Adrenocortical Carcinoma Clinical Trial
Official title:
A Phase 1b, Open-Label Study of Relacorilant in Combination With Pembrolizumab for Patients With Adrenocortical Carcinoma With Excess Glucocorticoid Production
Verified date | February 2024 |
Source | Corcept Therapeutics |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 15 |
Est. completion date | January 12, 2024 |
Est. primary completion date | October 17, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Histologically or cytologically confirmed ACC (advanced unresectable and/or metastatic) - Measurable disease based upon RECIST v1.1 as determined by the Investigator. - Documented GC excess (too much cortisol). - For patients who have received mitotane within 3 months prior to screening, mitotane levels must be <4 mg/L at screening. - Eastern Cooperative Oncology Group (ECOG) performance status =2. - Adequate organ and bone marrow function (determined through blood and urine tests) - Negative pregnancy test for patients of childbearing potential at the Screening and every 6 weeks (+ or - 7 days) in female patients of childbearing potential. Exclusion Criteria: - Major surgery within 4 weeks prior to enrollment. If the participant underwent major surgery, they must have recovered adequately prior to starting study treatment. - Have received and responded (complete response [CR] or partial response [PR]) to prior treatment with any prior checkpoint inhibitor or any other agents targeting T-cell stimulation pathways - Taking a concomitant medication that is a strong Cytochrome P450 3A (CYP3A) inducer, or that is a substrate of CYP3A with a narrow therapeutic index - Known untreated parenchymal brain metastasis or have uncontrolled central nervous system (CNS) metastases. Patients must not require steroids and must be neurologically stable without corticosteroids for a minimum of 3 weeks prior to the commencement of the study. Patients with neurologic symptoms must undergo a CT/MRI to rule out occult CNS metastases. - Requirement for chronic systemic GC treatment, such as active autoimmune disease requiring systemic treatment (corticosteroids or other immunosuppressive medication) - Patients requiring inhaled glucocorticoids but have no other alternative treatment option if their condition deteriorates during the study. - Clinically relevant toxicity from prior systemic cytotoxic therapies or radiotherapy that in the opinion of the Investigator has not resolved to NCI-CTCAE v5.0 Grade 1 or less prior to the first dose of relacorilant. - Treated with the following prior to the first dose of relacorilant: 1. Any investigational product, systemic anticancer therapy, or radiation therapy within 21 days 2. Antibodies or anticancer vaccines within 60 days 3. Mifepristone or other GR antagonists within 5 half-lives of these medications 4. Adrenostatic medications within 5 half-lives of these medications - History of severe hypersensitivity to another monoclonal antibody - Other concurrent cancer or a history of another invasive malignancy within the last 3 years that has a likelihood of recurrence of >30% within the next 5 years. Adequately treated basal and squamous skin cancers, ductal carcinoma in situ, cervical cancer, prostate cancer, non-muscle invasive urothelial cancer or other tumors curatively treated with no evidence of disease are permissible. - Human immunodeficiency virus (HIV) or current chronic/active infection with hepatitis C virus or hepatitis B virus including: Chronic or active hepatitis B as diagnosed by serologic tests. In equivocal cases, hepatitis B or C polymerase chain reaction may be performed and must be negative for enrollment. - Clinically significant uncontrolled condition(s) or a condition which, in the opinion of the Investigator, may confound the results of the trial or interfere with the patient's participation, including but not limited to: 1. Unstable angina pectoris, angioplasty, cardiac stenting, or myocardial infarction 3 months before study entry. 2. Active infection that requires parenteral antibiotics. 3. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial. |
Country | Name | City | State |
---|---|---|---|
United States | Site #074, University of Michigan Medical School | Ann Arbor | Michigan |
United States | Site #183, The University of Texas M.D. Anderson Cancer Center | Houston | Texas |
United States | Site #051, Memorial Hospital | New York | New York |
United States | Site #030 Mayo Clinic | Rochester | Minnesota |
United States | Site #150, Stanford Cancer Center | Stanford | California |
United States | Site #007, Moffitt Cancer Center | Tampa | Florida |
Lead Sponsor | Collaborator |
---|---|
Corcept Therapeutics |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Dose-limiting Toxicity (DLT) | Evaluate the percentage of patients with a dose-limiting toxicity | Up to 12 weeks | |
Secondary | Non-Progression Rate (NPR) | Evaluate the non-progression rate (NPR) per RECIST v1.1 | 24 weeks from enrollment | |
Secondary | Progression-Free Survival (PFS) | Evaluate progression-free survival (PFS) per RECIST v1.1 | 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 | |
Secondary | Number of Participants with Adverse Events | Adverse events (AEs) by severity grade using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI CTCAE v5.0) | Up to 37 days post-treatment | |
Secondary | Plasma Concentrations of Relacorilant in Combination with Pembrolizumab in Patients with Advanced ACC and Glucocorticoid Excess | Plasma concentrations of relacorilant in combination with pembrolizumab will be calculated in patients with advanced ACC and glucocorticoid excess | Up to 24 months |
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