Avelumab in Previously Untreated Patients With Epithelial Ovarian Cancer (JAVELIN OVARIAN 100)

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)