Recurrent Platinum-Resistant Ovarian Carcinoma Clinical Trial
Official title:
EON: A Single-Arm Phase II Study of Etigilimab (OMP-313M32) in Combination With Checkpoint Inhibition (Nivolumab) in Patients With Platinum-Resistant, Recurrent Epithelial Ovarian Cancer
This phase II trial the side effects and possible benefits of etigilimab and nivolumab in treating patients with platinum-resistant clear cell ovarian, primary peritoneal, or fallopian tube cancer that has come back (recurrent). Immunotherapy with monoclonal antibodies, such as etigilimab and nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. The goal of this clinical trial is to learn if adding etigilimab to nivolumab therapy can help to control clear cell ovarian, fallopian tube, and primary peritoneal cancers that are resistant to platinum-based therapy.
PRIMARY OBJECTIVES: I. To estimate the objective response rate of the combination of etigilimab and nivolumab in patients with platinum resistant clear cell ovarian cancer. II. To evaluate the toxicity of the combination of etigilimab and nivolumab in patients with platinum resistant clear cell ovarian cancer. SECONDARY OBJECTIVES: 1. To determine progression free survival (PFS) of the combination of etigilimab and nivolumab in patients with platinum resistant clear cell ovarian cancer. II. To estimate the disease control rate of the combination of etigilimab and nivolumab in patients with platinum resistant clear cell ovarian cancer. III. To investigate molecular and immunological changes associated with the combination of TIGIT and PD-1 inhibition; specifically to describe changes in T cell populations (including but not limited to CD3, CD8, CD4, FOXP3) and cell proliferation, as well as report changes in the proportion of macrophage phenotypes M1 and M2 (with phenotypic markers potentially including arginase1, CD11b, PDL-1, and CD206). OUTLINE: Patients receive etigilimab intravenously (IV) over 30-90 minutes on days 1 and 15 and nivolumab IV over 30 minutes on days 2 and 15 of cycle 1 and days 1 and 15 of subsequent cycles. Cycles repeat every 28 days for up to 24 months in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 and 90 days. ;
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