Adjuvant Pembrolizumab for Stage IIB or IIC Melanoma: A Secondary Analysis of a Randomized Clinical Trial.

ABSTRACT:

Importance

Patients with melanoma are at risk of developing subsequent cutaneous malignant neoplasms, and the effect of prior immunotherapy is unknown.

Objective

To analyze new skin cancers in participants with high-risk stage II melanoma treated with adjuvant pembrolizumab or placebo.

Design, setting, and participants

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.

Interventions

Participants were randomly assigned to receive intravenous pembrolizumab, 200 mg (2 mg/kg for pediatr

SUBMITTER: Leachman SA 

PROVIDER: S-EPMC12914490 | biostudies-literature | 2026 Feb

REPOSITORIES: biostudies-literature