Exclusion rates of patients living with HIV from cancer immunotherapy clinical trials.

Abstract

e19035 Background: Although patients living with HIV are at increased risk for developing several cancers, they have often been excluded from practice-changing immunotherapy clinical trials across many tumor types. Emerging retrospective and prospective studies indicate that immunotherapies can be safe and effective in patients with HIV. ASCO and Friends of Cancer Research have supported the inclusion of patients with HIV in cancer clinical trials. We determined the rate of HIV exclusion from recent cancer immunotherapy clinical trials according to tumor type, immunotherapy treatment, and phase of trial. Methods: We compiled trials on the ClinicalTrials.gov database with study start dates from January 1, 2019 to October 10, 2020, using the search term “cancer” for disease, and the following intervention terms: “immunotherapy, PD-1, PD-L1, CTLA-4, pembrolizumab, nivolumab, atezolizumab, durvalumab, avelumab, cemiplimab, ipilimumab, tremelimumab, sintilimab, spartalizumab.” Observational studies and trials not offering immune checkpoint inhibitors (ICIs) or cellular immunotherapy were excluded. Eligibility criteria for each trial were reviewed to determine rate of exclusion for HIV, human immunodeficiency virus, acquired immunodeficiency, or immune deficiency. Cellular immunotherapies were defined as modified T cell, dendritic cell, NK cell, or other peripheral blood leukocyte treatments. Results: Of 1090 analyzed trials, 795 (72.9%) specifically excluded patients with HIV, and another 80 (7.3%) trials included patients with HIV only if certain criteria were met (e.g. undetectable viral load, minimum CD4+ T cell count). By tumor type, the rate of HIV exclusion ranged from 60.9% (renal cancer) to 85.7% (cervical cancer), with hematologic malignancies having a significantly higher rate of HIV exclusion than solid tumor trials (85.2% vs. 73.3%, p = 0.015). Trials combining ICIs with cellular immunotherapies were more likely to exclude HIV (N = 22, 90.9% exclusion) than trials with ICIs alone (N = 1003, 71.4% exclusion, p = 0.044). Phase I (N = 271, 73.1% exclusion, p = 0.0012), I/II (N = 165, 70.9% exclusion, p = 0.010), and II trials (N = 519, 77.5% exclusion, p < 0.0001) had higher rates of exclusion than phase III trials (N = 101, 55.4% exclusion). Conclusions: Despite ASCO and Friends of Cancer Research recommendations to include patients with HIV in cancer clinical trials, the vast majority of immunotherapy clinical trials in 2019 exclude patients with cancer and HIV.