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

Safety Study of Ketamine for Preventing Depression in Patients Undergoing Treatment for Head and Neck Cancer

The primary purpose of this study is to see if it is safe to give patients with head and neck cancer a low dose of the FDA approved anesthetic drug ketamine at the same time they receive radiation, chemotherapy, and/or surgery for their cancer treatment to prevent depression and its effects. Researchers would also like to see if giving ketamine at the same time as cancer treatment is practical and reasonably acceptable to the patient.

Eligibility:

  • Stage III or IV epidermoid cancer of the head and neck
  • Within two weeks of starting or from having started, curative intent therapy for head and neck cancer
  • Meets Mini International Neuropsychiatric interview (MINI) criteria for major depression, schizophrenia, bipolar illness, delirium or psychosis

Exclusions:

  • Use of monoamine oxidase inhibitors within 14 days of study entry
  • History of allergic reactions or hypersensitivity to ketamine
  • History of significant tachyarrhythmia, severe angina, or myocardial ischemia

Full description on ClinicalTrials.gov: NCT02442739

Full title: PII-Ketamine Prevention: Piloting a Randomized Feasibility Study of Oral Ketamine Versus Placebo for Prevention of Depression in Patients Undergoing Therapy for Head and Neck Cancer

Principal investigator: Assuntina Sacco, MD

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

Recurrent / Metastatic Disease Studies

Safety and Efficacy Study of Palbociclib Plus Cetuximab Versus Cetuximab to Treat Head and Neck Cancer

The purpose of this study is to determine whether the combination of palbociclib with cetuximab is superior to cetuximab in prolonging overall survival in HPV-negative, cetuximab-naïve patients with recurrent/metastatic squamous cell carcinoma of the head and neck.

Eligibility:

  • Histologically or cytologically confirmed squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx, not amenable for salvage surgery or radiotherapy
  • HPV-negative SCCHN tumor as determined per institutional standard

Exclusions:

  • Prior nasopharyngeal cancer, salivary gland or sinus tumors.

Full description on ClinicalTrials.gov: NCT02499120

Full title: A Randomized, Multicenter, Double-Blind Phase 2 Study Of Palbociclib Plus Cetuximab Versus Cetuximab For The Treatment of Human Papillomavirus-Negative, Cetuximab-Naïve Patients With Recurrent/Metstatic Squamous Cell Carcinoma Of The Head And Neck After Failure Of One Prior Platinum-Containing Chemotherapy Regimen

Principal investigator: Assuntina Sacco, MD

Contact: Chloe Lalonde, email or 858-246-0357

Study of the Combination of ACP-196 and Pembrolizumab in Subjects with Advanced Head and Neck Squamous Cell Carcinoma (KEYNOTE147)

Study of the combination of ACP-196 and pembrolizumab in subjects with advanced head and neck squamous cell carcinoma.

Eligibility:

  • Histologically or cytologically confirmed recurrent, metastatic or unresectable HNSCC of the oral cavity, oropharynx, hypopharynx, and larynx that has either progressed during or after platinum-based chemotherapy administered for metastatic disease or has recurred during or within 6 months after the completion of platinum-based neoadjuvant or adjuvant therapy

Exclusions:

  • Prior malignancy (other than HNSCC), except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer from which the subject has been disease free for ≥ 2 years or which will not limit survival to < 2 years
  • Known central nervous system metastases and/or carcinomatous meningitis

Full description on ClinicalTrials.gov: NCT02454179

Full title: A Phase 2 Proof-of-Concept Study of the Combination Of ACP-196 and Pembrolizumab in Subjects with Advanced Head and Neck Squamous Cell Carcinoma

Principal investigator: Ezra Cohen, MD

Contact: Nini Huynh, email or 858-822-4950

A Study of PF-05082566 in Combination with Mogamulizumab in Patients with Advanced Solid Tumors

This study is a Phase 1b, open label, multicenter, multi-dose trial designed to estimate the maximum tolerated dose (MTD) and select the recommended dose for phase 2 (RP2D) investigations of PF-05082566 in combination with KW-0761 (mogamulizumab) in patients with advanced solid tumors.

Eligibility:

  • Histological or cytological diagnosis of advanced/metastatic solid tumor malignancy which has progressed on standard therapy or for which no curative therapy is available

Exclusions:

  • History of autoimmune disease or known inflammatory bowel disease
  • Systemic steroids, any other form of immunosuppressive therapy or radiation therapy within 14 days prior to registration
  • Systemic anticancer therapy or major surgery within 28 days prior to registration. In absence of toxicity from prior systemic anticancer therapy 5 half-lives since completion of prior systemic anticancer therapy is allowed

Full description on ClinicalTrials.gov: NCT02444793

Full title:A Phase 1b Study of PF-05082566 in Combination with Mogamulizumab (KW-0761) in Patients with Advanced Solid Tumors

Principal investigator: Ezra Cohen, MD

Contact: Edison Gosoco, email or 858-822-6940

A Phase I Study to Evaluate the Safety, Tolerability and Efficacy of MED14736 (Durvalumab) with Tremelimumab in Head and Neck Cancer

This is multicenter, open-label, dose exploration study to evaluate the safety, tolerability, antitumor activity, PK, pharmacodynamics, and immunogenicity of MED14736 in combination with tremelimumab in subjects with recurrent/metastatic squamous cell carcinoma of the head and neck.

Eligibility:

  • Histologically or cytologically confirmed recurrent or metastatic squamous cell carcinoma of the head and neck
  • Subject eligibility will be based on PD-L1 expression as determined by a specified IHC assay

Exclusions:

  • Any concurrent chemotherapy, immunotherapy, biologic, or hormonal therapy for cancer treatment, receipt of last dose of an approved anticancer therapy within 21 days
  • Concurrent or prior use of immunosuppressive medication within 14 days
  • Active or prior documented autoimmune or inflammatory disease within 3 years with some exceptions

Full description on ClinicalTrials.gov: NCT02262741

Full title:A Phase I Study to Evaluate the Safety, Tolerability, and Efficacy of MED14736 in Combination with Tremelimumab in Subjects with Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck

Principal investigator: Ezra Cohen, MD

Contact: Nini Huynh, email or 858-822-4950

Phase II Study of MED14736, Tremelimumab, and MED14736 in Combination with Tremelimumab Squamous Cell Carcinoma of the Head and Neck

The purpose of this study is to determine the efficacy and safety of investigational medical products (NED14736 monotherapy, tremelimumab monotherapy, and MED14736 + tremelimumab combination therapy) in the treatment of patients with recurrent or metastatic carcinoma of the head and neck who have progressed during or after treatment with a platinum containing regimen for recurrent/metastatic disease.

Eligibility:

  • Histologically confirmed recurrent or metastatic SCCHN; tumor progression or recurrence during or after treatment with only one systemic regimen for recurrent or metastatic disease that must have contained a platinum agent
  • Confirmed PD-L1 negative SCCHN
  • No prior exposure to immune-mediated therapy
  • Received more than 1 regimen for recurrent or metastatic disease

Full description on ClinicalTrials.gov: NCT02319044

Full title:A Phase II, Randomized, Open-Label, Multicenter, Global Study of MED14736 in Combination With Tremelimumab in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck

Principal investigator: Ezra Cohen, MD

Contact: Chloe Lalonde, email or 858-246-0357

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