Research

Research

We are dedicated to contributing to high-level research in oral, head and neck surgical treatment. Through our partnership with Providence Oral, Head, and Neck Cancer Center, we work with other scientific collaborators from the Earle A. Chiles Research Institute to develop a productive translational immunotherapy program. Through sponsorship and our own research, we focus on stimulating the body’s own immune system to fight cancer.

The Head and Neck Institute currently offers more clinical trials for head and neck cancer patients than anywhere on the west coast. Clinical trials currently available to head and neck cancer patients are listed below.


Phase Ib Study of a Monoclonal Antibody to OX40 (MEDI6469) Administered Prior to Definitive Surgical Resection in Patients with Locoregionally Advanced, Oral Head and Neck Squamous Cell Carcinoma
Description: The purpose of this study is to test the safety of the anti-OX40 antibody, MEDI6469, given prior to surgery in patients with advanced head and neck squamous cell carcinoma.
Lead Researcher: R Bryan Bell MD, DDS
Location: Providence Cancer Center/Providence Portland Medical Center


A Phase 1 Dose Escalation and Cohort Expansion Study of the Safety, Tolerability, and Efficacy of Anti-LAG-3 Monoclonal Antibody (BMS-986016) Administered Alone and in Combination with Anti-PD-1 Monoclonal Antibody (Nivolumab, BMS-936558) in Advanced Solid Tumors
Description: To assess the safety and tolerability, characterize the dose-limiting toxicities, and identify the maximum tolerated dose of BMS-986016 (Anti-LAG-3) alone and in combination with Nivolumab (Anti-PD-1) in subjects with select advanced (metastatic and/or unresectable) solid tumors and to provide preliminary information on the clinical benefits of the combination.
Lead Researcher: Rachel Sanborn MD
Location: Providence Cancer Center/Providence Portland Medical Center


A Phase 1, Open-Label, Dose Escalation Study of MGA271 in Combination with Ipilimumab in Patients with B7-H3-Expressing Melanoma, Squamous Cell Cancer of the Head and Neck or Non Small Cell Lung Cancer
Description: The purpose of this study is to evaluate the safety of MGA271 in combination with Yervoy (ipilimumab) when given to patients with B7-H3-expressing melanoma, squamous cell carcinoma of the head and neck (SCCHN) or non small cell lung cancer (NSCLC). The study will also evaluate what is the best dose of MGA271 to use when given with ipilimumab. Assessments will also be done to see how the drug acts in the body (pharmacokinetics (PK), pharmacodynamics) and to evaluate potential anti-tumor activity of MGA271 in combination with ipilimumab.
Lead Researcher: Walter Urba MD, PhD
Location: Providence Cancer Center/Providence Portland Medical Center


A Phase 1 Study of MEDI6383 (an OX40 Agonist) in Adult Subjects with Select Advanced Solid Tumors
Description: This is a first-time-in-human (FTIH) Phase 1, multicenter, open-label, dose-escalation, and dose-expansion study of MEDI6383 (OX40 Ligand fusion protein) to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, pharmacodynamics, and antitumor activity in adult subjects with recurrent or metastatic solid tumors.
Lead Researcher: Brendan Curti MD
Location: Providence Cancer Center/Providence Portland Medical Center


A Phase 1 Study of the Safety, Tolerability, Pharmacokinetics and Immunoregulatory Activity of Urelumab (BMS-663513) in Subjects with Advanced and/or Metastatic Solid Tumors and Relapsed/Refractory B-cell Non-Hodgkin’s Lymphoma (B-NHL)
Description: The purpose of the study is to assess the safety, tolerability, pharmacokinetics and immunoregulatory activity of urelumab, anti-CD137 antibody (BMS-663513) in cancer subjects with advanced and/or metastatic tumors and relapsed/refractory B-Cell Non-Hodgkin’s Lymphoma.
Lead Researcher: Walter Urba MD, PhD
Location: Providence Cancer Center/Providence Portland Medical Center, Providence St. Vincent Medical Center


A Phase 1b/2, Open-label Study to Evaluate the Safety and Tolerability of MEDI6469 in Combination with Immune Therapeutic Agents or Therapeutic Monoclonal Antibodies in Subjects with Selected Advanced Solid Tumors or Aggressive B-cell Lymphomas
Description: The main purpose of this study is to determine the best dose of MEDI6469 (anti-PD-L1) that is safe and tolerable when given as monotherapy and in combination with tremelimumab (anti-CTLA-4), MEDI4736, or rituximab in subjects with either advanced solid tumors or diffuse large B-cell lymphoma (DLBCL). Tremelimumab and MEDI4736 will be tested with MEDI6469 in a set of subjects with advanced solid tumors while rituximab will be tested with MEDI6469 in subjects with DLBCL. MEDI6469 will be tested as monotherapy in subjects with advanced solid tumors.
Lead Researcher: Brendan Curti MD
Location: Providence Cancer Center/Providence Portland Medical Center


A Phase 1b, Open-Label, Multicenter Study of Urelumab (BMS-663513) in Combination with Cetuximab in Subjects with Advanced/Metastatic Colorectal Cancer or Advanced/Metastatic Squamous Cell Carcinoma of the Head and Neck
Description: The purpose of the study is to determine the safety, tolerability and maximum tolerated dose of Urelumab (anti-CD137) in combination with Cetuximab in patients with Advanced/Metastatic Colorectal Cancer or Advanced/Metastatic Squamous Cell Carcinoma of the Head and Neck.
Lead Researcher: Rom Leidner MD
Location: Providence Cancer Center/Providence Portland Medical Center


A Phase I Dose Escalation and Cohort Expansion Study of the Safety, Tolerability and Efficacy of Anti-KIR (BMS-986015) Administered in Combination with Anti-PD-1 (BMS-936558) in Advanced Refractory Solid Tumors
Description: The purpose of this study is to assess the safety and tolerability of BMS-986015 (Anti-KIR) given in combination with BMS-936558 (Anti-PD-1) and to identify dose limiting toxicities (DLTs) and the maximally tolerated dose (MTD) of the combination, in subjects with advanced (metastatic and/or unresectable) solid tumors.
Lead Researcher: Rachel Sanborn MD
Location: Providence Cancer Center/Providence Portland Medical Center


A Phase I, Open-label, Multiple-ascending Dose Trial to Investigate the Safety, Tolerability, Pharmacokinetics, Biological and Clinical Activity of avelumab MSB0010718C in Subjects With Metastatic or Locally Advanced Solid Tumors and Expansion to Selected Indications
Description: This is a Phase 1, open-label, dose-escalation trial of avelumab [antibody targeting programmed death ligand 1 (anti PD-L1)] with consecutive parallel group expansion in subjects with selected tumor indications including head and neck squamous cell carcinoma.
Lead Researcher: Rachel Sanborn MD
Location: Providence Cancer Center/Providence Portland Medical Center


Phase I Study of Alpha-tocopheryloxyacetic Acid (α-TEA) in Patients with Advanced Cancer
Description: The goal of this study is to find the highest dose of α-TEA that can be given to patients safely, to identify potential side effects of α-TEA, and to measure the amount of α-TEA in patients’ blood. Additional goals of this study are to monitor the effect on tumors, to check for specific immune cells circulating in the blood, and to see if there are certain features of tumors that make it possible to predict the response to α-TEA.
Lead Researcher: Brendan Curti MD
Location: Providence Cancer Center/Providence Portland Medical Center


A Phase 1 Dose Escalation and Cohort Expansion Study of the Safety, Tolerability, and Efficacy of Anti-LAG-3 Monoclonal Antibody (BMS-986016) Administered Alone and in Combination With Anti-PD-1 Monoclonal Antibody (Nivolumab, BMS-936558) in Advanced Solid Tumors
Description: To assess the safety and tolerability, characterize the dose-limiting toxicities, and identify the maximum tolerated dose of BMS-986016 (anti-LAG-3) alone and in combination with Nivolumab (Anti-PD-1) in subjects with select advanced (metastatic and/or unresectable) solid tumors and to provide preliminary information on the clinical benefits of the combination.
Lead Researcher: Rom Leidner MD
Location: Providence Cancer Center/Providence Portland Medical Center


A Phase l/ll Dose Escalation and Cohort Expansion Study of the Safety, Tolerability and Efficacy of Anti-CD27 Antibody (Varlilumab) Administered in Combination With Anti-PD-1 (Nivolumab) in Advanced Refractory Solid Tumors
Description: This is a study to determine the clinical benefit (how well the drug works), safety, and tolerability of combining varlilumab and nivolumab (also known as BMS-936558). Both drugs target the immune system and may act to promote anti-cancer effects. The study will enroll patients with the following cancer types: Non-Small Cell Lung Cancer, Melanoma, Colorectal, Ovarian or Head and Neck Squamous Cell Carcinoma.
Lead Researcher: Rachael Sanborn MD
Location: Providence Cancer Center/Providence Portland Medical Center


A Phase 1 Study to Evaluate the Safety, Tolerability, and Efficacy of MEDI4736 in Combination with Tremelimumab or Tremelimumab Alone in Subjects with Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
Description: This is a multicenter, open-label, dose-exploration and dose-expansion study to evaluate the safety, tolerability, anti-tumor activity, PK and immunogenicity of MEDI4736 in combination with tremelimumab in subjects with select advanced solid tumors.
Lead Researcher: Rom Leidner MD
Location: Providence Cancer Center/Providence Portland Medical Center


A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Clinical Activity of MEDI0562 in Adult Subjects with Selected Solid Tumors
Description: This is a first-time-in-human (FTIH) Phase 1, multicenter, open-label, single-arm, dose-escalation, and dose-expansion study of MEDI0562 (humanized antibody to OX40) in subjects with select advanced solid tumors.
Lead Researcher:
Rom Leidner MD
Location: Providence Cancer Center/Providence Portland Medical Center


A First-in-Human Study of Repeat Dosing with REGN2810, a Monoclonal, Fully Human Antibody to Programmed Death – 1 (PD-1), as Single Therapy and in Combination with Other Anti-Cancer Therapies in Patients with Advanced Solid Tumors
Description: This study measures safety, tolerability, and dose limiting toxicities (DLTs) of REGN2810 administered intravenously as monotherapy, or in combination with other anti-cancer therapies in patients with advanced malignancies. In the first portion of the study, REGN2810 will initially be tested as monotherapy, or in combination with targeted radiation, low dose cyclophosphamide, or both in patients with advanced solid malignancies.
Lead Researcher: Marka Crittenden MD, PhD
Location: Providence Cancer Center/Providence Portland Medical Center

Phase II Randomized Trial of Transoral Surgical Resection Followed by Low-dose or Standard-dose IMRT in Resectable p16+ Locally Advanced Oropharynx Cancer
Description: This randomized phase II trial studies how well transoral surgery followed by low-dose or standard-dose radiation therapy works in treating patients with human papilloma virus (HPV) positive stage III-IVA oropharyngeal cancer. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy with chemotherapy may kill any tumor cells that remain after surgery. It is not yet known how much extra treatment needs to be given after surgery.
Lead Researcher: R. Bryan Bell, MD, DDS
Location: Providence Cancer Center/Providence Portland Medical Center


A Phase II, Randomized, Open-Label, Multi-Center, Global Study of MEDI4736 Monotherapy, Tremelimumab Monotherapy, and MEDI4736 in Combination with Tremelimumab in Patients with Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)
Description: The purpose of this study is to determine the efficacy and safety of investigational medical products (MEDI4736 monotherapy, tremelimumab monotherapy, and MEDI4736 + 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.


A Phase 2 Randomized Study of Efatutazone, an Oral PPAR Agonist, In Combination with Paclitaxel Versus Paclitaxel in Patients with Advanced Anaplastic Thyroid Cancer
Description: This randomized phase II trial studies how well efatutazone with paclitaxel compared to paclitaxel alone works in treating patients with advanced anaplastic thyroid cancer. Drugs used in chemotherapy, such as efatutazone and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells by stopping them from dividing or by stopping them from spreading. It is not yet known whether efatutazone in combination with paclitaxel is more effective than paclitaxel alone in treating patients with advanced anaplastic thyroid cancer.
Lead Researcher: Keith Lanier MD
Location: Providence Cancer Center/Providence Portland Medical Center


A Phase II, Multi-Center, Single-Arm, Global Study of MEDI4736 Monotherapy in Patients with Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)
Description: This is a phase II, multi-center, single-arm, global study of MEDI4736 monotherapy in patients with PD-L1 positive recurrent or metastatic Squamous cell carcinoma of the head and neck.
Lead Researcher: Rom Leidner MD
Location: Providence Cancer Center/Providence Portland Medical Center


A Phase 1/2 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI4736 in Subjects with Advanced Solid Tumors
Description: This is a multicenter, open-label, first-time-in-human study of MEDI4736 (Anti-PD-L1) with a standard 3+3 dose-escalation phase in subjects with advanced solid tumors followed by an expansion phase in patients with advanced solid tumors.
Lead Researcher: Rachel Sanborn MD
Location: Providence Cancer Center/Providence Portland Medical Center


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
Description: The purpose of this study is to compare the progression-free survival of patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) treated with VTX-2337 + cisplatin or carboplatin + 5-FU + cetuximab versus patients treated with cisplatin or carboplatin + 5-FU + cetuximab alone (standard-of-care; SOC). Safety and overall survival will also be evaluated.
Lead Researcher: Rom Leidner MD
Location: Oncology and Hematology Care Eastside


A Randomized Phase II Study of Adjuvant Concurrent Radiation and Chemotherapy Versus Radiation Alone in Resected High-Risk Malignant Salivary Gland Tumors
Description: This randomized phase II trial is studying radiation therapy with or without chemotherapy to see how well it works in treating patients with high-risk malignant salivary gland tumors that have been removed by surgery.
Lead Researcher: Matthew Solhjem MD
Location: Providence Cancer Center/Providence Portland Medical Center, Providence St. Vincent Medical Center


Phase 2, Multi-center, Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Brilacidin Oral Rinse Administered Daily for 7 Weeks in Attenuating Oral Mucositis in Patients with Head and Neck Cancer Receiving Concurrent Chemotherapy and Radiotherapy
Description: Oral Mucositis (OM) is a painful and debilitating side effect of many of the drug or radiation regimens used to treat cancer. This study will examine whether daily oral rinses with a solution containing brilacidin will prevent the occurrences of OM or lessen the severity of OM if it occurs. Patients will use an oral rinse 3 times daily for up to seven weeks during chemoradiation for head and neck cancer.
Lead Researcher: Rom Leidner MD
Location: Providence Cancer Center/Providence Portland Medical Center

A Phase III Placebo-Controlled, Randomized Three-Arm Study of Doxepin and a Topical Rinse in the Treatment of Acute Oral Mucositis Pain in Patients Receiving Radiotherapy With or Without Chemotherapy
Description: Patients are stratified according to sex (male vs. female), concurrent use of chemotherapy (no vs. yes), patient age at registration (less than 60).
Lead Researcher: Kelly Perlewitz MD
Location: Providence Cancer Center/Providence Portland Medical Center,
Providence St. Vincent Medical Center


A Phase III Prospective Randomized Trial of Acupuncture for Treatment of Radiation-Induced Xerostomia in Patients with Head and Neck Cancer
Description: This randomized phase III trial is studying to see how well one set of acupuncture points work in comparison to a different set of acupuncture points.
Lead Researcher: Kelly Perlewitz MD
Location: Providence Cancer Center/Providence Portland Medical Center,
Providence St. Vincent Medical Center


A Phase III Study of Postoperative Radiation Therapy (IMRT) +/- Cetuximab for Locally-Advanced Resected Head and Neck Cancer
Description: This randomized phase III trial is studying radiation therapy to see how well it works compared with radiation therapy given together with cetuximab in treating patients who have undergone surgery for locally advanced head and neck cancer.
Lead Researcher: Matthew Solhjem MD
Location: Providence Cancer Center/Providence Portland Medical Center,
Providence St. Vincent Medical Center


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
Description: 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. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as cisplatin and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or transmit tumor killing molecules to them. It is not yet known whether radiation therapy is more effective when given with cisplatin, docetaxel, or cetuximab and docetaxel.
Lead Researcher: Matthew Solhjem MD
Location: Providence Cancer Center/Providence Portland Medical Center,
Providence St. Vincent Medical Center


Observational Study of Swallowing Function After Treatment of Advanced Laryngeal Cancer
Description: The purpose of this prospective, multi-institutional, observational cohort study is to determine if an initial surgical approach leads to better function and quality of life than primary chemoradiation in a subset of patients with advanced hypopharyngeal and laryngeal cancers.
Lead Researcher: R Bryan Bell MD
Location: Providence Cancer Center/Providence Portland Medical Center