Clinical Trial Protocol for ROSELLA: a phase 3 study of relacorilant in combination with nab-paclitaxel versus nab-paclitaxel monotherapy in advanced platinum-resistant ovarian cancer

Olawaiye, AB; Kim, JW; Bagameri, A; Bishop, E; Chudecka-Głaz, A; Devaux, A; Gladieff, L; Gordinier, ME; Korach, J; McCollum, ME; Mileshkin, L; Monk, BJ; Nicum, S; Nogueira-Rodrigues, A; Oaknin, A; O&#39;Malley, DM; Orlando, M; Dreiling, L; Tudor, IC; Lorusso, D

Author(s): Olawaiye, AB; Kim, JW; Bagameri, A; Bishop, E; Chudecka-Głaz, A; Devaux, A; Gladieff, L; Gordinier, ME; Korach, J; McCollum, ME; Mileshkin, L; Monk, BJ; Nicum, S; Nogueira-Rodrigues, A; Oaknin, A; O'Malley, DM; Orlando, M; Dreiling, L; Tudor, IC; Lorusso, D;
Details: Publication Year 2024-07,Volume 35,Issue #4,Page e111
Journal Title: Journal of Gynecologic Oncology
Publication Type: Protocol
Abstract: BACKGROUND: Ovarian cancer has the highest mortality among gynecologic cancers, primarily because it typically is diagnosed at a late stage and because of the development of chemoresistance in recurrent disease. Improving outcomes in women with platinum-resistant ovarian cancer is a substantial unmet need. Activation of the glucocorticoid receptor (GR) by cortisol has been shown to suppress the apoptotic pathways used by cytotoxic agents, limiting their efficacy. Selective GR modulation may be able to counteract cortisol's antiapoptotic effects, enhancing chemotherapy's efficacy. A previous phase 2 study has shown that adding intermittently dosed relacorilant, a selective GR modulator, to nab-paclitaxel improved outcomes, including progression-free survival (PFS) and overall survival (OS), with minimal added toxicity, in women with recurrent platinum-resistant ovarian cancer. The ROSELLA study aims to confirm and expand on these findings in a larger population. METHODS: ROSELLA is a phase 3, randomized, 2-arm, open-label, global multicenter study in women with recurrent, platinum-resistant, high-grade serous epithelial ovarian, primary peritoneal, or fallopian tube cancer. Eligible participants have received 1 to 3 lines of prior systemic anticancer therapy, including ≥1 prior line of platinum therapy and prior treatment with bevacizumab, with documented progressive disease or intolerance to the most recent therapy. There is no biomarker-based requirement for participant selection. Participants are randomized 1:1 to receive intermittently dosed relacorilant in combination with nab-paclitaxel or nab-paclitaxel monotherapy. The study's primary efficacy endpoint is PFS as assessed by blinded independent central review. Secondary efficacy endpoints include OS, investigator-assessed PFS, objective response rate, best overall response, duration of response, clinical benefit rate at 24 weeks, and cancer antigen 125 response. The study is also evaluating safety and patient-reported outcomes. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT05257408; European Union Drug Regulating Authorities Clinical Trials Database Identifier: 2022-000662-18.
Keywords: Humans; Female; *Paclitaxel/administration & dosage/therapeutic use; *Albumins/administration & dosage/therapeutic use; *Drug Resistance, Neoplasm; *Ovarian Neoplasms/drug therapy/pathology; *Antineoplastic Combined Chemotherapy Protocols/therapeutic use; Carcinoma, Ovarian Epithelial/drug therapy; Neoplasm Recurrence, Local/drug therapy; Clinical Trials, Phase III as Topic; Progression-Free Survival; Randomized Controlled Trials as Topic; Multicenter Studies as Topic; Glucocorticoid Receptor; Nab-paclitaxel; Neoplasm Drug Resistance; Ovarian Neoplasms; Relacorilant
Department(s): Medical Oncology
Publisher's Version: https://doi.org/10.3802/jgo.2024.35.e111
Open Access at Publisher's Site: https://doi.org/10.3802/jgo.2024.35.e111
Terms of Use/Rights Notice: Refer to copyright notice on published article.

Creation Date: 2024-09-03 05:21:03

Last Modified: 2024-09-03 05:25:14