A Study of Navicixizumab in Patients With Platinum Resistant Ovarian Cancer
Status:
Not yet recruiting
Trial end date:
2024-08-15
Target enrollment:
Participant gender:
Summary
This is a Phase 3, randomized, open-label, 2-stage, multicenter study of navicixizumab with
or without paclitaxel compared with paclitaxel monotherapy in patients with
platinum-resistant advanced epithelial ovarian cancer and specific biomarkers, as measured by
the proprietary and validated Xerna™ TME Panel biomarker assay. Eligible patients must have
received at least 2 prior regimens but not more than 5 prior regimens, including treatment
with a monoclonal antibody angiogenesis inhibitor (e.g., bevacizumab), must be considered
platinum-resistant, and must be considered appropriate to receive single-agent paclitaxel
chemotherapy as a next line of therapy. All patients must be willing and able to provide a
formalin-fixed paraffin embedded (FFPE) archive or core tumor sample collected during
screening for classification as B+ or B- biomarker status based on RNA expression data from
the Xerna™ TME Panel biomarker assay. The co-primary efficacy endpoints are ORR by RECIST
v1.1 and PFS (as assessed by blinded independent radiological review [BIRR]) analyzed at
different timepoints. Analysis of the ORR primary efficacy endpoints will occur at the end of
Stage 1 and at the end of Stage 2; the PFS primary efficacy endpoint will be analyzed at the
end of Stage 2.