Neoadjuvant Immunotherapy Cancer Study

New Clinical Trial Examines Neoadjuvant Immunotherapy in Head and Neck Cancers

The Head and Neck Oncology Center at Dana-Farber/Brigham and Women’s Cancer Center is one of only two sites nationwide participating in a new clinical trial evaluating the role of neoadjuvant immunotherapy in improving locoregional recurrence and distant metastatic rates in patients with locally advanced head and neck squamous cell carcinomas (HNSCCs).

“Immunotherapies are now being more broadly used in the treatment of recurrent metastatic cancers, including head and neck cancers,” said Ravindra Uppaluri, MD, PhD, Surgical Director of the Head and Neck Oncology Center. “By introducing these therapies during an earlier phase of the treatment process, our goal is to improve the upfront, first-line therapies offered to patients when they first present with cancer, particularly those at the highest risk for recurrence.”

Checkpoint Inhibitors

Dr. Uppaluri is the site Principal Investigator of this Phase II study (Immunotherapy with MK-3475 in surgically resectable head and neck squamous cell carcinoma) using pembrolizumab in patients with surgically resectable Stage III or IV HNSCCs, including cancers of the oral cavity, hypopharynx, oropharynx, and larynx.

Patients participating in the study will be given pembrolizumab intraveniously once over the course of 30 minutes approximately two-to-three weeks before standard-of-care surgery. Adjuvant therapy may include intensity modulated radiation therapy (IMRT), risk-based cisplatin, and pembrolizumab every three weeks for a maximum of six doses (for participants found to have positive margins or extracapsular extension).

“Checkpoint inhibitors like pembrolizumab are designed to address homeostatic mechanisms that regulate immune responses and prevent the patient’s own immune system from recognizing and attacking cancer cells,” said Dr. Uppaluri. “These new agents essentially release the brakes on the patient’s immune system.”

The Head and Neck Oncology Center team participated in studies that recently led to the FDA approval of the use of immunotherapies, including pembrolizumab, in patients with recurrent metastatic HNSCCs (J Clin Oncol. 2016 Sep 19 and NEngl J Med. 2016 Oct 8.).

Additional Aspects of Neoadjuvant Study

The neoadjuvant approach will help the team to define specific responders to the therapy by observing responses before surgery and examining molecular changes in the tumor after surgery. Patients who do respond to the neoadjuvant therapy may also benefit from a reduction in extent of surgical resection, as well as treatments and treatment-related toxicities after surgery. (To learn more about this study, please contact Dr. Uppaluri at

Access to our Otolaryngology Services

At Brigham and Women’s Hospital and Dana-Farber/Brigham and Women’s Cancer Center, our specialists are available for timely consultations and will work with you to develop treatment plans for your patients. Our Physician Liaison Ellen Steward can provide direct assistance with patient referrals and consultations. Ellen can be reached at (617) 582-4733 or


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