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Alisertib + Pembrolizumab for Head and Neck Cancer
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
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- 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.
- Group 1: Treatment (alisertib, pembrolizumab)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
Frequently Asked Questions
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."
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."
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."
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."
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