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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)
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
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
Pembrolizumab
2017
Completed Phase 2
~2010
Alisertib
2010
Completed Phase 2
~1140
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,987 Previous Clinical Trials
1,797,990 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,717 Previous Clinical Trials
40,953,339 Total Patients Enrolled
Faye M JohnsonPrincipal InvestigatorM.D. Anderson Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My doctor thinks I can't handle chemotherapy as a first treatment.I will not donate sperm during the study or for 120 days after the last dose.My treatment is not the first attempt to manage my condition.I have a GI condition or had surgery that may affect medication absorption.My kidney function is good, with a creatinine clearance rate of at least 30 ml/min.I am on long-term steroids not just for adrenal replacement.I have an autoimmune disease but it's either vitiligo, type I diabetes, hypothyroidism needing only hormone therapy, or psoriasis not needing systemic treatment.I need ongoing medication for stomach acid or pancreatic enzymes.I have not had serious metabolic acidosis in the past.You are unable to swallow pills or follow the instructions for taking alisertib.I have a confirmed diagnosis of an advanced solid tumor with no standard treatment options.My hemoglobin level is above 9 g/dL without recent blood transfusions.My head or neck cancer is HPV positive, confirmed by a specific test.I do not have active lung disease or a history of it that required strong immune-suppressing drugs recently.You are already taking part in another medical study to treat a health condition.I can take medication by mouth or through a feeding tube.You agree to give a blood and tissue sample for research purposes.I am not pregnant or breastfeeding, confirmed by a negative pregnancy test.I do not have any severe health or mental conditions that could affect my participation.My tumor is PD-L1 positive and suitable for pembrolizumab as a first treatment.I haven't had a heart attack in the last 6 months and don't have severe heart issues.I have not received treatments targeting the immune system like nivolumab or pembrolizumab.I have HIV, hepatitis B, or hepatitis C but it is under control.I had brain radiation or gamma knife surgery and am stable without needing steroids or seizure meds.I am a woman who is either postmenopausal, surgically sterile, using reliable birth control methods, or practicing true abstinence.My throat cancer lacks the Rb protein and cannot be cured with standard treatments.I do not have severe health issues that would stop me from joining the study.I haven't had major surgery in the last 28 days or still have mild side effects.I haven't taken any cancer treatment or experimental drugs in the last 21 days.I haven't had or been treated for cancer, except for certain skin cancers or low-risk prostate cancer, in the last 2 years.My tumor does not express the Rb protein.I have conditions like severe sleep apnea or COPD that make me very sleepy during the day.You have received a bone marrow or organ transplant from someone else in the past.I am a male willing to use effective contraception or practice true abstinence during and up to 120 days after the study.I have received radiation therapy to a large portion of my bone marrow.I do not plan to donate eggs during or within 120 days after the study.I have not received a live vaccine in the last 30 days.I can take care of myself but might not be able to do heavy physical work.You are allergic to the ingredients in the alisertib enteric coated tablets or have had a severe reaction to any human monoclonal antibody.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (alisertib, pembrolizumab)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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