Study

A092204: A PHASE II STUDY OF CABOZANTINIB IN COMBINATION WITH CEMIPLIMAB (REGN2810) (CABO-CEMIPLIMAB (REGN2810)) VERSUS CABOZANTINIB ALONE IN ADOLESCENTS AND ADULTS WITH ADVANCED ADRENOCORTICAL CANCER

PRIMARY OBJECTIVE: To determine whether the combination of cabozantinib plus cemiplimab (REGN2810) (Cabo-Cemiplimab [REGN2810]) improves progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) version (v.) 1.1 relative to cabozantinib alone in patients with locally advanced unresectable or recurrent/metastatic advanced adrenocortical cancer.

Why this Research Matters

This phase II trial compares the effect of giving cabozantinib with or without cemiplimab in patients with adrenocortical cancer that has spread to nearby tissue or lymph nodes (locally advanced), and that cannot be removed by surgery (unresectable) or that has come back after a period of improvement (recurrent) or that has spread from where it first started (primary site) to other places in the body (metastatic). Cabozantinib is in a class of medications called tyrosine kinase inhibitors. It works by blocking the action of an abnormal protein that signals cancer cells to multiply, which may help keep cancer cells from growing. Immunotherapy with monoclonal antibodies, such as cemiplimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving cabozantinib with cemiplimab may kill more tumor cells in patients with locally advanced unresectable or recurrent/metastatic adrenocortical cancer.

Who can Participate

Adult

Patients must have documented histologically or cytologically confirmed adrenocortical carcinoma Locally advanced unresectable or recurrent/metastatic disease Up to 3 prior lines of systemic therapy will be allowed in the unresectable/recurrent/metastatic setting. Treatment naïve patients will be allowed. Note: Combination etoposide, doxorubicin, cisplatin, and mitotane (EDP-M) is considered 1 line of therapy. For patients who received mitotane ≤ 6 months prior to registration, mitotane should be discontinued 28 days prior to study registration AND a mitotane level must be documented to be < 2 mg/L prior to registration. Patients who have received mitotane within 6 months of enrollment and who have mitotane levels ≥ 2 mg/L will not be eligible to enroll No prior treatment with cabozantinib or other cMET inhibitors, or anti-CTLA-4, or anti-PD-1/PD-L1 therapy Detailed eligibility criteria is available on ClinicalTrials.gov. These requirements will be discussed with your doctor and/or study representative. ClinicalTrials.gov to learn more about this study.