Nivolumab + Doxorubicin, Vinblastine, and Dacarbazine in HIV-Associated Advanced-Stage Classic Hodgkin Lymphoma.

PURPOSE: S1826 was an international phase 3 randomized trial that demonstrated improved progression-free survival of nivolumab plus doxorubicin, vinblastine, and dacarbazine (N+AVD) over brentuximab vedotin plus AVD (BV+AVD) in newly diagnosed advanced stage classic Hodgkin lymphoma (cHL). Here we report results of enrolled participants with HIV. PARTICIPANTS AND METHODS: People with HIV (PWH) with a CD4+ T-cell above ≥200 cells/μL and on effective ART with an undetectable HIV viral load within 6 months prior to enrollment were eligible. Participants were randomly assigned in a 1:1 ratio to receive six 28-day cycles of either N+AVD or BV+AVD intravenously. The primary endpoint was progression-free survival. RESULTS: 16 eligible PWH were enrolled, 11 received N+AVD and 5 received BV+AVD. The median follow-up duration was 32.7 months in the N+AVD arm and 26.7 months in the BV+AVD arm. The 2-year PFS rate was 77.9% in N+AVD arm and 75.0% in the BV+AVD arm. The 2-year OS was 85.7% in the N+AVD arm and 75.0% in the BV+AVD arm. Grade ≥ 3 adverse events were observed in 45% of participants in the N+AVD arm and 50% in the BV+AVD arm with more frequent febrile neutropenia, and severe infections observed in the BV+AVD arm. CONCLUSIONS: N+AVD is safe and effective in newly diagnosed HIV-associated advanced stage cHL. Clinicaltrials.gov number NCT03907488.