Chemotherapy (neoadjuvant and adjuvant): Paclitaxel 175 mg/m2 IV followed by carboplatin AUC 5-6 IV starting on C1D1. During the neoadjuvant period, there will be a total of 4 – 6 cycles, at the Investigator’s discretion, repeated every 21 days. Adjuvant chemotherapy for another 3 cycles.
BEV 15 mg/kg IV administration will be on Day 1 of Cycles 2, 3, 6, and 7. During the maintenance phase, BEV 15 mg/kg will be administered every 3 weeks as a single agent until disease progression or unacceptable toxicity for an additional 18 cycles. In total, BEV may be administered up to 22 cycles. FDA approved BEV biosimilars may be used in this study in place of BEV.
In addition to the standard drug regimen of the control arm, GEN-1 80 mg/m2 IP will be administered weekly beginning C1D15. At the conclusion of chemotherapy, GEN-1 will be administered every 21 days with BEV in subjects who are BRCA-/HRP until disease progression or unacceptable toxicity for up to an additional 18 cycles.
Paclitaxel 175 mg/m2 IV
Drug: Carboplatin
Carboplatin AUC 5-6 IV
Drug: Bevacizumab
BEV 15 mg/kg IV administration will be on Day 1 of Cycles 2, 3, 6, and 7. During the maintenance phase, BEV 15 mg/kg will be administered every 3 weeks as a single agent until disease progression or unacceptable toxicity for an additional 18 cycles. In total, BEV may be administered up to 22 cycles. FDA approved BEV biosimilars may be used in this study in place of BEV.
Drug: GEN1
IL-12 Plasmid Formulated with PEG-PEI-Cholesterol Lipopolymer
Source: View full study details on ClinicalTrials.gov
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