Clinical Trials
Last updated 3/15/21
MD Anderson uses clinical trials to find better ways to prevent, diagnose and treat cancer. Our patients have access to clinical trials offering promising new treatments that cannot be found anywhere else.
A list of clinical trials available in the Head and Neck Surgery department is provided below. If you are interested in participating in one of these clinical trials, please call the Information Line toll-free at 1-800-MDA-06789 or visit the MD Anderson Clinical Trials site.
Trial availability may change without notice. Individual trial spots may open or close without notice. Click on the study links for detailed information about each clinical trial.
Head & Neck Squamous Cell Carcinoma - All Sites
Open-label Study using ASP-1929 Photoimmunotherapy in Combination with anti-PD1 Therapy in EGFR Expressing Advanced Solid Tumors
Phase III, randomized, double-arm, open-label, controlled trial of ASP-1929 vs physician's choice standard of care for the treatment of locoregional, recurrent head and neck squamous cell carcinoma in patients who have failed or progressed on or after at least two lines of therapy.
Oral Cancer & Precancer
Post-operative Adjuvant Treatment for HPV-positive Tumours (PATHOS)
A Phase III trial of risk-stratified, reduced intensity adjuvant treatment in patients undergoing transoral surgery for Human papillomavirus (HPV)-positive oropharyngeal cancer.
A Phase II/III Randomized Trial of Sentinel Lymph Node Biopsy Versus Elective Neck Dissection for Early-Stage Oral Cavity Cancer
This multicenter phase II/III trial, led nationally by Stephen Y. Lai, M.D., Ph.D., Department of Head and Neck Surgery, studies how well sentinel lymph node biopsy works and compares sentinel lymph node biopsy surgery to standard neck dissection as part of the treatment for early-stage oral cavity cancer. Sentinel lymph node biopsy surgery is a procedure that removes a smaller number of lymph nodes from your neck because it uses an imaging agent to see which lymph nodes are most likely to have cancer. Standard neck dissection, such as elective neck dissection, removes many of the lymph nodes in your neck. Using sentinel lymph node biopsy surgery may work better in treating patients with early-stage oral cavity cancer compared to standard elective neck dissection.
HPV-related Oropharyngeal and Uncommon Cancers Screening Trial Of meN - HOUSTON Study
This trial studies the screening of human papillomavirus (HPV)-related oropharyngeal and uncommon cancers. Learning the relationship between HPV and cancer risk in men who test positive for HPV antibodies may help doctors to develop early methods of screening for certain types of cancer, and screening for HPV may help doctors to learn which patients may be at a higher risk for developing certain types of cancer.
Multimodal Imaging for Surveillance of Patients with Oral Potentially Malignant Disorders
This early phase I trial studies how well multimodal imaging
works for surveillance in patients with oral potentially malignant
disorders. New types of imaging devices may help doctors decide if a
lesion in the mouth is pre-cancerous or cancerous.
Wide-Field and High Resolution In Vivo Imaging of Oral Neoplasia Using Topical Fluorescent Dyes: A Feasibility Study
This clinical trial studies wide-field and high resolution in
vivo imaging in visualizing lesions in patients with abnormal or
uncontrolled oral cell growth (neoplasia) undergoing surgery.
Diagnostic procedures, such as wide-field and high resolution in vivo
imaging, are devices that let researchers look at a wide area of the
lining of the mouth by shining different colors inside the mouth and
taking pictures and this may help doctors to decide if a mouth lesion
has a high risk of being pre-cancerous or cancerous.
Thyroid Cancer
Neoadjuvant/Adjuvant Treatment with Selpercatinib in RET-Altered Thyroid Cancers
This phase II trial studies the effect of selpercatinib given before surgery in treating patients with thyroid cancer whose tumors have RET alterations (changes in the genetic material [deoxyribonucleic acid (DNA)]. Selpercatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving selpercatinib before surgery may help shrink the tumors and help control the disease.
Pilot Study of Metabolic Guidance for Therapy in Patients with Thyroid Cancer
This trial investigates whether hyperpolarized magnetic resonance imaging (hpMRI) can predict treatment response in patients with thyroid cancer undergoing radiation therapy and/or receiving systemic therapy before surgery. An hpMRI is like a standard MRI but involves the use of an imaging contrast agent called hyperpolarized 13-C-pyruvate. Diagnostic procedures, such as hpMRI, may predict a patient's response to treatment and may help plan the best treatment.
Skin Cancer
Phase II Study of REGN2810 Prior to Surgery in Patients with Advanced-Stage, Resectable Cutaneous Squamous Cell Carcinoma of the Head and Neck
This phase II trial studies how well cemiplimab works before surgery in treating participants with stage III-IV head and neck squamous cell cancer that has come back. Immunotherapy with monoclonal antibodies, such as cemiplimab, may help the body's immune system attack the cancer and may interfere with the ability of tumor cells to grow and spread.
Ophthalmology
Collaborative Ocular Oncology Group Uveal Melanoma Validation Study Number 2 (COOG2)
This is a multi-center collaborative study to validate the prognostic value of PRAME as an addition to the DecisionDx-UM prognostic test for uveal melanoma.
*This study is currently closed to new patient enrollment.
Multidisciplinary Collaborations
Clinical trials are how progress is made in medicine. “They’re really essential to drive our ability to deliver better cancer care,” says Funda Meric-Bernstam, M.D.
Enrollment in a clinical trial is entirely voluntary, but cancer patients can benefit from joining one while also helping future patients. The insights we gain from clinical trials today helps us improve treatment options that will benefit other patients.
Clinical trials are complex, though, and there are a lot of misconceptions surrounding them. Here's what you should know before you join a clinical trial – or decide it’s not for you.
Clinical trials are safe
“Safety is the most important thing,” says Ecaterina Ileana Dumbrava, M.D. Because patients on clinical trials are the first ones to receive experimental medications, there are many safeguards in place to ensure they’re not harmed.
In addition to the routine assessments cancer patients receive for standard treatment, clinical trial participants typically need additional clinical visits, lab work, imaging scans and biopsies.
Also, you’re not just communicating with your oncologist and your cancer care team. Patients on clinical trials also have continuous contact with a research team to ensure they’re doing well on the new drug.
“We’re talking to patients, often weekly, to see if they’re experiencing any side effects and just checking in to see if they have any questions,” Meric-Bernstam says. Your clinical trial team also provides guidance on next steps if the patient does experience any side effects. “There's a lot of help built in with clinical trials to make sure that patients are getting optimal care,” Meric-Bernstam adds.
But the focus on safety doesn’t start there – it happens well before patients are enrolled. “The FDA doesn’t come in just at the end of the trial to approve a drug; they approve the drug before it can be even be administered to patients in the trial,” Dumbrava says.
At MD Anderson, clinical trials are designed by experts and go through several rounds of approval to ensure they’re safe for patients. A proposed clinical trial receives its final approval from the Institutional Review Board (IRB), a committee made up of physicians, nurses, researchers, patients and lawyers.
Clinical trials occur in phases
There are four phases of clinical trials, and each has its own goal. When a new drug or a new drug combination is developed, it's tested in Phase I clinical trials. These usually have a small number of patients, about 15 to 50. “These trials are designed to determine the safety of the drug or drug combination, and what dose to use in following trials,” Meric-Bernstam says. “We’re also looking efficacy, and identifying which patients are the most likely to benefit from the drug, and, therefore, be enrolled in future studies."
Phase II clinical trials may focus on a specific cancer type and examine how it responds to the experimental drug or procedure. These trials may enroll patients with specific diseases or based on certain test results called biomarkers.
Phase III clinical trials test whether a new treatment is better than what’s being used as the standard treatment. At this point, the drug or procedure may go to the FDA for approval, but studies of the drug aren’t done. A fourth phase (Phase IV) reviews the new treatment’s long-term benefits and side effects.
Clinical trials don’t just examine new drugs
Although many clinical trials study new medicines, they help improve all aspects of cancer care. They can study new ways of dispensing treatment, explore a new dosage, test a new drug combination or examine a drug’s success in treating different cancer types.
They also focus on ways to prevent cancer or a recurrence as well as ways to reduce treatment side effects. “We want to save more lives, but we also want to maintain patients’ quality of life,” Dumbrava says.
Clinical trials don’t limit your access to other care
“No matter what the scenario, often the best treatment choice is a clinical trial,” Meric-Bernstam says. She notes that if there’s already an effective treatment approach, clinical trials offer the opportunity to build on that to make it more effective. They usually require patients to receive known effective treatment options before starting something that’s more investigational. If there aren’t clear, effective treatments, clinical trials offer access to something new that may work.
“Unfortunately, we don’t know if an experimental treatment will be effective, but that’s true for some standard treatments, too,” Meric-Bernstam says.
If your disease isn’t controlled on a clinical trial, your doctor will stop your participation and may offer another treatment option. In some cases, you may enroll in another clinical trial.
“By joining a trial, you’ll usually be getting a treatment that we think may be better than our current options,” Meric-Bernstam says.
Dumbrava agrees, adding, “At minimum, you’ll be receiving the best treatment available.”
And even if you personally don’t see clinical benefit from the experimental treatment, your participation still helps advance cancer research.
Clinical trials are for patients at all stages of cancer
Although all clinical trials have criteria for the participants, clinical trials are available to patients at all stages of cancer. The eligibility criteria, which is meant to ensure patients’ safety, may include the patient’s age, gender, cancer type and stage, previous treatments and overall health.
Your doctor is the best resource for knowing your treatment options. But don’t hesitate to ask if there are clinical trials that are available to you.
“It's also an opportunity to pay it forward and truly contribute to better outcomes for future patients,” Meric-Bernstram says.
Request an appointment at MD Anderson online or by calling 1-877-632-6789.