A Phase III Study of Pembrolizumab Immunotherapy versus Placebo in Patients with Surgically Removed High-Risk Stage II Melanoma

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Adjuvant Therapy with Pembrolizumab Versus Placebo in Resected High-risk Stage II Melanoma: A Randomized, Double-blind Phase III Study (WIRB)

Purpose

The purpose of this study is to see if the immunotherapy drug pembrolizumab can reduce the chance of high-risk stage II melanoma coming back after surgery. Pembrolizumab is already used to treat metastatic melanoma and stage III melanoma; its use in this study is considered investigational.

Pembrolizumab works by blocking a molecule called PD-1 that shuts down the immune response. Blocking PD-1 can allow the immune system to detect and attack cancer cells. It is given intravenously.

Patients in this study will be randomly assigned to receive pembrolizumab or a placebo (inactive drug) every three weeks for about one year. Those whose cancer progresses while receiving the placebo may be offered treatment with pembrolizumab.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have stage IIB or IIC melanoma that was surgically removed within 12 weeks of entering the study.
  • Patients may not have received any additional therapy other than surgery for their melanoma.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for patients age 12 and older.

For more information and to inquire about eligibility for this study, please contact Dr. Paul Chapman at 646-888-4162.

Protocol

18-510

Phase

III

Investigator

Co-Investigators

Diseases