Study on Nenocorilant and Nivolumab Combination for Advanced Solid Tumors
Sponsor: Corcept Therapeutics
ClinicalTrials ID:NCT07276373
This clinical trial is testing a new treatment combining the drugs nenocorilant and nivolumab to find the best dose and evaluate its safety in patients with advanced solid tumors.
Patient Parameters
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Program Overview
The study aims to determine the safest and most effective dose of nenocorilant when used with nivolumab in patients with advanced solid tumors. It will also explore how well this combination works in treating these cancers. The trial is divided into two parts: the first part focuses on finding the right dose, and the second part, which is optional, will further test the treatment's effectiveness.
Description
This study is divided into two phases. In the first phase, researchers will test different doses of nenocorilant combined with a fixed dose of nivolumab in patients with advanced solid tumors. Patients will receive the combination treatment in 28-day cycles. Nenocorilant is taken orally once a day with food, while nivolumab is given through an IV every two weeks. After three months, patients who tolerate the treatment well may switch to a higher dose of nivolumab given every four weeks.
The second phase of the study is optional and will further evaluate how well the combination treatment works in patients with advanced solid tumors.
Eligibility Criteria
Inclusion Criteria
- Must sign a consent form approved by an ethics committee.
- Have advanced solid tumors that have not responded to standard treatments or for which no standard treatment exists.
- Have a life expectancy of at least 3 months.
- Have measurable disease based on specific criteria.
- Be in good overall health with a performance status of 0 or 1.
- Have adequate organ function.
- Women of childbearing potential must have a negative pregnancy test.
- Must agree to use effective birth control methods unless permanently sterilized.
Exclusion Criteria
- Have had severe immune-related side effects from previous similar treatments.
- Have a history of autoimmune or inflammatory diseases requiring immune-suppressing medications.
- Have a history of adrenal gland problems.
- Have had major surgery within 4 weeks before starting the study.
- Are taking certain medications like mifepristone or other similar drugs.
- Cannot swallow or absorb oral medications.
- Are participating in another clinical trial.
- Have unresolved side effects from previous treatments.
- Need medications that are not allowed in the study.
- Have severe allergies to the study drugs or similar medications.
- Are pregnant, breastfeeding, or planning to become pregnant during the study.
- Have uncontrolled medical conditions that could affect the study results or patient safety.
- Have a psychiatric disorder that would interfere with following the study.
- Have infections like HIV, hepatitis B, or hepatitis C.
- Have untreated or uncontrolled brain cancer spread.
- Have had another cancer within the last 2 years unless cured.
- Have had an organ or tissue transplant.
- Have heart rhythm issues or take medications that affect heart rhythm.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Site 03 | 90025 | Los Angeles | California |
| Site 04 | 49546 | Grand Rapids | Michigan |
| Site 01 | 78229 | San Antonio | Texas |
| Site 02 | 84119 | West Valley City | Utah |
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