Nenocorilant plus nivolumab for advanced solid tumors
Official title: A Phase 1b/2, Open-Label, Dose-Finding and Proof of Concept Study of Nenocorilant in Combination With Anti-Programmed Cell Death/(Ligand) 1 in Patients With Advanced Solid Malignancies
Run by Corcept Therapeutics · NCT07276373 · Data updated 2026-11-12
This trial tests whether adding the oral drug nenocorilant to nivolumab is safe and can identify the best dose for people with advanced solid tumors.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | Corcept Therapeutics Industry-sponsored |
| Drugs / interventions | nivolumab |
| Locations | 5 sites (Los Angeles, California and 4 other locations) |
| Status | Recruiting |
| Started | January 16, 2026 |
| Main results expected | September 2026 |
| Study ends | January 2027 |
| Registry record updated | August 19, 2026 |
| Trial ID | NCT07276373 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with advanced solid tumors who have no remaining standard therapy options (or are intolerant), an ECOG performance status of 0–1, measurable disease, and adequate organ function are the intended candidates.
✕Probably not a fit
Patients with prior severe immune-related adverse events from PD-1/PD-L1 therapy (grade ≥3), poor performance status, uncontrolled medical conditions, or pregnancy are unlikely to benefit or may be excluded.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Phase 1b/2 trial combines daily oral nenocorilant with fixed-dose IV nivolumab in 28-day cycles to determine safety, tolerability, and the maximum-tolerated or optimal dose. The Phase 1b dose-escalation evaluates nenocorilant doses (200–400 mg) alongside nivolumab given every 2 weeks, with an option to switch to 480 mg every 4 weeks after three months for tolerated patients. Eligible participants have advanced solid malignancies with measurable disease and have exhausted standard therapies or are intolerant to them. An optional Phase 2 proof-of-concept expansion may be added to further explore anti-tumor activity at the selected dose.
Why it matters
Potential benefit: If successful, the combination could provide a new treatment option that improves responses to immunotherapy for some patients with advanced solid tumors.
How similar studies have gone: Nivolumab and other PD-1 inhibitors have shown benefit across multiple tumor types, but combining them with agents like nenocorilant is a relatively new strategy with limited prior clinical data.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: Part 1 * Signed and dated institutional review board (IRB)/ independent ethics committee (IEC)-approved informed consent form (ICF) * Has solid malignancies that have received all available standard therapies for the specific tumor type or for which no standard therapy exists, unless patient is intolerant of treatment * Has a life expectancy of ≥ 3 months * Has evaluable disease based on RECIST v1.1 * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Has adequate organ function * Negative serum or urine pregnancy test for female patients of childbearing potential * Agreement to use appropriate precautions to avoid pregnancy, unless the patient and/or their sole sexual partner is permanently sterilized Exclusion Criteria: Part 1 * Past or current immune-related adverse events (irAEs) due to anti-programmed cell death protein 1 ligand 1 (PD\[L\]1) therapy that meet any of the following criteria: 1. Grade ≥ 3 2. Resulted in discontinuation of anti-PD(L)1 therapy * Medical history of an autoimmune or inflammatory disease requiring immunosuppressive therapy * Medical history of adrenal insufficiency * Has had any major surgery within 4 weeks prior to the first dose of study treatment * Concurrent treatment with mifepristone or another glucocorticoid receptor (GR) modulator * Unable to swallow, retain, or absorb oral medication * Concurrent participation in another interventional clinical trial * Has toxicities due to prior therapies that are reversible and have not resolved * Requirement for treatment with prohibited medications, including but not limited to systemic corticosteroids and cytochrome P450(CYP)3A inducers or inhibitors * Has a known history of severe hypersensitivity to any of the study drugs, or other human/humanized monoclonal antibodies * Pregnant or lactating patients or female patients expecting to conceive children within the projected duration of the trial * Has clinically significant uncontrolled condition(s) which, in the opinion of the Investigator, may confound the results of the trial or interfere with the patient's safety or participation * Known psychiatric disorder that would interfere with trial compliance * Has infection with HIV, hepatitis C virus, or hepatitis B virus * Has untreated parenchymal brain metastasis or has uncontrolled central nervous system metastases * Has a history of another malignancy within 2 years prior to study treatment, unless cured * Has received prior autologous or allogeneic organ or tissue transplantation * A QTcF interval \>450 msec, a family history of long QT syndrome or unexplained sudden death at young age, or a requirement for use of medication that may prolong the QTc interval
Where it's running
-
Site 03
Los Angeles, California, United States Recruiting -
Site 05
Chicago, Illinois, United States Recruiting -
Site 04
Grand Rapids, Michigan, United States Recruiting -
Site 01
San Antonio, Texas, United States Recruiting -
Site 02
West Valley City, Utah, United States Recruiting
Study contacts
- Study coordinator: Corcept Therapeutics
- Email: corceptstudy750@corcept.com
- Phone: (669) 251-7034
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.