Phase II Open Label, Single-Arm Study of Cabozantinib in Combination With Pembrolizumab in the Treatment of Locally Advanced or Metastatic Adrenocortical Carcinoma
Emory University
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.
Description
PRIMARY OBJECTIVE: I. To evaluate the anti-tumor activity of the combination of cabozantinib S-malate (cabozantinib) and pembrolizumab by assessing the overall response rate (ORR) as measured by Response Evaluation Criteria in Solid Tumors (RECIST 1.1.). SECONDARY OBJECTIVE: I. To evaluate the efficacy of the combination of cabozantinib and pembrolizumab as measured by progression free survival and overall survival assessed up to 2 years, safety and tolerability of the combination. TERTIARY/EXPLORATORY OBJECTIVE: I. To assess tissue-based assays in archival tissue and correlative changes…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 t…
Interventions
- BiologicalPembrolizumab
Given IV
- ProcedureBiospecimen Collection
Undergo collection of blood samples
- DrugCabozantinib S-malate
Given PO
- ProcedureComputed Tomography
Undergo CT
- ProcedureMagnetic Resonance Imaging
Undergo MRI
Locations (2)
- Emory University Hospital MidtownAtlanta, Georgia
- Emory University Hospital/Winship Cancer InstituteAtlanta, Georgia