Study on Pembrolizumab for Advanced Adrenocortical Cancer

Inclusion Criteria

• Be willing and able to provide written consent to participate in the study.
• Be 18 years or older.
• Have a confirmed diagnosis of adrenocortical carcinoma (ACC) that cannot be surgically removed or has spread and is considered incurable by local treatments.
• Have a performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
• Have measurable disease based on specific medical criteria.
• Provide a tissue sample for PD-L1 biomarker analysis, either from stored tissue or a new biopsy.
• Agree to the use of stored tissue for research purposes.
• Have adequate organ function as shown by specific blood tests done within 28 days before starting treatment.
• For women of childbearing potential, have a negative pregnancy test within 72 hours before the first dose of the study drug and agree to use two methods of birth control or be surgically sterile, or abstain from heterosexual activity during the study and for 120 days after the last dose.
• For men, agree to use an adequate method of contraception from the first dose of the study drug through 120 days after the last dose.

Exclusion Criteria

• Currently participating in another study or have used an investigational drug or device within 4 weeks before the first dose of the study drug.
• Have an immune system deficiency or are taking systemic steroids or other immunosuppressive drugs within 7 days before the first dose of the study drug.
• Have received a monoclonal antibody within 4 weeks before the study or have not recovered from side effects of previous treatments.
• Have had chemotherapy or targeted therapy within 2 weeks before the study or have not recovered from side effects of previous treatments, except for mild neuropathy or hair loss.
• Have had major surgery and not fully recovered from it before starting the study.
• Have another progressing cancer that requires treatment, except for certain skin cancers or cervical cancer that has been treated.
• Have active brain metastases or cancer in the brain lining, unless previously treated and stable.
• Have an active autoimmune disease needing treatment within the past 3 months, except for certain conditions like stable hypothyroidism or Sjogren's syndrome.
• Have lung disease or history of lung inflammation needing steroids.
• Have an active infection needing treatment.
• Have any condition or treatment that might interfere with the study or not be in the best interest of the patient.
• Have psychiatric or substance abuse disorders that would interfere with the study.
• Are pregnant or breastfeeding, or planning to conceive or father children during the study and for 120 days after the last dose.
• Have received prior therapy targeting specific immune pathways.
• Have a history of HIV or active hepatitis B or C.
• Have received a live vaccine within 30 days before the first dose of the study drug, except for certain flu vaccines.