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    Summary
    EudraCT Number:2020-004497-21
    Sponsor's Protocol Code Number:GASPAR
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2020-12-04
    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 ConcernedFrance - ANSM
    A.2EudraCT number2020-004497-21
    A.3Full title of the trial
    Perioperative Treatment in Resectable Gastric Cancer with Spartalizumab (PDR001) in Combination with fluorouracil, leucovorin, oxaliplatin, and docetaxel (FLOT): A phase II study (GASPAR)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Perioperative Treatment in Resectable Gastric Cancer with Spartalizumab (PDR001) in Combination with fluorouracil, leucovorin, oxaliplatin, and docetaxel (FLOT): A phase II study (GASPAR)
    A.4.1Sponsor's protocol code numberGASPAR
    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 SponsorCentre François Baclesse
    B.1.3.4CountryFrance
    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 supportFrench Cancer Institute and the ARC French Foundation for Cancer Research
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCentre François Baclesse
    B.5.2Functional name of contact pointLECONTE
    B.5.3 Address:
    B.5.3.1Street Address3 Avenue du Général Harris
    B.5.3.2Town/ cityCAEN
    B.5.3.3Post code14076
    B.5.3.4CountryFrance
    B.5.4Telephone number332314550505384
    B.5.5Fax number33231455158
    B.5.6E-maila.leconte@baclesse.unicancer.fr
    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.3.1Product nameSPARTALIZUMAB
    D.3.2Product code PDR001
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSPARTALIZUMAB
    D.3.9.2Current sponsor codePDR001
    D.3.9.4EV Substance CodeSUB191185
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number400
    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
    Resectable gastric or gastroesophageal junction adenocarcinoma
    E.1.1.1Medical condition in easily understood language
    Resectable gastric or gastroesophageal junction adenocarcinoma
    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 PT
    E.1.2Classification code 10017758
    E.1.2Term Gastric cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the pathologic response after pre-operative treatment
    E.2.2Secondary objectives of the trial
    - To evaluate the impact of perioperative treatment on survival outcomes
    - To evaluate the histological R0 resection margin
    - To establish the association between pCR response and survival outcomes
    - To determine the safety profile of the combination Spartalizumab + FLOT regimen
    - To evaluate the post-operative morbidity and mortality
    - To evaluate the ctDNA levels over time
    - To determine potential biomarkers associated with clinical efficacy.
    These biomarkers may include:
    - PD-L1 expression measured as the CPS
    - TMB, including MSI status
    - EBV status
    - To compare the characteristics of the initial tumor with the organoids cultures
    - To evaluate treatment responses with tumor organoid cultures
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Age ≥ 18 years
    - Untreated localized gastric or GEJ adenocarcinoma considered resectable (clinical stage ≥cT2 and/or cN+ and no metastasis)
    - Histologically confirmed adenocarcinoma
    - ECOG performance status score of 0 or 1
    - All subjects must consent to allow the acquisition of blood samples and fresh tumor samples for performance of correlative studies.
    - Screening laboratory values must meet the following criteria:
    o WBC ≥ 2000/ mm³
    o Neutrophils ≥ 1500/ mm³
    o Platelets ≥ 100 000/ mm³
    o Hemoglobin ≥ 9.0 g/dL
    o Bilirubin ≤ 1.5 x ULN, AST and ALT ≤ 3 x ULN
    o Serum creatinine ≤ 1.5 x ULN or measured or calculated creatinine ≥ 50 ml/min clearance (CrCl) (using the Cockcroft-Gault formula)
    - Female subjects of childbearing potential must have a negative urine or serum pregnancy test within 72h before study start
    - Subjects in reproductive age must be willing to use adequate contraception during the study and at least 6 months after the last dose of investigational drug
    - Subjects affiliated to a social security regimen
    - Patient has signed informed consents obtained before any trial related activities and according to local guidelines
    E.4Principal exclusion criteria
    - Subject with any distant metastasis
    - Subject with no recovering from the effects of major surgery or significant traumatic injury within 14 days before inclusion
    - Documented significant cardiovascular disease within the past 6 months before the first dose of study treatment, including: history of congestive heart failure (defined as NYHA III or IV), myocardial infarction, unstable angina, coronary angioplasty, coronary stenting, coronary artery bypass graft, cerebrovascular accident or hypertensive crisis
    - History of other malignancy within the previous 3 years (except for appropriately treated in-situ cervix carcinoma and non-melanoma skin carcinoma)
    - Subject with active, known, or suspected autoimmune disease
    - Subject with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of start of study treatment
    - Subject with symptomatic interstitial lung disease
    - Known history of HIV or HBV infection
    - Known active HCV infection
    - Known history of active tuberculosis
    - Vaccination with live vaccine within 30 days before the first dose of study treatment
    - Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2 or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
    - Prior anticancer therapy for the current malignancy
    - Known hypersensitivity to any of the study drugs or their excipients
    - Chronic inflammable gastro-intestinal disease
    - Uracilemia ≥ 16 ng/ml
    - QT/QTc > 450 msec for men and > 470 msec for women
    - Peripheral neuropathy ≥ Grade II
    - Uncontrolled diabetes
    - Active infection requiring systemic therapy
    - Participation in another therapeutic clinical study
    - Patient deprived of liberty or placed under the authority of a tutor
    - Patient assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the proportion of patients with pCR in the primary tumour defined as: no tumour residue found in the tissue collected during the surgery evaluated by the pathologist.
    E.5.1.1Timepoint(s) of evaluation of this end point
    During the surgery
    E.5.2Secondary end point(s)
    - DFS defined as time between inclusion and first progression according to RECIST v1.1 criteria or death whatever cause (in the absence of progression); patients without disease progression or death at the time of analysis will be censored at the time of the latest date of assessment.
    - OS defined as the time between inclusion and death whatever cause; any patient not known to have died at the time of analysis will be censored based on the last recorded date on which the patient was known to be alive.
    - Proportion of patients with margin-free resection (R0), defined as a microscopically margin-negative resection, in which no gross or microscopic tumor remains in the primary tumor bed
    - Correlation between pCR and DFS
    - Correlation between pCR and OS
    - Toxicities of the combination Spartalizumab + FLOT regimen according to NCI CTCAE criteria v5.0
    - Post-operative morbidity, defined post-operative complications grades II-V according to Clavien-Dindo classification during surgery, within 30 days after surgery or during the hospital stay
    - Post-operative mortality, defined as the rate of patients died due to any cause during the 30 days post-surgery


    Exploratory end point:
    - To evaluate the ctDNA levels over time
    - To determine potential biomarkers associated with clinical efficacy by analyzing biomarker measures.
    These biomarkers may include:
    - PD-L1 expression measured as the CPS
    - TMB, including MSI status
    - EBV status
    - To compare the characteristics of the initial tumor with the organoids cultures
    - To evaluate treatment responses with tumor organoid cultures
    E.5.2.1Timepoint(s) of evaluation of this end point
    up to disease progression
    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 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 concerned16
    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
    up to disease progression
    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 months60
    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: 34
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 33
    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 state67
    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 Decision2021-01-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-01-13
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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