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Clinical trial tests whether immunotherapy helps prevent melanoma recurrence

Andrew Poklepovic reviewing imaging results on his office computer.
Andrew Poklepovic, M.D.

A stage 2 clinical trial testing the use of immunotherapy after surgery to reduce melanoma recurrence is currently underway at VCU Massey Cancer Center. Led by Andrew Poklepovic, MD, the trial is eligible to any adult patient with stage 2b or 2c melanoma who recently underwent surgery and has no evidence of metastatic disease.

Stage 2b melanomas are between 2-4mm thick with ulcerated, or broken, skin covering the tumor or larger than 4mm and not ulcerated. Stage 2c melanomas are larger than 4mm and ulcerated.

The aim of the trial is to determine whether the immunotherapy pembrolizumab (trade name KEYTRUDA) helps prevent metastasis and disease recurrence. Trial participants will either receive the current best standard of care in addition to pembrolizumab, or the standard of care plus a placebo. The two groups will be monitored to also determine any differences in quality of life.

Pembrolizumab is a form of immunotherapy known as checkpoint inhibitors, which block certain proteins that prevent the immune system from recognizing and attacking cancer cells. Pembrolizumab targets the PD-1 protein, and it is approved by the U.S. Food and Drug Administration (FDA) to treat patients with advanced melanoma, lung cancer, head and neck cancer, kidney cancer, esophagus cancer, stomach cancer, bladder cancer, liver cancer, endometrial cancer, cervical cancer, mediastinal B cell lymphoma, and Hodgkin lymphoma. In 2017, it was also approved to treat any inoperable or metastatic solid tumor showing specific genetic anomalies.

“There is evidence that using immunotherapy following surgery helps to reduce the risk of melanoma recurrence in patients with stage 3 melanoma,” says Poklepovic, a medical oncologist and member of the Developmental Therapeutics Research Program at Massey Cancer Center. “We also know patients with stage 2 melanoma remain at substantial risk of disease recurrence.  This trial will help determine whether pembrolizumab should be part of the standard of care for patients with high risk stage 2 melanoma, which currently lacks good treatment options.”

Additional study details are available on the National Cancer Institute’s website. If you are interested in enrolling in the study or have additional questions, please contact Faith McFadden, MSN, RN, clinical research nurse at Massey Cancer Center, at (804) 628-0616 or by email at mcfaddenfr@vcu.edu.

Written by: John Wallace

Posted on: January 30, 2020

Category: Research