Pembrolizumab (Keytruda®) Adjuvant Therapy

Even after successfully removing melanoma through surgery, patients may be at risk for melanoma coming back. Pembrolizumab (Keytruda) in the adjuvant setting reduces this risk by stimulating the body’s immune system to fight any remaining cancer cells.

In February 2019, the U.S. Food and Drug Administration (FDA) approved the use of pembrolizumabin the adjuvant setting for melanoma patients with lymph node involvement following complete lymph node resection. Treatment after surgery is known as adjuvant therapy. The goal of pembrolizumab as adjuvant therapy is to reduce the risk of melanoma coming back after surgery.

Patients with Stage III melanoma usually undergo surgery to remove the primary melanoma and the nearby lymph nodes. With pembrolizumab as adjuvant therapy after surgery, patients can reduce their risk of melanoma returning or improving what doctor’s call recurrence-free survival (RFS).

FDA approval of pembrolizumab in the adjuvant setting is based on results from the KEYNOTE-054 trial. In this phase-three study, pembrolizumab significantly reduced melanoma recurrence/death (26%) compared with patients receiving placebo (43%). The safety of pembrolizumab has been evaluated in 4,948 patients with various cancers and the most commonly reported adverse reactions were fatigue, rash, and nausea. This side effect profile is consistent with what was seen in the KEYNOTE-054 trial.

Learn more about adjuvant therapy for high-risk melanoma.

What Is Pembrolizumab (Keytruda)?

Pembrolizumab blocks the activity of a molecule called PD-1, a protein that prevents T cells (white blood cells that help your body fight disease) from recognizing and attacking inflamed tissues and cancer cells. PD-1 can trick your immune system into overlooking melanoma cells as normal cells.

In addition to its use for the adjuvant therapy of melanoma, pembrolizumab is also used to treat advanced melanoma that is unresectable or has spread to organs and other parts of the body.  Learn more about the use of nivolumab for advanced melanoma.

How Is Adjuvant Pembrolizumab (Keytruda) Given?

Patients receive nivolumab intravenously (into a blood vein).

  • Each dose takes about 30 minutes to complete.
  • Patients usually receive pembrolizumab every three weeks for up to 1 year. Your doctor will determine how many treatments are needed.
  • Pembrolizumab is given on an outpatient basis without the need for a hospital stay.

What Are the Goals of Adjuvant Pembrolizumab (Keytruda)?

In the adjuvant setting, the goal of Pembrolizumab is to reduce the risk of melanoma returning following surgery.

What Should I Ask My Doctor About Adjuvant Pembrolizumab (Keytruda)?

Not all treatments work for all patients, because everyone is different. If you are interested in learning more about pembrolizumab, here are some questions you should ask your physicians:

  • Will my melanoma tumor be tested for BRAF genetic mutations?
  • Am I eligible for pembrolizumab?
  • What is your experience with pembrolizumab?
  • Is pembrolizumab a good option for my melanoma treatment?
  • Is there an alternative to pembrolizumab for me?
  • How successful has pembrolizumab been for patients like me?
  • What are the side effects of pembrolizumab?
  • Are there any clinical trials for pembrolizumab that I should consider?
  • What other treatments are FDA-approved for adjuvant therapy of melanoma?
  • What are the risks and benefits of the available treatment options?
  • What are the goals for my treatment?

Need Help Paying for Pembrolizumab (Keytruda)?

Patient Assistant Programs (PAPs) are designed so that you still have access to the treatments you need, in any financial circumstance. Learn more about the manufacturer’s patient assistance program and other options here.

Manufacturer’s Patient Assistance

Latest Treatments for Melanoma

Learn more about the latest, most effective treatments for patients who have melanoma:

Melanoma Research

The Melanoma Research Alliance is the largest, non-profit funder of melanoma research worldwide. Since 2007, we have directly funded over $131 million in innovative grants to improve prevention, detection, and treatment of melanoma. We have also leveraged an additional $415 million in outside funds for research. Learn more about our funded research.

Last updated: August, 2021