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    Summary
    EudraCT Number:2019-000572-41
    Sponsor's Protocol Code Number:LUC19-002
    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:2019-03-06
    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 number2019-000572-41
    A.3Full title of the trial
    An open label phase II study combining anti-PD-1 or PD-L1 and Celecoxib
    in patients with advanced « cold » solid tumors
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study combining 2 medications against cancer (Anti-PD-1 or PD-L1 and Celecoxib)
    A.3.2Name or abbreviated title of the trial where available
    NICE-COMBO
    A.4.1Sponsor's protocol code numberLUC19-002
    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 SponsorCliniques Universitaires Saint-Luc
    B.1.3.4CountryBelgium
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCliniques Universitaires Saint-Luc
    B.5.2Functional name of contact pointguichet académique CTC Leva
    B.5.3 Address:
    B.5.3.1Street AddressAvenue Hippocrate, 10
    B.5.3.2Town/ cityBrussels
    B.5.3.3Post code1200
    B.5.3.4CountryBelgium
    B.5.6E-mailguichetacademique-saintluc@uclouvain.be
    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 Celecoxib PSUSA/00000616/20
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    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 nameCElecoxib
    D.3.2Product code M01AH01
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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
    Indication of treatment with anti-PD1 antibodies such as
    • Melanoma non BRAF mutated in first line of treatment
    • Melanoma BRAF mutated in first or second line of treatment
    • Lung cancer (NSCLC) in second line of treatment
    • Renal cell Cancer (RCC) in second line of treatment
    • Head and Neck squamous carcinoma (HNSC) after platinum salt based chemotherapy
    • Bladder cancer after platinum salt based chemotherapy
    • Endometrial carcinoma
    • Squamous cell skin carcinoma
    •Merkel cell carcinoma
    E.1.1.1Medical condition in easily understood language
    metastatic cancer requiring immunotherapy
    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
    Safety Run-in : To assess the safety and tolerability of celecoxib in combination with anti-PD1 antibodies
    Phase II : To evaluate the objective response rate (ORR) of celecoxib in combination with anti-PD1 antibodies
    E.2.2Secondary objectives of the trial
    To assess the safety and tolerability of celecoxib in combination with anti-PD1 antibodies
    To evaluate the anti tumor effect of celecoxib in combination with anti-PD1 antibodies

    Exploratory : To determine whether this treatment results in decreased tumoral IDO1 expression and increased tumoral infiltration by
    T cells.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Men and women ≥ 18 years of age.
    2. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
    3. Measurable disease as per RECIST 1.1.
    4. Adequate renal, hepatic and hematologic functions as defined by laboratory parameters within ≤ 7 days before treatment initiation.
    - Platelet count ≥100x103/μL
    - Leukocyte count ≥ 3x103/μL
    - Hemoglobin ≥ 9 g/dL
    - ASAT and ALAT ≤ 2xULN
    - Serum creatinine ≤1.5xULN
    - Total bilirubin ≤ 1.5xULN
    - LDH ≤ 1.5xULN
    5. Viral serology : negative antibodies for HCV and HIV; negative antigens for HBV
    6. Metastases biopsiable on two occasions
    7. Patients should agree to perform biopsies and blood collections for translational research
    8. Recently acquired (within 90 days prior to treatment) tumor tissue from an unresectable or metastatic site of disease must be provided for biomarker analyses. In order to include only IDO positive (≥5% expression of tumor cells) and non T-cell infiltrated tumors (<1% T cells infiltrating
    the tumor bed).
    9. Signed informed consent from the patient or legal representative must be obtained.
    10. Cancer types with an indication of treatment with anti-PD1 antibodies such as
    - Melanoma non BRAF mutated in first line
    - Melanoma BRAF mutated in first or second line
    - Lung cancer (NSCLC) in second line of treatment
    - Renal cell Cancer (RCC) in second line
    - Head and Neck squamous carcinoma (HNSC) after platinum salt based chemotherapy
    - Bladder cancer after platinum salt based chemotherapy
    - Endometrial carcinoma
    - Squamous cell skin carcinoma
    - Merkel cell carcinoma
    E.4Principal exclusion criteria
    1. Active brain metastases or leptomeningeal metastases.
    2. Ocular melanoma
    3. Subjects with active, known or suspected autoimmune disease. Subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement therapy, psoriasis not requiring systemic treatment, or conditions not expected to
    recur in the absence of an external trigger are permitted to enroll.
    4. Clinically significant cardiovascular disease (including cardiac insufficiency NYHA grade III and IV, unstable angina, arrythmia, myocardial infarction, symptomatic congestive heart failure) in the past 12 months before enrollment
    5. Other serious acute or chronic illnesses, e.g. active infections requiring antibiotics, bleeding disorders or other conditions requiring concurrent medications not allowed during this study
    6. Concomitant chemotherapy or radiotherapy for curative intent.
    7. Administration of anti-angiogenic drugs or immunomodulatory agents.
    8. Pregnancy or breast-feeding or planning to become pregnant within 6 months after the end of treatment.
    9. Subject (male or female) not willing to use highly effective methods of contraception (per institutional standard) during treatment and for 6 months after the end of treatment.
    E.5 End points
    E.5.1Primary end point(s)
    Overall response rate (ORR), defined as the percentage of subjects having a complete response (CR) or partial response (PR), as determined by investigator assessment of radiographic disease as per RECIST v1.1.
    E.5.1.1Timepoint(s) of evaluation of this end point
    week 12
    E.5.2Secondary end point(s)
    Safety, tolerability of celecoxib in combination with anti-PD-1 antibodies, as assessed by AEs, clinical laboratory tests, physical examination results using CTC-NCIv4.03.
    E.5.2.1Timepoint(s) of evaluation of this end point
    up to progression of disease or until end of treatment (maximum of 2 years)
    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 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) 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.8.3 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 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
    Length of study : maximum 96 months and corresponds to the last visit of follow up of the last patient.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months0
    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: 50
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 18
    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 state68
    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 Decision2019-04-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-04-29
    P. End of Trial
    P.End of Trial StatusOngoing
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