OncoMatch

OncoMatch/Clinical Trials/NCT06900595

Testing the Addition of an Anti-Cancer Drug, Cabozantinib to the Immunotherapy Drug Cemiplimab (REGN2810), in Adolescents and Adults With Advanced Adrenocortical Cancer

Is NCT06900595 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Cemiplimab and Cabozantinib for locally advanced adrenal cortical carcinoma.

Phase 2RecruitingNational Cancer Institute (NCI)NCT06900595Data as of May 2026

Treatment: Cabozantinib · CemiplimabThis 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.

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Extracted eligibility criteria

Cancer type

Tumor Agnostic

Disease stage

Required: Stage III, IV, STAGE III, STAGE IV (AJCC v8)

Locally advanced unresectable or recurrent/metastatic disease

Performance status

ECOG/LANSKY/KARNOFSKY 0–2

ECOG performance 0 - 2 (age 18 and above); Lansky scale ≥ 50 (12 to <16 years); Karnofsky scale ≥ 50 (≥16 to <18 years)

Prior therapy

Max 3 prior lines
Min 0 prior lines

Cannot have received: cMET inhibitor (cabozantinib)

No prior treatment with cabozantinib or other cMET inhibitors

Cannot have received: anti-CTLA-4 therapy

No prior treatment with anti-CTLA-4

Cannot have received: anti-PD-1 therapy

No prior treatment with anti-PD-1/PD-L1 therapy

Cannot have received: anti-PD-L1 therapy

No prior treatment with anti-PD-1/PD-L1 therapy

Lab requirements

Blood counts

ANC ≥ 1,000/mcL; Platelet count ≥ 100,000/mcL; Hemoglobin ≥ 8 g/dL

Kidney function

Random Urine Creatinine Ratio (UPCR) ≤ 1 mg/mg; Calculated creatinine clearance ≥ 30 mL/min

Liver function

Total bilirubin ≤ 1.5 x ULN (≤ 3 mg/dL for Gilbert's); AST/ALT ≤ 3 x ULN

Cardiac function

NYHA class II or better if cardiac history; no congenital long QT syndrome; no myocarditis; no MI or unstable angina within 6 months

ANC ≥ 1,000/mcL; Platelet count ≥ 100,000/mcL; Hemoglobin ≥ 8 g/dL; Total bilirubin ≤ 1.5 x ULN (≤ 3 mg/dL for Gilbert's); AST/ALT ≤ 3 x ULN; UPCR ≤ 1 mg/mg; Creatinine clearance ≥ 30 mL/min; NYHA class II or better if cardiac history

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • UC San Diego Moores Cancer Center · La Jolla, California
  • Lurie Children's Hospital-Chicago · Chicago, Illinois
  • Northwestern University · Chicago, Illinois
  • Northwestern Medicine Cancer Center Kishwaukee · DeKalb, Illinois
  • Northwestern Medicine Cancer Center Delnor · Geneva, Illinois

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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