Relacorilant + Nab-paclitaxel + Bevacizumab for Ovarian Cancer

Recruiting at 52 trial locations

Overseen By Corcept Therapeutics

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: Corcept Therapeutics

Must not be taking: Corticosteroids, Mifepristone

Disqualifiers: Hypertension, Peripheral neuropathy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: 1

Duration: Up to 18 months

270 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness of a new drug combination for certain types of ovarian and endometrial cancer. The goal is to determine if adding relacorilant, an experimental treatment, to other cancer therapies can benefit patients whose cancers have resisted or returned after previous treatments. Participants may qualify if they have ovarian cancer unresponsive to platinum-based treatments or endometrial cancer that has returned or spread. The trial evaluates safety and effectiveness, offering an option if previous treatments have failed. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

Do I need to stop my current medications to join the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, you cannot take certain treatments like corticosteroids, hormonal anticancer therapies, or anticoagulants close to the start of the study. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Studies have shown that the combination of relacorilant, nab-paclitaxel, and bevacizumab is generally well-tolerated by patients. Research indicates that adding relacorilant to nab-paclitaxel extends the time patients live without their cancer worsening. Importantly, the side effects were manageable and similar to those expected with these cancer treatments.

When relacorilant is used with nab-paclitaxel, it has been found to be safe and improved patients' tolerance to the treatment, resulting in fewer or less severe side effects. While detailed data on side effects for the combination of relacorilant, nab-paclitaxel, and bevacizumab is lacking, the safety of each drug individually is well-documented and acceptable in other studies.

This trial is in Phase 2, indicating that the treatment has already demonstrated some safety in earlier testing. Researchers are now assessing its effectiveness and confirming its safety in a larger group. This phase helps ensure the treatment is safe enough for wider use if it continues to show positive results. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for ovarian cancer because they combine relacorilant with nab-paclitaxel and bevacizumab, offering a potentially powerful new approach. Unlike standard chemotherapy treatments like carboplatin and paclitaxel, which typically target cancer cells broadly, this combination specifically leverages relacorilant's ability to modulate the body's stress hormone receptors. This mechanism could enhance the effectiveness of nab-paclitaxel and bevacizumab, which are already known to disrupt cancer cell growth and blood supply. In addition, relacorilant's unique action might help overcome resistance in platinum-resistant ovarian cancer, a significant challenge with current treatments.

What evidence suggests that this trial's treatments could be effective for ovarian cancer?

Research has shown that combining relacorilant with nab-paclitaxel and bevacizumab may help treat ovarian cancer. In this trial, Arm A evaluates this combination in patients with platinum-resistant ovarian cancer, while Arm B assesses it in patients with platinum-sensitive ovarian cancer who have progressed during treatment with a polymerase inhibitor. One study found that using relacorilant with nab-paclitaxel helped patients live longer without their cancer worsening, particularly for those previously treated with certain other cancer drugs. Arm C of this trial explores the combination of relacorilant and nab-paclitaxel in patients with previously-treated advanced, recurrent, or metastatic endometrial cancer. Another study reported that relacorilant and nab-paclitaxel significantly improved survival for patients with ovarian cancer unresponsive to platinum-based treatments. These findings suggest that this treatment could improve outcomes for gynecological cancers. ^{1 2 3 6 7}

Who Is on the Research Team?

Sachin Pai, MD, MS

Principal Investigator

Corcept Therapeutics

Are You a Good Fit for This Trial?

This trial is for adults with advanced ovarian, primary peritoneal, or fallopian-tube cancer who've had up to three prior treatments. They must be able to take oral meds, have a good performance status (able to carry out daily activities), and have at least one measurable tumor. Those resistant to platinum-based therapy after less than 6 months can join.

Inclusion Criteria

My doctor expects me to live 3 months or more.

I have at least one tumor that can be measured.

I have been diagnosed with a specific type of ovarian, peritoneal, or fallopian tube cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive relacorilant in combination with nab-paclitaxel and bevacizumab. Relacorilant is administered orally for 3 consecutive days around nab-paclitaxel infusion, which is given on Days 1, 8, and 15 of each 28-day cycle. Bevacizumab is administered on Days 1 and 15 of each cycle.

Up to 18 months

Visits on Days 1, 8, and 15 of each 28-day cycle

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Open-label extension (optional)

Participants may opt into continuation of treatment long-term

Long-term

What Are the Treatments Tested in This Trial?

Interventions

• Bevacizumab
• Nab-paclitaxel
• Relacorilant

Trial Overview The study tests relacorilant combined with nab-paclitaxel and bevacizumab in patients with certain types of ovarian cancer. It's an open-label Phase 2 trial where all participants receive the same treatment regimen to assess its effectiveness and safety.

How Is the Trial Designed?

Group I: Arm C: Relacorilant in Combination with Nab-Paclitaxel Experimental Treatment 2 Interventions

In Arm C, patients with previously-treated advanced, recurrent, or metastatic endometrial cancer will receive relacorilant in combination with nab-paclitaxel.

Group II: Arm B: Relacorilant in Combination with Nab-Paclitaxel and Bevacizumab Experimental Treatment 3 Interventions

In Arm B, patients with platinum-sensitive ovarian cancer who have progressed while receiving treatment with a polymerase inhibitor will receive relacorilant in combination with nab-paclitaxel and bevacizumab.

Group III: Arm A: Relacorilant in Combination with Nab-paclitaxel and Bevacizumab Experimental Treatment 3 Interventions

In Arm A, patients with platinum-resistant ovarian cancer will receive the combination of relacorilant with nab-paclitaxel and bevacizumab.

Who Is Running the Clinical Trial?

Corcept Therapeutics

Lead Sponsor

Trials

72

Recruited

7,700+

Dr. Joseph K. Belanoff

Corcept Therapeutics

Chief Executive Officer since 2014

MD from Stanford University

Dr. William Guyer

Corcept Therapeutics

Chief Medical Officer since 2021

PharmD

Published Research Related to This Trial

In a study of 164 patients with recurrent ovarian cancer, the combination of bevacizumab (BEV) with paclitaxel and carboplatin significantly improved progression-free survival (PFS), overall survival (OS), and objective response rate (ORR) compared to the control group receiving only paclitaxel and carboplatin.

The experimental group experienced fewer adverse reactions, such as allergies and gastrointestinal issues, and showed a significant improvement in quality of life after treatment, indicating that BEV combined with paclitaxel is both effective and safer for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapeutic effect of bevacizumab combined with paclitaxel and carboplatin on recurrent ovarian cancer. Cong, J., Liu, R., Hou, J., et al.[2020]

Bevacizumab, a monoclonal antibody targeting vascular endothelial growth factor-A, has shown response rates of 16-21% as a single-agent treatment for recurrent ovarian cancer, indicating its efficacy in this context.

In combination with standard chemotherapy for advanced ovarian cancer, bevacizumab significantly improves progression-free survival, although it does not enhance overall survival; the main safety concern is hypertension, with rare but serious risks including gastrointestinal perforation and toxicity to the kidneys and central nervous system.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bevacizumab and ovarian cancer. Garcia, A., Singh, H.[2021]

Bevacizumab has been shown to be effective in managing epithelial ovarian cancer, particularly when combined with cytotoxic chemotherapy, as indicated by phase III trial data that demonstrate improved progression-free survival.

There is a compelling argument for using bevacizumab as a single agent in patients with platinum-resistant ovarian cancer, suggesting a more rational and potentially cost-effective approach to treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of bevacizumab in the management of ovarian cancer: an argument for single-agent rather than combination therapy. Markman, M.[2020]

In a phase III trial involving 484 patients with platinum-sensitive recurrent ovarian cancer, the combination of bevacizumab (BV) with gemcitabine and carboplatin (GC) significantly improved progression-free survival (PFS) compared to GC alone, with a median PFS of 12.4 months versus 8.4 months.

The addition of BV also led to a higher objective response rate (78.5% vs. 57.4%) and longer duration of response (10.4 months vs. 7.4 months), although it was associated with increased rates of grade 3 or higher hypertension and proteinuria, indicating a need for monitoring these side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

OCEANS: a randomized, double-blind, placebo-controlled phase III trial of chemotherapy with or without bevacizumab in patients with platinum-sensitive recurrent epithelial ovarian, primary peritoneal, or fallopian tube cancer. Aghajanian, C., Blank, SV., Goff, BA., et al.[2022]

In a phase 3 trial involving 682 patients with recurrent ovarian cancer, the combination of carboplatin-pegylated liposomal doxorubicin and bevacizumab showed a median progression-free survival of 13.3 months, significantly longer than the 11.6 months observed with the standard carboplatin-gemcitabine-bevacizumab regimen (p=0.012).

The safety profile was comparable between the two treatment groups, with hypertension and neutropenia being the most common severe adverse events; however, treatment-related deaths were rare, occurring in less than 1% of patients in both groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bevacizumab and platinum-based combinations for recurrent ovarian cancer: a randomised, open-label, phase 3 trial. Pfisterer, J., Shannon, CM., Baumann, K., et al.[2022]

Bevacizumab, a monoclonal antibody that targets VEGF, has shown anticancer activity in ovarian cancer, both as a single agent and in combination with chemotherapy, leading to its FDA approval for several cancers.

While bevacizumab can be effective, there is a significant risk of gastrointestinal perforation, especially in patients who have been heavily pretreated, which is an important consideration for patients and healthcare providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bevacizumab and its use in epithelial ovarian cancer. Matulonis, UA.[2019]

In a study of 299 patients with advanced ovarian cancer, combining bevacizumab with carboplatin/paclitaxel resulted in a median progression-free survival of 15.4 months, indicating its efficacy as a front-line treatment.

The treatment was generally safe, with 54% of patients experiencing grade 3/4 adverse events, primarily hypertension and neutropenia, and a 1-year overall survival rate of 94%, suggesting a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of front-line bevacizumab in advanced ovarian cancer: the OSCAR study. Hall, M., Bertelli, G., Li, L., et al.[2020]

In a study of 51 patients with recurrent epithelial ovarian cancer, the combination of weekly paclitaxel and biweekly bevacizumab showed a high overall response rate of 60%, with a median progression-free survival of 7 months and median overall survival of 12 months.

The treatment was found to have an acceptable toxicity profile, with the most severe side effects being fatigue (16%), hematologic issues (9%), and neurotoxicity (7%), indicating that while effective, careful monitoring for side effects is necessary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sustained progression-free survival with weekly paclitaxel and bevacizumab in recurrent ovarian cancer. Hurt, JD., Richardson, DL., Seamon, LG., et al.[2015]

Citations

1. ir.corcept.com ir.corcept.com/news-releases/news-release-details/corcept-presents-esmo-2025-late-breaker-relacorilant

Corcept Presents ESMO 2025 Late-Breaker: Relacorilant ... New data from pivotal Phase 3 ROSELLA trial reinforce relacorilant plus nab-paclitaxel improves progression-free and overall survival in ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06906341

NCT06906341 | Relacorilant in Combination With Different ... This is a Phase 2, open-label, global, multi-arm study to evaluate efficacy and safety of relacorilant in combination with other treatments in patients with ...

3. onclive.com onclive.com/view/emerging-agents-and-paradigm-shifts-in-gynecologic-cancer-expert-takeaways-from-esmo-2025

Emerging Agents and Paradigm Shifts in Gynecologic ... Experts reflect on pivotal data, emerging agents, and notable advancements in gynecologic cancer spotlighted during the 2025 ESMO Congress.

4. esmo.org esmo.org/oncology-news/adding-relacorilant-to-nab-paclitaxel-prolongs-survival-compared-with-a-weekly-taxane-in-patients-with-platinum-resistant-epithelial-ovarian-cancer

Adding Relacorilant To Nab-paclitaxel Prolongs Survival ... The addition of relacorilant to nab-paclitaxel for patients with platinum-resistant epithelial ovarian cancer showed a statistically significant improvement in ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12226313/

Relacorilant plus nab-paclitaxel for recurrent, platinum ... The phase 2, open-label, randomized, 3-arm study (NCT03776812) found that intermittently dosed relacorilant + nab-paclitaxel improved progression-free ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0140673625010402

Relacorilant and nab-paclitaxel in patients with platinum ... This study aimed to show whether the addition of relacorilant to nab-paclitaxel improves progression-free and overall survival in females with platinum- ...

7. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06906341/relacorilant-in-combination-with-nab-paclitaxel-and-bevacizumab-in-advanced-epithelial-ovarian-primary-peritoneal-or-fallopian-tube-cancer?state=OR&city=Eugene

Relacorilant in Combination With Different Treatment ... This is a Phase 2, open-label, global, multi-arm study to evaluate efficacy and safety of relacorilant in combination with other treatments ...