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  • TP019/#1387  Rosella (GOG-3073, ENGOT-OV72/MITO): a phase 3 study of relacorilant + nab paclitaxel vs. nab-paclitaxel in platinum-resistant ovarian cancer

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ePoster Viewing: Trials-in-Progress
AS11. Ovarian cancer
TP019/#1387  Rosella (GOG-3073, ENGOT-OV72/MITO): a phase 3 study of relacorilant + nab paclitaxel vs. nab-paclitaxel in platinum-resistant ovarian cancer
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  1. Domenica Lorusso1,
  2. Andrea Bagameri2,
  3. Erin Bishop3,
  4. Anita Chudecka-Glaz4,
  5. Alix Devaux5,
  6. Laurence Gladieff6,
  7. Mary Gordinier7,
  8. Jae-Weon Kim8,
  9. Jacob Korach9,
  10. Michael Mccollum10,
  11. Linda Mileshkin11,
  12. Bradley Monk12,
  13. Shibani Nicum13,
  14. Angélica Nogueira-Rodrigues14,
  15. Ana Oaknin15,
  16. David O’Malley16,
  17. Mauro Orlando17,
  18. Lyndah Dreiling18,
  19. Iulia Cristina Tudor19 and
  20. Alexander Olawaiye20
  1. 1Fondazione Policlinico Gemelli and Catholic University of the Sacred Heart, Division of Gynecologic Oncology, Rome, Italy
  2. 2National Institute of Oncology, Gynecologic Oncology, Budapest, Hungary
  3. 3Medical College of Wisconsin, Cancer Center, Milwaukee, USA
  4. 4Pomeranian Medical University, Gynecological Surgery and Gynecological Oncology of Adults and Adolescents, Szczecin, Poland
  5. 5Grand Hopital de Charleroi, Oncology, Charleroi, Belgium
  6. 6Institut Claudius Regaud – IUCT-O, Oncology, TOULOUSE, France
  7. 7Norton Healthcare, Norton Cancer Institute, Louisville, USA
  8. 8Seoul National University, Obstetrics and Gynecology, Seoul, Korea, Republic of
  9. 9Sheba Medical Center, Gynecology Oncology, Ramat Gan, Tel Aviv, Israel
  10. 10Virginia Oncology Associates, Brock Cancer Center, Norfolk, USA
  11. 11Peter MacCallum Cancer Centre, Department of Medical Oncology, Melbourne, Australia
  12. 12GOG-Foundation and HonorHealth University of Arizona College of Medicine and Creighton University School of Medicine, Division of Gynecologic Oncology, Phoenix, USA
  13. 13University College London, Cancer Institute, London, UK
  14. 14Federal University of Minas Gerais, Dom Oncologia and Oncoclinicas – Brazil, Belo Horizonte, Brazil
  15. 15Vall d’Hebron University Hospitl, Oncology, Baracelona, Spain
  16. 16The Ohio State University and the James Cancer Center, Department of Obstetrics and Gynecology, Columbus, USA
  17. 17Instituto Alexander Fleming, Oncology, Buenos Aires, Argentina
  18. 18Corcept Therapeutics, Inc., Research and Development, Menlo Park, USA
  19. 19Corcept Therapeutics, Inc., Biometrics, Menlo Park, USA
  20. 20University of Pittsburgh, Obstetrics, Gynecology and Reproductive Sciences, Pittsburgh, USA

Abstract

Introduction Single-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.

Methods ROSELLA (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 Status Currently enrolling

https://doi.org/10.1136/ijgc-2023-IGCS.479

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