Alisertib + Pembrolizumab for Head and Neck Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This phase I/II trial investigates the best dose and effect of alisertib in combination with pembrolizumab in treating patients with Rb-deficient head and neck squamous cell cancer. Alisertib may help block the growth of cancer.. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Giving alisertib in combination with pembrolizumab may help control Rb-deficient head and neck squamous cell cancer. HPV positive head and neck cancers are Rb-deficient.
Who Is on the Research Team?
Faye M. Johnson
Principal Investigator
M.D. Anderson Cancer Center
Are You a Good Fit for This Trial?
This trial is for patients with Rb-deficient head and neck squamous cell cancer, who have no standard curative therapy available. They must not have had prior treatments that target PD-1/PD-L1 or similar immune pathways, should be in a relatively stable condition (ECOG <=2), and able to swallow medication. Women of childbearing potential and men must agree to use contraception.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive alisertib orally twice daily on days 1-7 and pembrolizumab intravenously on day 1. Cycles repeat every 21 days.
Follow-up
Participants are monitored for safety and effectiveness after treatment completion every 2-3 months.
What Are the Treatments Tested in This Trial?
Interventions
- Alisertib
- Pembrolizumab
Alisertib is already approved in United States, European Union for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
M.D. Anderson Cancer Center
Lead Sponsor
National Cancer Institute (NCI)
Collaborator