Phase II Study of Oral Cabozantinib and Intravenous Pembrolizumab for Treating Advanced or Metastatic Adrenal Cortical Cancer

What this Trial Is About

Researchers are evaluating how well a combination of cabozantinib and pembrolizumab works for patients with adrenal cortical cancer that has spread locally, to other parts of the body, or cannot be removed by surgery. This phase II trial studies cabozantinib, which may reduce tumor growth and blood vessel formation, alongside pembrolizumab, an immunotherapy that helps the immune system attack cancer cells. The goal is to see if this combination is more effective than these drugs used alone. Participants receive cabozantinib orally once daily on days 1 to 21 of each 21-day cycle. Pembrolizumab is given intravenously over 30 minutes on day 1 of each cycle. Treatment continues until the cancer progresses or side effects become unacceptable. Imaging scans like CT or MRI are done at screening and every 12 weeks during the study. Blood samples are collected at screening, during treatment, and at the end. Patients without available tumor tissue undergo a biopsy before treatment. During the study, researchers monitor tumor response using standardized criteria every 12 weeks for up to 2 years. They assess progression-free survival, overall survival, safety, and side effects for up to 2 years. After treatment ends, participants are followed for 28 days and then up to 2 years for long-term monitoring. The study also explores changes in immune cells and inflammatory markers in blood and tissue samples to better understand treatment effects.

Cabozantinib in Combination With Pembrolizumab for the Treatment of Patients With Locally Advanced, Metastatic, or Unresectable Adrenal Cortical Cancer