Actively Recruiting
Two Part Study of Nenocorilant Combined With Nivolumab in Patients With Advanced Solid Malignancies
Led by Corcept Therapeutics · Updated on 2026-04-03
50
Participants Needed
4
Research Sites
50 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This open-label, dose-finding, and proof of concept study will evaluate the safety, tolerability, maximum-tolerated dose (MTD) and/or optimal dose of nenocorilant when administered in combination with nivolumab in patients with advanced solid malignancies.
CONDITIONS
Official Title
Two Part Study of Nenocorilant Combined With Nivolumab in Patients With Advanced Solid Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent approved by the ethics committee
- Has solid tumors that have had all standard treatments or no standard treatment exists, or cannot tolerate standard treatment
- Life expectancy of 3 months or more
- Has measurable disease based on standard criteria (RECIST v1.1)
- ECOG performance status of 0 or 1
- Adequate organ function
- Negative pregnancy test if female and able to become pregnant
- Agreement to use birth control or have sterilized partner unless not applicable
You will not qualify if you...
- Past or current severe immune-related side effects from anti-PD(L)1 therapy (grade 3 or higher or caused stopping treatment)
- History of autoimmune or inflammatory disease needing immunosuppressive drugs
- History of adrenal gland insufficiency
- Major surgery within 4 weeks before starting study treatment
- Taking mifepristone or other glucocorticoid receptor modulators
- Unable to swallow or absorb oral medication
- Participating in another experimental treatment trial
- Unresolved toxicities from prior treatments
- Need for prohibited medications like systemic corticosteroids or CYP3A inducers/inhibitors
- Severe allergy to study drugs or similar antibodies
- Pregnant, breastfeeding, or planning pregnancy during study
- Uncontrolled serious medical conditions that could affect safety or results
- Psychiatric disorders interfering with study compliance
- Infection with HIV, hepatitis B or C
- Untreated or uncontrolled brain metastases
- Another cancer within 2 years unless cured
- Prior organ or tissue transplant
- Heart rhythm abnormalities or family history of sudden death related to QT interval issues
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Site 03
Los Angeles, California, United States, 90025
Actively Recruiting
2
Site 04
Grand Rapids, Michigan, United States, 49546
Actively Recruiting
3
Site 01
San Antonio, Texas, United States, 78229
Actively Recruiting
4
Site 02
West Valley City, Utah, United States, 84119
Actively Recruiting
Research Team
C
Corcept Therapeutics
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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