Trial to test relacorilant combo in platinum-resistant ovarian cancer
Safety, efficacy of triple treatment is focus of new Corcept Phase 2 study
Corcept Therapeutics is launching a Phase 2 clinical trial to evaluate the safety and efficacy of relacorilant as a triple combination treatment — with the therapies nab-paclitaxel and bevacizumab — in people with platinum-resistant ovarian cancer, according to a company press release.
The open-label BELLA trial (NCT06906341) trial expects to enroll 90 women with recurrent, platinum-resistant ovarian cancer at about 50 sites in North America, Europe, and Asia. All patients will receive relacolirant together with the chemotherapy agent nab-paclitaxel and bevacizumab, an antibody-based therapy. Patient recruitment has not yet started.
Among female cancer patients, ovarian cancer is the fifth most common cause of death, the release noted, with “few treatment options for these women.”
Platinum-based chemotherapy drugs are a standard first-line treatment for ovarian cancer. However, in some patients, the cancer returns within six months of completing treatment — a condition then known as platinum-resistant ovarian cancer. For these patients, treatment options are more limited and often less effective.
Relacorilant is an oral therapy that works by blocking the activity of receptors for the stress hormone cortisol, which, according to Corcept, may be involved in cancer resistance to chemotherapy.
An earlier Phase 3 clinical trial, dubbed ROSELLA (NCT05257408), enrolled 381 people with platinum-resistant ovarian cancer to test relacorilant in combination with nab-paclitaxel. Participants were randomly assigned to receive the combination or nab-paclitaxel alone.
In our pivotal Phase 3 ROSELLA trial, treatment with relacorilant and nab-paclitaxel improved patients’ progression-free and overall survival, without increasing their side effect burden. … BELLA will examine whether combining relacorilant with two medications — nab-paclitaxel and bevacizumab — will offer patients an additional treatment option.
The results showed that the combination treatment improved outcomes for patients, extending both median progression-free survival, from 5.5 to 6.5 months, and overall survival, from 11.5 to 16 months.
“In our pivotal Phase 3 ROSELLA trial, treatment with relacorilant and nab-paclitaxel improved patients’ progression-free and overall survival, without increasing their side effect burden,” said Bill Guyer, Corcept’s chief development officer. “BELLA will examine whether combining relacorilant with two medications — nab-paclitaxel and bevacizumab — will offer patients an additional treatment option.”
The BELLA trial will evaluate the combination of relacorilant with nab-paclitaxel and bevacizumab, a targeted therapy that works by blocking the formation of new blood vessels — a process called angiogenesis — that tumors need to grow and survive.
Patients will receive 150 mg of relacorilant orally once daily for three days: the day before, the day of, and the day after receiving nab-paclitaxel. Nab-paclitaxel will be administered through intravenous, or into-the-vein, infusions on days 1, 8, and 15 of each 28-day treatment cycle. Bevacizumab will also be given intravenously, on days 1 and 15 of each cycle.
Treatment will be given until patients experience disease progression or unmanageable toxicity. The trial’s main goal is to assess progression-free survival, or the time from the first dose until disease progression, or death, for up to 1.5 years.
Secondary goals include assessing the proportion of patients and time to achieve a complete or partial response, as well as overall survival and the number of participants experiencing at least one adverse event.
