UMGCCC Launches Novel Trial for Recurrent Head and Neck Cancer

This article is a part of University of Maryland Rounds, which features clinical and research updates from the University of Maryland School of Medicine and University of Maryland Medical Center. See more Rounds articles.

A dearth of options to effectively treat recurrent, inoperable squamous cell carcinoma of the head and neck (SCCHN) has spurred researchers at the University of Maryland Marlene and Stewart Greenebaum Comprehensive Cancer Center (UMGCCC) to launch a novel clinical trial combining immunotherapy with radiation in hopes of extending patients’ lives. 

Dan Zandberg, M.D., an assistant professor at the University of Maryland School of Medicine and a medical oncologist specializing in head and neck cancer at UMGCCC, is leading the trial. It’s the first of its kind to use an FDA-approved drug known as pembrolizumab, or MK-3475, in tandem with radiation therapy to treat any type of cancer. 

Patients with localized, recurrent squamous cell carcinoma of the head and neck often have already undergone radiation as part of their first-line treatment, which can also include surgery and/or chemotherapy. But if the cancer returns and surgery isn’t an option, treatment options diminish. Re-irradiation may be given in combination with a variety of chemotherapy agents as part of current standard of care, but the median progression-free survival for these patients is still only about 7 to 8 months.

“Our hope is that our trial will work to improve median progression-free survival to upwards of 12 months and improve overall survival as well,” Dr. Zandberg explains. “My interest is in developing new options for these patients as there is a clear need for improvement in outcomes.”

Breakthrough Immunotherapy Drug Gets New Use

The new head and neck cancer trial, which will eventually include three other sites across the region and enroll 48 patients over three years, is just one of the innovative clinical trials being conducted at UMGCCC, and Dr. Zandberg is a huge proponent of their usefulness. 

“While we have made a lot of progress in the field of oncology, there is still the need to improve outcomes across multiple tumor types. Clinical trials are very important in order to continue to develop new and better therapeutic options for our patients,” he says. 

New therapies are limited in head and neck cancer, which accounts for 3% of all malignancies in the United States. The trial led by Dr. Zandberg capitalizes on the breakthrough drug pembrolizumab, which was approved in late 2014 by the Food and Drug Administration for the treatment of advanced melanoma. This immunotherapy drug blocks the PD-1 protein, a molecule on the surface of immune cells which normally acts as a brake to prevent the immune system from destroying tumors. Blocking PD-1 removes the brakes, allowing patients’ own immune cells to attack the cancer. MK-3475 is being combined with radiation because radiation has been observed to activate the immune system, and pre-clinical data shows synergy between PD-1 blockade and radiation treatment.

In the trial, patients will undergo radiation twice a day for five weeks, with MK-3475 given intravenously every three weeks beginning on the first day of radiation. The drug will then be continued for at least an additional three months following the completion of radiation. No patients will receive a placebo; all will receive MK-3475. Toxicity will be monitored closely and patients’ quality of life will also be assessed during the research through questionnaires. 

“We have a phenomenal multidisciplinary head and neck cancer team here at the Greenebaum Comprehensive Cancer Center,” adds Dr. Zandberg. “And together we are working to improve outcomes for head and neck cancer patients.” 

For more information about any of UMGCCC’s current clinical trials, visit http://oncore.umm.edu/sip/SIPMain.