NCT04373265

Study of Relacorilant in Combination With Pembrolizumab for Patients With Adrenocortical Carcinoma Which Produces Too Much Stress Hormone (Cortisol)

A Phase 1b, Open-Label Study of Relacorilant in Combination With Pembrolizumab for Patients With Adrenocortical Carcinoma With Excess Glucocorticoid Production

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Corcept Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Adrenocortical Carcinoma

Interventions

Type	Name	Description
DRUG	Relacorilant	Relacorilant, 100 mg soft gel capsules orally once daily
DRUG	Pembrolizumab	Pembrolizumab 400 mg infusion every 6 weeks

Timeline

• Start date: 2020-09-30
• Primary completion: 2023-10-17
• Completion: 2024-01-12
• First posted: 2020-05-04
• Last updated: 2024-02-23

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study