Overall, ORR was 10.9% (95% CI, 5.6−18.7); 1 pt had a CR and 10 pts had PR. Among pts with PD-L1–positive tumors, 8 of 84 (9.5%; 95% CI, 4.2−17.9) had CR or PR; among pts with PD-L1–negative tumors, 2 of 7 (28.6%; 95% CI, 3.7−71.0) had CR or PR. Among pts with a response, median DOR was 20.4 months (range, 2.1+ to 28.0). Among all enrolled pts (n=101), median PFS was 2.1 months (95% CI, 2.0−2.1) and median OS was 6.2 months (95% CI, 4.9−9.4 months). Pembrolizumab monotherapy was associated with durable responses in a subset of pts with vulvar carcinoma (ORR, 10.9%; median DOR, 20.4 months). Responses occurred in both PD-L1- positive and PD-L1-negative pts.