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    Summary
    EudraCT Number:2015-000449-21
    Sponsor's Protocol Code Number:CLAG525X2101C
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-07-16
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2015-000449-21
    A.3Full title of the trial
    A Phase I/II, open label, multicenter study of the safety and efficacy of LAG525 single agent and in combination with PDR001 administered to patients with advanced malignancies
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An interventional study of LAG525 alone and in combination with PDR001 in patients with advanced malignancies
    A.4.1Sponsor's protocol code numberCLAG525X2101C
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02460224
    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 AG
    B.5.2Functional name of contact pointClinical Trial Information Desk
    B.5.3 Address:
    B.5.3.1Street AddressForum 1, Novartis Campus
    B.5.3.2Town/ cityBasel
    B.5.3.3Post code4056
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number+41613241111
    B.5.5Fax number+41613248001
    B.5.6E-mailclinicaltrial.enquiries@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 LAG525
    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.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNnot available
    D.3.9.2Current sponsor codeLAG525
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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.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 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 Powder 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.3.8INN - Proposed INNnot available
    D.3.9.3Other descriptive namePDR001
    D.3.9.4EV Substance CodeSUB171710
    D.3.10 Strength
    D.3.10.1Concentration unit mg/kg milligram(s)/kilogram
    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
    Solid tumors
    E.1.1.1Medical condition in easily understood language
    Solid tumors
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10065252
    E.1.2Term Solid tumor
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Phase I part - To estimate the RP2D or MTD for:
    ● Single agent LAG525 in all patients (including for Japanese patients)
    ● Combination of LAG525 and PDR001.
    Phase II part - To estimate the overall response rate per RECIST V1.1:
    ● Single agent LAG525
    ● Combination of LAG525 and PDR001
    E.2.2Secondary objectives of the trial
    Key Secondary Objectives:
    1) To characterize the safety and tolerability of single agent LAG525 given alone and in combination with PDR001
    2) To characterize the pharmacokinetic profile of single agent LAG525 given alone and in combination with PDR001
    3) To assess emergence of anti-LAG525, and anti-PDR001 antibodies following one or more intravenous (i.v.) infusions of single agent LAG525 given alone or in combination with PDR001
    4) To evaluate the preliminary antitumor activity of single agent LAG525 given alone or in combination of PDR001
    Other Secondary Objectives are defined in the protocol.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Phase I part:
    - Patients with advanced/metastatic solid tumors, with measurable or
    non-measurable disease as determined by RECIST version 1.1 (refer to
    Appendix 1), who have progressed despite standard therapy or are
    intolerant of standard therapy, or for whom no standard therapy exists
    Phase II part:
    •Patients with advanced/metastatic solid tumors, with at least one
    measurable lesion as determined by RECIST version 1.1, who have had
    disease progression. Additionally the following must apply:
    •Group 1: NSCLC
    •Group 2: Melanoma
    •Group 3: Renal cancer
    •Group 4: Mesothelioma
    •Group 5: TNBC
    •Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1
    Other protocol-defined inclusion criteria may apply.
    E.4Principal exclusion criteria
    History of severe hypersensitivity reactions to study treatment
    ingredients or other mAbs
    •Active, known or suspected autoimmune disease
    •Active infection requiring systemic antibiotic therapy
    •HIV infection. Active hepatitis B virus (HBV) or hepatitis C virus (HCV)
    infection
    •Patients receiving chronic treatment with systemic steroid therapy (>
    10 mg/day prednisone or equivalent) within 7 days of the first dose of
    study treatment, other than replacement-dose corticosteroids in the setting of adrenal
    insufficiency
    •Patients receiving systemic treatment with any immunosupressive
    medication
    •Use of live vaccines against infectious disease within 4 weeks of
    initiation of study treatment
    •Systemic anti-cancer therapy within 2 weeks of the first dose of study
    treatment.
    •Presence of symptomatic central nervous system (CNS) metastases or
    CNS metastases that require local CNS-directed therapy or increasing
    doses of corticosteroids within the prior 2 weeks
    •History of drug-induced pneumonitis or current pneumonitis.
    Other protocol-defined exclusion criteria may apply
    E.5 End points
    E.5.1Primary end point(s)
    Phase I part:
    - The incidence of dose limiting toxicities ( DLTs) with single agent LAG525 & for the combination treatment of LAG525 and PDR001

    Phase II part:
    Overall response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. of single agent LAG525 & the combination of LAG525 and PDR001.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Phase I:
    - the incidence of DLTs continously: during the first cycle of treatment with single agent LAG525; for the combination treatment of LAG525 and PDR001, the DLT window will be 2 cycles of the treatment.

    Phase II:
    - Every 8 weeks ± 1 week after Cycle 1 Day 1 until 40 weeks , then every 12 weeks until progression of disease per irRC or patient withdrawal.

    E.5.2Secondary end point(s)
    1. a) Safety incidence and severity if adverse events (AEs) and serious adverse events (SAEs) including changes in laboratory parameters, vital signs and ECGs; b) Tolerability: Dose interruptions, reductions and dose intensity.
    2. Serum PK parameters (e.g. AUC, Cmax, Tmax, t1/2 half-life))
    3. Presence and/ or concentration of anti-LAG525 and anti-PDR001 antibodies
    4. Phase I Part: ORR, progression free survival (PFS), duration of response (DOR) and disease control rate (DCR); Phase II Part: ORR per immune related Response Criteria (irRC), PFS, DOR, DCR per RECIST V1.1 and per irRC

    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Assessed continuously
    2. Every Cycle until Cycle 6
    3. Every Cycle until Cycle 6
    4. Every 8 weeks ± 1 week after Cycle 1 Day 1 until 40 weeks , then every 12 weeks until progression of disease per irRC or patient withdrawal.
    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 Yes
    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) Yes
    E.7.1.1First administration to humans Yes
    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 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 trial3
    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 concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA9
    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
    Australia
    Belgium
    Canada
    France
    Germany
    Hong Kong
    Italy
    Japan
    Korea, Republic of
    Singapore
    Spain
    Taiwan
    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
    The end of study will be when 80% of the patients per disease group in
    the phase II part have completed the follow-up for disease progression
    or discontinued the study for any reason, and all patients have
    completed treatment and the 150 day safety follow-up period, or if the
    study is terminated early, or another clinical study becomes available
    that can continue to provide study treatment in this patient population, and all patients ongoing are transferred to that clinical study.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months58
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months58
    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: 276
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 140
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 140
    F.4.2.2In the whole clinical trial 416
    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 Decision2015-08-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-08-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-12-31
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