Study of Relacorilant in Combination With Pembrolizumab for Patients With Adrenocortical Carcinoma Which Produces Too Much Stress Hormone (Cortisol)

Korábbi kezelés

• 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.
• 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:
  • Any investigational product, systemic anticancer therapy, or radiation therapy within 21 days
  • Antibodies or anticancer vaccines within 60 days
  • Mifepristone or other GR antagonists within 5 half-lives of these medications
  • Adrenostatic medications within 5 half-lives of these medications
• 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:
  • Unstable angina pectoris, angioplasty, cardiac stenting, or myocardial infarction 3 months before study entry.
  • Active infection that requires parenteral antibiotics.
  • Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.

Más betegség

• 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.
• 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.

• 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.