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

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)