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    Summary
    EudraCT Number:2015-003239-36
    Sponsor's Protocol Code Number:B9991010
    National Competent Authority:Latvia - SAM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2016-08-19
    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 ConcernedLatvia - SAM
    A.2EudraCT number2015-003239-36
    A.3Full title of the trial
    A Randomized, Open-Label, Multicenter, Phase 3 Study to Evaluate the Efficacy and Safety of Avelumab (MSB0010718C) in Combination with and/or Following
    Chemotherapy in Patients with Previously Untreated Epithelial Ovarian Cancer

    Javelin Ovarian 100
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Determine the Effect and Safety of Avelumab When Combined with Chemotherapy or Following Chemotherapy in Patients who have Previously Untreated Epithelial Ovarian Cancer
    A.4.1Sponsor's protocol code numberB9991010
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02718417
    A.5.4Other Identifiers
    Name:US INDNumber:IND #126,174
    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 SponsorPfizer Inc, 235 East 42nd Street, New York, NY 10017
    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 supportPfizer Inc., 235 East 42nd Street, New York, NY 10017
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPfizer Inc.
    B.5.2Functional name of contact pointClinical Trials.gov Call Center
    B.5.3 Address:
    B.5.3.1Street Address235 East 42nd Street
    B.5.3.2Town/ cityNew York
    B.5.3.3Post codeNY 10017
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1800 718 1021
    B.5.5Fax number+1303 739 1119
    B.5.6E-mailclinicaltrials.govcallcenter@pfizer.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 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 nameAvelumab
    D.3.2Product code MSB0010718C
    D.3.4Pharmaceutical form Concentrate for 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 INNAvelumab
    D.3.9.3Other descriptive nameMSB0010718C
    D.3.9.4EV Substance CodeSUB176547
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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
    Epithelial ovarian cancer (EOC)
    E.1.1.1Medical condition in easily understood language
    Cancer of the ovaries
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level PT
    E.1.2Classification code 10033128
    E.1.2Term Ovarian 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
    1. To demonstrate that avelumab in combination with platinum-based chemotherapy followed by avelumab maintenance (Arm C) is superior to platinum-based chemotherapy alone followed by observation (Arm A) in prolonging progression free survival (PFS) in patients with previously untreated epithelial ovarian cancer (EOC).

    2. To demonstrate that platinum-based chemotherapy alone followed by avelumab maintenance (Arm B) is superior to platinum-based chemotherapy alone followed by observation (Arm A) in prolonging PFS in patients with previously untreated EOC.
    E.2.2Secondary objectives of the trial
    • To compare Arm C and Arm B to Arm A in patients with untreated EOC, with respect to overall survival.
    • To evaluate the anti-tumor activity in each arm.
    • To evaluate the overall safety profile in each arm.
    • To evaluate the pharmacokinetics of paclitaxel and carboplatin alone and in combination with avelumab.
    • To evaluate the PK of avelumab alone and in combination with carboplatin-paclitaxel (Arms B and C).
    • To evaluate the immunogenicity of avelumab alone and in combination with carboplatinpaclitaxel (Arms B and C).
    • To evaluate candidate predictive biomarkers of sensitivity or resistance to avelumab in combination with and/or following carboplatin-paclitaxel in pre-treatment tumor tissue, that may aid in the identification of patient subpopulations most likely to benefit from treatment.
    • To evaluate patient reported outcome in each treatment arm in patients with previously untreated EOC including the assessment of treatment side effects and diseaserelated symptoms.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Histologically confirmed Stage III-IV epithelial ovarian, fallopian tube, or primary peritoneal cancer (according to AJCC/UICC TNM and International Federation of Gynecology and Obstetrics (FIGO) Staging System 2014 edition), including malignant mixed Müllerian tumors with high grade serous component.
    2. Patients must be candidates for platinum-based chemotherapy and previously untreated.
    3. Patients must have completed a surgical debulking procedure, or be candidates for neoadjuvant chemotherapy.
    a. For patients enrolling after debulking surgery, the following conditions must be met:
    • The minimum surgery required is an abdominal surgery with an attempt at cytoreduction providing tissue for histologic evaluation and establishing and documenting the primary site and stage.
    • Patient must be randomized at a maximum of 8 weeks after surgery.
    b. For patients who are candidates for neoadjuvant chemotherapy, the following conditions must be met:
    • A core tissue (not fine needle aspiration) biopsy is required. The tissue must be consistent with a tumor of Müllerian origin.
    • Stage IIIC–IV documented via imaging or surgery (without attempt at
    cytoreduction).
    • Serum CA125/ CEA ratio > 25. If the serum CA125/CEA ratio is < 25, workup should be negative for the presence of a primary gastrointestinal or breast malignancy (< 6 weeks before randomization).
    • Plan to receive carboplatin-paclitaxel neoadjuvant chemotherapy.
    • Randomization must occur within 8 weeks after diagnosis.
    4. Availability of an archival formalin-fixed, paraffin-embedded (FFPE) tumor tissue block or a minimum of 15 slides. If archived FFPE tissue is not available, a
    de novo (ie, fresh) tumor sample must be obtained in accordance with local institutional practice for tumor biopsies.
    5. Eastern Cooperative Group (ECOG) performance status 0-1
    6. Age ≥18 years (or ≥20 years in Japan).
    7. Adequate hematological function (ANC ≥1.5 x 10 to the power 9/L, Hgb ≥9.0 g/dL, and platelet count ≥100 x 10 to the power 9/L).
    8. Adequate liver function tests (ALT/AST ≤2.5 x ULN, total serum bilirubin level ≤1.5 x ULN).
    9. Adequate renal function by estimated creatinine clearance ≥50 mL/min as calculated using the Cockcroft-Gault method.
    10. Estimated life expectancy of at least 12 weeks.
    11. Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
    12. Patients who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
    13. Patients of childbearing potential and at risk for pregnancy must agree to use 2 highly effective methods of contraception throughout the study and for at least 60 days after the last dose of assigned treatment.
    Patients of non-childbearing potential must meet at least one of the following criteria:
    • Have undergone a documented hysterectomy and/or bilateral oophorectomy;
    • Have medically confirmed ovarian failure; or
    • Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; status may be confirmed by having a serum follicle-stimulating hormone (FSH) level confirming the post-menopausal state.
    All other patients (including patients with tubal ligations) will be considered to be of childbearing potential.
    E.4Principal exclusion criteria
    1. Non-epithelial tumors, or ovarian tumors with low malignant potential (ie, borderline tumors).
    2. Mucinous tumors.
    3. Patients for whom, in the opinion of the Investigator, there is clinical benefit to administer bevacizumab as a first-line treatment and for whom bevacizumab is approved and available in this setting.
    4. Cancer for which intraperitoneal cytotoxic chemotherapy is planned.
    5. Prior systemic anti-cancer treatment for EOC, FTC, or PPC.
    6. Prior immunotherapy with IL-2, IFN-α, or anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-cytotoxic T lymphocyte associated antigen 4 (anti-CTLA-4) antibody (including ipilimumab), or any other antibody or drug specifically targeting T cell co-stimulation or immune checkpoint pathways.
    7. Major surgery (other than debulking surgery) for any reason within 4 weeks prior to randomization and/or incomplete recovery from surgery.
    8. Known brain, leptomeningeal, or spinal cord metastases.
    9. Current or prior use of immunosuppressive medication within 7 days prior to randomization, except the following: intranasal, inhaled, topical steroids, or local steroid injections (eg, intra-articular injection); systemic corticosteroids at physiologic doses ≤10 mg/day of prednisone or equivalent; steroids as premedication for hypersensitivity reactions [eg, computed tomography (CT) scan premedication].
    10. Active autoimmune disease that might deteriorate when receiving an immunostimulatory agents except patients with diabetes type I, vitiligo, psoriasis, hypo- or hyperthyroidism not requiring immunosuppressive treatment.
    11. Any of the following in the previous 6 months: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident, transient ischemic attack, deep vein thrombosis or symptomatic pulmonary embolism.
    12. Active and clinically significant bacterial, fungal or viral infection, any positive tests for hepatitis B (HBV), hepatitis C (HCV) indicating acute or chronic infection (positive HBV surface antigen or HCV RNA if anti-HCV antibody screening test positive), known history of a positive test for human immunodeficiency virus (HIV), or acquired immunodeficiency syndrome (AIDS) related illness.
    13. Administration of a live vaccine within 30 days prior to study entry.
    14. Known severe hypersensitivity reactions to monoclonal antibodies, carboplatin, paclitaxel, or other platinum-containing compounds (NCI CTCAE v4.03 Grade ≥3).
    15. Persisting NCI CTCAE v4.03 Grade >1 toxicity related to prior therapy.
    16. Previous malignant disease other than the target malignancy to be investigated in this trial within the last 5 years with the exception of adequately treated basal or squamous cell carcinoma of the skin, cervical carcinoma in situ, lobular carcinoma in situ (LCIS), or ductal carcinoma in situ (DCIS).
    17. Patients who are investigational site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or patients who are Pfizer employees directly involved in the conduct of the study.
    18. Participation in other clinical studies involving investigational drug(s) within 4 weeks prior to study randomization and/or during study participation.
    19. Other severe/severe acute or chronic medical, including colitis, inflammatory bowel disease, and pneumonitis, or psychiatric condition, including recent (within the past year) or active suicidal ideation or behavior) or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study.
    20. Pregnant patients or breastfeeding patients.
    21. Patients with bleeding tumors.
    E.5 End points
    E.5.1Primary end point(s)
    • Progression-free survival (PFS) as determined by blinded independent central review (BICR) by RECIST version 1.1
    E.5.1.1Timepoint(s) of evaluation of this end point
    As in protocol
    E.5.2Secondary end point(s)
    • Efficacy: Overall survival (OS), PFS by Investigator assessment as well as Objective response (OR), Duration of response (DR), Maintenance PFS by BICR assessments and Investigator assessment, pathological Complete Response (pCR), PFS2, and PFS by Gynecological Cancer Intergroup (GCIG) criteria
    • Safety: AEs (as graded by NCI CTCAE v.4.03); laboratory abnormalities (as graded by NCI CTCAE v.4.03); vital signs (blood pressure, pulse rate); electrocardiograms (ECGs)
    • Patient-Reported Outcomes: FOSI-18 and EuroQoL5 Dimension (EQ-5D-5L)
    • Pharmacokinetics: PK parameters, including Ctrough, Cmax, volume of distribution (Vd), clearance (CL), area under the concentration time curve (AUC) for avelumab, paclitaxel, and carboplatin, as data permit
    • Immunogenicity: anti-drug antibodies (ADA) and neutralizing antibodies (Nab) against avelumab
    • Candidate predictive biomarkers in tumor tissue including, but not limited to, PD-L1 expression and tumor infiltrating CD8+ T lymphocytes as assessed by immunohistochemistry (IHC)
    E.5.2.1Timepoint(s) of evaluation of this end point
    As in protocol
    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 Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    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) No
    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 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 Yes
    E.8.2.3.1Comparator description
    Chemotherapy
    E.8.2.4Number of treatment arms in the trial3
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA84
    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
    Bulgaria
    Canada
    Croatia
    Estonia
    Germany
    Hong Kong
    Hungary
    Ireland
    Italy
    Japan
    Korea, Republic of
    Latvia
    Mexico
    Netherlands
    Poland
    Romania
    Russian Federation
    Singapore
    Slovakia
    Spain
    Switzerland
    Taiwan
    Turkey
    Ukraine
    United Kingdom
    United States
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months11
    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: 476
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 475
    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 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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 555
    F.4.2.2In the whole clinical trial 951
    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)
    For patients who remain on treatment with avelumab at the end of study, another source of access to avelumab will be proposed.
    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 Decision2016-11-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-08-16
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2019-05-16
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