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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.