A phase 2 study to determine the pathological (path) response to neoadjuvant nivolumab (nivo) and relatlimab (rela) in high-risk stage II cutaneous melanoma: NeoReNi II.

• DOI: 10.1200/jco.2023.41.16_suppl.tps9610
• Publication Date: 2023-06-04T16:22:07Z
• Authors: Maria Gonzalez; Alexander Christo...; Andrew John Spillane; Sydney Ch'ng; Kerwin Frank Shannon; Jonathan Stretch; Michael Alexander...; Thomas Pennington; Robyn P.M. Saw; Alexander M. Menzies; Robert V Rawson; Linda Martin; Pascale Guitera; Mary Jane Gregorio; Kevin London; Rony Kapoor; Edward Hsiao; Serigne N. Lo; Richard A. Scolyer; Georgina V. Long
• Keywords: Neoadjuvant Therapy; Breslow Thickness

TPS9610 Background: Patients diagnosed with stage II melanoma account for ~50% of those who develop metastatic disease and die (Poklepovic et al., 2020). Neoadjuvant therapy (NAT) is a powerful treatment platform to rapidly assess drug activity in resectable cancers using the International Melanoma Consortium (INMC) path response criteria (Tetzlaff 2018), wherein major (≤10% viable tumor) correlates low risk recurrence III (Menzies 2021). Other benefits include early insight into response, feedback pts regarding their individual prognosis, ability tailor subsequent management, collection translational specimens explore mechanisms resistance (Amaria 2019). NAT an opportunity improve survival rates beyond gains achieved adjuvant therapy, as illustrated by phase SWOG 1801 trial (Patel 2022) melanoma. The NeoReNi will examine whether combination PD-1 blockade plus lymphocyte-activation 3 (LAG3) checkpoint inhibition achieve high rate manageable toxicity. Methods: Pts histologically confirmed AJCC (8 th ed.) clinical IIA (T2b, T3A), IIB (T3b, T4a), or IIC (T4b) primary cutaneous from partial biopsy, residual macroscopic at study entry, are eligible (N = 20). must have estimated ≥20% 5 years, according Institute Australia calculator (melanomarisk.org.au). All undergo wide excision sentinel lymph node resection (RES) wk 6 following 2 doses nivo (480 mg, IV) rela (160 IV). no ( > 50% 10% - ≤50% receive further 11 cycles (Q4W) mg) mg), radiological surveillance. complete (pCR; 0% near-complete surveillance after RES. be followed (6 monthly CT) 10 years. Lymphatic mapping, dermoscopy, vivo confocal microscopy, CT, FDG PET/CT performed baseline (BL) prior RES measure NAT. Tumour fecal samples collected BL, RES, recurrence. Blood 4, endpoint pCR wks INMC 2018). Secondary endpoints assessing feasibility pt population, RFS, OS, safety/tolerability, surgical outcomes, changes microscopy positivity lymphatic QOL, biomarker analyses. Clinical information: NCT05418972 .