OncoMatch/Clinical Trials/NCT06006013
Cabozantinib in Combination With Pembrolizumab for the Treatment of Patients With Locally Advanced, Metastatic, or Unresectable Adrenal Cortical Cancer
Is NCT06006013 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Pembrolizumab and Cabozantinib S-malate for locally advanced adrenal cortex carcinoma.
Treatment: Pembrolizumab · Cabozantinib S-malate — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Tumor Agnostic
Disease stage
Required: Stage III, IV (AJCC v8)
Locally advanced, metastatic, or unresectable adrenal cortical carcinoma. Measurable disease per RECIST v1.1.
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: small molecule kinase inhibitor
Receipt of any type of small molecule kinase inhibitor including investigational kinase inhibitor within 2 weeks before first dose of study treatment
Cannot have received: CD137 agonist
Prior treatment with CD137 agonists
Cannot have received: immune checkpoint blockade therapy
Prior treatment with immune checkpoint blockade therapies, including anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies
Cannot have received: cytotoxic, biologic or other systemic anticancer therapy
Receipt of any type of cytotoxic, biologic or other systemic anticancer therapy (including immunostimulatory agents or investigational agents) within 4 weeks or 5 half-lives of the drug (whichever is longer) before first dose of study treatment
Cannot have received: radiation therapy
Radiation therapy for bone metastasis within 2 weeks or any other radiation therapy within 4 weeks before first dose of study treatment. Systemic treatment with radionuclides within 6 weeks before first dose of study treatment.
Cannot have received: mitotane (mitotane)
Exception: Mitotane must have been discontinued 28 days prior to first dose of study treatment, with mitotane serum level < 2 mg/L if mitotane administered within last 6 months
Concomitant mitotane use
Lab requirements
Blood counts
ANC ≥ 1500/uL without G-CSF support; lymphocyte count ≥ 0.5 x 10^9/L; WBC ≥ 2500/uL; platelets ≥ 100,000/uL without transfusion; hemoglobin ≥ 9 g/dL (may be transfused to meet criterion)
Kidney function
Serum creatinine ≤ 1.5 x ULN or calculated creatinine clearance ≥ 40 mL/min; urine protein/creatinine ratio ≤ 1 mg/mg or 24-h urine protein ≤ 1 g
Liver function
ALT, AST, ALP ≤ 3 x ULN (ALP ≤ 5 x ULN with documented bone metastases); total bilirubin ≤ 1.5 x ULN (≤ 3 x ULN for Gilbert's disease); serum albumin ≥ 2.8 g/dl
Cardiac function
PT/INR or PTT < 1.3 x ULN; QTcF ≤ 500 ms
ANC ≥ 1500/uL without granulocyte colony-stimulating factor support; lymphocyte count 0.5 x 10^9/L; WBC ≥ 2500/uL; platelets ≥ 100,000/uL without transfusion; hemoglobin ≥ 9 g/dL (may be transfused); ALT, AST, ALP ≤ 3 x ULN (ALP ≤ 5 x ULN with documented bone metastases); total bilirubin ≤ 1.5 x ULN (≤ 3 x ULN for Gilbert's disease); serum albumin ≥ 2.8 g/dl; PT/INR or PTT < 1.3 x ULN; serum creatinine ≤ 1.5 x ULN or calculated creatinine clearance ≥ 40 mL/min; urine protein/creatinine ratio ≤ 1 mg/mg or 24-h urine protein ≤ 1 g; QTcF ≤ 500 ms
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Emory University Hospital Midtown · Atlanta, Georgia
- Emory University Hospital/Winship Cancer Institute · Atlanta, Georgia
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