New Alliance trial studies targeted therapies for rare adrenal cancers

The Alliance for Clinical Trials in Oncology has launched a new clinical trial to explore if using two targeted medications can help slow tumor growth in people with advanced adrenocortical carcinoma (ACC), a rare and aggressive cancer of the adrenal glands.

In the study (Alliance A092204), researchers will test whether combining two medications (cabozantinib and cemiplimab) can help slow the growth of ACC and improve outcomes for patients whose cancer has spread or returned after treatment.

“This trial is evaluating a new approach for patients diagnosed with a condition that has few available treatments.,” said Alliance study chair Bhavana Konda, MD, MPH, Section Chief, Neuroendocrine Tumors and Endocrine Medical Oncology at The Ohio State University Comprehensive Cancer Center. “We’re investigating whether a combination of targeted therapy and immunotherapy may improve disease control and improve quality of life for patients with this condition.”

ACC is a rare cancer that starts in the outer layer of the adrenal glands, which sit on top of the kidneys and help regulate hormones. Adrenal tumors are very common, found in about one in every 10 people, according to the American Cancer Society. Most of those tumors are benign. However, a very small percentage of these tumors are cancerous, affecting about one person out of a million in the U.S. Because ACC is often diagnosed at a late stage, treatment options are often limited, and outcomes can be challenging.

Participants will be randomly assigned to one of two groups:

• Standard Arm: This group will receive cabozantinib, a pill taken once a day that blocks signals helping cancer cells grow. 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.
• Intervention Arm: This group will receive cabozantinib plus cemiplimab, an intravenous immunotherapy that helps the immune system recognize and attack cancer cells. Immunotherapy medications like cemiplimab help the body's immune system attack the cancer, interfering with the ability of tumor cells to grow and spread. Researchers are testing to see if giving cabozantinib and cemiplimab together can kill more tumor cells in patients with locally advanced adrenocortical cancer.

Treatment will continue for up to two years, so long as the treatment continues to help reduce the tumors and side effects are management. Researchers will track how long patients live without their cancer getting worse (called progression-free survival), how well the cancer responds to treatment, and how long those responses last. The team will also monitor overall survival and any side effects.

“By studying this combination of therapies, we aim to identify more effective treatment approaches for this rare cancer,” added Dr. Konda. “The trial is part of a broader effort to advance research for patient populations with limited treatment options.”

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Reference: Alliance A0922014/NCT06900595-Testing the Addition of an Anti-Cancer Drug, Cabozantinib to the Immunotherapy Drug Cemiplimab (REGN2810), in Adolescents and Adults With Advanced Adrenocortical Cancer.

The Alliance for Clinical Trials in Oncology is a national leader in advancing cancer research, uniting more than 25,000 cancer specialists at 115 main institutions and 1,400 affiliates across the U.S. and Canada. As part of the National Clinical Trials Network and a leading research base for the NCI Community Oncology Research Program, the Alliance conducts pioneering, practice-changing clinical trials that improve outcomes and reshape standards of care. Our work has led to multiple FDA approvals, influenced national guidelines, and produced hundreds of high-impact publications. More than 40,000 participants have taken part in Alliance studies, and our growing biospecimen repository now includes more than 1.5 million samples, collected over the past 30 years. Learn more at www.AllianceforClinicalTrialsinOncology.org.

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