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

著者 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
Future Oncol.2019 Dec 24 ; ():.
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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, NCT03553836.
PMID: 31870188 [PubMed - as supplied by publisher]
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