Conditions: Head and Neck Cancer
Keywords: immunotherapy abemaciclib pembrolizumab Cyclin-Dependent Kinase (CDK): CDK4 Cyclin-Dependent Kinase (CDK): CDK6
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1
Healthy volunteers: no

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.

Arms:
arm 1: Patients with metastatic or recurrent head and neck cancer who have not been treated previously with immunotherapy. arm 2: Patients with metastatic or recurrent head and neck cancer who have been treated previously with immunotherapy.

Interventions: intervention 1: Cohort 1 Not Previously Treated intervention 2: Cohort 2 Treated Previously
Intervention descriptions: intervention 1: Abemaciclib 150mg by mouth twice daily Pembrolizumab 200mg IV every 3 weeks intervention 2: Abemaciclib 150mg by mouth twice daily Pembrolizumab 200mg IV every 3 weeks

Protocol document:
Prot_SAP_000.pdf: