24 Participants Needed

Alisertib + Pembrolizumab for Head and Neck Cancer

FM
Overseen ByFaye 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
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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?

FM

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

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.
See 18 more

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.
See 21 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive alisertib orally twice daily on days 1-7 and pembrolizumab intravenously on day 1. Cycles repeat every 21 days.

Approximately 33 months

Follow-up

Participants are monitored for safety and effectiveness after treatment completion every 2-3 months.

Approximately 33 months

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Treatment (alisertib, pembrolizumab)Experimental Treatment2 Interventions

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

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Approved in United States as Alisertib for:
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Approved in European Union as Alisertib for:

Find a Clinic Near You

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+
Unbiased ResultsWe believe in providing patients with all the options.
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