Alisertib + Pembrolizumab for Head and Neck Cancer

Overseen By Faye M Johnson, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: M.D. Anderson Cancer Center

Must be taking: PD-1/PD-L1 checkpoint blockade

Must not be taking: Proton pump inhibitors

Disqualifiers: Organ transplant, Uncontrolled infection, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

24 Participants Needed

Trial Summary

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.

Research Team

Faye M. Johnson

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

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

My doctor thinks I can't handle chemotherapy as a first treatment.

My treatment is not the first attempt to manage my condition.

My kidney function is good, with a creatinine clearance rate of at least 30 ml/min.

Exclusion Criteria

I will not donate sperm during the study or for 120 days after the last dose.

I have a GI condition or had surgery that may affect medication absorption.

I am on long-term steroids not just for adrenal replacement.

Treatment Details

Interventions

• Alisertib
• Pembrolizumab

Trial Overview The trial is testing the combination of Alisertib, which may block cancer growth, with Pembrolizumab, an immunotherapy drug that helps the immune system attack tumors. It's designed to see what doses are best and how effective this combo is against head and neck cancers lacking the Rb protein.

Participant Groups

Group I: Treatment (alisertib, pembrolizumab) Experimental Treatment 2 Interventions

Patients receive alisertib PO BID on days 1-7 and pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Alisertib is already approved in United States, European Union for the following indications:

Approved in United States as Alisertib for:

• Acute myeloid leukemia (AML)

Approved in European Union as Alisertib for:

• None approved; under investigation for various cancers

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+