Study on Adding Cabozantinib to Immunotherapy Drug Cemiplimab for Adolescents and Adults with Advanced Adrenocortical Cancer
Sponsor: National Cancer Institute (NCI)
ClinicalTrials ID:NCT06900595
This clinical trial is exploring whether combining the drug cabozantinib with the immunotherapy drug cemiplimab can improve treatment outcomes for adolescents and adults with advanced adrenocortical cancer that cannot be surgically removed or has spread.
Patient Parameters
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Program Overview
This study is testing a new treatment approach for adrenocortical cancer that has spread or cannot be removed by surgery. The trial compares the effects of using cabozantinib alone versus combining it with cemiplimab, an immunotherapy drug. Cabozantinib works by blocking proteins that help cancer cells grow, while cemiplimab helps the immune system attack cancer cells. The goal is to see if the combination can better control the cancer and improve patient outcomes.
Description
The main goal of this study is to find out if combining cabozantinib with cemiplimab can help patients with advanced adrenocortical cancer live longer without the disease getting worse. Researchers will also look at how well patients tolerate the treatment and any side effects they experience.
Participants will be randomly assigned to one of two groups. One group will receive cabozantinib alone, while the other group will receive both cabozantinib and cemiplimab. Both treatments will be given in cycles, with cabozantinib taken daily and cemiplimab given every three weeks.
Throughout the study, participants will have regular scans and blood tests to monitor their health and the cancer's response to treatment. If the cancer progresses, participants in the cabozantinib-only group may switch to the combination treatment.
After completing the study treatment, participants will have follow-up visits every three months to check on their health and any changes in their cancer.
Eligibility Criteria
Inclusion Criteria
- Must have confirmed adrenocortical cancer that is advanced, cannot be removed by surgery, or has spread.
- Can have had up to three previous treatments for the cancer.
- Must not have been treated with cabozantinib or similar drugs before.
- Must be 12 years or older and meet specific health criteria, including good blood counts and organ function.
- Must not be pregnant or nursing and agree to use effective birth control if of childbearing potential.
- Must not have certain heart conditions or uncontrolled high blood pressure.
- Must not have active infections like hepatitis or HIV unless well-controlled.
- Must not have active autoimmune diseases or be on high doses of steroids.
- Must not be taking certain medications that could interfere with the study drugs.
- Must be able to swallow pills and not have allergies to similar drugs.
- Must not have other cancers that could affect the study results.
- Must have stable brain metastases if present and not require steroids.
- Must not have had major surgery recently or have ongoing complications from surgery.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Lurie Children's Hospital-Chicago | 60611 | Chicago | Illinois |
| Saint Jude Children's Research Hospital | 38105 | Memphis | Tennessee |
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