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Protein Kinase Inhibitor

Alisertib + Pembrolizumab for Head and Neck Cancer

Phase 1 & 2
Waitlist Available
Led By Faye M Johnson, MD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Front line therapy for those who cannot tolerate chemotherapy per the judgement of the treating physician
As second line or greater line of therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights

Study Summary

This trial is investigating the best dose and effect of the drug alisertib when given together with another drug, pembrolizumab, to treat patients with a type of head and neck cancer that is lacking a protein called Rb. Alisertib may help by blocking the growth of cancer cells. Immunotherapy with monoclonal antibodies, such as pembrolizumab, helps the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Giving alisertib together with pembrolizumab may help control Rb-deficient head and neck

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Possible side effects include reactions related to the immune system attacking normal organs (autoimmune reactions), infusion-related reactions from Pembrolizumab, as well as fatigue, nausea, blood count changes from Alisertib. Each patient's experience with side effects can vary.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My doctor thinks I can't handle chemotherapy as a first treatment.
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My treatment is not the first attempt to manage my condition.
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My kidney function is good, with a creatinine clearance rate of at least 30 ml/min.
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I have a confirmed diagnosis of an advanced solid tumor with no standard treatment options.
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My hemoglobin level is above 9 g/dL without recent blood transfusions.
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My head or neck cancer is HPV positive, confirmed by a specific test.
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I can take medication by mouth or through a feeding tube.
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My tumor is PD-L1 positive and suitable for pembrolizumab as a first treatment.
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I have not received treatments targeting the immune system like nivolumab or pembrolizumab.
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I am a woman who is either postmenopausal, surgically sterile, using reliable birth control methods, or practicing true abstinence.
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My throat cancer lacks the Rb protein and cannot be cured with standard treatments.
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My tumor does not express the Rb protein.
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I am a male willing to use effective contraception or practice true abstinence during and up to 120 days after the study.
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I can take care of myself but might not be able to do heavy physical work.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
(Overall response rate [ORR]) (Phase II)
Maximum tolerated dose (Phase I)
Progression free survival (PFS) (Phase II)

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (alisertib, pembrolizumab)Experimental Treatment2 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Alisertib
2010
Completed Phase 2
~1140
Pembrolizumab
2017
Completed Phase 2
~1950

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,958 Previous Clinical Trials
1,798,245 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,607 Previous Clinical Trials
40,914,138 Total Patients Enrolled
Faye M Johnson, MDPrincipal InvestigatorM.D. Anderson Cancer Center

Media Library

Alisertib (Protein Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04555837 — Phase 1 & 2
Cancer Research Study Groups: Treatment (alisertib, pembrolizumab)
Cancer Clinical Trial 2023: Alisertib Highlights & Side Effects. Trial Name: NCT04555837 — Phase 1 & 2
Alisertib (Protein Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04555837 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any other trials on record that have examined the effects of Pembrolizumab?

"Currently, 967 trials for Pembrolizumab are in operation. Of this number, 122 of them are at Phase 3 and over 35000 locations worldwide are running associated studies. Houston, Texas is the primary site for these investigations."

Answered by AI

What is the sample size of this trial?

"Affirmative. Clinicaltrials.gov reveals that the trial is actively searching for volunteers, with an initial post date of September 15th 2020 and a last modified date of June 10th 2022. 47 individuals are sought from 1 medical centre to partake in this experiment."

Answered by AI

What ailment is Pembrolizumab commonly prescribed to address?

"Pembrolizumab is commonly used to treat malignant neoplasms, yet it has applications for treating other medical issues like unresectable melanoma and disease progression after chemotherapy. Additionally, this drug may be beneficial for patients with microsatellite instability high."

Answered by AI

Is this research experiment still recruiting participants?

"Affirmative. According to records present on clinicaltrials.gov, this research is currently in recruitment mode since September 15th 2020 and has been updated as of June 10th 2022. 47 participants are being sought from a single site for the trial's duration."

Answered by AI
~6 spots leftby May 2025