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Protein Kinase Inhibitor

Alisertib + Pembrolizumab for Head and Neck Cancer

Phase 1 & 2

Waitlist Available

Led By Faye M Johnson

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

As second line or greater line of therapy

Rb deficient HNSCC includes Clinical Laboratory Improvement Act (CLIA)-certified testing confirming one of the following: Human papillomavirus (HPV) positive as determined by any one of the following: p16 immunohistochemistry (IHC), HPV ribonucleic acid (RNA) in situ hybridization (ISH), RNAscope (messenger RNA [mRNA] ISH), deoxyribonucleic acid (DNA) ISH, DNA polymerase chain reaction (PCR), or quantitative reverse transcriptase PCR (qRT PCR)

Must not have

Known gastrointestinal (GI) disease or GI procedures that could interfere with the oral absorption or tolerance of alisertib. Examples include, but are not limited to partial gastrectomy, history of small intestine surgery, and celiac disease

Patients who are on (or will require) prolonged systemic corticosteroid treatment during the study except for replacement dosing for adrenal insufficiency

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

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.

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.

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 treatment is not the first attempt to manage my condition.

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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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My tumor does not express the Rb protein.

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I can take care of myself but might not be able to do heavy physical work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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

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I do not have any severe health or mental conditions that could affect my participation.

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I haven't had a heart attack in the last 6 months and don't have severe heart issues.

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I haven't had major surgery in the last 28 days or still have mild side effects.

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I have conditions like severe sleep apnea or COPD that make me very sleepy during the day.

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I have received radiation therapy to a large portion of my bone marrow.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

(Overall response rate [ORR]) (Phase II)

Maximum tolerated dose (Phase I)

Progression free survival (PFS) (Phase II)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

Pembrolizumab

2017

Completed Phase 3

~3150

Alisertib

2010

Completed Phase 2

~1260