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    Summary
    EudraCT Number:2019-000914-12
    Sponsor's Protocol Code Number:GASOLINE
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-01-16
    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 ConcernedGermany - PEI
    A.2EudraCT number2019-000914-12
    A.3Full title of the trial
    Gazyvaro Targeting Tumor Promoting, Regulatory B-cells in Solid Tumors
    Gazyvaro (Obinutuzumab) als zielgerichtete Therapie gegen Tumorwachstum fördernde, regulatorische B-Zellen bei soliden Tumoren
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Gazyvaro Targeting Tumor Promoting, Regulatory B-cells in Solid Tumors
    A.4.1Sponsor's protocol code numberGASOLINE
    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 SponsorUniversity of Cologne
    B.1.3.4CountryGermany
    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 supportF. Hoffmann La Roche
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationClinical Trials Centre Cologne
    B.5.2Functional name of contact pointClinical Trials Centre Cologne
    B.5.3 Address:
    B.5.3.1Street AddressGleueler Str. 269
    B.5.3.2Town/ citycologne
    B.5.3.3Post code50935
    B.5.3.4CountryGermany
    B.5.4Telephone number+49022147888790
    B.5.5Fax number+49022147888209
    B.5.6E-mailsebastian.meller@uk-koeln.de
    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 TECENTRIQ (atezolizumab)
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration GmbH
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameTECENTRIQ (atezolizumab)
    D.3.4Pharmaceutical form Infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    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) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product Yes
    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 Yes
    D.2.1.1.1Trade name GAZYVA (Obinutuzumab)
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration GmbH
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameGAZYVA (Obinutuzumab/
    D.3.4Pharmaceutical form Infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    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) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product Yes
    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: 3
    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 GAZYVA (Obinutuzumab)
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration GmbH
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameGAZYVA (Obinutuzumab/
    D.3.4Pharmaceutical form Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntralesional use
    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) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product Yes
    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
    • Melanoma: unresectable stage III with macroscopic lymph node, in transit/satellite metastasis or stage IV after ≥ 2 lines of therapy (incl. checkpoint blockade, BRAF inhibitor)
    • Prostate carcinoma: castration-resistant, 2 lines of chemotherapy failed
    • CTCL: ≥ stage IIB, ≥ 2 previous lines of treatment
    E.1.1.1Medical condition in easily understood language
    Patients with late stage Melanoma, Prostate carcinoma or Cutaneous T cell lymphoma (CTCL)
    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 determine disease control rate (CR, PR, SD) upon treatment with:
    o Obinutuzumab monotherapy
    o Combination therapy with obinutuzumab and atezolizumab
    o Atezolizumab monotherapy (sequential treatment of obinutuzumab and atezolizumab)
    • To determine induction of an immunosupportive tumor microenvironment by:
    o Immunoscore improvement (25% increase in CD3+ and CD8+ cell infiltration compared to baseline), 25% decrease of FoxP3+ and CD4+ cells in tumor microenvironment (immunohistochemistry)
    o Increase of T-cell activation by 25% in MFI or frequency of activated T-cells (peripheral blood)
    E.2.2Secondary objectives of the trial
    1. Evaluation of ORR, PFS, DOR, OS
    2. To determine the impact of obinutuzumab treatment on CD20+ cells intratumorally and in the peripheral blood
    3. To identify prognostic and predicitive value of intratumoral CD20 expression
    4. To identify the prognostic and predictive value of intratumoral CD20 expression
    5. To evaluate of safety of obinutuzumab or atezolizumab monotherapy or combination therapy in different cancer entities
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
     18 years of age or older
     Written, signed and dated informed consent before conduct of any study-specific procedure
     ECOG performance status of 0-2
     Life expectancy of more than 3 months
     Advanced disease:
     Prostate Cancer: Castration resistant metastatic disease,
    2 prior lines of treatment have failed, known PSA serum level at baseline
     Melanoma: Unresectable stage III melanoma with N3 macroscopic lymph nodes or in-transit/satellite metastases or stage IV melanoma after standard therapy Known
    PD-L1, PD-1 and BRAF status at baseline level.
     CTCL: ≥ stage IIB, ≥ 2 previous lines of treatment (1 skin directed, 1 systemic); continuing skin directed therapyMeasurable lesion according to RECIST 1.1/iRECIST and CTCL according to consensus criteria
     Recent biopsy confirming the diagnosis (< 4 weeks old)
     Adequate organ function
    o WBC ≥ 2500/µL
    o ANC ≥ 1000/µL
    o Platelets ≥ 50 x 103/µL
    o Hemoglobin ≥ 9 g/dL
    o Estimated glomerular filtration rate > 30mL/min/1.73m2
    o AST ≤ 2.5 x ULN for patients without liver metastasis, ≤ 5 x ULN for patients with liver metastasis
    o Bilirubin ≤ 1.5 x ULN, (except patients with Gilbert’s Syndrome), Total bilirubin less than 3.0 mg/dL)
    • Reproductive Status (see protocol)
    E.4Principal exclusion criteria
     Any medical, mental or psychological condition which in the opinion of the investigator would not permit the patient to understand the patient information or complete the study
     Concurrent systemic immune therapy, ongoing chemotherapy or therapy with any anticancer drug not indicated in the study protocol
     Prior treatment with atezolizumab or obinutuzumab
     Any investigational agent(s) within 4 weeks prior to study entry
     Immuncheckpoint inhibitors, other immunomodulating agents or chemotherapy administered less than 4 weeks before first intake of study drug
     Active or history of autoimmune disease that required systemic steroids or immunosuppressive medications, with exception of vitiligo or resolved childhood asthma
     New and active brain metastasis or meningeosis neoplastica. Note: Patients with stable or treated brain metastasis (e.g. after resection, intra or radiation therapy) are allowed to participate in this trial
     Ongoing necessity for systemic corticosteroids >10mg daily prednisone equivalent. Inhaled or topical steroids and adrenal replacement steroid doses > 10mg daily prednisone equivalent are permitted in the absence of active autoimmune disease.
     Active infection with HIV, HBV or HCV
     Active tuberculosis
     Active uncontrolled infection diseases
     History of another primary malignancy except for
     Malignancy treated with curative intent and with no known active disease ≥ 5 years before the first dose of IP and of low potential risk for recurrence
    Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
    Adequately treated carcinoma in situ without evidence of disease
    Patients with severe cardiovascular disease (e.g. NYHA functional class III or IV, myocardial infarction within 6 months before inclusion, ventricular tachyarrhythmia requiring ongoing treatment, unstable angina pectoris)
     History of active primary immunodeficiency
     Treatment with immunosuppressive medications (including but not limited to corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor) within 2 weeks prior to study entry. Inhaled or topical steroids and adrenal replacement steroid doses ≤10mg daily prednisone equivalent are permitted in the absence of active autoimmune disease.
     Major surgery (defined as opening at least one body cavity) within 4 weeks prior to study entry
     History of idiopathic pulmonary fibrosis, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening CT scan
     Prior allogeneic bone marrow transplantation or prior solid organ transplantation
     Pregnant or breastfeeding females
     Current treatment within another therapeutic clinical trial with experimental and not approved drugs and treatment combinations
     after allogeneic bone marrow transplantation or after solid organ transplantation
     Allergies and Adverse Drug Reaction
     History of allergy to study drug components
     History of severe hypersensitivity reaction to any monoclonal antibody
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is:
    • To determine disease control rate (CR, PR, SD)

    The co-primary/key efficacy endpoints are:
    • Clinical response (CR, PR or SD) until staging after 4 cycles and immunological response after cycle 2 or 6.
    • Immunological response after 2 cycles (monotherapy) and clinical response (CR, PR or SD) after cycle 6.
    E.5.1.1Timepoint(s) of evaluation of this end point
    • Clinical response (CR, PR or SD) until staging after 4 cycles and immunological response after cycle 2 or 6.
    • Immunological response after 2 cycles (monotherapy) and clinical response (CR, PR or SD) after cycle 6.
    E.5.2Secondary end point(s)
    The secondary efficacy endpoints are:
    • Overall response rate (ORR)
    • Duration of response (DOR)
    • Progression-free survival (PFS)
    • Overall survival (OS)
    E.5.2.1Timepoint(s) of evaluation of this end point
    1)until staging after 4 cycles and immunological response after cycle 2 or 6.
    2) at last visit
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months6
    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: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 7
    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 state27
    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)
    In case of continuing response to treatment after cycle 8, patients will receive atezolizumab until loss of clinical benefit or progressive disease if they agree to. Administration of the medication will continue to take place at the trial center.
    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 Decision2020-04-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-06-12
    P. End of Trial
    P.End of Trial StatusOngoing
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