Alisertib + Pembrolizumab for Head and Neck Cancer

Recruiting in Palo Alto (17 mi)

Overseen by Faye M. Johnson

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: M.D. Anderson Cancer Center

No Placebo Group

Breakthrough Therapy

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 (Protein Kinase Inhibitor)
• Pembrolizumab (Checkpoint Inhibitor)

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.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Dr. Peter WT Pisters

M.D. Anderson Cancer Center

Chief Executive Officer since 2017

MD from University of Western Ontario

Dr. Jeffrey E. Lee

M.D. Anderson Cancer Center

Chief Medical Officer

MD from Stanford University School of Medicine

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School