Decitabine + Nivolumab for Head and Neck Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a combination of two drugs, decitabine and nivolumab, for head and neck cancer that has returned or spread and cannot be cured with standard treatments. Decitabine, typically used for another cancer type, stops cancer cells from growing. Nivolumab, an immunotherapy drug, helps the immune system attack the cancer. The trial aims to evaluate how well these drugs work together and determine the safest dose. People with head and neck cancer in the mouth, throat, or voice box, who have not received certain treatments before, might be suitable candidates. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to be among the first to receive this innovative combination therapy.
Do I have to stop taking my current medications to join the trial?
The trial information does not specify if you need to stop taking your current medications. However, it does mention that participants should not have received prior treatment with immune checkpoint inhibitors and should not be on systemic immunosuppressant medications within 2 weeks before starting the study drugs. It's best to discuss your specific medications with the trial team.
Is there any evidence suggesting that this treatment is likely to be safe for humans?
Previous studies have examined the safety of using decitabine and nivolumab together for people with head and neck cancer. The FDA has approved decitabine for other conditions, indicating prior safety testing. This trial tests its use specifically for head and neck cancer. Nivolumab is already approved for treating this cancer type, confirming its safety for these patients.
Research shows that while nivolumab is well understood, the combination with decitabine is still under study. The goal of using both drugs together is to enhance the immune system's ability to fight cancer. Patients generally tolerate nivolumab well, though some may experience side effects like tiredness or a rash. Decitabine can cause low blood cell counts, so doctors monitor patients closely.
This trial is in its early stages, focusing on the safety of the combination and determining optimal doses. Since the FDA has approved decitabine for other uses, it suggests potential safety, but more information is needed for this specific use. Trial participants will help gather important safety information.12345Why are researchers excited about this study treatment for head and neck cancer?
Researchers are excited about the combination of Decitabine and Nivolumab for treating head and neck cancer because it offers a novel approach compared to standard therapies like surgery, radiation, and chemotherapy. Decitabine is a DNA methylation inhibitor, which can make cancer cells more recognizable to the immune system, while Nivolumab is an immune checkpoint inhibitor that helps activate the immune system to attack cancer cells more effectively. This dual-action strategy could enhance the immune response against cancer, potentially leading to better outcomes for patients. Unlike traditional treatments that directly target cancer cells, this combination leverages the body's own immune system to fight the disease, offering a promising new avenue for treatment.
What evidence suggests that this treatment might be an effective treatment for head and neck cancer?
Studies have shown that nivolumab, a type of immunotherapy, can extend the lives of people with head and neck cancer. One study found that patients receiving nivolumab lived longer than those receiving standard chemotherapy. Decitabine, a chemotherapy drug, alters the DNA in cancer cells, potentially slowing their growth or causing them to die. It may also enhance the ability of drugs like nivolumab to locate and attack cancer cells. In this trial, participants will receive both decitabine and nivolumab to enhance effectiveness. Early research suggests that this combination could boost the immune system's ability to fight cancer.13467
Who Is on the Research Team?
Kyunghee Burkitt, DO, PhD, MS
Principal Investigator
Case Comprehensive Cancer Center, Cleveland Clinic
Are You a Good Fit for This Trial?
This trial is for people with recurrent or metastatic head and neck squamous cell carcinoma that can't be cured locally. Candidates must have a tumor in the oral cavity, oropharynx, hypopharynx, or larynx and be eligible for anti-PD-L1 therapy as first-line treatment.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive 28-day cycles of decitabine followed by nivolumab for up to 35 cycles or until disease progression or other adverse event(s)
Follow-up
Participants are monitored for safety and effectiveness after treatment discontinuation
What Are the Treatments Tested in This Trial?
Interventions
- Decitabine
- Nivolumab
Find a Clinic Near You
Who Is Running the Clinical Trial?
Kyunghee Burkitt, DO, PhD
Lead Sponsor