Dr. Steven Chinn received his medical degree from the Keck School of Medicine at the University of Southern California in 2008, graduating with Senior Honors and elected into the National Alpha Omega Alpha Honor Medical Society. He completed his post-graduate surgical training in Otolaryngology-Head and Neck Surgery at the University of Michigan in 2014 during which he completed an 18-month NIH funded research fellowship in the Molecular Genetics and Cellular Biology of Head and Neck Cancer. He then completed a two-year dual fellowship in Head & Neck Surgical Oncology and Microvascular Reconstructive Surgery at the University of Texas MD Anderson Cancer Center. Dr. Chinn also holds a graduate degree (MPH) in Molecular Epidemiology from the University of Michigan School of Public Health.

Dr. Chinn joined the faculty at the University of Michigan in 2016, and currently serves as an Assistant Professor in the Department of Otolaryngology-Head and Neck Surgery. He is a member of the Head and Neck Oncology Division, an active member of the Head and Neck Oncology Translational Research Program, and a member of the University of Michigan Comprehensive Cancer Center. His clinical expertise is in the treatment of all types of head and neck cancer, including minimally invasive robotic surgery and complex oral cancers. He also specializes in complex reconstructive surgery to restore form and function after cancer treatment. His research interests include molecular genetics of oral cavity cancer, head and neck cancer stem cells, the molecular mechanisms of metastasis, and outcomes research with an emphasis on improving survival and functional status.

Randomized Phase II study of DCE-MRI-based dose escalation for poor-prognosis head and neck cancer (Phase II)
Primary Investigator: Mierzwa, Michelle
This study aims to improve locoregional control of poor prognosis Head and Neck Cancer (HNC) patients by selectively escalating the radiotherapy dose to subvolumes of tumor likely to be resistant to standard Radiation Therapy (RT) using DCE-MRI (Dynamic Contrast Enhanced Magnetic Resonance Imaging). Standard doses of radiotherapy to the rest of the tissues and surrounding normal tissues will be maintained.

VISmodegib for ORbital and periocular Basal cell carcinoma (VISORB) (Phase IV)
Primary Investigator: Kahana, Alon
Basal cell carcinoma (BCCA) is the most common human cancer, and frequently affects facial structures. While rarely fatal, facial BCCA can be disfiguring and expensive to treat. ;Vismodegib is a small molecule inhibitor of SMO developed for the treatment of tumors in which the Hh signaling pathway appears to contribute to the development and maintenance of tumorigenesis. Vismodegib was recently approved by the Food and Drug Administration (FDA) for treatment of metastatic and locally advanced BCCA. Recent reports have suggested that vismodegib treatment for orbital BCCA may facilitate eye preservation even if surgery is eventually required ;In order to assess the potential of vismodegib to improve the ophthalmic outcomes following treatment for orbital and/or periocular BCCA, this study will follow patients with globe-threatening orbital and lacrimal-threatening periocular BCCA who are being treated with vismodegib as standard of care.

Pain Control Using Neuromodulation in Patients Undergoing Definitive Chemoradiotherapy or Radiation Therapy for Locally Advanced Head and Neck Cancer (Phase II)
Primary Investigator: Dasilva, Alexandre
The purpose of this study is to determine if Transcranial Direct Current Stimulation (tDCS) can reduce pain perception associated with the effects of receiving definitive radiation therapy or chemoradiotherapy in head and neck cancer (HNCa) patients.

A Phase I, open-label, dose escalation study of oral LGK974 in patients with malignancies dependent on Wnt ligands (Phase I)
Primary Investigator: Smith, David
This primary purpose of this study is to find the recommended dose of LGK974 that can be safely given to adult patients with maliganacies dependent on Wnt ligands for whom no effective standard treatment is available.

A phase 1, open-label, dose-escalation study of SEA-CD40 in adult patients with advanced malignancies (Phase I)
Primary Investigator: Smith, David
This study will examine the safety profile of SEA-CD40. The study will test increasing doses of SEA-CD40 given at least every 3 weeks to small groups of patients. The goal is to find the highest dose of SEA-CD40 that can be given to patients that does not cause unacceptable side effects. The pharmacokinetics, pharmacodynamic effects, biomarkers of response, and antitumor activity of SEA-CD40 will also be evaluated.

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 (Phase II/III)
Primary Investigator: Worden, Francis
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.

The validation of a novel adherence method for oral oncolytics (N/A)
Primary Investigator: Kraft, Shawna

A Phase 1/1b Study of MGCD516 in Patients With Advanced Solid Tumor Malignancies (Phase I)
Primary Investigator: Alva, Ajjai
MGCD516 is a receptor tyrosine kinase (RTK) inhibitor shown in preclinical models to inhibit a closely related spectrum of RTKs including MET, AXL, MER, and members of the VEGFR, PDGFR, DDR2, TRK and Eph families. In this study, MGCD516 is orally administered to patients with advanced solid tumor malignancies to evaluate its safety, pharmacokinetic, metabolism, pharmacodynamic and clinical activity profiles. ;During the Phase 1 segment, the dose and regimen of MGCD516 will be assessed; during the Phase 1b segment, the clinical activity of MGCD516 will be evaluated in selected patient populations. ;Patients anticipated to be enrolled in Phase 1b will be selected based upon having a tumor type, including but not limited to, non small cell lung cancer and head and neck cancer positive for specific activating MET, NTRK2, NTRK3, or DDR2 mutations, MET or KIT/PDGFRA/KDR gene amplification, selected gene rearrangements involving the MET, RET, AXL, NTRK1, or NTRK3 gene loci, or having loss of function mutations in the CBL gene. In addition patients with clear cell renal cell carcinoma refractory to angiogenesis inhibitors or metastatic prostate cancer with bone metastasis will be enrolled.

RANDOMIZED PHASE II AND PHASE III STUDIES OF INDIVIDUALIZED TREATMENT FOR NASOPHARYNGEAL CARCINOMA BASED ON BIOMARKER EPSTEIN BARR VIRUS (EBV) DEOXYRIBONUCLEIC ACID (DNA) (Phase II/III)
Primary Investigator: Worden, Francis
There are two study questions we are asking in this randomized phase II/III trial based on a blood biomarker, Epstein Barr virus (EBV) deoxyribonucleic acid (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 fluorouracil chemotherapy versus gemcitabine and paclitaxel. Radiation therapy uses high energy x rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin, fluorouracil, gemcitabine hydrochloride, 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 giving cisplatin and fluorouracil is more effective than gemcitabine hydrochloride and paclitaxel after radiation therapy in treating patients with nasopharyngeal cancer.

Molecular Analysis for Therapy Choice (MATCH) (Phase II)
Primary Investigator: Alva, Ajjai
This phase II trial studies how well treatment that is directed by genetic testing works in patients with solid tumors or lymphomas that have progressed following at least one line of standard treatment or for which no agreed upon treatment approach exists. Genetic tests look at the unique genetic material (genes) of patients tumor cells. Patients with genetic abnormalities (such as mutations, amplifications, or translocations) may benefit more from treatment which targets their tumors particular genetic abnormality. Identifying these genetic abnormalities first may help doctors plan better treatment for patients with solid tumors or lymphomas.

Phase II Treatment Stratification Trial Using Neck Dissection-Driven Selection to Improve Quality of Life for Low Risk Patients with HPV+ Oropharyngeal Squamous Cell Cancer (Phase II)
Primary Investigator: Worden, Francis
Investigators will determine whether treatment stratification by neck dissection, to more accurately pathologically stage patients, minimizing the number of treatment modalities in patients with low risk oropharyngeal squamous cell carcinoma, can improve quality of life.

Non-Comparative, Open-label, Multiple Cohort, Phase 1/2 Study of Nivolumab Monotherapy and Nivolumab Combination Therapy in Subjects with Virus-Positive and Virus-Negative Solid Tumors (Phase I/II)
Primary Investigator: Lao, Christopher
The purpose of this study to investigate the safety and efficacy of using nivolumab, and nivolumab in combination with ipilimumab, to treat subjects who have virus-associated tumors. Certain viruses that infect human cells have been known to play a role in tumor formation and growth. This study will investigate the effects of the study drugs nivolumab, and nivolumab in combination with ipilimumab, in human subjects who have the following types of tumors: Epstein Barr Virus (EBV) positive gastric cancer; EBV positive nasopharyngeal cancer (NPC); Human Papilloma Virus (HPV) positive cervical, vaginal, vulvar cancer; HPV positive squamous cell cancer of the head and neck (SCCHN); and Polyomavirus positive merkel cell cancer.

Phase II Investigation of Adjuvant Combined Cisplatin and Radiation with Pembrolizumab in Resected HNSCC (Phase II)
Primary Investigator: Worden, Francis

Phase II Expansion Trial Evaluating Axitinib in Patients with Unresectable Recurrent, or Metastatic Head and Neck Cancer utilizing Choi Response Criteria (Phase II)
Primary Investigator: Worden, Francis
This study will be a prospective, single-institution, single-arm phase II study of Axitinib in patients with unresectable recurrent and metastatic head and neck squamous cell carcinoma. The subjects will be started on treatment with 5 mg of Axitinib twice a day continuously, with subsequent dose escalation to 7 mg and then 10 mg twice a day in the absence of grade 2 or worse toxicities. This will be followed by clinical and/or radiologic response assessment after 8 weeks and subsequently every 2 months until disease progression or intolerable toxicity.

An Open Label, Randomized, Two Arm Phase III Study of Nivolumab in Combination with Ipilimumab versus Extreme Study Regimen (cetuximab + cisplatin/carboplatin + fluorouracil) as First Line Therapy in Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN) (Phase III)
Primary Investigator: Worden, Francis
The main purpose of this study is to compare nivolumab and ipilimumab with the Extreme study regimen as first line treatment in patients with recurrent or metastatic squamous cell of the head and neck cancer

Phase II Randomized Trial of Adjuvant Radiotherapy with or Without Cisplatin for p53 Mutated, Surgically Resected Squamous Cell Carcinoma of the Head and Neck (SCCHN) (Phase II)
Primary Investigator: Worden, Francis
;This phase II trial studies how well radiation therapy with or without cisplatin works in treating patients with stage III-IV squamous cell carcinoma of the head and neck who have undergone surgery. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as cisplatin, 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 if radiation therapy is more effective with or without cisplatin in treating patients with squamous cell carcinoma of the head and neck.

Phase II Randomized Trial of Adjuvant Radiotherapy with or Without Cisplatin for p53 Mutated, Surgically Resected Squamous Cell Carcinoma of the Head and Neck (SCCHN) (Phase II)
Primary Investigator: Worden, Francis
This phase II trial studies how well radiation therapy with or without cisplatin works in treating patients with stage III-IV squamous cell carcinoma of the head and neck who have undergone surgery. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as cisplatin, 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 if radiation therapy is more effective with or without cisplatin in treating patients with squamous cell carcinoma of the head and neck.

Phase I/II Trial of the Addition of PD 0332991 to Cetuximab in Patients with Incurable SCCHN (Phase I/II)
Primary Investigator: Worden, Francis

An Open Label Phase II Study of Tipifarnib in Advanced Non-Hematological Malignancies with HRAS Mutations (Phase II)
Primary Investigator: Worden, Francis

A Randomized Phase III study of pembrolizumab given concomitantly with chemoradiation and as maintenance therapy versus chemoradiation alone in subjects with locally advanced head and neck squamous cell carcinoma (KEYNOTE-412) (Phase III)
Primary Investigator: Worden, Francis

DART: DUAL ANTI-CTLA-4 AND ANTI-PD-1 BLOCKADE IN RARE TUMORS (Phase II)
Primary Investigator: Zalupski, Mark

A Phase 2, multi-center, randomized, double-blind, placebo-controlled study to assess the safety and efficacy of topically applied AG013 for the attenuation of oral mucositis in subjects with cancers of the head and neck receiving concomitant chemoradiation therapy.(Phase II)
Primary Investigator: Worden, Francis
The purpose of the study is to evaluate the efficacy, safety and tolerability of topically administered AG013 compared to placebo for reducing Oral Mucositis (OM) in patients undergoing chemoradiation for the treatment of head and neck cancer.

A Multi-Center open label single arm phase II trial evaluating the efficacy of palbociclib in combination with carboplatin for the treatment of unresectable recurrent or metastatic head and neck squamous cell carcinoma (Phase II)
Primary Investigator: Swiecicki, Paul

A Phase 1a Open-Label, Dose Escalation Study of the Safety and Pharmacokinetics of OMP-336B11 Administered as a Single Agent to Subjects with Locally Advanced or Metastatic Solid Tumors (Phase I)
Primary Investigator: Smith, David

A MULTI-CENTER PHASE II TRIAL OF INDIVIDUALIZED ADAPTIVE DE-ESCALATED RADIOTHERAPY USING PRE and MID-TREATMENT FDG-PET/CT FOR HPV-RELATED OROPHARYNX CANCER (Phase II)
Primary Investigator: Mierzwa, Michelle

Randomized Phase II/III Trial of Radiotherapy with Concurrent MEDI4736 (Durvalumab) vs. Radiotherapy with Concurrent Cetuximab in Patients with Stage III-IVB Head and Neck Cancer with a Contraindication to Cisplatin (Phase II/III)
Primary Investigator: Worden, Francis

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