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Otolaryngology – Research and Clinical Trials

Otolaryngology – Research and Clinical Trials

Otolaryngology physician inserting a syringe into a test tube

Learn more about ear nose and throat clinical research at Penn State Health Milton S. Hershey Medical Center

Clinical trials are conducted to find out if new treatments are more effective or improved over current or standard treatments. For some patients with otolaryngology issues or head and neck conditions or diseases, taking part in a clinical trial may be a viable treatment choice. 

New discoveries lead to improved patient care

The doctors at Penn State Health Milton S. Hershey Medical Center and Penn State College of Medicine conduct medical research together. We seek to discover new treatments for head and neck conditions. We also teach medical students. When we share new techniques with the doctors of tomorrow, our patients receive the latest care. 

Clinical trials for head and neck cancers

Members of your otolaryngology care team take part in many studies. Your doctor may ask you to join a clinical trial patient group. You might try a new treatment for your condition. Or you may share some of your medical data with our researchers who look for new ways to help patients.

Otolaryngology researchers at Penn State College of Medicine are currently involved in many head and neck cancer clinical trials. View our open clinical trials listed below.

Quick links

Visit StudyFinder for complete information about all the clinical trials underway at Penn State Health.

Head and neck cancer clinical trials

Current clinical trials

Head and neck squamous

Protocol ID: PSHCI 15-069 DYNAVAX

IRB No: IRB-3680

Short title: A Phase1B/II, Open-Label, Multicenter, Dose-Escalation and Expansion Trial of Intratumoral Sd-101 in Combination with Pembrolizumab in patients with Metastatic Melanoma or Recurrent or Metastatic Head and Neck Squamous Cell CA

PI: Dr. Hershock, Dr. Almokadem, Dr. Goldenberg, Dr. Goyal, and Dr. Andrews

Coordinator: Becky Hale, 717-531-0003 

Eligibility:

  • Fresh biopsy after most recent treatment for central review
  • HNSCC that is recurrent or metastatic
  • Brain mets ok
  • No active auto-immune disease requiring medication in last 2 years
  • Any number of prior treatments

Treatment synopsis: 

  • Cohort 1 and 2 Melanoma
  • Cohort 3: PD-1/L1 naïve:
    • Pembrolizumab
    • Day 22, SD-101 once per wk x4 wks
    • 1 dose every 3 wks x 3
    • Pts will have the option to enter a 2nd cycle of SD-101 treatment in combination with Pembrolizumab, beginning on Day 190
  • Cohort 4: Progression on PD-1/L1 therapy:
    • Starting on Day 1, SD-101 once per week for 4 wks -1 dose every 3 wks x3
    • Pts will have the option to enter a 2nd cycle of SD-101 treatment in combination with Pembrolizumab, beginning on Day 190

Status: Pending


Protocol ID: PSHCI 17-003 NRG-HN003

IRB No: 

Short title: A Phase I and Expansion Cohort Study of Adjuvant Cisplatin, Intensity-Modulated Radiotherapy, and MK-3475 (Pembrolizumab) in High-Risk Head and Neck Squamous Cell Carcinoma (HNSCC)

PI: Dr. Hershock, Dr. Almokadem

Coordinator: Becky Hale, 717-531-0003 

Eligibility:

  • Pts with stage III-Ivb, high-risk squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx; patients with oropharyngeal cancer must be p16-negative.  

Treatment synopsis: 

  • Phase I:  Starting Schedule: Pembrolizumab, 200mg IV, week -1,  Wks 3 & 6 of CRT, Maintenance:  q 3 for wks 9, 12, 15, 18 & 21 Cisplatin 40 mg/m2/week for wks 1-6 of IMRT   IMRT, 60Gy over 30 fractions, 5 fractions / week, weeks 1-6.  

Status: Pending


Protocol ID: PSHCI 17-003 NRG-HN003

IRB No: IRB-6450

Short title: A Randomized Phase III Trial of Cisplatin-Based Chemoradiotherapy (Crt)+/- Nivolumab (Anti-Pdl-1) in High-Risk Local-Regionally Advanced Head and Neck Squamous Cell CA (With Phase I Lead In)

PI: Dr. Hershock, Dr. Almokadem

Coordinator: Becky Hale, 717-531-0003 

Eligibility:

  • Phase I lead-in: Oropharynx cancer that is p16 positive or negative, either less than 10 pack years or more.
  • Randomized to ARMS 1-3, Arm 4 automatic entry-see criteria under Arm 4:
  • Phase III:  Same pts as above
  • Stratification by disease site, N stage, positive vs negative and stage
  • Randomize to Nivolumab or Placebo along with Cisplatin 40mg/m2 per week x 7
  • IMRT: 70 Gy  

Treatment synopsis: 

  • Phase I:  Starting Schedule: Pembrolizumab, 200mg IV, week -1,  Wks 3 & 6 of CRT, Maintenance:  q 3 for wks 9, 12, 15, 18 & 21 Cisplatin 40 mg/m2/week for wks 1-6 of IMRT   IMRT, 60Gy over 30 fractions, 5 fractions / week, weeks 1-6.  

Status: Pending

 

Salivary

Protocol ID: PSHCI 16-128 ALLIANCE A091404

IRB No: CIRB-6186

Short title: A Phase II Study of Enzalutamide (Nsc#766085) for Patients with Androgen Receptor Positive Salivary Cancers

PI: Dr. Hershock, Dr. Almokadem

Coordinator: Becky Hale, 717-531-0003 

Eligibility:

  • Salivary CA by central path review
  • Androgen Receptor expression by   central path review
  • Locally advanced/unresectable or metastatic
  • Any prior number of treatments
  • No brain mets   

Treatment synopsis: 

  • Tissue submission for review
  • Enzalutamide, 160mg, po, daily, continuously  for maximum of 15 mos 

Status: Open


Advanced Anaplastic Thyroid   

Protocol ID: 17-006 ALLIANCE A091305

IRB No: CIRB-6688

Short title: A Phase II Study of Efatutazone, an Oral Ppar Agonist, In Combination With Pactlitaxel in Patients with Advanced Anaplastic Thyroid Cancer

PI: Dr. Hershock, Dr. Almokadem

Coordinator: Becky Hale, 717-531-0003 

Eligibility:

  • Advanced ATC
  • Measureable disease
  • Metastatic or locally advanced unresectable
  • No limit of number of prior lines of therapy
  • No prior Taxan therapy within 6mos except as a radiosensitizer
  • Brain Mets allowed that is treated and controlled
  • DM insulin dependent or TZD oral agents are not eligible
  • ECOG </=2           

Treatment synopsis: 

  • Sub-study mandatory to be asked, not mandatory to participate.
  • Register
  • Paclitaxel 175mg/m2 IV every 21 days and Efatutazone 0.5mg, po., bid  

Status: Pending


Phase I

Protocol ID: PSHCI 15-094  ECOG-ACRIN

IRB No: CIRB-3545

Short title: Molecular Analysis for Therapy Choice (MATCH)

PI: Dr. Belani

Coordinator: Becky Hale, 717-531-0003 

Eligibility:

  • Solid tumors requiring therapy that have progressed following at least one line of standard systemic therapy and/or for whose disease no standard treatment exists that has been shown to prolong survival.                    
  • Biopsy needed or archived tissue that has been within the most recent 6mos.
  • No targeted therapy after biopsy or fresh biopsy is needed. 

Treatment synopsis: 

  • *Multiple agents, depending on mutation

Status: Open


Protocol ID: PSHCI 15-053   REGENERON

IRB No: IRB-3959

Short title: Study of REGN2810 (Anti-PD-1) in Patients With Advanced Malignancies

PI: Dr. Yee

Coordinator: Michele St. Pierre, 717-531-4300

Eligibility:

  • Must be refractory to at least 1st line therapy in the recurrent or metastatic disease setting.
  • Pt's must have disease for which palliative RT is clinically indicated.
  • Sites will include primary tumors of the oral cavity, oropharynx, larynx or hypopharynx.  

Treatment synopsis: 

  • 3mg/kg REGN2810 & RT (9Gy x3), Cyclophosphamide 200mg/m2 & GM-CSF
  • REGN2810 every 2 wks IV   x 4 doses / cycle
  • Cyclophosphamide x 4 doses in 1st  cycle only                                                            
  • GM-CSF x 4 doses for 7 days in 1st cycle only      
  • RT in 2nd week of 1st Cycle only  

Status: Open

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