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NCT06900595 · ClinicalTrials.gov registry record · Phase 2
Testing the Addition of an Anti-Cancer Drug, Cabozantinib to the Immunotherapy Drug Cemiplimab (REGN2810), in Adolescents and Adults With Advanced Adrenocortical Cancer
A Phase 2 study of Recurrent Adrenal Cortical Carcinoma and Locally Advanced Adrenal Cortical Carcinoma, sponsored by National Cancer Institute (NCI).
- Recruiting
- Registry status
- Phase 2
- Development phase
- 48
- Enrollment target
- 20
- Study locations
NCT06900595: Recruiting Phase 2 study of Recurrent Adrenal Cortical Carcinoma and Locally Advanced Adrenal Cortical Carcinoma, sponsored by National Cancer Institute (NCI).
NCT06900595 is a Phase 2 study of Recurrent Adrenal Cortical Carcinoma and Locally Advanced Adrenal Cortical Carcinoma that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 48 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (64% lower). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06900595, a Phase 2 study of Recurrent Adrenal Cortical Carcinoma and Locally Advanced Adrenal Cortical Carcinoma, is actively recruiting participants, sponsored by National Cancer Institute (NCI).
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 48 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase II trial compares the effect of giving cabozantinib with or without cemiplimab in patients with adrenocortical cancer that has spread to nearby tissue or lymph nodes (locally advanced), and that cannot be removed by surgery (unresectable) or that has come back after a period of improvement (recurrent) or that has spread from where it first started (primary site) to other places in the body (metastatic). Cabozantinib is in a class of medications called tyrosine kinase inhibitors. It works by blocking the action of an abnormal protein that signals cancer cells to multiply, which may help keep cancer cells from growing. Immunotherapy with monoclonal antibodies, such as cemiplimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving cabozantinib with cemiplimab may kill more tumor cells in patients with locally advanced unresectable or recurrent/metastatic adrenocortical cancer.
Primary Outcome
Per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v 1.1). Will be analyzed using an intention-to-treat approach. Kaplan-Meier methodology will be used to estimate the distributions for the treatment arms. The hazard ratio, median PFS, and estimated PFS rates at 5, 10 and 15 months will be estimated along with corresponding 95% confidence intervals. A one-sided log rank-test will be used to compare the PFS distributions between the two treatment arms.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- PROCEDURE Magnetic Resonance Imaging
- BIOLOGICAL Cemiplimab
- DRUG Cabozantinib
Study Locations (20)
Illinois
- Lurie Children's Hospital-Chicago - Chicago
- Northwestern University - Chicago
- Northwestern Medicine Cancer Center Kishwaukee - DeKalb
- Northwestern Medicine Cancer Center Delnor - Geneva
- Northwestern Medicine Glenview Outpatient Center - Glenview
- Northwestern Medicine Grayslake Outpatient Center - Grayslake
- Northwestern Medicine Lake Forest Hospital - Lake Forest
- Northwestern Medicine Oak Brook - Oak Brook
- Northwestern Medicine Orland Park - Orland Park
- Memorial Hospital East - Shiloh
- Northwestern Medicine Cancer Center Warrenville - Warrenville
Missouri
- Siteman Cancer Center at Saint Peters Hospital - City of Saint Peters
- Siteman Cancer Center at West County Hospital - Creve Coeur
- CoxHealth South Hospital - Springfield
- Washington University School of Medicine - St Louis
- Siteman Cancer Center-South County - St Louis
- Siteman Cancer Center at Christian Hospital - St Louis
California
- UC San Diego Moores Cancer Center - La Jolla
Massachusetts
- Dana-Farber Cancer Institute - Boston
Nebraska
- Nebraska Medicine-Bellevue - Bellevue
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2026-02-22 |
| Est. Completion | 2029-06-02 |
| Phase | Phase 2 |
What NCT06900595 shows while recruiting
NCT06900595 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (64% lower).
The record links to 6 conditions, with Recurrent Adrenal Cortical Carcinoma appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT06900595 names 20 study sites across 5 states, led by Illinois, Missouri, California.
Frequently Asked Questions
What is clinical trial NCT06900595 about?
NCT06900595 is a clinical study titled "Testing the Addition of an Anti-Cancer Drug, Cabozantinib to the Immunotherapy Drug Cemiplimab (REGN2810), in Adolescents and Adults With Advanced Adrenocortical Cancer". This phase II trial compares the effect of giving cabozantinib with or without cemiplimab in patients with adrenocortical cancer that has spread to nearby tissue or lymph nodes (locally advanced), and that cannot be removed by surgery (unresectable) or that has come back after a period of improvemen...
What is the current status of trial NCT06900595?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 48 participants. The study started on 2026-02-22. Estimated completion is 2029-06-02.
What conditions does trial NCT06900595 study?
This clinical trial studies the following conditions: Recurrent Adrenal Cortical Carcinoma, Locally Advanced Adrenal Cortical Carcinoma, Metastatic Adrenal Cortical Carcinoma, Stage III Adrenal Cortical Carcinoma AJCC v8, Stage IV Adrenal Cortical Carcinoma AJCC v8.
What interventions are being tested in trial NCT06900595?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Magnetic Resonance Imaging (PROCEDURE), Cemiplimab (BIOLOGICAL), Cabozantinib (DRUG).
Who is sponsoring clinical trial NCT06900595?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06900595 being conducted?
This trial has 20 study locations across California, Illinois, Massachusetts, Missouri, Nebraska. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06900595's enrollment target sits among peer trials
48 1265th of 2000 higher than 719 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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