Spots Global Cancer Trial Database for Study of Relacorilant in Combination With Pembrolizumab for Patients With Adrenocortical Carcinoma Which Produces Too Much Stress Hormone (Cortisol)
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Trial Identification
Brief Title: Study of Relacorilant in Combination With Pembrolizumab for Patients With Adrenocortical Carcinoma Which Produces Too Much Stress Hormone (Cortisol)
Official Title: A Phase 1b, Open-Label Study of Relacorilant in Combination With Pembrolizumab for Patients With Adrenocortical Carcinoma With Excess Glucocorticoid Production
Study ID: NCT04373265
Conditions
Study Description
Brief Summary: 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).
Detailed Description: 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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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
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
Contact Details
Name: Andreas G Moraitis, MD
Affiliation: Corcept Therapeutics
Role: STUDY_DIRECTOR
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