Alisertib + Pembrolizumab for Head and Neck Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores the effectiveness of combining two drugs, alisertib and pembrolizumab, for treating head and neck cancer. Alisertib aims to stop cancer cells from growing, while pembrolizumab, an immunotherapy, helps the immune system attack cancer cells. The trial seeks participants with Rb-deficient head and neck cancer, particularly those who have not found success with other treatments. Participants should have previously tried treatments like PD-1 or PD-L1 therapies and experienced cancer progression. As a Phase 1, Phase 2 trial, this research focuses on understanding the treatment's effects in people and measuring its effectiveness in an initial, smaller group, offering participants a chance to contribute to groundbreaking cancer treatment advancements.
Do I need to stop my current medications for the trial?
The trial protocol does not specify if you need to stop your current medications. However, certain medications like proton pump inhibitors and systemic corticosteroids are restricted during the study. It's best to discuss your specific medications with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that using alisertib with pembrolizumab may help treat certain cancers. Studies have found that this combination is generally well-tolerated, though it can have side effects.
For alisertib, individuals with liver problems might experience higher drug levels in their bodies, potentially leading to more side effects. In other cases, the side effects are manageable. Pembrolizumab, already used for other cancers, is usually safe but can cause immune-related side effects due to increased immune activity.
Overall, past research suggests that the combination is tolerable. It is important to consult a doctor to understand personal risks and benefits.12345Why are researchers excited about this study treatment for head and neck cancer?
Researchers are excited about alisertib combined with pembrolizumab for head and neck cancer because this duo targets cancer in a new way. Alisertib is a unique drug that blocks a protein called Aurora A kinase, which helps cancer cells divide and grow. Pembrolizumab is an immune therapy that boosts the body's ability to fight cancer by targeting a checkpoint protein called PD-1. Together, these treatments could potentially stop cancer growth more effectively than current treatments, which often include chemotherapy and radiation, by both blocking cancer cell growth and enhancing the immune response.
What evidence suggests that alisertib and pembrolizumab might be an effective treatment for head and neck cancer?
This trial will evaluate the combination of alisertib and pembrolizumab for managing Rb-deficient head and neck cancers. Research has shown that this combination might help manage these cancers, which lack a protein that usually controls cell growth. Early tests suggest that alisertib, which blocks a protein called Aurora kinase A, can enhance the effectiveness of immune-based treatments like pembrolizumab. Some patients who no longer responded to other treatments found their cancer stopped growing with this combination. Cancers missing the Rb protein seem to depend on Aurora kinases to survive, so blocking them might be a promising strategy. Overall, this combination holds promise for these difficult-to-treat cancers.23678
Who Is on the Research Team?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive alisertib orally twice daily on days 1-7 and pembrolizumab intravenously on day 1. Cycles repeat every 21 days.
Follow-up
Participants are monitored for safety and effectiveness after treatment completion every 2-3 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?
1
Treatment groups
Experimental Treatment
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.
Alisertib is already approved in United States, European Union for the following indications:
- Acute myeloid leukemia (AML)
- None approved; under investigation for various cancers
Find a Clinic Near You
Who Is Running the Clinical Trial?
M.D. Anderson Cancer Center
Lead Sponsor
National Cancer Institute (NCI)
Collaborator
Citations
Phase I/II Study of the Aurora Kinase A Inhibitor Alisertib and ...
The combination of alisertib and pembrolizumab was well tolerated and led to prolonged SD in some immunotherapy-resistant patients, ...
Alisertib and Pembrolizumab for the Treatment of Patients ...
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- ...
3.
aacrjournals.org
aacrjournals.org/clincancerres/article/31/3/479/751211/Phase-I-II-Study-of-the-Aurora-Kinase-A-InhibitorPhase I/II Study of the Aurora Kinase A Inhibitor Alisertib and ...
Data from preclinical models suggest that inhibition of Aurora kinase A (AURKA; Aurora A) may enhance the efficacy of ICI in patients with HPV-positive HNSCC.
Phase I/II Study of the Aurora Kinase A Inhibitor Alisertib ...
Purpose Effective therapy for recurrent head and neck squamous cell carcinoma (HNSCC) that is refractory to chemotherapy and immunotherapy ...
5.
aacrjournals.org
aacrjournals.org/mct/article/22/12_Supplement/LB_C12/730612/Abstract-LB-C12-Alisertib-and-pembrolizumab-in-RbAbstract LB_C12: Alisertib and pembrolizumab in Rb-deficient ...
Preclinical studies demonstrate that cancers with retinoblastoma (Rb) loss are dependent upon Aurora kinases for survival.
Phase 1/2 Study of the Aurora Kinase A Inhibitor Alisertib and ...
Purpose: Effective therapy for recurrent head and neck squamous cell carcinoma (HNSCC) that is refractory to chemotherapy and immunotherapy is a ...
Population Pharmacokinetics and Exposure‐Safety ...
Adult patients with moderate or severe hepatic impairment have ≈150% higher unbound alisertib exposures compared with patients with normal hepatic function. A ...
Alisertib MDACC
Subsequently, flat dose-exposure response relationships were also observed in other tumor types including head and neck cancer, bladder cancer, ...
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