About this study
Adrenocortical tumor (ACT) is a rare cancer that forms in the adrenal gland. It is also called adrenocortical cancer, or ACC. Many people are not diagnosed with ACT until the cancer has spread. Treatments do not always work well, and the cancer may return after treatment.
The only FDA-approved medicine for ACT is called mitotane. It helps some people, but it can cause strong side effects. Doctors are studying new medicines for advanced ACT that may work better and have fewer side effects.
This study tests 2 medicines: cabozantinib and cemiplimab.
- Cabozantinib is a targeted therapy, given by mouth. It blocks the signals that help cancer cells grow and spread.
- Cemiplimab is an immunotherapy, given through the veins. It helps the body’s immune system find and attack cancer cells.
People who join this study are placed into 1 of 2 groups.
- One group receives cabozantinib alone.
- The other group receives cabozantinib plus cemiplimab.
Patients are assigned to their group randomly.
Doctors want to learn whether adding cemiplimab lowers the chance of advanced ACT growing or spreading.
Doctors will check blood tests, scans, and symptoms often to make sure the treatment is safe. Researchers will use scans, (such as CT or MRI) to see if the cancer shrinks, stays the same, or grows. Researchers will also study how the medicines affect symptoms, quality of life, and side effects.
Patients will stay on treatment as long as it helps them and side effects are manageable.
This information may help improve future treatment for people with this rare cancer.
Eligibility overview
- Adrenocortical tumor that is advanced. This includes tumor that has either:
- Spread to tissues near the adrenal gland and cannot be removed by surgery
- Returned after treatment
- Spread to other parts of the body
- 12–19 years old
- Has not already received cabozantinib or similar drugs, or certain immunotherapy treatments for cancer
- Has stopped any mitotane use at least 28 days before joining the study