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A Phase II Trial of Pembrolizumab and Cabozantinib in Patients with RM SCCHN Who Have Failed Platinum Based Therapy

Status
Active
Cancer Type
Head and Neck Cancer
Oral Cancer
Skin Cancer (Non-Melanoma)
Unknown Primary
Trial Phase
Phase II
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCD ID
NCT03468218
Protocol IDs
Winship4234-17 (primary)
NCI-2017-02419
IRB00100269
Study Sponsor
Emory University Hospital / Winship Cancer Institute

Summary

This phase II trial studies how well pembrolizumab and cabozantinib work 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. Cabozntinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving pembrolizumab and cabozantinib may work better in treating patients with head and neck squamous cell cancer.

Objectives

PRIMARY OBJECTIVES:
I. 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:
I. To estimate the progression-free survival (PFS) of patients treated with the combination of pembrolizumab and cabozantinib.
II. To identify potential biomarkers related to response to the combination of pembrolizumab and cabozantinib in patients with RM SCCHN.
III. To evaluate whether markers of angiogenesis, Met or pMet expression, or inflammatory activation can predict response to the combination or PFS.
IV. 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 cMET, pMET, HGF, HER2, HER3 and heregulin messenger ribonucleic acid [mRNA] level).
V. 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 at 30-37 days and 1 and 2 years.
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