Relacorilant in Combination With Nab-Paclitaxel in Advanced, Platinum-Resistant, High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian-Tube Cancer

Summary

The primary objectives of this study are to evaluate progression-free survival (PFS) by blinded independent central review (BICR) and overall survival (OS) (evaluated independently, as dual primary endpoints) in patients treated with intermittent regimen of relacorilant in combination with nab-paclitaxel compared with patients treated with nab-paclitaxel monotherapy.

Timeline

Start

2022-06-29

Primary completion

2025-03-31

Completion

2026-12

Outcome

Met primary endpoint

paper Patients receiving relacorilant plus nab-paclitaxel had a statistically significant improvement in progression-free survival assessed by blinded independent central review compared with those receiving nab-paclitaxel monotherapy PMID 40473448 ↗

release “In ROSELLA, patients treated with relacorilant in addition to nab-paclitaxel chemotherapy experienced a 30 percent reduction in risk of disease progression” corcept.com ↗

release “ROSELLA met its primary endpoint of improved progression-free survival” corcept.com ↗

release “ROSELLA, the company's pivotal Phase 3 trial of relacorilant plus nab-paclitaxel to treat patients with platinum-resistant ovarian cancer, met its overall survival (OS) primary endpoint.” corcept.com ↗

release “Corcept previously announced that ROSELLA also met its primary endpoint of improved progression-free survival, as assessed by blinded independent central review (PFS-BICR).” corcept.com ↗

release “ROSELLA – Both dual primary endpoints (progression-free and overall survival) met” corcept.com ↗

Publications

• Results Olawaiye AB, Gladieff L, O'Malley DM, Kim JW, Garbaos G, Salutari V, Gilbert L, Mileshkin L, Devaux A, Hopp E, Lee YJ, Oaknin A, Scaranti M, Kim BG, Colombo N, McCollum ME, Diakos C, Clamp A, Leiser AL, Balazs B, Monk BJ, Scandurra G, McClung E, Kaczmarek E, Slomovitz B, De La Cueva H, de Carvalho Calabrich AF, Cassani C, You B, Van Gorp T, Churruca C, Caruso G, Nicum S, Bagameri A, Artioli G, Bodnar L, Kang S, Vergote I, Kesner-Hays A, Pashova HI, Pai SG, Tudor IC, Jubb AM, Lorusso D. Relacorilant and nab-paclitaxel in patients with platinum-resistant ovarian cancer (ROSELLA): an open-label, randomised, controlled, phase 3 trial. Lancet. 2025 Jun 21;405(10496):2205-2216. doi: 10.1016/S0140-6736(25)01040-2. Epub 2025 Jun 2.
• Results Lorusso D, Gladieff L, O'Malley DM, Kim JW, Garbaos G, Fagotti A, Gilbert L, Mileshkin L, Quesada S, Hopp E, Lee YJ, Oaknin A, Scaranti M, Kim BG, Clamp A, Prillaman C, Diakos C, Bagameri A, Leiser AL, Salutari V, Monk BJ, Follana P, McClung E, Carbone V, Slomovitz B, Giudice E, Cannizzaro MC, Gavoille L, Devaux A, Scollo P, Scandurra G, Cassani C, Artioli G, Van Gorp T, Santaballa A, Dreiling LK, Kesner-Hays A, Tudor IC, Jubb AM, Colombo N, Olawaiye AB. Overall survival with relacorilant and nab-paclitaxel in patients with platinum-resistant ovarian cancer (ROSELLA): a phase 3 randomised controlled trial. Lancet. 2026 Apr 18;407(10538):1513-1524. doi: 10.1016/S0140-6736(26)00462-9. Epub 2026 Apr 10.
• Olawaiye AB, Kim JW, Bagameri A, Bishop E, Chudecka-Glaz 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. 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. J Gynecol Oncol. 2024 Jul;35(4):e111. doi: 10.3802/jgo.2024.35.e111.
• Colombo N, Van Gorp T, Matulonis UA, Oaknin A, Grisham RN, Fleming GF, Olawaiye AB, Nguyen DD, Greenstein AE, Custodio JM, Pashova HI, Tudor IC, Lorusso D. Relacorilant + Nab-Paclitaxel in Patients With Recurrent, Platinum-Resistant Ovarian Cancer: A Three-Arm, Randomized, Controlled, Open-Label Phase II Study. J Clin Oncol. 2023 Oct 20;41(30):4779-4789. doi: 10.1200/JCO.22.02624. Epub 2023 Jun 26.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Nab-paclitaxel	Small molecule	80 mg/m2	Intravenous
Subject	Nab-paclitaxel	Small molecule	100 mg/m2	Intravenous
Subject	Relacorilant	Small molecule	150 mg	Oral

Indications