KEYNOTE-716: Phase III study of adjuvant pembrolizumab versus placebo in resected high-risk stage II melanoma

Jason J. Luke, Paolo A. Ascierto, Matteo S. Carlino, Jeffrey E. Gershenwald, Jean Jacques Grob, Axel Hauschild, John M. Kirkwood, Georgina V. Long, Peter Mohr, Caroline Robert, Merrick Ross, Richard A. Scolyer, Charles H. Yoon, Andrew Poklepovic, Piotr Rutkowski, James R. Anderson, Sama Ahsan, Nageatte Ibrahim, Alexander M. M Eggermont

Research output: Contribution to journalReview articlepeer-review

58 Citations (Scopus)


Patients with high-risk stage II melanoma are at significant risk for recurrence after surgical resection. Adjuvant treatment options to lower the risk for distant metastases are limited. Although adjuvant IFN-α2b is associated with improved relapse-free survival in patients with high-risk melanoma, toxicity and limited overall survival benefits limit its use. Adjuvant treatment with the PD-1 inhibitor pembrolizumab significantly improved recurrence-free survival, compared with placebo, in patients with resected stage III melanoma in the Phase III KEYNOTE-054 trial; efficacy in patients with stage II disease has not been established. This article describes the design and rationale of KEYNOTE-716 (NCT03553836), a two-part, randomized, placebo-controlled, multicenter Phase III study of adjuvant pembrolizumab in patients with surgically resected high-risk stage II melanoma. Clinical trial registry & ID:, NCT0355383.

Original languageEnglish
Pages (from-to)4429-4438
Number of pages10
JournalFuture oncology (London, England)
Issue number3
Publication statusPublished - 10 Jan 2019
Externally publishedYes


  • adjuvant therapy
  • high-risk stage II melanoma
  • immune checkpoint inhibitor
  • pembrolizumab


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