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Study of Nenocorilant with Nivolumab for Advanced Solid Cancers

This study is testing a new combination of two drugs, nenocorilant and nivolumab, for people with advanced solid cancers. You might be able to join if your cancer has already been treated with standard therapies, or if there are no standard treatments available. Researchers want to find the safest and most effective dose of nenocorilant when given with nivolumab. They will be watching closely for any side effects (adverse events) that happen during the study. This is an open-label study, meaning both you and your doctors will know which treatments you are receiving. The study aims to enroll about 50 participants.

Study design
This is an open-label, two-part study (Phase 1b/2) that will enroll about 50 participants. It is designed to find the right dose of nenocorilant when combined with nivolumab.
What's involved
You would take nenocorilant by mouth once daily and receive nivolumab intravenously (through a vein) every 2 or 4 weeks. This treatment would be given in 28-day cycles.
Compensation
Not stated in the trial record.
Follow-up
Researchers will track any side effects for up to 28 days after your last dose of study treatment, and assess them for up to 9 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07276373

Two Part Study of Nenocorilant Combined With Nivolumab in Patients With Advanced Solid Malignancies

Recruiting
PHASE1Ages 18+InterventionalTreatment
Corcept Therapeutics
~50 participants
Updated 2026-08-19 on ClinicalTrials.gov
What's tested:Nenocorilant 200 mgNenocorilant 300 mgNenocorilant 400 mgNivolumab

At a glance

Recruiting sites
5 of 5 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Patients With 1 or More Adverse Event
Measured over From first dose of study treatment up to 28 days after final dose, assessed up to 9 months
+3 more outcomes measured

Conditions

Neoplasms

Explore related trials

Solid Neoplasm

NCT07276373

Where you'd take part

This study runs at 5 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Site 01

    San Antonio, Texasno site contact published

    Recruiting

  • Site 02

    West Valley City, Utahno site contact published

    Recruiting

  • Site 03

    Los Angeles, Californiano site contact published

    Recruiting

  • Site 04

    Grand Rapids, Michiganno site contact published

    Recruiting

  • Site 05

    Chicago, Illinoisno site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Camille Renard · STUDY_DIRECTOR · Corcept Therapeutics

Who to contact

Corcept Therapeutics
[email protected]
(669) 251-7034
Email the study team

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Eligibility criteria

Inclusion

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

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:
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

What this trial measures

  • Number of Patients With 1 or More Adverse EventFrom first dose of study treatment up to 28 days after final dose, assessed up to 9 months
  • Number of Patients With 1 or More Serious Adverse EventsFrom first dose of study treatment up to 28 days after final dose, assessed up to 9 months
  • Number of Patients With 1 or More Adverse Events Leading to Study Drug DiscontinuationFrom first dose of study treatment up to final dose, assessed up to 9 months
  • Percent of Patients who Experience Dose Limiting Toxicity (DLT)Up to 28 days after initiation of Cycle 1 (each cycle consists of 28 days)