Avelumab in Previously Untreated Patients With Epithelial Ovarian Cancer (JAVELIN OVARIAN 100)
Condition: Ovarian Cancer
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial
Intervention: carboplatin; paclitaxel; Avelumab; Avelumab
Intervention description: Given Q3W during chemotherapy phase; Investigator choice of weekly or Q3W during chemotherapy phase; Given Q3W in combination with carboplatin/paclitaxel during chemotherapy portion; Given as single agent in maintenance portion Q2W
Intervention MeSH terms: Paclitaxel; Carboplatin; Avelumab; Antibodies, Monoclonal
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 998.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: untreated epithelial ovarian; fallopian tube; primary peritoneal cancer

Summary:

      This is a Phase 3, open-label, international, multi-center, efficacy, and safety study of
      avelumab in combination with and/or following platinum-based chemotherapy. Eligible patients
      must have previously untreated, histologically confirmed Stage III-IV epithelial ovarian
      (EOC), fallopian tube cancer (FTC), or primary peritoneal cancer (PPC) and be candidates for
      platinum-based chemotherapy.

      The primary purpose of the study is to demonstrate if avelumab given as single agent in the
      maintenance setting following frontline chemotherapy or in combination with
      carboplatin/paclitaxel is superior to platinum-based chemotherapy alone followed by
      observation in this population of newly diagnosed ovarian cancer patients.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Histologically confirmed Stage III-IV epithelial ovarian, fallopian tube, or primary
             peritoneal cancer, 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

        Key Exclusion Criteria:

          -  Non epithelial tumors or ovarian tumors with low malignant potential (ie, borderline
             tumors) or mucinous tumors

          -  Prior systemic anti-cancer treatment for EOC, FTC, or PPC including 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

          -  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.

          -  Cancer for which intraperitoneal cytotoxic chemotherapy is planned

          -  Active autoimmune disease (some exceptions include diabetes type I, vitiligo,
             psoriasis, hypo- or hyperthyroidism not requiring immunosuppressive treatment)