About this trial
This trial looks at whether adding cabozantinib to the immunotherapy drug cemiplimab helps patients with advanced adrenocortical cancer. This cancer can be hard to treat when it has spread or cannot be removed by surgery. Cabozantinib blocks signals that help cancer cells grow, while cemiplimab boosts the immune system to fight cancer. The main goal is to see if the combination helps keep cancer from progressing longer than cabozantinib alone.
The trial's ID is NCT06900595. It is a Phase 2 study, which means it is looking at how well the treatment works and its safety. The trial hopes to include about 48 participants, and it is regulated by the FDA.
Who can join
This study is for teenagers and adults aged 12 and older. It is open to both men and women who have confirmed adrenocortical cancer that is locally advanced, recurrent, or metastatic. Participants should not have had certain previous treatments, and they need to meet other health criteria. The trial team will check if you are eligible before you can join.
Conditions
Locally Advanced Adrenal Cortical Carcinoma, Metastatic Adrenal Cortical Carcinoma, Recurrent Adrenal Cortical Carcinoma, Stage III Adrenal Cortical Carcinoma AJCC v8, Stage IV Adrenal Cortical Carcinoma AJCC v8, Unresectable Adrenal Cortical Carcinoma
The study team makes the final call on eligibility.
What happens in the study
Participants are randomly assigned to one of two groups. In Arm A, they receive cabozantinib by mouth each day for 21 days at a time. In Arm B, they receive cemiplimab through an IV on the first day and cabozantinib by mouth for 21 days as well. Both groups will have regular scans and blood tests throughout the study. If someone in Arm A has disease progression, they can switch to Arm B.
Where
This trial is running at 69 locations in the United States. All of them are currently recruiting.
BI-LO Charities Children's Cancer Center
Greenville, South Carolina
Broadlawns Medical Center
Des Moines, Iowa
Carle at The Riverfront
Danville, Illinois
Carle BroMenn Medical Center
Normal, Illinois
Carle Cancer Center
Urbana, Illinois
Carle Cancer Institute Normal
Normal, Illinois
Carle Physician Group-Effingham
Effingham, Illinois
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois
The first 8 of 69 sites are listed here. The registry record has the full list.