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NCT06006013 · ClinicalTrials.gov registry record · Phase 2
Cabozantinib in Combination With Pembrolizumab for the Treatment of Patients With Locally Advanced, Metastatic, or Unresectable Adrenal Cortical Cancer
A Phase 2 study of Adrenal Cortical Carcinoma and Stage IV Adrenal Cortex Carcinoma AJCC v8, sponsored by Emory University.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 21
- Enrollment target
- 2
- Study locations
NCT06006013: Recruiting Phase 2 study of Adrenal Cortical Carcinoma and Stage IV Adrenal Cortex Carcinoma AJCC v8, sponsored by Emory University.
NCT06006013 is a Phase 2 study of Adrenal Cortical Carcinoma and Stage IV Adrenal Cortex Carcinoma AJCC v8 that is actively recruiting participants, run by Emory University. The registered enrollment target is 21 participants, below the 332-participant average among 3 other Adrenal Cortical Carcinoma trials with a reported enrollment target (94% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06006013, a Phase 2 study of Adrenal Cortical Carcinoma and Stage IV Adrenal Cortex Carcinoma AJCC v8, is actively recruiting participants, sponsored by Emory University.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 21 participants
- Enrollment target
- 2
- Study locations
Study 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.
Primary Outcome
Overall response rate is defined as the proportion of patients with a complete response or partial response to treatment according to Response Evaluation Criteria in Solid Tumors version 1.1. Overall response rate will be estimated by the Clopper-Pearson method with 95% confidence intervals. Descriptive statistics on continuous data will include means, medians, standard deviations, and ranges, while categorical data will be summarized using frequency counts and percentages. Will explore whether
Conditions Studied
Interventions
- BIOLOGICAL Pembrolizumab
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- PROCEDURE Magnetic Resonance Imaging
- DRUG Cabozantinib S-malate
Study Locations (2)
Georgia
- Emory University Hospital Midtown - Atlanta
- Emory University Hospital/Winship Cancer Institute - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2025-01-15 |
| Est. Completion | 2028-12-16 |
| Phase | Phase 2 |
What NCT06006013 shows while recruiting
NCT06006013 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 332-participant average among 3 other Adrenal Cortical Carcinoma trials with a reported enrollment target (94% lower).
The record links to 5 conditions, with Adrenal Cortical Carcinoma appearing as the primary indexed condition, and to 5 interventions - of which Pembrolizumab is the first listed.
NCT06006013 reports a single indexed study location in Georgia.
Frequently Asked Questions
What is clinical trial NCT06006013 about?
NCT06006013 is a clinical study titled "Cabozantinib in Combination With Pembrolizumab for the Treatment of Patients With Locally Advanced, Metastatic, or Unresectable Adrenal Cortical Cancer". 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 (metastat...
What is the current status of trial NCT06006013?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 21 participants. The study started on 2025-01-15. Estimated completion is 2028-12-16.
What conditions does trial NCT06006013 study?
This clinical trial studies the following conditions: Adrenal Cortical Carcinoma, Stage IV Adrenal Cortex Carcinoma AJCC v8, Unresectable Adrenal Cortex Carcinoma, Locally Advanced Adrenal Cortex Carcinoma, Stage III Adrenal Cortex Carcinoma.
What interventions are being tested in trial NCT06006013?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Magnetic Resonance Imaging (PROCEDURE), Cabozantinib S-malate (DRUG).
Who is sponsoring clinical trial NCT06006013?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06006013 being conducted?
This trial has 2 study locations across Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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