trial
    Nivolumab dose optimization during nivolumab therapy in melanoma patients after achieving a complete or partial response (NIVOPTIMIZE-trial)
    Optimalisatie van de nivolumab dosering tijdens de behandeling met nivolumab bij melanoom patiënten na het bereiken van een complete of partiële respons (NIVOPTIMIZE-trial)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Nivolumab dose optimization during nivolumab therapy in melanoma patients after achieving a complete or partial response (NIVOPTIMIZE-trial)
    Optimalisatie van de nivolumab dosering tijdens de behandeling met nivolumab bij melanoom patiënten na het bereiken van een complete of partiële respons (NIVOPTIMIZE-trial)
    A.3.2Name or abbreviated title of the trial where available
    NIVOPTIMIZE-trial
    NIVOPTIMIZE-trial
    A.4.1Sponsor's protocol code numberNIVOPTIMIZE-trial
    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 SponsorErasmus Medical Center Rotterdam
    B.1.3.4CountryNetherlands
    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 supportErasmus Medical Center
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationErasmus Medical Center Rotterdam
    B.5.2Functional name of contact pointE.A. Basak
    B.5.3 Address:
    B.5.3.1Street AddressDr. Molewaterplein 40
    B.5.3.2Town/ cityRotterdam
    B.5.3.3Post code3015GD
    B.5.3.4CountryNetherlands
    B.5.6E-maile.basak@erasmusmc.nl
    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 Company
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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.3.4Pharmaceutical 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 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 with advanced or metastatic melanoma treated with nivolumab monotherapy in a 480 mg 4 weekly scheme (either from start or after combination therapy with ipilimumab), have a confirmed CR or PR, are at least 6 months on treatment and are willing to receive 3 reduced doses of 240 mg
    Patiënten met gevorderd of uitgezaaid melanoom, behandeld met nivolumab monotehrapie in een 4-wekelijks 480 mg schema, die een bevestigde CR of PR hebben, minimaal 6 maanden behandeling hebben gehad en bereid zijn om 3 gereduceerde nivolumab doseringen te ontvangen.
    E.1.1.1Medical condition in easily understood language
    Patients with advanced or metastatic melanoma treated with nivolumab monotherapy and have a durable response
    Patiënten met gevorderd of uitgezaaid melanoom, behandeld met nivolumab monotherapie en een duurzaam respons.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective is to demonstrate that the nivolumab steady-state level after 3 cycles with a reduced nivolumab dosage (240 mg every 4 weeks) is not lower than the nivolumab concentration 4 weeks after the first 480 mg dose.
    Aantonen dat de nivolumab steady-state spiegels na 3 kuren met een gereduceerde dosering (240 mg, 4 wekelijks) niet lager is dan de spiegel na de eerste kuur met 480 mg.
    E.2.2Secondary objectives of the trial
    - Explore PD1 receptor occupancy in PBMCs
    - Safety of reduced nivolumab doses
    - Efficacy of reduced nivolumab doses
    - Pharmacokinetic profile of nivolumab
    - Cost effectiveness
    - PD1 receptor bezetting onderzoeken in PBMCs
    - Veiligheid van gereduceerde nivolumab doseringen
    - Effectiviteit van gereduceerde nivolumab doseringen
    - Pharmacokinetisch profiel van nivolumab
    - Kosten-effectiviteit
    E.2.3Trial contains a sub-study No
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    No sub-study
    Geen sub-studie
    E.3Principal inclusion criteria
    1. Age ≥ 18 years
    2. Advanced or metastatic melanoma
    3. Current treatment with nivolumab for advanced or metastatic melanoma, in a 480 mg, 4 weekly scheme
    4. Documented confirmed and ongoing CR or PR according to RECIST v1.1
    5. On treatment for at least 6 months
    1. Leeftijd ≥ 18 jaar
    2. Gevorderd of gemetastaseerd melanoom
    3. Huidige behandeling met nivolumab voor gevorder of gemetastaseerd melanoom, in een 4 wekelijks 480 mg schema
    4. Beschreven en bevestigd voortdurende CR of PR volgens RECIST v1.1
    5. Minimaal 6 maanden op behandeling
    E.4Principal exclusion criteria
    - Unable to draw blood for study purposes
    - Patients willing to participate or already included in the SAFE-STOP trial
    - Niet mogelijk om bloed af te nemen
    - Patiënt wil of neemt reeds deel aan SAFE-STOP trial
    E.5 End points
    E.5.1Primary end point(s)
    Difference between the mean trough level 4 weeks after the 3rd nivolumab dose of 240 mg and the mean trough level 4 weeks after treatment start (i.e. 4 weeks after the first 480 mg dose)
    Verschil tussen nivolumab dalspiegels op 4 weken na de 3de gereduceerde kuur van 240 mg met de dalspiegels na de 1ste kuur met 480 mg
    E.5.1.1Timepoint(s) of evaluation of this end point
    4 weeks after the 3rd reduced dose of 240 mg and 4 weeks after the 1st dose of 480 mg
    4 weken na 3de gereduceerde kuur van 240 mg en 4 weken na 1ste kuur van 480 mg
    E.5.2Secondary end point(s)
    - PD-1 receptor occupancy in PBMCs, measured 4 weeks after 3 reduced nivolumab doses
    - Grade ≥3 adverse events during reduced doses
    - Number of patients with new PD during 3 reduced doses
    - Pharmacokinetic profile of nivolumab
    - Cost effectiveness
    - PD-1 receptor bezetting in PBMCs, gemeten 4 weken na de 3rde gereduceerde nivolumab dosering
    - Graad ≥3 bijwerkingen tijdens de gereduceerde kuren
    - Aantal patiënten met nieuwe PD tijdens de gereduceerde kuren
    - Pharmacokinetisch profiel van nivolumab
    - Kosten-effecitiviteit
    E.5.2.1Timepoint(s) of evaluation of this end point
    4 weeks after the 3rd reduced dose of 240 mg
    4 weken na de 3de gereduceerde nivolumab dosering.
    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.8.2.4Number 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.8.5The 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
    LVLP
    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 months4
    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: 31
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 60
    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 state91
    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)
    According to standard of care
    Volgens reguliere behandeling
    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 Decision2021-04-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-07-08
    P. End of Trial
    P.End of Trial StatusOngoing
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