Study of Relacorilant in Combination With Pembrolizumab for Patients With Adrenocortical Carcinoma With Excess Glucocorticoid Production

• Status: Recruiting
• Trial end date: 2023-07-31
• Target enrollment: 0
• Participant gender: All

Summary

This study will investigate the safety and efficacy of Relacorilant in combination with Pembrolizumab for Patients with Adrenocortical Carcinoma with Excess Glucocorticoid Production.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Corcept Therapeutics
• Treatments: Pembrolizumab

Criteria

Inclusion Criteria: Patients must have the following:

• 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.

• If received mitotane, have a mitotane level <4mg/L at within 3 months prior to Screening. Mitotane testing is not required for patients who have not received mitotane within 3 months of Screening, nor for patients who have a mitotane test result of less than 4 mg/L after their last dose of mitotane. Note: The mitotane level may be screened/retested multiple times to confirm that the level is trending down and reaches the protocol eligibility requirement.

• 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: Patients must not have the following:

• 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 (CR or PR) to prior treatment with any prior treatment with a programmed cell death protein 1 (anti-PD-1),PD-1 Ligand 1 (anti-PD-L1), or PD-1 Ligand 2 (anti-PD-L2) therapy,

• Prior therapy with anti-Cluster of Differentiation (CD)137, cytotoxic T-lymphocyte-associated (CTLA) proteinCTLA-4 antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell stimulation or checkpoint 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 (e.g., ketoconazole, metyrapone, etomidate, or fluconazole) 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.