Abstract
IntroductionSingle-agent chemotherapies are commonly used in platinum-resistant ovarian cancer (OC), but outcomes are generally poor. Cortisol, which binds to the glucocorticoid receptor (GR), can suppress apoptotic pathways used by chemotherapy. The selective GR modulator relacorilant may reverse cortisol’s anti-apoptotic effects to enhance chemotherapy efficacy. In a phase 2 study in patients with recurrent, platinum-refractory/resistant OC (NCT03776812), intermittently dosed relacorilant + nab-paclitaxel showed clinically meaningful improvement in progression-free survival (PFS), duration of response (DoR), and overall survival (OS) without increased side effect burden vs. nab-paclitaxel monotherapy. The ROSELLA study aims to confirm these findings in a larger patient population.MethodsROSELLA (NCT05257408) is a randomized, phase 3, 2-arm, open-label study of relacorilant + nab-paclitaxel vs. nab-paclitaxel monotherapy. Approximately 360 women with platinum-resistant ovarian, primary peritoneal, or fallopian tube cancer who have received 1–3 prior systemic anticancer therapies, including prior bevacizumab, and ≥1 platinum-based therapy are being enrolled. Patients with primary platinum-refractory disease are excluded. Patients are being randomized 1:1 to relacorilant (150 mg the day before, of, and after nab-paclitaxel) + nab-paclitaxel (80 mg/m2) or nab-paclitaxel monotherapy (100 mg/m2); stratified by prior lines of therapy (1 vs >1) and region of world (North America vs. Europe vs. rest of world). Nab-paclitaxel is administered on days 1, 8, and 15 of each 28-day cycle. The primary endpoint is PFS by blinded independent central review. Key secondary and exploratory endpoints include OS, PFS by investigator assessment, objective response rate, best overall response, DoR, safety, pharmacokinetics, pharmacodynamics, patient-reported outcomes, and quality of life.Current Trial StatusCurrently enrolling