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    Summary
    EudraCT Number:2017-002805-36
    Sponsor's Protocol Code Number:ENGOT-OV30/NSGO
    National Competent Authority:Finland - Fimea
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-04-22
    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 ConcernedFinland - Fimea
    A.2EudraCT number2017-002805-36
    A.3Full title of the trial
    NSGO-OV-UMB1; ENGOT OV30: A phase II umbrella trial in patients with
    relapsed ovarian cancer.
    Vaiheen II usean hoitohaaran tutkimus uusiutunutta munasarjasyöpää sairastavilla potilailla.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Immunotherapy in ovarian cancer
    Immuuniterapia munasarjasyövän hoidossa
    A.3.2Name or abbreviated title of the trial where available
    ENGOT-OV30 / NSGO
    ENGOT-OV30 / NSGO
    A.4.1Sponsor's protocol code numberENGOT-OV30/NSGO
    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 SponsorNSGO
    B.1.3.4CountryDenmark
    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 supportAstraZeneca
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNSGO
    B.5.2Functional name of contact pointProject Manager
    B.5.3 Address:
    B.5.3.1Street AddressDept of Oncology 9431, Rigshospitalet
    B.5.3.2Town/ cityDenmark
    B.5.3.3Post code2100
    B.5.3.4CountryDenmark
    B.5.4Telephone number4535453311
    B.5.5Fax number4535452898
    B.5.6E-maildorte.noervang@region.dk
    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 nameMEDI 9447
    D.3.4Pharmaceutical form Powder for solution for injection
    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) 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 Yes
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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 nameDurvalumab
    D.3.2Product code MEDI 4736
    D.3.4Pharmaceutical form Concentrate and solvent for solution for 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) 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
    Ovarian cancer
    munasarjasyöpä
    E.1.1.1Medical condition in easily understood language
    Ovarian cancer
    munasarjasyöpä
    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 HLT
    E.1.2Classification code 10033129
    E.1.2Term Ovarian neoplasms malignant (excl germ cell)
    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
    The overall objective in part 1 is to obtain preliminary evidence of
    efficacy of novel agents for the management of relapsed ovarian c er, and in part 2 efficacy of
    novel agents compared to the standard of care (SoC).
    Disease control rate (DCR) (CR+PR+SD) according to RECIST v1.1 at 16
    weeks.
    E.2.2Secondary objectives of the trial
    •Progression-Free Survival (PFS) by RECIST v1.1: at 6 & 12 months
    and median PFS
    •PFS by Immune-RECIST: at 6 & 12 months and median PFS
    •Overall survival
    •Objective response rate according to RECIST v1.1 (ORR)
    •Duration of (Overall) Response (DoR)
    •Safety and tolerability.4.3.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion criteria Cohort A
    A patient will be eligible for inclusion only if all of the following criteria are fulfilled:
    1.Platinum-sensitive disease: defined as disease progression ≥ 6 months following the last
    administered dose of platinum-based therapy. Patients must have received atleast one line of
    chemotherapy for platinum-sensitive disease. OR
    2.Platinum-resistant disease: defined as disease progression < 6 months following the last
    administered dose of platinum-based therapy. OR
    3.Platinum-refractory disease: defined as lack of response or disease
    progression while receiving the most recent therapy.

    Other inclusion criteria
    4.Histological confirmed ovarian, fallopian tube or peritoneal cancers.
    5.Histological types: high-grade
    serious, high-grade endometriod, undifferentiated, carcinosarcoma or mixed histology.
    6.Subjects must have at least 1 measurable lesion as defined by RECIST guidelines. This should not
    be the same lesion used for biopsy.
    7.Patients entering cohort A: Archival tumour tissue must be
    screened for CD73 and only CD73 positive patients (defined as >10% of tumor cells positive) will
    enter this trial.
    8.Patient agrees to undergo all analysis (blood, serum, tissue); radiological examinations
    according to protocol.
    9.Mandatory tumour biopsy before treatment (before day 0) and at day 56 of treatment.
    10.Patients must give informed consent. 11.DPatients must be at least 18 years of age. 12.DECOG
    performance status 0-1 13.DSerum albumin >30g/l.
    14.Adequate organ function
    oAbsolute neutrophil count (ANC) ≥1,500/mcL (without growth factors for >21 days)
    oPlatelets >100,000/mcL (without platelet transfusion for >21 days)
    oHemoglobin ≥ 9g/dl (5.6
    mmol/L), without blood transfusion for >21 days
    oSerum creatinine ≤1.5x upper limit of normal (ULN) or calculated creatinine clearance ≥50mL/min
    using Cockcroft-Gault formula.
    oTotal bilirubin ≤1.5x ULN. Total bilirubin ≤3x ULN in the presence of liver metastases.
    oAlanine
    aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5x ULN unless liver metastases are
    present, in which case they must be ≤5x ULN.
    15.Life expectancy of at least 12 weeks.
    16.Patients must be fit to receive Investigational medical products (IMPs) (MEDI9447 +
    durvalumab).
    17.Patients of child-bearing potential: who are sexually active must use at least one highly
    effective method of contraception from the time of screening, and must agree to continue using such
    pre-cautions for 90 days after the last dose of MEDI9447 + durvalumab combination therapy.
    Non-sterilised male partners of a female subject must use male condom plus spermicide throughout
    this period. Cessation of birth control after this point should be discussed with a responsible
    phy- sician. Not engaging in sexual activity for the total duration of the drug treatment and the
    drug washout period is an acceptable practice; however, periodic abstinence, the rhythm method, and
    the withdrawal method are not acceptable methods of contraception. Female subjects should re-frain
    from breastfeeding throughout this period.
    18. All patients: Patients should not donate blood or blood components while participating in this
    study and through 90 days after re eipt of the
    final dose of MEDI9447 + durvalumab combination therapy.
    E.4Principal exclusion criteria
    1.Subjects using immunosuppressive medications within 14 days prior
    to first dose with the excep-tion of topical (intranasal, inhaled, local injection, systemic
    (prednison equivalent 10 mg/day or less) or as needed for hypersentivity reactions such as CT scan
    premedication.
    2.Immunodeficiency or organ transplant
    3.Live vaccines within 28 days prior to the first dose. 4.Major surgery within 28 days prior to
    the first dose..
    5.Ovarian sarcomas, small cell carcinoma with neuroendocrine differentiation, non-epithelial can-cers.
    6.Cancer therapies (chemotherapy, ra ry, immunotherapy, biologic or hormonal
    therapy) within 28 days prior to the first dose.
    7.Concurrent treatment with an investigational agent or participation in another clinical trial.
    8.Previous malignant disease: patients are not eligible for the study if actively being treated of
    inva-sive cancer other than ovarian cancer.
    Patients with previous malignant disease other than ovarian cancer who are relapse-free and
    treatment-free for more than three years may enter this study. Pa-tients with previous history of
    in-situ carcinoma, stage 1A cervical cancer or non-invasive basal cell and squamous cell skin
    carcinoma can enter this trial.
    9.Active infection including tuberculosis (clinical evaluation that includes clinical history,
    physical examination and radiographic findings, and TB testing in line with local practice),
    hepatitis B (known positive HBV surface antigen (HBsAg) result), hepatitis C, or human
    immunodeficien-cy virus (positive HIV 1/2 antibodies). Patients with a past or resolved HBV
    infection (defined as the presence of hepatitis B core antibody [anti-HBc] and absence of HBsAg)
    are eligible. Patients positive for hepatitis C (HCV) antibody are eligible only if polymerase
    chain reaction is negative for HCV RNA.
    10.History of a cerebral vascular accident, transient ischemic attack or subarachnoid hemorrhage
    within the past 6 months.
    11.History of clinically significant hemorrhage in the past 3 months.
    12.Untreated CNS disease,
    leptomeningeal disease or cord compression. Subjects with treated dis-ease should have at least 4
    weeks of neurologic and radiographic stability and be off of steroids for 14 days.
    13.Significant cardiovascular disease's, including uncontrolled hypertension, clinically relevant
    car-diac arrhythmia, unstable angina or myocardial infarction within 6 months prior to
    randomization, congestive heart failure > NYHA II, severe peripheral vascular disease, QT
    prolongation >470msec, clinically significant pericardial effusion.
    14.Persistance of clinically relevant therapy related toxicity from previous anticancer therapy
    (any grade 3-4 toxicity or grade ≥2 neuropathy).
    15.Known hypersensitivity to the trial drugs, or to their excipients. 16.DHas had prior exposure
    to IMPs, or any other immunotherapy. 17.DActive or prior documented autoimmune or inflammatory
    disorders (including inflammatory bowel disease [eg, colitis or Crohn's disease], diverticulitis
    [with the exception of diverticulosis], systemic lupus erythematosus, Sarcoidosis syndrome, or
    Wegener syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis,
    hypophysitis, uveitis, etc]). The following are exceptions to this criterion:
    −Patients with vitiligo or alopecia
    −Patients with hypothyroidism (eg, following Hashimoto syndrome) stable on hormone re-placement
    −Any chronic skin condition that does not require systemic therapy
    −Patients without active disease in the last 5 years may be included but only after consulta-tion
    with the study physician
    −Patients with celiac disease controlled by diet alone
    18.For cohorts B and C: Medical condition requiring current systemic anticoagulation, or a history
    of congenital hypercoagulable condition. Subjects taking aspirin at doses < 325 mg per day are
    eligible provided that prothrombin time is within the institutional range of normal. Use of
    local anti-coagulation for port maintenance is permitted
    E.5 End points
    E.5.1Primary end point(s)
    •Disease control rate (DCR) (CR+PR+SD) at 16 weeks.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Every 8 weeks until disease progression
    E.5.2Secondary end point(s)
    •Progression-Free Survival (PFS) by RECIST v1.1: at 6 & 12 months
    and median PFS
    •PFS by Immune-RECIST at 6 & 12 months and median PFS
    •Overall survival (OS)
    •Objective response rate according to RECIST v1.1 (ORR)
    •Duration of (Overall) Response (DoR)
    •Safety and tolerability.
    E.5.2.1Timepoint(s) of evaluation of this end point
    every 8 weeks until disease progression and registration of survival data
    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 concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA25
    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
    Canada
    Japan
    Korea, Republic of
    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
    01 Sep 2022
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years5
    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: 35
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    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 state5
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 38
    F.4.2.2In the whole clinical trial 75
    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
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Nordic Society of Gyeaecological Oncology
    G.4.3.4Network Country Denmark
    G.4 Investigator Network to be involved in the Trial: 2
    G.4.1Name of Organisation GCIG Gynecologic Cancer InterGroup
    G.4.3.4Network Country Canada
    G.4 Investigator Network to be involved in the Trial: 3
    G.4.1Name of Organisation ENGOT European Network of Gynaecological
    G.4.3.4Network Country Czech Republic
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2018-05-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-05-18
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-12-31
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