%0 Journal Article
%A Leachman, Sancy A
%A Luke, Jason J
%A Ascierto, Paolo A
%A Long, Georgina V
%A Khattak, Muhammad A
%A Rutkowski, Piotr
%A Xu, Zhi Jin
%A Fukunaga-Kalabis, Mizuho
%A Krepler, Clemens
%A Eggermont, Alexander M M
%A Schadendorf, Dirk
%T Adjuvant Pembrolizumab for Stage IIB or IIC Melanoma: A Secondary Analysis of a Randomized Clinical Trial.
%J JAMA network open
%V 9
%N 2
%@ 2574-3805
%C Chicago, Ill.
%I American Medical Association
%M DKFZ-2026-00379
%P e2559603
%D 2026
%Z #DKTKZFB9# / #NCTZFB9#
%X Patients with melanoma are at risk of developing subsequent cutaneous malignant neoplasms, and the effect of prior immunotherapy is unknown.To analyze new skin cancers in participants with high-risk stage II melanoma treated with adjuvant pembrolizumab or placebo.The multicenter double-blind, phase 3 KEYNOTE-716 randomized clinical trial enrolled 976 participants 12 years or older with completely resected stage IIB or IIC cutaneous melanoma between September 23, 2018, and November 4, 2020. Follow-up was completed on February 16, 2024. This analysis was not prespecified in the trial protocol.Participants were randomly assigned to receive intravenous pembrolizumab, 200 mg (2 mg/kg for pediatric participants), or placebo, every 3 weeks for no more than 17 cycles.Secondary analyses of incidence and time to diagnosis of new melanoma or other cutaneous malignant neoplasm, sensitivity analysis of recurrence-free survival (RFS) with new primary melanoma counted as an event, and incidence of immune-mediated severe skin reactions.A total of 976 participants were assigned to treatment (487 to pembrolizumab and 489 to placebo), of whom 589 (60.3
%K Humans
%K Antibodies, Monoclonal, Humanized: therapeutic use
%K Antibodies, Monoclonal, Humanized: administration & dosage
%K Melanoma: drug therapy
%K Melanoma: pathology
%K Male
%K Female
%K Middle Aged
%K Skin Neoplasms: drug therapy
%K Skin Neoplasms: pathology
%K Double-Blind Method
%K Aged
%K Antineoplastic Agents, Immunological: therapeutic use
%K Adult
%K Chemotherapy, Adjuvant
%K Neoplasm Staging
%K Antibodies, Monoclonal, Humanized (NLM Chemicals)
%K pembrolizumab (NLM Chemicals)
%K Antineoplastic Agents, Immunological (NLM Chemicals)
%F PUB:(DE-HGF)16
%9 Journal Article
%$ pmid:41701495
%R 10.1001/jamanetworkopen.2025.59603
%U https://inrepo02.dkfz.de/record/309929