Head and Neck Cancer Research and Clinical Trials

Our team is dedicated to clinical research. Your physician may discuss with you the possibility of joining a clinical trial, which could offer new treatment approaches that are not otherwise available.

The information below was updated in May 2015, but may not be a complete list of all of our head and neck cancer trials. For more information on our trials or to find out eligibility criteria, please contact Larissa K. Low by email or 858-822-5223.

Locally Advanced Disease Studies

TRYHARD: Radiation Therapy Plus Cisplatin With or Without Lapatinib in Treating Patients With Head and Neck Cancer

This trial is studying if and how well lapatinib adds to the effectiveness of radiation therapy plus cisplatin in patients who have head and neck cancer that is not related to the HPV virus.

Eligibility:

  • Pathologically confirmed squamous cell cancer of oropharynx (p16 negative), hypopharynx, or larynx
  • Stage III or IV disease including no distant metastases

Full description on ClinicalTrials.gov: NCT01711658

Full title: NRG: RTOG 3501 Tryhard: A Phase II, Randomized, Double Blind, Placebo-Controlled Study Of Lapatinib (Tykerb®) For Non-HPV Locally Advanced Head And Neck Cancer With Concurrent Chemoradiation stage III or IV disease (T2 N2-3 M0, T3-4 any N M0, T1 N2b, N2c, or N3 p16 negative oropharynx cancer, or T1-2 any N hypopharynx cancer)

Principal investigator: Loren Mell, MD

Contact: Cammie Nguyen, email or 858-822-5356

Radiation Therapy With Cisplatin, Docetaxel, or Cetuximab After Surgery in Treating Patients With Stage III-IV Squamous Cell Head and Neck Cancer

This randomized phase II/III trial studies how well radiation therapy works when given together with cisplatin compared to docetaxel or cetuximab and docetaxel after surgery in treating patients with stage III-IV squamous cell head and neck cancer.

Eligibility:

  • Stage III or IV HNSCC involving the oral cavity, oropharynx (p16 neg.), larynx, or hypopharynx within 63 days of registration
  • Must have undergone surgical resection of high-risk oral cavity, oropharynx (p16 negative), larynx, or hypopharynx within 63 days prior to registration
  • Must have at least 1 of the following high-risk pathologic features: extracapsular nodal extension or invasive cancer at the primary tumor resection margin (tumor or ink)

Full description on ClinicalTrials.gov: NCT01810913

Full title: NRG: RTOG 1216: 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 advanced stage

Principal investigator: Loren Mell, MD

Contact: Cammie Nguyen, email or 858-822-5356

Individualized Treatment in Treating Patients With Stage II-IVB Nasopharyngeal Cancer Based on EBV DNA

This randomized Phase II and Phase III trial is looking at Epstein Barr Virus (EBV) DNA for locoregionally advanced non-metastatic nasopharyngeal cancer. All patients will first undergo standard concurrent chemotherapy and radiation therapy. When this standard treatment is completed, if there is no detectable EBV DNA in their plasma, then patients are randomized to either standard adjuvant cisplatin and fluorouracil chemotherapy or observation. If there is still detectable levels of plasma EBV DNA, patients will be randomized to standard cisplatin and flurouracil chemotherapy versus gemcitabine and paclitaxel.

Eligibility:

  • Biopsy proven diagnosis of nasopharynx cancer
  • Must have detectable pretreatment plasma EBV DNA
  • Stage II-IVB disease with no distant metastasis

Full description on ClinicalTrials.gov: NCT02135042

Full title: NRG: RTOG 0920: A Phase III Study of Postoperative Radiation Therapy (IMRT) +/- Cetuximab for Locally-Advanced Head and Neck Cancer

Principal investigator: Loren Mell, MD

Contact: Cammie Nguyen, email or 858-822-5356

Reduced-Dose Intensity-Modulated Radiation Therapy With or Without Cisplatin in Treating Patients With Advanced Oropharyngeal Cancer

This randomized phase II trial studies how well modestly reduced-dose intensity-modulated radiation therapy (IMRT) with or without cisplatin works in treating patients with advanced oropharyngeal cancer.

Eligibility:

  • Pathologically proven diagnosis of squamous cell carcinoma of oropharynx
  • Immunohistochemical staining for p16 must be performed
  • Smoking history cannot exceed 10 packs per year

Full description on ClinicalTrials.gov: NCT02254278

Full title: NRG-HN002: A Randomized Phase II trial for Patients with p16 Positive, Non-Smoking Associated, Locoregionally Advanced Oropharyngeal Cancer

Principal investigator: Loren Mell, MD

Contact: Cammie Nguyen, email or 858-822-5356

Recurrent / Metastatic Disease Studies

A Phase 3 Trial of Pembrolizumab (MK-3475) vs Standard Treatment in Recurrent or Metastatic Head and Neck Cancer

A study to evaluate the effectiveness of Pembrolizumab for treatment of recurrent/metastatic head and neck cancer compared to current, FDA-approved standard of care medications (cetuximab, docetaxel, & methotrexate). Participants have a 1:1 chance of either receiving Pembrolizumab or a standard of care medication and will be aware of what they are receiving.

Eligibility:

  • Progression at any time after treatment with a platinum agent for recurrent/metastatic disease OR recurrence/progression within 6 months after initial treatment
  • Have not been treated with 3 or more medication regimens for recurrent/metastatic disease
  • No active infections requiring therapy

Full description on ClinicalTrials.gov: NCT02252042

Full title: MK3475-040/KEYNOTE-040: A Phase 3 Trial of Pembrolizumab (MK-3475) vs Standard Treatment in Recurrent or Metastatic Head and Neck Cancer

Principal investigator: Ezra Cohen, MD

Contact: Avikar Saini, email or 858-534-0253

Chemotherapy Plus Cetuximab in Combination With VTX-2337 in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck

A study to evaluate the effectiveness of adding VTX-2337 to Cetuximab, 5-Fluorouracil, & Carboplatin/Cisplatin. Participants have a 1:1 chance of receiving the VTX-2337 or placebo.

Eligibility:

  • Recurrence after at least 6 months of completing prior systemic therapy for initial treatment
  • No previous systemic treatment for recurrent/metastatic disease
  • Excludes nasopharyngeal, salivary gland, lip, and sinonasal carcinoma
  • No significant cardiac events within 6 months, brain metastases, or active infections

Full description on ClinicalTrials.gov: NCT01836029

Full title: VRXP-A202: A Randomized, Double-Blind, Placebo-Controlled Study of Chemotherapy Plus Cetuximab in Combination with VTX-2337 in Patients with Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck

Principal investigator: Assuntina Sacco, MD

Contact: Avikar Saini, email or 858-534-0253

Thyroid Cancer Studies

Dabrafenib With or Without Trametinib in Treating Patients With Recurrent Thyroid Cancer

This randomized phase II trial studies how well dabrafenib works with or without trametinib in treating patients with recurrent thyroid cancer. Dabrafenib and trametinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether dabrafenib is more effective when given with or without trametinib in treating thyroid cancer.

Eligibility:

  • Histologically or cytologically confirmed papillary thyroid cancer or follicular thyroid cancer
  • Presence of BRAF mutation in tumor tissue
  • Must have disease that is refractory (unresponsive) to radioactive iodine (RAI)
  • Progressive disease within 13 months

Full description on ClinicalTrials.gov: NCT01723202

Full title: OSU 12064: A Randomized Phase 2 Study of single agent Dabrafenib (BRAFi) vs. combination regimen Dabrafenib (BRAFi) and Trametinib (MEKi) in patients with BRAF mutation or BRAF gene fusion defect in thyroid

Principal investigator: Greg Daniels, MD

Contact: Nisha Parikh, email or 858-822-4171