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    Summary
    EudraCT Number:2021-000058-24
    Sponsor's Protocol Code Number:Connect&Go
    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:2021-05-18
    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 number2021-000058-24
    A.3Full title of the trial
    Administration of immune checkpoint inhibitors through an elastomeric pump. A patient preference study and cost analysis.
    Toediening van immune checkpoint inhibitors via een elastomeer pomp. Een patiëntenvoorkeuronderzoek en een kostenanalyse.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Patient preference for administration of cancer immunotherapy via an elastomeric pump. A patient preference study and an economic analysis.
    Patiëntvoorkeur voor toediening van kankerimmunotherapie via een elastomeer pomp. Een patiëntenvoorkeuronderzoek en een economische analyse.
    A.3.2Name or abbreviated title of the trial where available
    Connect&Go
    Connect&Go
    A.4.1Sponsor's protocol code numberConnect&Go
    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 MC Cancer Institute
    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 MC
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationErasmus MC Cancer Institute
    B.5.2Functional name of contact pointR. Malmberg
    B.5.3 Address:
    B.5.3.1Street Address Dr. Molewaterplein 40
    B.5.3.2Town/ cityRotterdam
    B.5.3.3Post code3015 GD
    B.5.3.4CountryNetherlands
    B.5.4Telephone number0031 0107033202
    B.5.6E-mailr.malmberg@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
    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.3.1Product nameNivolumab
    D.3.4Pharmaceutical form Concentrate for 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 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.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 holderMSD
    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.3.1Product namePembrolizumab
    D.3.4Pharmaceutical form Concentrate for 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 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
    Solid tumors for which nivolumab or pembrolizumab monotherapy is an EMA approved indication. This includes (but is not limited to) melanoma, renal-cell cancer, NSCLC and head and neck cancer.
    Vaste tumoren waarvoor nivolumab of pembrolizumab als monotherapie een door het EMA goedgekeurde indicatie is. Dit omvat (maar is niet beperkt tot) melanoom, niercelkanker, NSCLC en hoofd-halskanker.
    E.1.1.1Medical condition in easily understood language
    Various forms of cancer for which nivolumab or pembrolizumab monotherapy are prescribed as treatment.
    Diverse vormen van kanker waarvoor nivolumab of pembrolizumab als monotherapie worden voorgeschreven als behandeling.
    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 of this study is to evaluate the patient preference for either Immune Checkpoint Inhibitor (ICI) administered through an IV bag (hereafter called ICI-B) or ICI administration through an elastomeric pump (hereafter called ICI-P) in patients with a standard of care indication for ICI monotherapy.
    Het primaire doel van deze studie is om de patiëntvoorkeur te onderzoeken voor toediening van ICI via een infuuszak (ICI-B) of via een draagbare elastomeer pomp (ICI-P) bij patiënten met een standaardzorgindicatie voor ICI-monotherapie.
    E.2.2Secondary objectives of the trial
    Secondary objectives are:
    - to assess patient satisfaction with ICI-B and ICI-P
    - to establish the safety of ICI-B and ICI-P
    - to establish the healthcare professional preference for ICI-B or ICI-P
    - to perform a cost analysis.
    Secundaire doelstellingen zijn:
    - het vaststellen van de patiënttevredenheid over ICI-P en ICI-B
    - de veiligheid van ICI-P en ICI-B
    - de voorkeur van healthcare professionals voor ICI-B of ICI-P
    - het vaststellen van het effect van ICI-P op directe zorggerelateerde kosten en directe niet-zorggerelateerde kosten die verband houden met de
    toediening van ICI's.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Age ≥18 years
    - Able and willing to give written informed consent
    - Planned treatment with nivolumab or pembrolizumab monotherapy (with or without prior treatment with Nivolumab/Ipilimumab) for any EMA
    approved indication and with any dose
    - Adequate Dutch language proficiency (at least proficiency level C1)
    - At least 3 prior cycles of nivolumab or pembrolizumab in medical history
    - At least 4 remaining cycles of nivolumab or pembrolizumab monotherapy after inclusion in the study.
    - Leeftijd ≥18 jaar;
    - In staat en bereid om schriftelijke geïnformeerde toestemming te geven;
    - Geplande behandeling met nivolumab of pembrolizumab als monotherapie (met of zonder eerdere behandeling met nivolumab / ipilimumab) voor elke
    door het EMA goedgekeurde indicatie en met elke dosis;
    - Voldoende beheersing van de Nederlandse taal (minimaal vaardigheidsniveau C1)
    - Ten minste 3 eerdere cycli met nivolumab of pembrolizumab in de voorgeschiedenis
    - Ten minste 4 resterende cycli met nivolumab of pembrolizumab als monotherapie na inclusie in het onderzoek.
    E.4Principal exclusion criteria
    Prior hypersensitivity reactions to nivolumab or pembrolizumab (any grade).
    Eerdere overgevoeligheidsreacties op nivolumab of pembrolizumab (elke graad).
    E.5 End points
    E.5.1Primary end point(s)
    The percentage of patients indicating an overall preference for Nivolumab or Pembrolizumab administration via an elastomeric pump (ICI-P) or via an iv bag (ICI-P).
    Het percentage patiënten dat een algemene voorkeur aangeeft voor toediening van Nivolumab of Pembrolizumab via een elastomeerpomp (ICI-P) of via een infuuszak (ICI-B).
    E.5.1.1Timepoint(s) of evaluation of this end point
    This endpoint shall be evaluated after the last of the four cycles of study treatment with nivolumab or pembrolizumab. Subjects shall fill out a questionnaire in which they, amongst other topics, express their overall preference for either method of administration.
    Dit eindpunt wordt geëvalueerd na de laatste van de vier onderzoeksbehandelingen met nivolumab of pembrolizumab. De proefpersonen vullen een vragenlijst in waarin zij, onder andere, hun algemene voorkeur voor beide toedieningsmethoden kenbaar maken.
    E.5.2Secondary end point(s)
    Secondary endpoints are:
    - Patient satisfaction score of ICI-B and ICI-P assessed using the Rituximab Administration Satisfaction Questionnaire (RASQ)
    - The incidence of IRRs according to CTCAE v5.0.
    - The incidence of infusion site extravasations according to CTCAE v5.0.
    - The percentage of HCPs indicating an overall preference for either ICI-B or ICI-P administration.
    - Monetary costs of health care resources per cycle of ICI-B and ICI-P.
    - The total chair time required per cycle of ICI-B and ICI-P.
    - Total and task-specific HCP time required per cycle of ICI-B and ICI-P.
    Secundaire eindpunten zijn:
    - Patiënttevredenheid over ICI-B en ICI-P gescoord met behulp van de Rituximab Administration Satisfaction Questionnaire (RASQ).
    - De incidentie van infusiegerelateerde reacties volgens CTCAE v5.0.
    - De incidentie van extravasaties op de infusieplaats volgens CTCAE v5.0.
    - Het percentage healthcare professionals (HCP's) dat een algemene voorkeur voor aangeeft voor ICI-B of ICI-P
    - Monetaire kosten van gezondheidszorg middelen per cyclus ICI-B en ICI-P.
    - De totale stoeltijd die nodig is per cyclus van ICI-B en ICI-P.
    - Totale en taakspecifieke HCP-tijd vereist per cyclus van ICI-B en ICI-P.
    E.5.2.1Timepoint(s) of evaluation of this end point
    All secondary endpoints except patient satisfaction are evaluated continuously throughout the trial during the four cycles of nivolumab or pembrolizumab treatment during the study.

    Patient satisfaction is assessed directly after study treatment cycle number 2 and 4 using the RASQ.
    Alle secundaire eindpunten behalve patiënttevredenheid worden continu geëvalueerd tijdens het onderzoek tijdens de vier cycli van de nivolumab of pembrolizumab in studieverband.

    Patiënttevredenheid wordt gemeten direct na behandelcyclus 2 en 4 tijdens de studie door middel van de RASQ.
    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 Yes
    E.6.5Efficacy No
    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 Yes
    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 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 Yes
    E.8.1.6Cross over Yes
    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
    Nivolumab of Pembrolizumab toegediend via een infuuszak
    Nivolumab or Pembrolizumab administered via an iv bag
    E.8.2.4Number of treatment arms in the trial2
    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
    LVSV
    LVSV
    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 months
    E.8.9.1In the Member State concerned days
    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: 312
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 78
    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 state390
    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
    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 Decision
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-09-10
    P. End of Trial
    P.End of Trial StatusOngoing
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