Last updated on March 2019

Pembrolizumab & Cabozantinib in Patients With Head and Neck Squamous Cell Cancer Who Have Failed Platinum Based Therapy


Brief description of study

This phase II trial studies how well pembrolizumab and cabozantinib in treating patients with head and neck squamous cell cancer that has come back or spread to other places in the body and cannot be removed by surgery. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of tumor cells to grow and spread. Cabozantinib may stop the growth of tumor cells by blocking some of the pathways needed for cell growth. Giving pembrolizumab and cabozantinib may improve the chances of tumor response in patients with head and neck squamous cell cancer.

Detailed Study Description

PRIMARY OBJECTIVE:

To estimate the overall response rate (ORR) of patients with recurrent/metastatic (RM) squamous cell carcinoma of the head and neck (SCCHN) who receive the combination of pembrolizumab and cabozantinib.

SECONDARY OBJECTIVES:

  • To estimate the progression-free survival (PFS) of patients treated with the combination of pembrolizumab and cabozantinib.
  • To identify potential biomarkers related to response to the combination of pembrolizumab and cabozantinib in patients with RM SCCHN.
  • To evaluate whether markers of angiogenesis, Met or pMet expression, or inflammatory activation can predict response to the combination or PFS.
  • To gather exploratory clinical data on a potentially predictive set of biomarkers (potential biomarkers include MET expression by fluorescence in situ hybridization [FISH], next generation sequencing [NGS] and immunohistochemistry [IHC]/immunofluorescence [IHF] of MET proto-oncogene (cMET), phosphorylated cMET (pMET), hepatocyte growth factor (HGF), human epidermal growth factor receptor 2 (HER2), human epidermal growth factor receptor 3 (HER3) and heregulin messenger ribonucleic acid [mRNA] level).
  • To further define the toxicities associated with these regimens in patients with SCCHN.
    OUTLINE

Patients receive pembrolizumab intravenously (IV) over 30 minutes on day 1 and cabozantinib orally (PO) once daily (QD) on days 1-21. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up to 2 years.

Clinical Study Identifier: NCT03468218

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Recruitment Status: Open


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