Research & Clinical Trials

The Head and Neck Cancer Center hosts a diverse team of researchers interested in advancing the knowledge about head and neck cancer with the ultimate goal of translating it to patient care. We collaborate with a diverse team of experts and the Bloomberg~Kimmel Institute for Cancer Immunotherapy.

General Contact: Dr. Zubair Khan ([email protected])

In this section: 

Current Research and Clinical Trials

Clinical trials come from the discoveries made in basic science laboratories. By taking these investigations and discoveries, researchers and scientists can create new therapies and treatments. Below are the listings of our current clinical trials.

For a complete list of available clinical trials, please visit the database at the Johns Hopkins Institute for Clinical and Translation Research. You can also search by condition, researcher or doctor's name.

Screening and Prevention

Study of Men and Women Offering Understanding of Throat HPV (MOUTH) (IRB00119537)

Contact: Amber D'souza, Ph.D. (410-502-2583 or [email protected]) & Tanya Troy, MPH (443-287-8754 or [email protected])
Principal Investigator: Gypsyamber D'Souza, Ph.D.
Objective: To explore the effects of biologic (microbiome, oral immune response, biologic sex) risk factors for oncogenic oral HPV persistence.
Eligibility Criteria: Adults with history of anal or genital dysplasia or cancer. 
Learn More: about the Men and Women Offering Understanding of Throat HPV clinical trial.

Trials for Patients Who've Been Diagnosed with a Head and Neck Cancer for the First Time

Open-label conditioning therapy for peri-operative pain management in head and neck cancer patients (IRB00276225)

Objective: This research is being done to establish methods to improve pain management after surgery and decrease the risk of chronic opioid dependence. The second part of this research (optional portion) is being done to help better understand the potential impact of the audio interview that is recorded and placed in your electronic medical record. We want to investigate how and/or if it impacts the communication between the medical team and the patient and if it has any impact on your perceived satisfaction with care at the hospital.
Principal Investigator: Carole Fakhry, M.D., M.P.H
More Information: about the Open-label conditioning therapy for peri-operative pain management in head and neck cancer patients clinical trial.

Study of Neoadjuvant targeting of myeloid cell populations in combination with Nivolumab in head & neck cancer patients undergoing surgery (Spark2) (J2085)

Contact: Tanguy Seiwert, M.D. (443-287-8312 or[email protected]  ) & Zubair Khan M.D. (410-955-3157 or [email protected]
Principal Investigator: Tanguy Seiwert, M.D.
Objective: To assess safety and feasibility of pre-operative nivolumab in combination with BMS-986253 (anti-interleukin-8) in patients with squamous cell carcinoma of head and neck (SCCHN) who will undergo surgery.
Eligibility Criteria: Subjects must be human papillomavirus (HPV) negative (confirmed testing for oropharyngeal primary tumors - if otherwise suspected HPV positivity e.g. some oral cavity or sinonasal tumors if e.g. absence of smoking) OR (if HPV+) be high risk based on a 20-pack a year smoking history.
More Information: about the Neoadjuvant Targeting of Myeloid Cell Populations in Combination With Nivolumab in Head & Neck Ca study

A Phase II trial of Cemiplimab, or Cemiplimab-chemotherapy, followed by Biomarker-guided Treatment for Pts w/HPV H&N Ca (MINIMA) (J20118)

Contact: Tanguy Seiwert, M.D. (443-287- 8312 or [email protected]) and Zubair Khan M.D. (410-955-3157 or [email protected]
Principal Investigator: Tanguy Seiwert, M.D.
Objective: To determine if it is feasible to use neoadjuvant immunotherapy (or immunotherapy plus chemotherapy) to reduce treatment intensity and improve long-term quality of life while maintaining very high cure rates.
Eligibility Criteria: Subjects must have pathologically confirmed HPV-positive head and neck squamous cell carcinoma of the oropharynx. Confirmed HPV-positive disease of other subsites are uncommon but also eligible.
Learn More: about the Trial of Cemiplimab, or Cemip-Chemo Followed by Biomarker-guided Treatment for Pts w/HPV H&N Ca.

Myoarchitectural determinants of oropharyngeal bolus flow in patients with lingual carcinoma (IRB00275551)

Contact: Harry Quon, M.D. (410) 502-3877
Principal Investigator: Harry Quon, M.D.

Study of ctHPV DNA as a Dynamic, Quantitative Biomarker of Treatment Response in HPV-Related Carcinomas (IRB00289711)

Contact: Harry Quon, M.D. (410) 502-3877
Principal Investigator: Harry Quon M.D.
Objective: To understand how changes in tumor DNA levels detected in the blood throughout treatment can indicate individual treatment responsiveness.
Eligibility Criteria:  Any patient with HPV-related head and neck cancer who has been recommended induction chemotherapy and radiation therapy for curative treatment.

Trials for Patients Whose Head and Neck Cancer has Returned After Treatment

Open-label conditioning therapy for peri-operative pain management in head and neck cancer patients (IRB00276225)

Objective: This research is being done to establish methods to improve pain management after surgery and decrease the risk of chronic opioid dependence. The second part of this research (optional portion) is being done to help better understand the potential impact of the audio interview that is recorded and placed in your electronic medical record. We want to investigate how and/or if it impacts the communication between the medical team and the patient and if it has any impact on your perceived satisfaction with care at the hospital.
Principal Investigator: Carole Fakhry, M.D., M.P.H
More Information: about the Open-label conditioning therapy for peri-operative pain management in head and neck cancer patients clinical trial.

Study of Neoadjuvant targeting of myeloid cell populations in combination with Nivolumab in head & neck cancer patients undergoing surgery (Spark2) (J2085)

Contact: Tanguy Seiwert, M.D. (443-287-8312 or[email protected]  ) and Zubair Khan M.D. (410-955-3157 or [email protected]
Principal Investigator: Tanguy Seiwert, M.D.
Objective: To assess safety and feasibility of pre-operative nivolumab in combination with BMS-986253 (anti-interleukin-8) in patients with squamous cell carcinoma of head and neck (SCCHN) who will undergo surgery.
Eligibility Criteria: Subjects must be human papillomavirus (HPV) negative (confirmed testing for oropharyngeal primary tumors - if otherwise suspected HPV positivity e.g. some oral cavity or sinonasal tumors if e.g. absence of smoking) OR (if HPV+) be high risk based on a 20-pack a year smoking history.
More Information: about the Neoadjuvant Targeting of Myeloid Cell Populations in Combination With Nivolumab in Head & Neck Ca study

A Phase 1 study of NBTX3 activated by radiotherapy for patients with advanced cancer treated with an Anti-PD1 therapy (J1996)   

Contact: Tracey Adams
Principal Investigator: Tanguy Seiwert, M.D. (443-287- 8312 or [email protected]

A Phase 1b Study of Nivolumab in Patients with Autoimmune Disorders and Advanced Malignancies (AIM-NIVO) (ETCTN10204)

Contact: Clarissa Frimpong
Principal Investigator: Julie Brahmer

Observational Studies

Study of HPV in Sinonasal Ca: Retrospective Analysis Association of Human Papilloma Virus (HPV) Serology and Behavioral Risk Factors (NCT04979000)

Contact: Nyall London, M.D. (301-896-3332 or [email protected]) and Zubair Khan M.D. (410-955-3157 or [email protected]
Principal Investigator: Nyall London, M.D. 
Objective: To evaluate the role of anatomic site, gender and race in human papillomavirus-associated head and neck squamous cell cancers (HNSCC). We will explore the role of HPV, tobacco, alcohol and drug use, in HNSCC by tumor site with particular emphasis on the sinonasal cavity as well as differences in risk factors for HPV-positive HNSCC by gender and race.
Eligibility Criteria: Patients must be 18 years of age or older with a confirmed or suspected diagnosis of sinonasal cancer.
More Information: about the HPV in Sinonasal Ca: Retrospective Analysis Association of Human Papilloma Virus (HPV) Serology and Behavioral Risk Factors study.

Molecular Surveillance for Squamous Cell Carcinoma of the Upper Aerodigestive Tract  (NA_00037133)

Contact: Rebecca Dempsey ([email protected])
Principal Investigator: Wayne Koch

Detection of Genetic Alternations in Head and Neck Tumors (IRB00036235)

Contact: Amir Farrakhan
Principal Investigator: Wayne Koch

Head and Neck Cancer Tissue Bank 

The Johns Hopkins Head and Neck Cancer Tissue Bank enrolls patients and collects research specimens from Head and Neck Tumor patients, both cancerous and benign, with particular focus on Head and Neck Squamous Cell Cancer patients. Then goals are to collect, process and store biospecimens to make it available as a resource for researchers making discoveries in basic science laboratories. By using these specimens, researchers and scientists can create new therapies, treatments and  diagnostic tools.

Molecular Surveillance for Squamous Cell Carcinoma of the Upper Aerodigestive Tract (NA_00037133)

Contact: Clinical Trials Team ([email protected])
Principal Investigator: Wayne Koch

Detection of Genetic Alternations in Head and Neck Tumors (IRB00036235)

Contact: Clinical Trials Team ([email protected])
Principal Investigator: Wayne Koch

Research Team

Learn more about each researcher's areas of study and publications in their profile.