Abstract
Introduction/BackgroundDespite therapeutic advances in ovarian cancer, platinum-resistant recurrent ovarian cancer remains an area of high unmet clinical need and there is an urgent need for new treatments to further improve clinical outcomes. ENGOT-ov65/KEYNOTE-B96 (NCT05116189) compares the efficacy and safety of pembrolizumab plus weekly paclitaxel (± bevacizumab) versus placebo plus weekly paclitaxel (± bevacizumab) in patients with platinum-resistant recurrent ovarian cancer.MethodologyIn this randomized, placebo-controlled, double-blind, phase 3 study, eligible patients are aged ≥18 years with histologically confirmed epithelial ovarian, fallopian tube, or primary peritoneal carcinoma with 1–2 prior lines of systemic therapy, including at least 1 prior platinum-based therapy with ≥4 cycles in first line. Patients must have platinum-resistant disease (radiographic evidence of disease progression ≤6 months after last platinum-based therapy dose), be eligible for paclitaxel (with/without bevacizumab per investigator discretion), and have ECOG PS ≤1, radiographically evaluable disease per RECIST version 1.1, and a tumour sample for central evaluation of PD-L1 status. Approximately 616 patients will be randomized 1:1 to receive pembrolizumab 400 mg IV or placebo Q6W for up to 18 cycles (~2 years) plus paclitaxel 80 mg/m2 on days 1, 8, and 15 of each Q3W cycle (with/without bevacizumab 10 mg/kg Q2W per investigator discretion) until disease progression or unacceptable toxicity. Primary endpoint is PFS per RECIST version 1.1 by investigator review. Secondary endpoints are OS, PFS per RECIST version 1.1 by blinded independent central review, safety, and patient-reported outcomes. Enrolment is ongoing.ResultsN/AConclusionN/A