Pembrolizumab and Cabozantinib in Treating Patients with Recurrent or Metastatic Head and Neck Squamous Cell Cancer That Cannot Be Removed by Surgery

Active:	Yes
Cancer Type:	Head and Neck Cancer	NCT ID:	NCT03468218
Trial Phases:	Phase II	Protocol IDs:	Winship4234-17 (primary) NCI-2017-02419 IRB00100269
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Emory University Hospital/Winship Cancer Institute
NCI Full Details:	http://clinicaltrials.gov/show/NCT03468218

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 (recurrent) or spread to other places in the body (metastatic) and cannot be removed by surgery. 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. 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 OBJECTIVE:
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 S-malate (cabozantinib).

SECONDARY OBJECTIVES:
I. To estimate the progression-free survival (PFS) of patients treated with the combination of pembrolizumab and cabozantinib.
II. To further define the toxicities associated with these regimens in patients with SCCHN.

EXPLORATORY OBJECTIVES:
I. To identify potential biomarkers related to response to the combination of pembrolizumab and cabozantinib in patients with RM SCCHN.
II. To evaluate whether markers of angiogenesis, hypoxia, Met or pMet expression or inflammatory activation can predict response to the combination or PFS.
III. 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).
IV. To evaluate circulating cell-free deoxyribonucleic acid (cfDNA) in plasma and its association with response to the combination or PFS.
V. To evaluate potential neoantigens in the tumor deoxyribonucleic acid (DNA), their expression, and their association with response to the combination or PFS.
VI. To evaluate peripheral blood mononuclear cells (PBMC) for immune monitoring and their association with response to the combination or PFS.
VII. To determine a quantitative radiomics based on computed tomography (CT) and/or positron emission tomography (PET) images as a prognostic biomarker in recurrent or metastatic HNSCC.
VIII. To determine a computational pathology (or pathomics) based prognostic marker from standard digitized hematoxylin and eosin (H&E) images of the tumor in recurrent or metastatic HNSCC.

OUTLINE:
Patients receive pembrolizumab intravenously (IV) over 30 minutes on day and cabozantinib S-malate orally (PO) once daily (QD) on days 1-21. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients undergo computed tomography (CT) scan, magnetic resonance imaging (MRI) or positron emission tomography (PET) scan and blood sample collection throughout the study.

After completion of study treatment, patients are followed up at 30-37 days and 1 and 2 years.

Treatment Sites in Georgia

Emory University Hospital - Midtown
550 Peachtree Street NE
Atlanta, GA 30308
404-686-4411
www.emoryhealthcare.org

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