Actively Recruiting
Phase II Open Label, Single-Arm Study of Cabozantinib Combined With Pembrolizumab for Locally Advanced, Metastatic, or Unresectable Adrenal Cortical Carcinoma
Led by Emory University · Updated on 2026-02-18
21
Participants Needed
2
Research Sites
52 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
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.
CONDITIONS
Brief 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
- ECOG performance status 0 to 2 or Karnofsky score at least 50%
- Metastatic or unresectable locally advanced adrenal cortical carcinoma
- Histologically confirmed adrenal cortical carcinoma
- Untreated or previously treated with any number of therapies
- Measurable disease by RECIST version 1.1
- Life expectancy of at least 12 weeks
- Available tumor tissue samples or agreement to biopsy before treatment
- Recovery to baseline or grade 1 or less toxicity from prior treatments unless stable on supportive therapy
- Adequate blood counts and organ function within 28 days before treatment
- Negative or controlled HIV, hepatitis B and C infections
- Negative pregnancy test for females of childbearing potential
- Agreement to use effective contraception during and for 5 months after treatment
- Ability to comply with study visits, drug plan, tests, and restrictions
- Signed informed consent indicating understanding of the study and risks
You will not qualify if you...
- Use of kinase inhibitors within 2 weeks before treatment
- Prior treatment with immune checkpoint blockers like anti-PD-1 or anti-PD-L1
- Cytotoxic, biologic, or systemic anticancer therapy within 4 weeks or 5 half-lives before treatment
- Recent radiation therapy within specified timeframes or ongoing complications
- Known untreated or unstable brain metastases
- Use of certain anticoagulants or platelet inhibitors except specified exceptions
- Use of live vaccines within 30 days before treatment or planned during study
- Current use of mitotane or recent use with detectable levels
- Uncontrolled significant illnesses including serious heart, gastrointestinal, or infection conditions
- Significant bleeding history within 12 weeks before treatment
- Tumor invasion into major blood vessels or cavitating lung lesions
- Autoimmune diseases or immune deficiency except specific controlled conditions
- Recent systemic immunosuppressive medication use except allowed exceptions
- Active infections requiring systemic treatment
- Serious non-healing wounds or malabsorption syndrome
- Moderate to severe liver impairment or dialysis requirement
- History of organ or stem cell transplant
- Recent severe infections or COVID-19 unless recovered
- Recent major or minor surgery without complete healing
- Corrected QT interval over 500 ms on ECG or risk for torsades de pointes
- Pregnant or breastfeeding females
- Inability to swallow tablets or receive IV treatment
- Allergy to study drug components or severe infusion reactions
- Other active malignancies requiring treatment except certain cured cancers
- Current antiviral therapy for hepatitis B
- History of leptomeningeal disease
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Repeated 21-day cycles until disease progression or unacceptable toxicity
Participants receive cabozantinib orally once daily on days 1-21 of each 21-day cycle and pembrolizumab intravenously on day 1 of each cycle. Treatment cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Participants undergo CT and/or MRI scans every 12 weeks during treatment and have blood samples collected at screening, during treatment, and at the end of treatment. Participants without archival tissue also undergo biopsy at screening.
Visits every 3 weeks with imaging every 12 weeks and regular blood sample collections
Duration - 28 days then up to 2 years
After completion of study treatment, participants are followed for safety and survival assessments for up to 2 years.
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
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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