Abstract
BACKGROUND: People living with HIV (PWH) have an increased risk of developing aggressive skin cancers, yet they have been largely excluded from immune checkpoint inhibitor (ICI) trials. Consequently, evidence on the safety and efficacy of ICIs in this population remains scarce, particularly for the nivolumab plus ipilimumab (NIVO+IPI) combination. METHODS: This multicentre, real-world study included PWH treated with ICIs for melanoma or non-melanoma skin cancers. The objective was to evaluate patient characteristics, treatment management, and clinical outcomes across the different skin cancer types. RESULTS: Among the 54 patients, 89% were male, and 92.6% had a suppressed HIV viral load. Melanoma was the most frequent tumour (35/54, 64.8%), followed by cutaneous squamous cell carcinoma (12/54, 22.2%), Kaposi sarcoma (4/54, 7.4%), basal cell carcinoma (2/54, 3.7%), and one Merkel cell carcinoma. Anti-PD-1/PD-L1 monotherapy was given as first-line treatment in 81.5% (44/54). Immune-related adverse events (irAEs) occurred in 42.6% (23/54), with a median onset of 43.5 days (IQR, 20.5-126). The maximum toxicity grade was 1/2 in 39% (21/54), grade ≥ 3 in 13% (7/54). Seventeen melanoma patients received NIVO+IPI. Among them, 64.7% (11/17) experienced irAEs, including grade ≥ 3 events in 30% (5/17). Objective response rates were 43% (9/21) in melanoma, 58% (7/12) in cSCC, and 75% (3/4) in Kaposi sarcoma. CONCLUSIONS: PWH treated with ICIs for skin cancer demonstrated favourable outcomes, with a notably reassuring safety profile of NIVO+IPI. These findings support managing well-controlled PWH similarly to the general population and highlight the importance of including this population across all settings of skin cancer trials.