Combination treatment for advanced ovarian cancer
An Open-label, Global, Multi-Arm Study to Evaluate the Efficacy and Safety of Relacorilant in Combination With Different Treatment Regimens in Patients With Gynecological Cancers (BELLA)
This study is testing a new combination of medications for people with advanced ovarian cancer to see if it helps them feel better and stay healthier longer.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 270 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Corcept Therapeutics Industry-sponsored |
| Drugs / interventions | radiation, bevacizumab |
| Locations | 49 sites (Birmingham, Alabama and 48 other locations) |
| Trial ID | NCT06906341 on ClinicalTrials.gov |
What this trial studies
This Phase 2, single-arm, open-label study evaluates the efficacy and safety of relacorilant in combination with nab-paclitaxel and bevacizumab for patients with advanced ovarian, primary peritoneal, or fallopian-tube cancer. Participants will receive relacorilant orally for three consecutive days around nab-paclitaxel infusions, which are administered intravenously on specific days of a 28-day cycle. Bevacizumab will also be given intravenously every two weeks. The study aims to monitor treatment efficacy, safety, and tolerability until disease progression or unacceptable toxicity occurs.
Who should consider this trial
Good fit: Ideal candidates include those with high-grade serous or endometrioid epithelial ovarian cancer who are platinum-resistant and have received 1 to 3 lines of prior systemic therapy.
Not a fit: Patients with non-epithelial ovarian cancers or those who have not received prior platinum-based therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new effective option for patients with advanced ovarian cancer who have limited treatment choices.
How similar studies have performed: Other studies have shown promising results with similar combinations of chemotherapy and targeted therapies in treating ovarian cancer.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Arms A and B * Histologic diagnosis of epithelial ovarian, primary peritoneal, or fallopian-tube carcinoma * Arm A Only: Platinum-resistant disease * Arm B Only: Platinum-sensitive disease who had progression while receiving treatment with a poly(ADP-ribose) polymerase (PARP) inhibitor * Life expectancy of ≥3 months * Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 * Able to swallow and retain oral medication * 1 to 3 lines of prior systemic anticancer therapy * Adequate organ function * Negative pregnancy test for patients of childbearing potential Arm C * Stage III or IV, recurrent, or metastatic endometrial cancer * Life expectancy of ≥3 months * ECOG performance status of 0 or 1 * Able to swallow and retain oral medication * Prior treatment with a platinum agent and an approved anti-Programmed Cell Death Ligand 1 (PD\[L\]1) antibody * 1 to 2 lines of prior systemic anticancer therapy for endometrial cancer * Must consent to provide an available formalin-fixed paraffin-embedded (FFPE) tumor tissue block or recently cut sections * Adequate organ function * Negative pregnancy test for patients of childbearing potential Exclusion Criteria: Arm A and B * Arm A Only: Has progressed while receiving weekly paclitaxel or nab-paclitaxel * Prior enrollment in a clinical trial of relacorilant * Prior anticancer therapy related toxicities not resolved to grade ≤1 * Any surgery within 4 weeks prior to enrollment * Wide-field radiation to more than 25% of marrow-bearing areas * Medical conditions requiring chronic or frequent treatment with corticosteroids * Concurrent treatment with mifepristone or other glucocorticoid receptor modulators * Peripheral neuropathy from any cause \>Grade 1 * Hypertension: ≥150 mm Hg systolic or ≥100 mm Hg diastolic * Uncontrolled condition(s) which, may confound the results of the trial or interfere with the patient's safety or participation * Bowel obstruction ≤12 weeks prior to study entry * Ascites or pleural effusions requiring therapeutic paracentesis * Untreated or symptomatic central nervous system metastases * History of other malignancy within 3 years prior to enrollment * Has received a live vaccine within 30 days prior to the study start date Arm C * Has progressed while receiving weekly paclitaxel or nab-paclitaxel * Prior enrollment in a clinical trial of relacorilant * Prior anticancer therapy related toxicities not resolved to grade ≤1 * Any surgery within 4 weeks prior to enrollment * Wide-field radiation to more than 25% of marrow-bearing areas * Medical conditions requiring chronic or frequent treatment with corticosteroids * Concurrent treatment with mifepristone or other glucocorticoid receptor modulators * Peripheral neuropathy from any cause \>Grade 1 * Uncontrolled condition(s) which, may confound the results of the trial or interfere with the patient's safety or participation * Bowel obstruction ≤12 weeks prior to study entry * Ascites or pleural effusions requiring therapeutic paracentesis * History of other malignancy within 3 years prior to enrollment * Has received a live vaccine within 30 days prior to the study start date * Patients with central nervous system metastases are not eligible, unless they have completed local therapy and have discontinued the use of corticosteroids for this indication for at least 4 weeks before starting treatment in this study.
Where this trial is running
Birmingham, Alabama and 48 other locations
- 004 — Birmingham, Alabama, United States (Recruiting)
- 150 — Palo Alto, California, United States (Recruiting)
- 014 — San Francisco, California, United States (Recruiting)
- 544 — Fort Myers, Florida, United States (Recruiting)
- 335 — Miami Beach, Florida, United States (Recruiting)
- 543 — West Palm Beach, Florida, United States (Recruiting)
- 518 — Minneapolis, Minnesota, United States (Recruiting)
- 334 — Kansas City, Missouri, United States (Recruiting)
- 521 — St Louis, Missouri, United States (Recruiting)
- 292 — Albuquerque, New Mexico, United States (Recruiting)
- 304 — Centerville, Ohio, United States (Recruiting)
- 517 — Eugene, Oregon, United States (Recruiting)
- 127 — Pittsburgh, Pennsylvania, United States (Recruiting)
- 522 — Fairfax, Virginia, United States (Recruiting)
- 300 — Norfolk, Virginia, United States (Recruiting)
- 121 — Milwaukee, Wisconsin, United States (Recruiting)
- 328 — Aalst, Belgium (Recruiting)
- 326 — Charleroi, Belgium (Recruiting)
- 325 — Hasselt, Belgium (Recruiting)
- 108 — Leuven, Belgium (Recruiting)
- 306 — Lille, France (Recruiting)
- 307 — Nancy, France (Recruiting)
- 310 — Nice, France (Recruiting)
- 324 — Pierre-Bénite, France (Recruiting)
- 323 — Plérin, France (Recruiting)
- 308 — Toulouse, France (Recruiting)
- 519 — Aachen, Germany (Recruiting)
- 255 — Berlin, Germany (Recruiting)
- 520 — Kempten, Germany (Recruiting)
- 321 — Catania, Italy (Recruiting)
- 122 — Milan, Italy (Recruiting)
- 516 — Milan, Italy (Recruiting)
- 295 — Pavia, Italy (Recruiting)
- 124 — Rome, Italy (Recruiting)
- 293 — Torino, Italy (Recruiting)
- 319 — Treviso, Italy (Recruiting)
- 341 — Gdynia, Poland (Recruiting)
- 329 — Siedlce, Poland (Recruiting)
- 396 — Seoul, Gangnam-gu, South Korea (Recruiting)
- 397 — Gyeonggi-do, Goyang-si, South Korea (Recruiting)
- 399 — Seoul, Jongno-gu, South Korea (Recruiting)
- 523 — Seoul, Seocho-gu, South Korea (Recruiting)
- 398 — Seoul, Seodaemun-gu, South Korea (Recruiting)
- 403 — Seoul, Songpa-gu, South Korea (Recruiting)
- 349 — Badalona, Spain (Recruiting)
- 115 — Barcelona, Spain (Recruiting)
- 114 — Madrid, Spain (Recruiting)
- 558 — Valencia, Spain (Recruiting)
- 330 — Valencia, Spain (Recruiting)
Study contacts
- Study coordinator: Corcept Therapeutics
- Email: corceptstudy557@corcept.com
- Phone: 650-684-0171
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.