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    Summary
    EudraCT Number:2020-002250-24
    Sponsor's Protocol Code Number:GCAR-7213
    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:2021-05-21
    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 number2020-002250-24
    A.3Full title of the trial
    GCAR-7213: GBM AGILE Global Adaptive Trial Master Protocol: An International, Seamless Phase II/III Response Adaptive Randomization Platform Trial Designed To Evaluate Multiple Regimens In Newly Diagnosed and Recurrent Glioblastoma (GBM), Version 3.2, Amendment 2.2, 14Apr2021

    APPENDIX A: ARM/ STUDY STATUS SUMMARY, Version 3.2, Amendment 2.2, 14Apr2021

    APPENDIX B: CONTROL ARM - TEMOZOLOMIDE (TMZ) AND LOMUSTINE (CCNU) STANDARD OF CARE, Version 3.2, Amendment 2.2, 14Apr2021

    APPENDIX C: REGORAFENIB (BAY 73-4506) - INVESTIGATIONAL AGENT INFORMATION SUMMARY, Version 3.2, Amendment 2.2, 14Apr2021

    Protocol Clarification Letter - Re: GBM AGILE; Protocol Clarification Letter: Regorafenib Investigator’s Brochure v17.0Contraception Language, dated 22Dec2020
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Trial Designed To Evaluate Multiple Regimens In Newly Diagnosed and Recurrent Glioblastoma (GBM)
    A.3.2Name or abbreviated title of the trial where available
    GBM AGILE: Glioblastoma Adaptive Global Innovative Learning Environment
    A.4.1Sponsor's protocol code numberGCAR-7213
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03970447
    A.5.4Other Identifiers
    Name:IND NumberNumber:128245
    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 SponsorGlobal Coalition for Adaptive Research
    B.1.3.4CountryUnited States
    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 supportGlobal Coalition for Adaptive Research
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIQVIA Biotech
    B.5.2Functional name of contact pointSenior Clinical Project Manager
    B.5.3 Address:
    B.5.3.1Street Address59 Forest Oaks Drive
    B.5.3.2Town/ cityMorrisville, NC
    B.5.3.3Post code27560
    B.5.3.4CountryUnited States
    B.5.4Telephone number+ 919 334 8749
    B.5.6E-mailjill.hutchinson@iqvia.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 Yes
    D.2.1.1.1Trade name STIVARGA
    D.2.1.1.2Name of the Marketing Authorisation holderBayer AG
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameSTIVARGA (Regorafenib)
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNREGORAFENIB
    D.3.9.1CAS number 755037-03-7
    D.3.9.3Other descriptive nameREGORAFENIB
    D.3.9.4EV Substance CodeSUB73090
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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
    Oncology - Glioblastoma (GBM)
    E.1.1.1Medical condition in easily understood language
    Malignant brain tumour
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10018336
    E.1.2Term Glioblastoma
    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 identify experimental therapies that improve overall survival (OS) for GBM patients in the Screening stage (Stage 1), determining if predefined patient subtypes or associated biomarkers uniquely benefit from the treatment.

    • To confirm identified efficacious experimental therapies and associated biomarker signatures in an expansion stage (Stage 2) designed to support a new drug application.
    E.2.2Secondary objectives of the trial
    • To evaluate Progression Free Survival (PFS), duration of response, and tumour response by each biomarker/therapeutic combination.
    • To evaluate OS by each biomarker/therapeutic combination.
    • To determine short- and long-term safety signals and quality of life (QOL) measures of an experimental Arm in GBM patients versus standard of care.

    Exploratory Objectives:
    • To generate general prognostic and predictive biomarker hypotheses.
    • To build and validate a longitudinal endpoint model of OS comprised of early assessments (eg, performance status, disease progression) that are associated with OS.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Main Inclusion Criteria - Newly Diagnosed:
    • Age ≥ 18 years.
    • Histologically confirmed Grade IV GBM/gliosarcoma (WHO criteria; IDH wild-type by immunohistochemistry [IHC] or sequencing for IDH) established following either a surgical resection or biopsy.
    • - An MRI scan performed within 21 days prior to randomization preferably.
    • Use of no more than 4mg of dexamethasone per day within 5 days prior to randomization.
    • Karnofsky performance status ≥ 60% performed within a 14-day window
    prior to randomization.
    • Availability of tumor tissue representative of GBM from definitive surgery or biopsy.

    Main Inclusion Criteria - Recurrent:
    • Age ≥ 18 years.
    • Histologically confirmed GBM/gliosarcoma (WHO criteria; non-IDH R132H mutant) at first or second recurrence after initial standard, control or experimental therapy that includes at a minimum Radiation Therapy (RT).
    • Evidence of recurrent disease (RD) demonstrated by disease progression using slightly modified Response Assessment in Neuro-Oncology (RANO) criteria.
    • Use of no more than 4mg of dexamethasone per day within 5 days prior to randomization.
    • Baseline MRI performed within 14 days prior to randomization.
    • Karnofsky performance status ≥ 70% performed within a 14-day window
    prior to randomization.
    • Availability of tumor tissue representative of GBM from initial definitive
    surgery and/or, recurrent surgery, if performed.
    E.4Principal exclusion criteria
    Main Exclusion Criteria - Newly Diagnosed:
    • Any prior treatment for glioma including: prior prolifeprospan 20 with
    carmustine wafer; prior intracerebral agent; prior radiation treatment for
    GBM or lower-grade glioma; prior chemotherapy or immunotherapy for
    GBM or lower-grade glioma.
    • Receiving additional, concurrent, active therapy for GBM outside of the trial
    • Extensive leptomeningeal disease.
    • QTc > 450 msec if male and QTc > 470 msec if female.
    • History of another malignancy in the previous 3 years, with a disease-free interval of < 3 years. Patients with prior history of in situ cancer or basal or squamous cell skin cancer are eligible.
    • Laboratory results that meet exclusionary parameters.

    Main Exclusion Criteria - Recurrent Exclusion Criteria:
    • Early disease progression prior to 3 months (12 weeks) from the
    completion of RT.
    • More than 2 prior lines for chemotherapy administration. (NOTE: In the
    1st line adjuvant setting, combination of Temozolomide (TMZ) with an
    experimental agent is considered one line of chemotherapy.).
    • Any prior treatment with lomustine, agents part of any of the experimental arms, and bevacizumab or other VEG)- or VEGF receptor-mediated targeted agent.
    • Any prior treatment with prolifeprospan 20 with carmustine wafer.
    • Any prior treatment with an intracerebral agent.
    • Receiving additional, concurrent, active therapy for GBM outside of the trial.
    • Extensive leptomeningeal disease.
    • QTc > 450 msec if male and QTc > 470 msec if female.
    • History of another malignancy in the previous 2 years, with a disease-free interval of < 2 years. Participant with prior history of in situ cancer or basal or squamous cell skin cancer are eligible.
    • Laboratory results that meet exclusionary parameters.
    E.5 End points
    E.5.1Primary end point(s)
    • Overall Survival:
    - defined from the time of randomization to death from any cause.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Defined from the time of randomization to death from any cause.
    E.5.2Secondary end point(s)
    • Progression-Free Survival:
    - defined as the time from randomization to clinically determined progression or death from any cause.
    •Tumor Response:
    - complete response, partial response, progressive disease, stable disease.
    • Duration of Response:
    - Complete Response + Partial Response
    - defined as time from date of response to date of clinically determined disease progression or death from any cause.
    E.5.2.1Timepoint(s) of evaluation of this end point
    • Progression-Free Survival:
    - defined as the time from randomization to clinically determined progression or death from any cause.
    • Tumor Response:
    - complete response, partial response, progressive disease, stable disease.
    • Duration of Response:
    - Complete Response + Partial Response
    - defined as time from date of response to date of clinically determined disease progression or death from any cause.
    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) Yes
    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 No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Response Adaptive Randomization Platform Trial
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Temozolomide, Lomustine
    E.8.2.4Number of treatment arms in the trial2
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA28
    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
    Canada
    China
    United States
    Austria
    France
    Germany
    Italy
    Switzerland
    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
    Last patient, last visit.
    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 months1
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months1
    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: 277
    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 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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 50
    F.4.2.2In the whole clinical trial 355
    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)
    All patients will be followed for safety and OS every 3 months (± 1 month) from study treatment discontinuation or completion until death, withdrawal of consent, or lost to follow up, whichever comes first.
    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 Decision2021-06-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-06-25
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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