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Brief Title: Abemaciclib and Pembrolizumab in Metastatic or Recurrent Head and Neck Cancer
Official Title: Clinical Trial of Abemaciclib in Combination With Pembrolizumab in Patients With Metastatic or Recurrent Head and Neck Cancer
Study ID: NCT03938337
Brief Summary: To assess the objective response rate of tumor lesions to abemaciclib in combination with pembrolizumab in patients with metastatic or recurrent squamous cell carcinoma of head and neck.
Detailed Description: Immunotherapy has been recently approved for patients with metastatic or recurrent squamous cell carcinoma of the head and neck. However, only a small percentage of patients experience long-term control, necessitating new therapeutic strategies. Recently, it was shown preclinically and in breast tumors that abemaciclib stimulates production of type III interferons and hence enhances tumor antigen presentation. Abemaciclib also suppressed the proliferation of regulatory T cells. These events promote cytotoxic T-cell-mediated clearance of tumor cells, which is further enhanced by the addition of immune checkpoint blockade. Based on these data, a phase II trial in patients with metastatic or recurrent head and neck cancer who are eligible for immunotherapy is proposed to investigate the combination of abemaciclib with pembrolizumab. Tumor \& blood analysis for interferon gamma signature will be explored as possible biomarkers.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
University of Alabama at Birmingham, Birmingham, Alabama, United States
Name: Eddy Yang, MD
Affiliation: University of Alabama at Birmingham
Role: PRINCIPAL_INVESTIGATOR