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

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