Study of Relacorilant in Combination With Pembrolizumab for Patients With Adrenocortical Carcinoma Which Produces Too Much Stress Hormone (Cortisol)
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|ClinicalTrials.gov Identifier: NCT04373265|
Recruitment Status : Recruiting
First Posted : May 4, 2020
Last Update Posted : February 25, 2022
|Condition or disease||Intervention/treatment||Phase|
|Adrenocortical Carcinoma||Drug: Relacorilant Drug: Pembrolizumab||Phase 1|
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 (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1b, Open-Label Study of Relacorilant in Combination With Pembrolizumab for Patients With Adrenocortical Carcinoma With Excess Glucocorticoid Production|
|Actual Study Start Date :||September 30, 2020|
|Estimated Primary Completion Date :||December 31, 2022|
|Estimated Study Completion Date :||July 31, 2023|
Experimental: Relacorilant in Combination with Pembrolizumab
Patients will treated with a lead-in of 300 mg relacorilant once daily from Day -3 to Cycle 1 Day 1 prior to the first dose of pembrolizumab. From Cycle 1 Day 1 until confirmed p or unacceptable toxicity with relacorilant and pembrolizumab. Pembrolizumab will be administered every 6 weeks (on Day 1 of each 42-day cycle) and relacorilant will be administered daily.
On Cycle 1 Day 2, the patient's dose increases to 100 mg relacorilant once daily for 2 weeks. The patient's relacorilant doses may then escalate by 100-mg increments every 2 weeks based on tolerability until they reach 400 mg relacorilant once daily.
For patients who tolerate the 400 mg relacorilant once daily, but their Cushing-syndrome symptoms persist, further dose escalation in 100-mg increments to a maximum of 600 mg relacorilant once daily may be considered after approval of the Medical Monitor and as long as the patient's AUC0-24 at their current dose does not exceed the maximum allowable exposure.
Relacorilant, 100 mg soft gel capsules orally once daily
Other Name: CORT125134
Pembrolizumab 400 mg infusion every 6 weeks
Other Name: Keytruda
- Objective Response Rate (ORR) [ 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 ]Evaluate the percentage of patients with measurable disease at baseline who achieve confirmed complete response (CR) or partial response (PR) per RECIST v1.1
- Dose-limiting Toxicity (DLT) [ Time Frame: Up to 9 weeks ]Evaluate the percentage of patients with a dose-limiting toxicity
- Non-Progression Rate (NPR) [ Time Frame: 24 weeks from enrollment ]Evaluate the non-progression rate (NPR) per RECIST v1.1
- Progression-Free Survival (PFS) [ 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 ]To evaluate progression-free survival (PFS) per RECIST v1.1
- Overall Survival (OS) [ Time Frame: From date of first treatment, until the date of death from any cause, up to month 24 ]To evaluate overall survival (OS)
- Duration of response (DOR) [ Time Frame: From date of response, until the date of first documented progression or date of death from any cause, whichever came first, up to month 24 ]To evaluate the duration of response (DOR) per RECIST v1.1 (in patients with objective response)
- Clinical manifestations of cortisol excess [ 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 ]To assess the effect of relacorilant in combination with pembrolizumab on the clinical manifestations of cortisol excess (e.g. hypertension and diabetes mellitus)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04373265
|Contact: Corcept Therapeuticsfirstname.lastname@example.org|
|Contact: Corcept Therapeuticsemail@example.com|
|United States, California|
|Site #150, Stanford Cancer Center||Recruiting|
|Stanford, California, United States, 94305|
|United States, Florida|
|Site #007, Moffitt Cancer Center||Recruiting|
|Tampa, Florida, United States, 33612|
|United States, Michigan|
|Site #074, University of Michigan Medical School||Recruiting|
|Ann Arbor, Michigan, United States, 48109|
|United States, New York|
|Site #051, Memorial Hospital||Recruiting|
|New York, New York, United States, 10022|
|United States, Texas|
|Site #183, The University of Texas M.D. Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Study Director:||Andreas G Moraitis, MD||Corcept Therapeutics|