RecruitingPhase 2NCT05317000

5-Azacytidine and/or Nivolumab in Resectable HPV-Associated HNSCC

A Window Trial of 5-Azacytidine or Nivolumab or Combination Nivolumab Plus 5-Azacytidine in Resectable HPV-Associated Head and Neck Squamous Cell Cancer

Sponsor

Barbara Burtness

Enrollment

50 participants

Start Date

Mar 23, 2023

Study Type

INTERVENTIONAL

Conditions

Squamous Cell Carcinoma of Head and Neck

Summary

This study is being done because both 5-azacytidine and nivolumab can influence the immune system's response to HPV-associated head and neck cancer, and we wish to evaluate whether taking 5-azacytidine will make HPV-associated head and neck cancer more sensitive to treatment with nivolumab. 5-Azacytidine (5-AZA) is a chemotherapy, and nivolumab is an immunotherapy. Both drugs are approved for use in the US by the Food and Drug Administration (FDA) for use in the treatment of different types of cancer, and nivolumab is approved for use in head and neck cancer that has previously been treated with chemotherapy. Because they are not approved to be used together in HPV-associated head and neck cancer, these drugs are considered experimental in this study. For this study, the drugs will be used either together or separately.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether 5-azacytidine (a drug that changes how genes are expressed) and/or nivolumab (an immunotherapy) given before surgery can shrink HPV-associated throat (oropharyngeal) cancer and prime the immune system to better fight cancer cells. The goal is to improve long-term outcomes for patients with this type of cancer. **You may be eligible if...** - You have resectable (surgically removable) squamous cell carcinoma of the oropharynx (throat), confirmed by biopsy - Your cancer is HPV-associated and stage T1–T3, N0–N2, M0 (has not spread to distant organs) - A surgeon has confirmed your tumor can be removed - You are willing to provide additional biopsy tissue for research purposes **You may NOT be eligible if...** - Your cancer is not resectable - You have serious immune or autoimmune conditions that prevent immunotherapy - You have had prior radiation to the head/neck area - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGCombination 5-azacytidine and nivolumab

The primary objective of the study is to determine whether exposure to the demethylating agent 5-azacytidine will sensitize HPV-associated oropharynx cancer to nivolumab by induction of interferon response, neoantigen expression, and augmentation of lymphocyte infiltration of the tumor microenvironment.

DRUG5-azacytidine

Chemotherapy is the use of drugs to destroy cancer cells. It usually works by keeping the cancer cells from growing, dividing, and making more cells. Because cancer cells usually grow and divide faster than normal cells, chemotherapy has more of an effect on cancer cells. 5-azacytidine works by slowing down the growth of cancer cells. 5-azacytidine has been demonstrated to improve the cell's ability to make some proteins which signal to the immune system.

DRUGNivolumab

Immunotherapy is a type of treatment that uses your body's own immune system to help fight cancer. Specifically, Nivolumab belongs to a class of anti-cancer drugs known as immune checkpoint inhibitors. Cancer cells are able to "turn off" the immune system by increasing the production of a protein called PD-1. Nivolumab can block PD-1 and may be able to re-activate the immune response to kill head and neck cancer cells.