Avelumab in Previously Untreated Patients With Epithelial Ovarian Cancer (JAVELIN OVARIAN 100)
- Clements University Hospital
David Miller, M.D.
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
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
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.
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)