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A Phase 1b, Open-Label Study of Relacorilant in Combination with Pembrolizumab for Patients with Adrenocortical Carcinoma with Excess Glucocorticoid Production
his study will investigate the safety and efficacy of Relacorilant in combination with Pembrolizumab for Patients with Adrenocortical Carcinoma with Excess Glucocorticoid Production.
Primary Objectives To determine the recommended regimen of relacorilant when given in combination with pembrolizumab in patients with advanced adrenocortical carcinoma (ACC) with glucocorticoid (GC) excess, based on safety, efficacy, and exposure-response modeling, including evaluation of: The dose-limiting toxicity (DLT) rate during the initial 5 cycles of treatment To determine the objective response rate (ORR) per Response Evaluation Criteria for Solid Tumors (RECIST v1.1) in patients with advanced ACC who have measurable disease at baseline following treatment with relacorilant in combination with pembrolizumab Secondary Objectives Safety To assess the safety of relacorilant in combination with pembrolizumab Efficacy To determine the non-progression rate (NPR) per RECIST v1.1 at 27 weeks To evaluate progression-free survival (PFS) per RECIST v1.1 To evaluate overall survival (OS) To evaluate the duration of response (DOR) per RECIST v1.1 who have measurable disease at baseline To assess the effect of relacorilant in combination with pembrolizumab on the clinical manifestations of cortisol excess (e.g. hypertension and diabetes mellitus)
Pembrolizumab (Keytruda); Relacorilant ()
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