Nenocorilant + Nivolumab for Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests how a new combination of two drugs, nenocorilant and nivolumab, works for people with advanced solid cancers. Researchers aim to determine the best and safest dosage of these drugs when used together. The trial targets individuals who have tried all standard treatments for their type of cancer or lack standard options. Participants will receive varying doses of nenocorilant and nivolumab to identify the most effective combination. This study suits those with a solid cancer diagnosis who have exhausted other treatment options. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to be among the first to receive this new combination therapy.
Will I have to stop taking my current medications?
The trial requires that you stop taking certain medications, such as systemic corticosteroids and drugs that affect liver enzymes (cytochrome P450). If you're on these, you may need to stop them before joining the trial.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that the combination of two drugs, nenocorilant and nivolumab, is being tested for safety and effectiveness in people with advanced solid tumors. Nenocorilant is not yet approved for any condition, so these trials gather information about its safety.
Nivolumab, however, is already used in cancer treatments and is generally well-tolerated. Like all medicines, it can have side effects, with common ones being tiredness, skin rash, and nausea.
The studies on the nenocorilant-nivolumab combination aim to find the safest and most effective doses. These trials will determine how well patients handle this combination. The trial is still in the early stages, so there is limited safety information available. However, since nivolumab is already approved for cancer treatment, it offers some reassurance about its safety.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these treatments because nenocorilant, combined with nivolumab, offers a new approach to cancer therapy. While most current treatments focus solely on immunotherapy or chemotherapy, nenocorilant is a selective glucocorticoid receptor antagonist, which may help enhance the immune system’s response against tumors when paired with nivolumab, an existing immunotherapy. This combination aims to create a more robust attack on cancer cells by potentially improving the efficacy of nivolumab. Additionally, the option to adjust the nivolumab dosage after three months could provide more personalized treatment, potentially improving both effectiveness and patient tolerance.
What evidence suggests that this trial's treatments could be effective for cancer?
Research shows that using nenocorilant with nivolumab might help patients with hard-to-treat advanced solid tumors. In this trial, participants will receive varying dosages of nenocorilant combined with nivolumab. Previous studies have found that similar treatments, such as relacorilant, helped patients live longer without cancer progression and improved overall survival in difficult cancer cases. Nivolumab alone has already demonstrated effectiveness, achieving impressive long-term survival rates in various cancers. This combination aims to enhance these results further, offering new hope for challenging cancer treatments.15678
Who Is on the Research Team?
Adrian Jubb, MD
Principal Investigator
Corcept Therapeutics
Are You a Good Fit for This Trial?
This trial is for adults with advanced solid tumors who've tried all standard treatments or have none available, unless intolerant. They must be expected to live at least 3 months, have measurable disease, be relatively active (ECOG 0-1), and have good organ function. Women of childbearing age need a negative pregnancy test and agree to prevent pregnancy.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Dose-Finding Treatment (Phase 1b)
Participants receive escalating doses of nenocorilant in combination with a fixed dose of nivolumab in 28-day cycles
Proof-of-Concept Treatment (Phase 2)
Optional phase to further evaluate the combination treatment in patients with advanced solid malignancies
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Nenocorilant
- Nivolumab
Trial Overview
The study tests different doses of Nenocorilant (200 mg, 300 mg, and 400 mg) combined with Nivolumab in patients with advanced cancers. It aims to find the safest and most effective dose by observing how well patients tolerate the combination treatment.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Cohort 1c: Patients will receive nenocorilant 400 mg orally under fed conditions once daily, and nivolumab 240 mg IV every 2 weeks. After 3 months of treatment, patients may choose to switch the nivolumab regimen to 480 mg IV every 4 weeks if the nenocorilant nivolumab combination is tolerated.
Cohort 1b: Patients will receive nenocorilant 300 mg orally under fed conditions once daily, and nivolumab 240 mg IV every 2 weeks. After 3 months of treatment, patients may choose to switch the nivolumab regimen to 480 mg IV every 4 weeks if the nenocorilant nivolumab combination is tolerated.
Cohort 1a: Patients will receive nenocorilant 200 mg orally under fed conditions once daily, and nivolumab 240 mg IV every 2 weeks. After 3 months of treatment, patients may choose to switch the nivolumab regimen to 480 mg IV every 4 weeks if the nenocorilant nivolumab combination is tolerated.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Corcept Therapeutics
Lead Sponsor
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
Citations
NCT07276373 | Two Part Study of Nenocorilant Combined ...
This open-label, dose-finding, and proof of concept study will evaluate the safety, tolerability, maximum-tolerated dose (MTD) and/or optimal dose of ...
2.
theglobeandmail.com
theglobeandmail.com/investing/markets/stocks/CORT/pressreleases/37301725/corcepts-nenocorilant-combo-study-moves-forward-expanding-its-oncology-ambitions/Corcept's Nenocorilant Combo Study Moves Forward ...
Together, the combination is meant to improve treatment outcomes in patients with advanced solid tumors that are hard to treat. Study Design
3.
ir.corcept.com
ir.corcept.com/news-releases/news-release-details/corcept-therapeutics-announces-third-quarter-financial-results-4Corcept Therapeutics Announces Third Quarter Financial ...
These trials' groundbreaking results, in which relacorilant improved progression-free and overall survival in patients with a highly challenging ...
Long-term outcomes of preoperative nivolumab with or ...
The combination of neoadjuvant nivolumab and chemotherapy resulted in an impressive 5-year overall survival rate of 95.3 % (82.7–98.8) among ...
Five-Year Outcomes With Nivolumab in Patients With Wild ...
Recent results of the Checkmate 067 trial conducted in patients alive and still in follow-up at 5 years showed that 74% of patients treated with nivolumab plus ...
6.
tipranks.com
tipranks.com/news/company-announcements/corcepts-nenocorilant-combo-study-moves-forward-expanding-its-oncology-ambitionsCorcept's Nenocorilant Combo Study Moves Forward, ...
Together, the combination is meant to improve treatment outcomes in patients with advanced solid tumors that are hard to treat.
Two Part Study of Nenocorilant Combined With Nivolumab ...
This open-label, dose-finding, and proof of concept study will evaluate the safety, tolerability, maximum-tolerated dose (MTD) and/or optimal ...
Two Part Study of Nenocorilant Combined With Nivolumab ...
Outcome Measure, Time Frame. Number of Patients With 1 or More Adverse Event, From first dose of study treatment up to 28 days after ... Download Trial Data.
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.