Symptoms and General Pathology

All Conditions

Neoplasms

Recurrence

Head and Neck Neoplasms

Antineoplastic Agents

All Drugs and Chemicals

Pembrolizumab

Immunomodulating Agents

Patients with metastatic or recurrent head and neck cancer who have not been treated previously with immunotherapy.

Patients with metastatic or recurrent head and neck cancer who have been treated previously with immunotherapy.

Abemaciclib 150mg by mouth twice daily Pembrolizumab 200mg IV every 3 weeks

Cohort 1 Not Previously Treated

Cohort 2 Treated Previously

Eddy Yang, MD

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.

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.

Abemaciclib and Pembrolizumab in Metastatic or Recurrent Head and Neck Cancer

Clinical Trial of Abemaciclib in Combination With Pembrolizumab in Patients With Metastatic or Recurrent Head and Neck Cancer

Patients will be evaluated for their tumor response to treatment using RECIST criteria on their scans

Measure adverse events grade 3 or greater to evaluate safety and tolerability

Using scan results to assess whether tumor has progressed and the time;

time that the patient is experiencing survival

using scan results to assess the time it takes for the tumor to respond to treatment

using scan results to measure the total amount of time that the tumor is responding to treatment

University of Alabama at Birmingham

Primary Investigator

Since study terminated prematurely due to toxicity from other trials with this combination, there were no SAEs and no mortality observed

Patients with metastatic or recurrent head and neck cancer who have not been treated previously with immunotherapy.

Cohort 1 Not Previously Treated: Abemaciclib 150mg by mouth twice daily Pembrolizumab 200mg IV every 3 weeks

Patients with metastatic or recurrent head and neck cancer who have been treated previously with immunotherapy.

Cohort 2 Treated Previously: Abemaciclib 150mg by mouth twice daily Pembrolizumab 200mg IV every 3 weeks

Total

Age, Categorical

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

study terminated prematurely due to toxicity from other trials with this combination

Eddy S. Yang

No analysis was performed since study terminated prematurely due to toxicity from other trials with this combination

Spots Global Cancer Trial Database for cohort 1 not previously treated