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    Summary
    EudraCT Number:2015-000454-38
    Sponsor's Protocol Code Number:CPDR001X2201
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-01-19
    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 ConcernedFrance - ANSM
    A.2EudraCT number2015-000454-38
    A.3Full title of the trial
    A phase II, open-label, randomized controlled study of PDR001 in patients with moderately differentiated/undifferentiated locally advanced recurrent or metastatic nasopharyngeal carcinoma who progressed on standard treatment
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An interventional study of PDR001 in adult patients with nasopharyngeal carcinoma (NPC) who have progressed on standard treatment
    A.4.1Sponsor's protocol code numberCPDR001X2201
    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 SponsorNovartis Pharma Services AG
    B.1.3.4CountrySwitzerland
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportNovartis Pharma Services AG
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovartis Pharma S.A.S
    B.5.2Functional name of contact pointInformation&CommunicationMédicales
    B.5.3 Address:
    B.5.3.1Street Address2-4 rue Lionel Terray
    B.5.3.2Town/ cityRueil Malmaison
    B.5.3.3Post code92500
    B.5.3.4CountryFrance
    B.5.4Telephone number+33155476600
    B.5.5Fax number+33155476100
    B.5.6E-mailicm.phfr@novartis.com
    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 No
    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.3.2Product code PDR001
    D.3.4Pharmaceutical form Lyophilisate for solution for infusion
    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.3.9.2Current sponsor codePDR001
    D.3.9.3Other descriptive namePDR001
    D.3.9.4EV Substance CodeSUB171710
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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
    Moderately differentiated/undifferentiated locally advanced recurrent or metastatic nasopharyngeal carcinoma
    E.1.1.1Medical condition in easily understood language
    Nasopharyngeal cancer
    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
    To assess the efficacy of PDR001 versus investigator’s choice
    of chemotherapy in patients with moderately differentiated / undifferentiated locally advanced recurrent or metastatic NPC who progressed on or after first-line therapy
    E.2.2Secondary objectives of the trial
    1- To evaluate the anti-tumor activity of PDR001 versus
    investigator ‘choice of chemotherapy in patients with moderately
    differentiated/undifferentiated locally advanced recurrent or
    metastatic NPC who progressed on or after first-line therapy
    2- To characterize the safety and tolerability of PDR001
    3- To characterize the pharmacokinetic profile of PDR001 (patients in PDR001 arm)
    4- To assess emergence of anti-PDR001 antibodies following one or more intravenous (i.v.) infusions of PDR001(patients in
    PDR001 arm)
    5- To assess the pharmacodynamic effect of PDR001 in peripheral blood (patients in PDR001 arm)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Histologically documented non-keratinizing locally advanced recurrent or metastatic NPC.
    2. Must be resistant to platinum-based chemotherapy (defined as progression on or after platinum-based chemotherapy given in the recurrent/metastatic setting).
    3. May have received at least 1 prior therapy for recurrent or metastatic disease, up to 2 prior systemic therapies.
    4. An archival tumor specimen or newly obtained tumor sample may be submitted at screening/baseline (a fresh tumor sample is preferred), unless agreed differently between Novartis and the Investigator.
    5. At least 1 measurable lesion (as per RECIST v1.1) progressing or new since last anti-tumor therapy.
    6. Prior treated brain or meningeal metastases must be without MRI evidence of progression for at least 8 weeks and off systemic steroids for at least 2 weeks prior to screening/baseline.
    7. Patient must be willing to undergo testing for human immunodeficiency virus (HIV) if not tested within the past 6 months. If HIV+ positive, patient will be eligible if: his/ her CD4+ count ≥ 300/μL; his/her viral load is undetectable; he/she is currently receiving highly active antiretroviral therapy (HAART).

    Other protocol-defined inclusion criteria may apply
    E.4Principal exclusion criteria
    1. History of severe hypersensitivity reactions to other mAbs
    2. Active autoimmune disease or a documented history of autoimmune disease, except vitiligo or resolved asthma/atopy that is treated with broncho-dilators.
    3. Active HBV or HCV infections requiring therapy.
    4. Prior PD-1- or PD-L1-directed therapy or any therapeutic cancer vaccine.
    5. Patients receiving systemic treatment with any immunosuppressive medication.
    6. Use of any vaccines against infectious diseases (e.g. varicella, pneumococcus) within 4 weeks of initiation of study treatment.

    Other protocol-defined exclusion criteria may apply
    E.5 End points
    E.5.1Primary end point(s)
    Progression free survival (PFS) as per RECIST v1.1 using central assessment
    E.5.1.1Timepoint(s) of evaluation of this end point
    PFS will be assessed after 70 events (progressive diseases or death due to any cause) are observed from the study
    E.5.2Secondary end point(s)
    1- Overall survival (OS), overall response rate (ORR), duration of
    response (DOR), time to progression (TTP) and immune related
    progression free survival (irPFS) as per irRC using central
    assessment
    2- Safety: Incidence and severity of adverse events (AEs),immunorelated AEs (irAEs) and serious adverse events (SAEs), including changes in laboratory parameters, vital signs and electrocardiograms (ECGs)
    3- Serum PK parameters (e.g. AUC, Cmax, Tmax, half-life); Serum concentration vs. time profiles
    4- Presence and/or concentration of anti-PDR001 antibodies
    5- Assess peripheral, soluble ligands and cytokine levels (including but not limited to IFN-γ, TNF-α, IL-6)
    E.5.2.1Timepoint(s) of evaluation of this end point
    1- During treatment: 8 weeks after Cycle 1 Day 1, and then every 8 weeks until week 40. Then every 12 until progression or patient withdrawal
    Follow up for progression: every 8 weeks until week 40, then every 12 weeks until progression or lost to follow-up
    2- Assessed continously throughout study for all patients. ECGs during screening on Cycle 1 and 3 on Day 1 and at end of treatment
    3- Cycle 1 and Cycle 3 on Day 1, 2, 8 and 15. Cycle 2 on Day 1, 8 and 15. Cycle 4, 5 and 6 on Day 1 and end of treatment
    4- Cycle 1 to Cycle 6 on Day 1 and end of treatement
    5- At Cycle 1 and Cycle 2 on Day 1, 8 and 15 (pre-dose) and end of treatment
    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 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 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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.3.1Comparator description
    Investigator's choice of chemotherapy
    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.8.4.1Number of sites anticipated in Member State concerned1
    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 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
    Canada
    China
    France
    Hong Kong
    Singapore
    Taiwan
    Thailand
    United States
    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
    End of study will be defined as the time when the last randomized patient has died, has been lost to follow-up, withdrawn consent, completed his/her final study visit, 24 months survival follow-up after his/her first dose or the date when the study is terminated early, whichever occurs first.
    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 months8
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years4
    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: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 74
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 state3
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 5
    F.4.2.2In the whole clinical trial 109
    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 Decision2015-10-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-09-16
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-02-19
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