Actively Recruiting
Cabozantinib in Combination With Pembrolizumab for the Treatment of Patients With Locally Advanced, Metastatic, or Unresectable Adrenal Cortical Cancer
Led by Emory University · Updated on 2026-02-18
21
Participants Needed
2
Research Sites
204 weeks
Total Duration
On this page
Sponsors
E
Emory University
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Cabozantinib in Combination With Pembrolizumab for the Treatment of Patients With Locally Advanced, Metastatic, or Unresectable Adrenal Cortical Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female
- Age 18 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 and Karnofsky score of 50% or higher
- Metastatic disease or unresectable locally advanced adrenal cortical carcinoma
- Histologically confirmed adrenal cortical carcinoma
- May be untreated or have received any number of prior therapies
- Measurable disease by RECIST version 1.1
- Life expectancy of at least 12 weeks
- Available tumor tissue samples or agreement to undergo biopsy
- Recovery to baseline or grade 1 or less toxicities from prior treatments, unless stable on supportive therapy
- Adequate blood counts and organ function within 28 days before starting treatment
- Negative or controlled HIV, hepatitis B, and hepatitis C tests
- Negative pregnancy test for females of childbearing potential
- Agreement to use effective contraception during and for 5 months after study
- Willingness and ability to comply with study visits, treatments, tests, and restrictions
- Signed informed consent
You will not qualify if you...
- Use of kinase inhibitors within 2 weeks before treatment
- Prior treatment with certain immune therapies such as anti-CTLA-4, anti-PD-1, or anti-PD-L1
- Cytotoxic or biologic anticancer treatments within 4 weeks before treatment
- Recent radiation therapy within specified timeframes
- Known untreated or unstable brain metastases
- Use of certain anticoagulants unless stable and without bleeding risks
- Live vaccine use within 30 days before treatment or planned during study
- Use of mitotane within 28 days before treatment
- Uncontrolled cardiovascular, gastrointestinal, or tumor-related conditions
- Active or uncontrolled infections including hepatitis, HIV, or tuberculosis
- Recent major or minor surgeries without complete healing
- Prolonged QT interval on ECG or history of related heart rhythm disorders
- Pregnant or lactating females
- Allergy to study drug components or severe infusion reactions
- Other active cancers requiring treatment
- History of leptomeningeal disease
- Inability or unwillingness to receive oral or IV treatments
- Use of systemic immunosuppressive drugs within 2 weeks before treatment except specific exceptions
- Severe infection or significant non-healing wounds
- Severe liver impairment or dialysis requirement
- History of organ or stem cell transplant
- Known COVID-19 infection unless recovered at least 30 days prior to treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Emory University Hospital Midtown
Atlanta, Georgia, United States, 30308
Actively Recruiting
2
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, United States, 30322
Actively Recruiting
Research Team
S
Shahid S. Ahmed, MBBS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here