Ignite Creation Date:
2025-12-24 @ 2:00 PM
Ignite Modification Date:
2025-12-27 @ 10:18 PM
Study NCT ID:
NCT06900595
Status:
RECRUITING
Last Update Posted:
2025-12-24
First Post:
2025-03-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Testing the Addition of an Anti-Cancer Drug, Cabozantinib to the Immunotherapy Drug Cemiplimab (REGN2810), in Adolescents and Adults With Advanced Adrenocortical Cancer
Sponsor:
National Cancer Institute (NCI)
Organization:
Study Overview
Official Title:
A Phase II Study of Cabozantinib in Combination With Cemiplimab (Cabo-Cemiplimab) Versus Cabozantinib Alone in Adolescents and Adults With Advanced Adrenocortical Cancer
Status:
RECRUITING
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed Description:
PRIMARY OBJECTIVE:
I. To determine whether the combination of cabozantinib plus cemiplimab (REGN2810) (Cabo-Cemiplimab \[REGN2810\]) improves progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) version (v.) 1.1 relative to cabozantinib alone in patients with locally advanced unresectable or recurrent/metastatic advanced adrenocortical cancer.
SECONDARY OBJECTIVES:
I. To assess tolerability and adverse events of Cabo-Cemiplimab (REGN2810) in advanced adrenocortical cancer (ACC) patients.
II. To assess objective response rate as per RECIST v 1.1. III. To assess duration of objective response, time to progression (TTP), and overall survival (OS) in ACC patients receiving Cabo-Cemiplimab (REGN2810).
EXPLORATORY OBJECTIVE:
I. To assess PFS from re-registration (per RECIST 1.1) and OS for patients who crossover to receive Cabo-Cemiplimab after progressing on cabozantinib alone.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM A: Patients receive cabozantinib orally (PO) once daily (QD) on days 1-21 of each cycle. Cycles repeat every 21 days for 2 years in the absence of disease progression or unacceptable toxicity. Patients undergo computed tomography (CT) scan or magnetic resonance imaging (MRI) and blood sample collection throughout the study. Upon disease progression, patients may elect to crossover to receive combination therapy on Arm B.
ARM B: Patients receive cemiplimab intravenously (IV) over 30 minutes on day 1 and cabozantinib PO QD on days 1-21 of each cycle. Cycles repeat every 21 days for 2 years in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan or MRI and blood sample collection throughout the study.
After completion of study treatment, patients are followed up every 12 weeks until disease progression and then every 6 months for 4 years post-registration.
I. To determine whether the combination of cabozantinib plus cemiplimab (REGN2810) (Cabo-Cemiplimab \[REGN2810\]) improves progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) version (v.) 1.1 relative to cabozantinib alone in patients with locally advanced unresectable or recurrent/metastatic advanced adrenocortical cancer.
SECONDARY OBJECTIVES:
I. To assess tolerability and adverse events of Cabo-Cemiplimab (REGN2810) in advanced adrenocortical cancer (ACC) patients.
II. To assess objective response rate as per RECIST v 1.1. III. To assess duration of objective response, time to progression (TTP), and overall survival (OS) in ACC patients receiving Cabo-Cemiplimab (REGN2810).
EXPLORATORY OBJECTIVE:
I. To assess PFS from re-registration (per RECIST 1.1) and OS for patients who crossover to receive Cabo-Cemiplimab after progressing on cabozantinib alone.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM A: Patients receive cabozantinib orally (PO) once daily (QD) on days 1-21 of each cycle. Cycles repeat every 21 days for 2 years in the absence of disease progression or unacceptable toxicity. Patients undergo computed tomography (CT) scan or magnetic resonance imaging (MRI) and blood sample collection throughout the study. Upon disease progression, patients may elect to crossover to receive combination therapy on Arm B.
ARM B: Patients receive cemiplimab intravenously (IV) over 30 minutes on day 1 and cabozantinib PO QD on days 1-21 of each cycle. Cycles repeat every 21 days for 2 years in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan or MRI and blood sample collection throughout the study.
After completion of study treatment, patients are followed up every 12 weeks until disease progression and then every 6 months for 4 years post-registration.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2025-02021 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| A092204 | OTHER | Alliance for Clinical Trials in Oncology | View | |
| A092204 | OTHER | CTEP | View | |
| U10CA180821 | NIH | None | https://reporter.nih.gov/quic… | View |