Efficacy and safety of nivolumab in people living with HIV and cancer: A single arm meta-analysis of randomized clinical trials.

438 Background: Nivolumab, a PD-1 immune checkpoint inhibitor, is widely used in the treatment of various advanced cancers. While immunotherapy has significantly evolved over recent years, data on safety and efficacy of Nivolumab in patients living with HIV (PLWH) and cancer remain limited. This meta-analysis aims to assess current evidence on the use of Nivolumab in this high-risk population. Methods: A systematic search of PubMed/MEDLINE, Cochrane Library, and ClinicalTrials.gov was conducted from inception through June 1, 2025, following predefined eligibility criteria. Studies evaluating the safety and efficacy of Nivolumab in PLWH with cancer were included. The primary outcome was objective response rate (ORR), with several secondary safety and efficacy outcomes assessed. Statistical analysis was performed using R (version 4.5.0). Results: Eight studies involving a total of 690 patients were included in the pooled analysis. The ORR was 26% (95% CI: 0.21–0.32; P = 0.84). Rates of progressive disease and stable disease were 37% (95% CI: 0.20–0.59; P < 0.0001) and 29% (95% CI: 0.17–0.44; P = 0.019), respectively. Complete response occurred in 2% of patients (95% CI: 0.0–0.16; P = 0.078), while partial response was seen in 27% (95% CI: 0.20–0.34; P = 0.31). Significant adverse effects were observed: grade ≥3 immune-related adverse events occurred in 14% (95% CI: 0.07–0.27; P < 0.0001), immune-mediated adverse events in 36% (95% CI: 0.18–0.59; P < 0.0001), treatment discontinuation in 61% (95% CI: 0.13–0.94; P < 0.0001), and treatment-related adverse events in 71% (95% CI: 0.63–0.78; P = 0.31). Conclusions: Nivolumab shows promise in stabilizing cancer among people living with HIV. However, the high incidence of immune-related adverse events underscores the need for vigilant monitoring and further research to guide its safe and effective use in this population.