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.
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
dose-limiting toxicity (DLT) rate during the initial 5 cycles of treatment
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
To assess the safety of relacorilant in combination with pembrolizumab
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
To assess the effect of relacorilant in combination with pembrolizumab on the clinical
manifestations of cortisol excess (e.g. hypertension and diabetes mellitus)
Major surgery within 4 weeks prior to enrollment. If the participant underwent major surgery, they must have recovered adequately prior to starting study treatment.
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 (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)
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) Systemic (oral or injectable) regular use, or prescription topical glucocorticoids within 28 days. Short courses (≤5 days) for noncancer-related reasons are allowed if clinically required (such as prophylaxis for CT). (4) Mifepristone or other GR antagonists within 21 days (5) Adrenostatic medications (e.g., ketoconazole, metyrapone, or fluconazole within 14 days; or etomidate within 7 days)
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, nonmuscle 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 6 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.
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