Avelumab Previously Untreated Patients With Epithelial Ovarian

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)

November 22, 2017

  • Clinical Trial Information

    Trial Contact: Quintiliani, Jennifer

    Trial Phone: 321.843.2026

  • IRB No: 16.079.07

    Protocol Abbrev: B9991010

    Principal Investigator: Veronica L Schimp, DO

    Sub Investigators: Moroose, Rebecca MD

    Phase: Drug: Phase III

    Age Group: Adult

    Secondary Protocol No: JAVELIN OVARIAN 100

    Treatment: Chemotherapy; Oncology: Adjuvant

    Applicable Disease Sites: Ovarian

    Therapies Involved: Paclitaxel, Carboplatin, Avelumab (MSB0010718C)

    ClinicalTrials.gov ID: NCT02718417

  • Objective

    To demonstrate that avelumab in combination with platinum-based chemotherapy followed by avelumab maintenance is superior to platinum-based chemotherapy alone followed by observation in prolonging progression free survival.

  • Key Eligibility

    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.
    Patients must be candidates for platinum based chemotherapy and previously untreated
    Patients must have completed a surgical debulking procedure, or be candidates for neoadjuvant chemotherapy
    Availability of an archival formalin fixed, paraffin embedded (FFPE) tumor tissue block or a minimum of 15 slides
    ECOG PS 0-1
    Adequate hematological, renal, and liver function