Ignite Creation Date:
2025-12-25 @ 2:55 AM
Ignite Modification Date:
2025-12-26 @ 1:35 AM
Study NCT ID:
NCT07216833
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-10-15
First Post:
2025-10-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Decitabine and Nivolumab in Participants With Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck
Sponsor:
Kyunghee Burkitt, DO, PhD
Organization:
Study Overview
Official Title:
Biomarker Driven Phase 1/1b Trial of Decitabine and Nivolumab in Patients With Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This research study is for people who have recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) that has been confirmed by tissue or cell analysis and is considered incurable with local treatments. People who are eligible to receive anti-PD-L1 therapy as a first line treatment and whose primary tumor is located in the oral cavity, oropharynx, hypopharynx, or larynx, may be eligible to participate.
The purpose of this study is to evaluate the immunogenicity of decitabine in combination with nivolumab, and to evaluate the safety and tolerability of decitabine in combination with nivolumab and to determine the maximum tolerated dose.
Decitabine is a drug that is currently approved by the Food and Drug Administration (FDA) for the treatment of myelodysplastic syndrome (MDS). Decitabine is considered an investigational (experimental) drug in this study because it is not approved by the FDA for the treatment of HNSCC. Decitabine is a chemotherapy drug that works by targeting DNA methylation, a process that can restore normal function to genes that are involved in cell growth and differentiation. This can help reduce the growth of cancer cells.
Nivolumab is a drug that is approved by the FDA for the treatment of HNSCC, as well as other types of cancer. Nivolumab is an immunotherapy drug that works by helping the body's immune system recognize and attack cancer cells.
The purpose of this study is to evaluate the immunogenicity of decitabine in combination with nivolumab, and to evaluate the safety and tolerability of decitabine in combination with nivolumab and to determine the maximum tolerated dose.
Decitabine is a drug that is currently approved by the Food and Drug Administration (FDA) for the treatment of myelodysplastic syndrome (MDS). Decitabine is considered an investigational (experimental) drug in this study because it is not approved by the FDA for the treatment of HNSCC. Decitabine is a chemotherapy drug that works by targeting DNA methylation, a process that can restore normal function to genes that are involved in cell growth and differentiation. This can help reduce the growth of cancer cells.
Nivolumab is a drug that is approved by the FDA for the treatment of HNSCC, as well as other types of cancer. Nivolumab is an immunotherapy drug that works by helping the body's immune system recognize and attack cancer cells.
Detailed Description:
Head and neck squamous cell carcinoma (HNSCC) is the 6th most common cancer worldwide with approximately 60,000 people diagnosed each year in the United States. People with human papilloma virus (HPV)-positive HNSCC usually have a good prognosis, but HPV-negative people have about a 50% chance that their cancer will come back even after being treated. People who have recurrent or metastatic (R/M) HNSCC who are treated for their cancer tend to have an even worse prognosis, with a median overall survival of about 10 months. An anti-programmed-death-1 (anti-PD1) inhibitor called pembrolizumab was recently approved to treat people with R/M HNSCC. Another type of anti-PD1 inhibitor is a drug called nivolumab, which is also approved to treat people with R/M HNSCC. However, response rates to both pembrolizumab and nivolumab monotherapy are as low as 19% and 13.3% respectively. This shows that there are immune-evasive mechanisms present, meaning that tumor cells can more easily evade being detected and destroyed. Decitabine is a drug that may help anti-PD1 inhibitors like nivolumab better detect and destroy tumor cells. Previous research has shown that using a DNA methyltransferase inhibitor before giving a PD1 inhibitor to treat cancer can help the body's immune system more effectively kill cancer cells. Decitabine is a drug that is a type of DNA methyltransferase inhibitor. The purpose of this study is to evaluate the safety and tolerability of using decitabine in combination with nivolumab to treat HNSCC.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: