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

Study ID
STU 092016-028

Study Sites

  • Parkland Health & Hospital System

Contact
Isabel Villalobos
214/648-7010
isabel.villalobos@utsouthwestern.edu

Principal Investigator
David Miller, M.D.

Official Title

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

Brief Overview

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

Key Inclusion Criteria:
- Histologically confirmed Stage III-IV epithelial ovarian, fallopian tube, or primary peritoneal cancer, including malignant mixed M├╝llerian 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 ╬▒, 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)