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

doi:10.2217/fon-2019-0666

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

Surgical Oncology

Research output: Contribution to journal › Review article › peer-review

57 Scopus citations

Abstract

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: ClinicalTrials.gov, NCT0355383.

Original language	English (US)
Pages (from-to)	4429-4438
Number of pages	10
Journal	Future Oncology
Volume	16
Issue number	3
DOIs	https://doi.org/10.2217/fon-2019-0666
State	Published - Jan 10 2019

Keywords

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

ASJC Scopus subject areas

Oncology
Cancer Research

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10.2217/fon-2019-0666

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Luke, J. J., Ascierto, P. A., Carlino, M. S., Gershenwald, J. E., Grob, J. J., Hauschild, A., Kirkwood, J. M., Long, G. V., Mohr, P., Robert, C., Ross, M., Scolyer, R. A., Yoon, C. H., Poklepovic, A., Rutkowski, P., Anderson, J. R., Ahsan, S., Ibrahim, N., & M Eggermont, A. M. (2019). KEYNOTE-716: Phase III study of adjuvant pembrolizumab versus placebo in resected high-risk stage II melanoma. Future Oncology, 16(3), 4429-4438. https://doi.org/10.2217/fon-2019-0666

Luke, JJ, Ascierto, PA, Carlino, MS, Gershenwald, JE, Grob, JJ, Hauschild, A, Kirkwood, JM, Long, GV, Mohr, P, Robert, C, Ross, M, Scolyer, RA, Yoon, CH, Poklepovic, A, Rutkowski, P, Anderson, JR, Ahsan, S, Ibrahim, N & M Eggermont, AM 2019, 'KEYNOTE-716: Phase III study of adjuvant pembrolizumab versus placebo in resected high-risk stage II melanoma', Future Oncology, vol. 16, no. 3, pp. 4429-4438. https://doi.org/10.2217/fon-2019-0666

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

abstract = "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: ClinicalTrials.gov, NCT0355383.",

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

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doi = "10.2217/fon-2019-0666",

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AU - Gershenwald, Jeffrey E.

AU - Grob, Jean Jacques

AU - Hauschild, Axel

AU - Kirkwood, John M.

AU - Long, Georgina V.

AU - Mohr, Peter

AU - Robert, Caroline

AU - Ross, Merrick

AU - Scolyer, Richard A.

AU - Yoon, Charles H.

AU - Poklepovic, Andrew

AU - Rutkowski, Piotr

AU - Anderson, James R.

AU - Ahsan, Sama

AU - Ibrahim, Nageatte

AU - M Eggermont, Alexander M.

PY - 2019/1/10

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N2 - 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: ClinicalTrials.gov, NCT0355383.

AB - 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: ClinicalTrials.gov, NCT0355383.

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

Abstract

Keywords

ASJC Scopus subject areas

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