RecruitingPhase 2NCT06006013

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

Phase II Open Label, Single-Arm Study of Cabozantinib in Combination With Pembrolizumab in the Treatment of Locally Advanced or Metastatic Adrenocortical Carcinoma

Sponsor

Emory University

Enrollment

21 participants

Start Date

Jan 15, 2025

Study Type

INTERVENTIONAL

Conditions

Adrenal Cortical Carcinoma Locally Advanced Adrenal Cortex Carcinoma Stage III Adrenal Cortex Carcinoma Stage IV Adrenal Cortex Carcinoma AJCC v8 Unresectable Adrenal Cortex Carcinoma

Summary

This phase II trial tests how well cabozantinib in combination with pembrolizumab works in treating patients with adrenocortical cancer that has spread to nearby tissue or lymph nodes (locally advanced), that has spread from where it first started (primary site) to other places in the body (metastatic), or that cannot be removed by surgery (unresectable). Cabozantinib inhibits receptor tyrosine kinases, which are receptors commonly over-expressed by tumor cells. This may result in an inhibition of both tumor growth and blood vessel formation, eventually leading to a decrease in tumor size or extent in the body. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer and may interfere with the ability of tumor cells to grow and spread. Adding cabozantinib to pembrolizumab may be more effective at treating patients with adrenal cortical cancer than giving these drugs alone.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a combination of two cancer immunotherapy drugs — cabozantinib and pembrolizumab — can treat adrenal cortical carcinoma, a rare cancer of the adrenal gland. **You may be eligible if:** - You are 18 or older - You have confirmed adrenal cortical carcinoma that has spread or cannot be removed surgically - You are in reasonably good health and your blood and organ tests are within acceptable ranges - You have no HIV, active hepatitis B or C, or active tuberculosis **You may NOT be eligible if:** - You have had prior treatment with checkpoint inhibitor immunotherapy drugs - You have active autoimmune disease (certain skin conditions may be acceptable) - You have had a heart attack, stroke, or blood clot within the past 6 months - You have significant heart, kidney, or liver problems - You are currently taking a blood thinner like warfarin or dabigatran - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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