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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.

  

 

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, PHD (410-502-2583 or gdsouza2@jhu.edu) & Tanya Troy, MPH (443-287-8754 or ttroy2@jhu.edu)
Principal Investigator: Gypsyamber D'Souza
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

Study of  Preoperative Immune Checkpoint Inhibitor for Patients with Primary Untreated or Recurrent/Metastatic Squamous Cell Carcinoma of Head and Neck (RM-SCCHN) Undergoing Surgical Resection (CA209-9H7) (J1923)

Contact: Kalindi Bambhania
Principal Investigator: Tanguy Seiwert
Objective: This research is being done to see if it is safe and feasible to give the investigational drugs, nivolumab (also known as BMS-936558) before surgery to people with newly diagnosed or recurrent squamous cell carcinoma of head and neck (SCCHN).
Eligibility Criteria: Subjects must have histologically confirmed previously untreated squamous cell carcinoma of the head and neck which is amenable to surgical resection as part of standard of care.
Learn More: about the Preoperative Immune Checkpoint Inhibitor for Patients With Primary Untreated or Recurrent Squamous Cell Carcinoma of Head and Neck Undergoing Resection study.

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 tseiwert@jhmi.edu) & Zubair Khan M.D. (410-955-3157 or zkhan@jhmi.edu) 
Principal Investigator: Tanguy Seiwert
Objective: The primary objective of this study is to assess safety and feasibility of pre-operative nivolumab in combination with either cabiralizumab, anti colony stimulating factor 1 receptor (CSF1R) or 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 year smoking history.
Learn More: about the Neoadjuvant Targeting of Myeloid Cell Populations in Combination With Nivolumab in Head & Neck Cancer Patients Undergoing Surgery 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 tseiwert@jhmi.edu) & Zubair Khan M.D. (410-955-3157 or zkhan@jhmi.edu) 
Principal Investigator: Tanguy Seiwert 
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.

Randomized Phase II/III Trial of Surgery and Postoperative Radiation Delivered with Concurrent Cisplatin versus Docetaxel versus Docetaxel and Cetuximab for High-Risk Squamous Cell Cancer of the Head and Neck (R1216)

Contact: Chelsea Miralles
Principal Investigator: Ana Kiess

Myoarchitectural determinants of oropharyngeal bolus flow in patients with lingual carcinoma (00275551)

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

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

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

Study of Children and Adults With Olfactory Neuroblastoma (NCT04755205)

Contact: Marissa B Mallek, R.N. (240) 760-7498
Principal Investigator: Charalampos Floudas, M.D.
Objective: To better understand ONB-the course of the disease, tumor characteristics, response to treatments, and management of the treatment.
Eligibility Criteria: People ages 3 years and older who have ONB. They must enroll in NIH studies #19-C-0016 and #18-DC-0051.
More Information: about the Natural History Study of Children and Adults With Olfactory Neuroblastoma 

Study of Bintrafusp Alfa in Recurrent/Metastatic Olfactory Neuroblastoma (BARON) (NCT05012098)

Contact: Sheri A McMahon, R.N. (240) 760-7968
Principal Investigator: Charalampos Floudas, M.D.
Objective: To learn if giving immunotherapy drug bintrafusp alfa can help ONB shrink or disappear.
Eligibility Criteria: People aged 18 years and older diagnosed with recurrent or metastatic ONB that has not responded to standard treatment.
More Information: about the Phase 2 Study of Bintrafusp Alfa in Recurrent/Metastatic Olfactory Neuroblastoma (BARON)

Study of Open-label Conditioning Therapy for Peri-operative Pain Management in Head and Neck Cancer Patients (NCT04973748)

Contact: Danielle Trakimas, M.D. (781-570-9483 or dtrakim1@jhmi.edu)
Principal Investigator: Danielle Trakimas, M.D.
Objective: Determine feasibility of open-label randomized controlled trial of conditioning therapy for post-operative pain management in complex head and neck cancer patients.
Eligibility Criteria: Adult head and neck cancer patients undergoing cancer surgery and microvascular reconstruction. 
More Information: about the Open-label Conditioning Therapy for Peri-operative Pain Management in Head and Neck Cancer Patients study.

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

Study of Preoperative Immune Checkpoint Inhibitor for Patients With Primary Untreated or Recurrent/Metastatic SCCHN (J1923)

Contact: N/A
Principal Investigator: Tanguy Seiwert, M.D.
Objective: To see if it is safe and feasible to give the investigational drugs, nivolumab (also known as BMS-936558) before surgery to people with newly diagnosed or recurrent squamous cell carcinoma of head and neck (SCCHN).
Eligibility Criteria: Subjects must have histologically confirmed previously untreated squamous cell carcinoma of the head and neck which is amenable to surgical resection as part of standard of care.
More Information: about the Preoperative Immune Checkpoint Inhibitor for Patients With Primary Untreated or Recurrent/Metastatic SCCHN study.

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 tseiwert@jhmi.edu) & Zubair Khan M.D. (410-955-3157 or zkhan@jhmi.edu) 
Principal Investigator: Tanguy Seiwert, M.D.
Objective: To assess safety and feasibility of pre-operative nivolumab in combination with either cabiralizumab, anti colony stimulating factor 1 receptor (CSF1R) or 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 year smoking history.
More Information: about the Neoadjuvant Targeting of Myeloid Cell Populations in Combination With Nivolumab in Head & Neck Ca stud

A Phase 1 study of NBTX3 activated by radiotherapy for patients with advanced cancer treated with an Anti-PD1 therapy (1996)   

Contact: Jessica Rogers
Principal Investigator: Tanguy Seiwert

A Phase 1/2 Study of Relatlimab (anti-LAG-3 Monoclonal Antibody) Administered in Combination with Both Nivolumab (anti-PD-1 Monoclonal Antibody) and BMS- 986205 (IDO1 inhibitor) or in Combination with Both Nivolumab and Ipilimumab (anti-CTLA-4 Monoclonal Antibody) in Advanced Malignant Tumors (CA224-048) (J1825)

Contact: Victoria Starikov
Principal Investigator: Evan Lipson

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 nlondon2@jhmi.edu) & Zubair Khan M.D. (410-955-3157 or zkhan@jhmi.edu) 
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. 

Study of Children and Adults With Olfactory Neuroblastoma (NCT04755205)

Contact: Marissa B Mallek, R.N. (240) 760-7498 or marissa.mallek@nih.gov
Principal Investigator: Charalampos Floudas, M.D.
Objective: To better understand ONB-the course of the disease, tumor characteristics, response to treatments, and management of the treatment.
Eligibility Criteria: Subjects must be enrolled on NCI protocol 19-C-0016: "Natural History and Biospecimen Acquisition Study for Children and Adults with Rare Solid Tumors" and NCI Protocol 18-DC-0051: "Biospecimen Procurement for NIDCD Clinical Protocols".
More Information: about the Study of Children and Adults With Olfactory Neuroblastoma 

Study of Bintrafusp Alfa in Recurrent/Metastatic Olfactory Neuroblastoma (BARON) (NCT05012098)

Contact: Sheri A McMahon, R.N. (240) 760-7968 or smcmahon@mail.nih.gov
Principal Investigator: Charalampos Floudas, M.D.
Objective: To assess the objective response rate (ORR) to bintrafusp alfa in participants with recurrent/metastatic ONB, immune checkpoint-naive (CN).
Eligibility Criteria: Participants must have histologically confirmed recurrent or metastatic ONB, not amenable to potentially curative local therapies.
More Information: about the Phase 2 Study of Bintrafusp Alfa in Recurrent/Metastatic Olfactory Neuroblastoma (BARON).

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

Contact: Rebecca Dempsey
Principal Investigator: Wayne Koch

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

Contact: Amir Farrakhan
Principal Investigator: Wayne Koch

Research Team

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

 

Understanding Clinical Trials

  • A clinical trial is one of the final stages of the cancer research process. Studies are done with cancer patients to find out whether promising approaches to cancer prevention, diagnosis, and treatment are safe and effective.

    • Treatment trials test new treatments (like a new cancer drug, new approaches to surgery or radiation therapy, new combination of treatments, or new methods such as gene therapy).
       
    • Prevention trials test new approaches (such as medicines, vitamins, minerals, or other supplements) that physicians believe may lower the risk of certain types of cancer. These trials look for the best way to prevent cancer in people who have never had cancer or to prevent cancer from coming back or a new cancer from occurring in people who already have cancer.
       
    • Screening trials test the best way to find cancer, especially in its early stages.
       
    • Quality of Life trials explore new ways to improve comfort and quality of life for cancer patients
    • Phase I Trials: These first studies in people evaluate how a new drug should be given (ie: by mouth, injected into the blood, or injected into the muscle), how often, and what dose is safe. A phase I trial usually enrolls only a small number of patients, sometimes as few as a dozen.
       
    • Phase II Trials: A phase II trial continues to test the safety of the drug, and begins to evaluate how well the new drug works. Phase II trials usually focus on a particular type of cancer.
       
    • Phase III Trials: These studies test a new drug, a new combination of drugs, or a new surgical procedure in comparison to the current standard. A person is usually assigned to the standard group or the new group at random (called randomization). Phase III trials often enroll large numbers of people and may be conducted at many physicians' offices, clinics, and cancer centers nationwide.

      In addition, after a treatment has been APPROVED and is being marketed, the drug's maker may study it further in -
       
    • Phase IV Trials: The purpose of the phase IV trial is to evaluate the side effects, risks, and benefits of a drug over a longer period of time and in a larger amount of people than in phase III clinical trials. Thousands of people are involved in a phase IV trial.

Learn more about clinical trials at Johns Hopkins Medicine

 
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