Abstract 401TiP
Background
The phase II OPEB-01/APGOT-OV4 study (NCT04361370) suggested that triplet maintenance therapy of bevacizumab, olaparib, and pembrolizumab achieved durable efficacy and tolerable safety in patients with BRCA wild-type, platinum-sensitive recurrent ovarian cancer. Findings of the Phase III DUO-O trial (NCT03737643) indicated that induction chemotherapy plus bevacizumab with durvalumab, followed by triplet maintenance with durvalumab, bevacizumab, and olaparib could increase progression-free benefit in patients with newly diagnosed advanced ovarian cancer without tumor BRCA1/2 mutation. Two Phase II clinical trials, OPAL (NCT03574779) and GINECO BOLD (NCT04015739) implied that patients with platinum-resistant ovarian cancer may benefit from the combination of bevacizumab with an immune checkpoint inhibitor and a PARP inhibitor.
Trial design
The key inclusion criteria of this single-center, single-arm, prospective study are 1) 18-75 years female; 2) ECOG Performance Status score of 0-1; 3) pathologically confirmed FIGO staging III-IV ovarian epithelial cancer, epithelial fallopian tube cancer, or primary peritoneal cancer; 4) tumor recurrence ≥ 6 months after the last dose of platinum-containing chemotherapy; 5) germline BRCA wild-type; 6) no more than 1 prior PARP inhibitor. All patients will receive paclitaxel/carboplatin plus bevacizumab and adebrelimab (a PD-L1 monoclonal antibody) induction therapy followed by maintenance therapy with bevacizumab plus adebrelimab and fluzoparib (a PARP inhibitor) until disease progression, intolerable toxicity, withdrawal of informed consent, or investigator assessment that continuation is inappropriate. The primary endpoint is the 12-month progression-free survival rate. The secondary endpoints are overall survival, objective response rate, progress-free survival in patients with complete response/partial response/stable disease after induction chemotherapy, and safety. Patient recruitment was started on June 7, 2024.
Clinical trial identification
NCT06446206.
Legal entity responsible for the study
The authors.
Funding
China Anti-Cancer Association- Hengrui PARP Nicotinamide Cancer Research Fund (Phase IV).
Disclosure
All authors have declared no conflicts of interest.