TY  - JOUR
AU  - Leachman, Sancy A
AU  - Luke, Jason J
AU  - Ascierto, Paolo A
AU  - Long, Georgina V
AU  - Khattak, Muhammad A
AU  - Rutkowski, Piotr
AU  - Xu, Zhi Jin
AU  - Fukunaga-Kalabis, Mizuho
AU  - Krepler, Clemens
AU  - Eggermont, Alexander M M
AU  - Schadendorf, Dirk
TI  - Adjuvant Pembrolizumab for Stage IIB or IIC Melanoma: A Secondary Analysis of a Randomized Clinical Trial.
JO  - JAMA network open
VL  - 9
IS  - 2
SN  - 2574-3805
CY  - Chicago, Ill.
PB  - American Medical Association
M1  - DKFZ-2026-00379
SP  - e2559603
PY  - 2026
N1  - #DKTKZFB9# / #NCTZFB9#
AB  - 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
KW  - Humans
KW  - Antibodies, Monoclonal, Humanized: therapeutic use
KW  - Antibodies, Monoclonal, Humanized: administration & dosage
KW  - Melanoma: drug therapy
KW  - Melanoma: pathology
KW  - Male
KW  - Female
KW  - Middle Aged
KW  - Skin Neoplasms: drug therapy
KW  - Skin Neoplasms: pathology
KW  - Double-Blind Method
KW  - Aged
KW  - Antineoplastic Agents, Immunological: therapeutic use
KW  - Adult
KW  - Chemotherapy, Adjuvant
KW  - Neoplasm Staging
KW  - Antibodies, Monoclonal, Humanized (NLM Chemicals)
KW  - pembrolizumab (NLM Chemicals)
KW  - Antineoplastic Agents, Immunological (NLM Chemicals)
LB  - PUB:(DE-HGF)16
C6  - pmid:41701495
DO  - DOI:10.1001/jamanetworkopen.2025.59603
UR  - https://inrepo02.dkfz.de/record/309929
ER  -