Study of Relacorilant in Combination With Pembrolizumab for Patients With Adrenocortical Carcinoma With Excess Glucocorticoid Production
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|ClinicalTrials.gov Identifier: NCT04373265|
Recruitment Status : Recruiting
First Posted : May 4, 2020
Last Update Posted : December 10, 2020
|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) with glucocorticoid (GC) excess.
Eligible patients are those with advanced ACC associated with GC excess.
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 :||November 2022|
|Estimated Study Completion Date :||February 2023|
Experimental: Relacorilant in Combination with Pembrolizumab
Relacorilant dose escalation starting with 100 mg once daily in Cycle 1, followed by 200 mg once daily in Cycle 2, followed by 300 mg once daily in Cycle 3, followed by 400 mg (or highest tolerated dose) once daily in subsequent cycles up to 24 months treatment. The relacorilant dose can be reduced if not tolerated and subsequently increased if tolerated. Pembrolizumab 200-mg IV infusion on Day 1 of each cycle. Cycle duration is 3 weeks.
Relacorilant, 25 mg and 100 mg softgel capsules orally once daily.
Other Name: CORT125134
Pembrolizumab 200 mg IV infusion on Day 1 of each 3-week cycle.
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 15 weeks (5 cycles) ]Evaluate the percentage of patients with a dose-limiting toxicity
- Non-Progression Rate (NPR) [ Time Frame: 27 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
- 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 Therapeuticsemail@example.com|
|Contact: Corcept Therapeuticsfirstname.lastname@example.org|
|United States, California|
|Stanford, California, United States, 94305|
|United States, Michigan|
|Ann Arbor, Michigan, United States, 48109|
|United States, Texas|
|Houston, Texas, United States, 77030|
|Study Director:||Andreas G Moraitis, MD||Corcept Therapeutics|