A Phase II Trial of Pembrolizumab and Cabozantinib in Patients with RM SCCHN
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.
Primary Objectives: Run in phase: To determine the safety and tolerability of pembrolizumab and cabozantanib in patients with recurrent and/or metastatic SCCHN who have failed platinum and cetuximab. Phase II: To estimate the overall response rate (ORR) of patients with RM SCCHN who receive the combination of pembrolizumab and cabozantanib Secondary Objectives: To estimate the progression free survival of patients treated with the combination of pembrolizumab and cabozantanib To identify potential biomarkers related to response to the combination of pembrolizumab and cabozantanib in patients recurrent and/or metastatic SCCHN. Specifically, to evaluate whether markers of angiogenesis, Met or pMet expression, or inflammatory activation can predict response to the combination or PFS
Cabozantinib (XL 184); Pembrolizumab (Keytruda)
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