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

PHASE2RecruitingINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

March 23, 2023

Primary Completion Date

September 30, 2026

Study Completion Date

February 28, 2027

Conditions
Squamous Cell Carcinoma of Head and Neck
Interventions
DRUG

Combination 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.

DRUG

5-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.

DRUG

Nivolumab

"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."

Trial Locations (1)

06511

RECRUITING

Yale University, New Haven

All Listed Sponsors
collaborator

National Institute of Dental and Craniofacial Research (NIDCR)

NIH

lead

Barbara Burtness

OTHER