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First-of-its-kind head and neck cancer immunotherapy clinical trial opens at Massey

Erin Alesi
Erin Alesi, M.D.

VCU Massey Cancer Center is recruiting participants for an international phase 2 clinical trial testing the first immune checkpoint inhibitors for head and neck cancer. Immune checkpoint inhibitors are drugs that cause the immune system to recognize and attack cancer cells, and they have shown dramatic results in treating certain types of skin and lung cancers.

The clinical trial is testing two experimental drugs known as durvalumab and tremelimumab in patients with recurring or metastatic squamous cell carcinoma of the head and neck who have already been treated with “platinum” chemotherapy, which is the current standard treatment for this type of disease. Approximately 239 patients will be recruited to the study at 150 sites around the world, and the drugs will be tested alone and in combination to determine which approach is most effective.

“Immune therapies are being explored for every cancer, and we are excited to be involved in one of the first studies testing these drugs for the treatment of squamous cell carcinoma of the head and neck,” says Erin Alesi, M.D., the medical oncologist leading the clinical trial at Massey. “All patients in the clinical trial will receive one of or a combination of the two drugs. And because it is an ‘open label’ study, participants will know to which treatment group they have been assigned.”

Durvalumab is what is known as a PD-L1 inhibitor. It works by binding to the PD-L1 receptor, which is overexpressed in some cancers, and it causes the immune system to launch a response against the tumor. Tremelimumab works by binding to receptors on T cells, which are a type of immune system cell, and this activates a signaling process that eventually leads to an immune response against cancer cells.

Researchers suspect that the drugs may be complementary. Approximately 25 percent of participants in the trial will receive durvalumab, another 25 percent will receive tremelimumab and the remaining 50 percent will receive a combination of both drugs.

Participants will also undergo PD-L1 testing to determine the importance of PD-L1 expression levels in regard to the effectiveness of the therapy. As with any clinical trial, participants will be closely monitored for side effects and can leave the trial at any time.

This trial is sponsored, in part, by AstraZeneca and MedImmune.

To participate in or learn more about the clinical trial, contact Faith McFadden, RN, clinical research nurse manager at Massey, at (804) 628-0616 or email mcfaddenfr@vcu.edu.

Written by: John Wallace

Posted on: January 28, 2016

Category: Research