Decrease (-) Restore Default Increase (+)

Clinical Trials

Topic   Cancer - Gynecologic Cancer
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
Summary   The aim of this study is to test the potential benefit of avelumab in combination with a platinum based chemotherapy regimen on newly diagnosed Stage III-IV epithelial ovarian, fallopian tube, or primary
peritoneal cancer. The primary objective of this study is to evaluate the anti-tumor activity in each treatment arm and study the effect it has on overall survival.
Description   Patients will be randomly assigned a treatment arm and will receive study treatment until confirmed progressive disease, unacceptable toxicity, withdrawl of consent, or have reached maximum duration of 34 months.
IRB Number   20160506
Inclusion/Notes   To be eligible for this study, patients must meet several criteria, including but not limited to the following: Patients must be 18 years or older, histologically confirmed stage III-IV epithelial ovarian, fallopian tube, primary peritoneal cancer, or mixed Mullerian tumors. Patients must be candidates for platinum based chemotherapy and previoulsy untreated. Patients must have completed a surgical debulking procedure, or be candidates for neoadjuvant chemotherapy. Patients with non-epithelial or mucinous tumors with low malignant potential will not be considered for this study.
Status   Open
Start Date   01/11/2017
Principal Name   Eva Chalas, MD
Contact Name   Christina Egan, RN
Email   CEgan@NYUWinthrop.org
Fax   516-663-1871
Current Trial Type   Interventional
Phone   516-663-1216
Alternate Phone   516-663-8391