This study will investigate the safety and efficacy of Relacorilant in combination with Pembrolizumab for Patients with Adrenocortical Carcinoma which Produces Too Much Stress Hormone (Cortisol).
Relacorilant is a small molecule antagonist of the glucocorticoid receptor (GR). The goal of this study is to assess the safety and efficacy of relacorilant when given in combination with pembrolizumab in patients with advanced adrenocortical carcinoma (ACC) which produces too much stress hormone (cortisol). Too much stress hormone (cortisol) is also called glucocorticoid (GC) excess. Eligible patients are those with advanced ACC that produces too much cortisol. Patients will receive treatment until progressive disease (PD) (per RECIST v1.1) is confirmed, experience unmanageable toxicity, or until other treatment discontinuation criteria are met. All patients will be followed for documentation of disease progression, survival information (i.e., date and cause of death) and subsequent treatment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
Relacorilant, 100 mg soft gel capsules orally once daily
Pembrolizumab 400 mg infusion every 6 weeks
Site #150, Stanford Cancer Center
Stanford, California, United States
Site #007, Moffitt Cancer Center
Tampa, Florida, United States
Site #074, University of Michigan Medical School
Ann Arbor, Michigan, United States
Site #030 Mayo Clinic
Rochester, Minnesota, United States
Dose-limiting Toxicity (DLT)
Evaluate the percentage of patients with a dose-limiting toxicity
Time frame: Up to 12 weeks
Non-Progression Rate (NPR)
Evaluate the non-progression rate (NPR) per RECIST v1.1
Time frame: 24 weeks from enrollment
Progression-Free Survival (PFS)
Evaluate progression-free survival (PFS) per RECIST v1.1
Time frame: From date of first treatment, until the date of first documented progression or date of death from any cause, whichever came first, up to month 24
Number of Participants with Adverse Events
Adverse events (AEs) by severity grade using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI CTCAE v5.0)
Time frame: Up to 37 days post-treatment
Plasma Concentrations of Relacorilant in Combination with Pembrolizumab in Patients with Advanced ACC and Glucocorticoid Excess
Plasma concentrations of relacorilant in combination with pembrolizumab will be calculated in patients with advanced ACC and glucocorticoid excess
Time frame: Up to 24 months
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Site #051, Memorial Hospital
New York, New York, United States
Site #183, The University of Texas M.D. Anderson Cancer Center
Houston, Texas, United States