Cabozantinib in Combination With Pembrolizumab for the Treatment of Patients With Locally Advance… (NCT06006013) | Clinical Trial Compass
RecruitingPhase 2
Cabozantinib in Combination With Pembrolizumab for the Treatment of Patients With Locally Advanced, Metastatic, or Unresectable Adrenal Cortical Cancer
United States21 participantsStarted 2025-01-15
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Male or female
* Age \>= 18 years
* Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 ,Karnofsky \>= 50%.
* Metastatic disease or unresectable locally advanced disease.
* Histologically documented adrenal cortical carcinoma.
* Untreated or having received any number of lines of prior therapy.
* Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1
* Life expectancy \>= 12 weeks
* Tumor tissue samples must be available for submission prior to initiation of study treatment. If not, agree to undergo biopsy.
* Recovery to baseline or =\< grade 1 Common Terminology Criteria for Adverse Events (CTCAE) version 5 from toxicities related to any prior treatments, unless adverse event (AE)(s) are clinically nonsignificant and/or stable on supportive therapy.
* Absolute neutrophil count (ANC) \>= 1500/uL without granulocyte colony-stimulating factor support within 28 days before first dose of study treatment.
* Lymphocyte count 0.5 x 10\^9/L (500/mL) within 28 days before first dose of study treatment.
* White blood cell count \>= 2500/uL within 28 days before first dose of study treatment.
* Platelets \>= 100,000/uL without transfusion within 28 days before first dose of study treatment.
* Hemoglobin \>= 9 g/dL (\>= 90 g/L). Patients may be transfused to meet this criterion within 28 days before first dose of study treatment.
* Alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phos…