Meeting enrollment targets in IMbrave152/SKYSCRAPER-14, a global phase 3 study in patients with unresectable hepatocellular carcinoma (HCC).

1585 Background: The FDA has released guidance that the patient population in clinical studies should be representative of the intended-use population and the epidemiology of the disease, particularly in terms of race and ethnicity. IMbrave152/SKYSCRAPER-14 (NCT05904886) is a global phase 3 trial in patients with HCC, a disease with a globally high Asian and African prevalence, and which significantly impacts underrepresented (including Black and Hispanic) patients in the USA. Enrollment goals (by race/ethnicity), as well as operational and protocol-driven tactics to meet those goals, were implemented for IMbrave152. As of January 2, 2025, the targets for Black and Hispanic patients were met. Methods: Global recruitment began on September 14, 2023. Operational tactics included: feasibility questions about the ability to recruit underrepresented populations; utilization of internal and external databases to identify sites that could enroll underrepresented patients; incorporation of patient input; and enhanced patient-support services to facilitate recruitment and retention. Protocol-driven tactics included: modifying inclusion and exclusion criteria (considering race/ethnicity); streamlining study assessments; flexibility to use decentralized processes; and inclusion of an Africa Extension Cohort, which allowed for the recruitment of patients in Africa beyond the intent-to-treat population. Results: As of January 2, 2025, the randomized, global population included 8% Black and 14% Hispanic patients (US recruitment included 16% Black and 19% Hispanic patients), exceeding other global HCC studies, which recruited 2% or fewer Black patients and 11% or fewer Hispanic patients. Only two out of seven phase 3 studies in recent years have reported on Hispanic patient recruitment. Conclusions: IMbrave152 recruited the highest percentage of Black and Hispanic patients to date in a global phase 3 HCC study. These results demonstrate that recruitment of an underrepresented population is feasible if operational and protocol-driven tactics are utilized. Clinical trial information: NCT05904886 . Study White, % Asian, % Black, % Hispanic, % Global enrollment from Asia (excl. Japan), % IMbrave152 32.7 54.7 8.0 13.6 46.7 IMbrave150 1 34.9 56.7 2.0 NR 40.1 REFLECT 2 28.9 69.2 NR NR 67.1* HIMALAYA 3 44.5 50.9 1.6 4.7 40.9 LEAP-002 4 43.5 43.5 1.6 † 11.2 30.7 CheckMate-459 5 53.2 44.7 0.7 NR 25.3 RATIONALE-301 6 NR NR NR NR 63.1 COSMIC-312 7 50.9 31.4 1.7 NR 28.8 1 Finn et al. NEJM 2020; 2 Kudo et al. Lancet 2018; 3 Abou-Alfa et al. NEJM Evid 2022; 4 Llovet et al. Lancet 2023; 5 Yau et al. Lancet Oncol 2022; 6 Qin et al. JAMA Oncol 2023; 7 Kelley et al. Lancet Oncol 2022.