Table 1. Descriptions of Studies of Neoadjuvant Immune Checkpoint Inhibitors in Patients With High-Risk Resectable Melanoma.
Study | Design | Drugs | Patients, No. | Melanoma stage | Melanoma type | Treatment-naive patients, No.a | End points | Key clinical observations |
---|---|---|---|---|---|---|---|---|
Amaria et al,13 2018 | Randomized, phase 2 |
|
23 | IIIB, IIIC, IIID, and IV | Cutaneous only; no mucosal or acral melanoma | 19 | Response rates; trAE; immune correlate of responses |
|
Blank et al,10 2018 | Randomized feasibility study, phase 1B |
|
20 | IIIB and IIIC | Cutaneous | 20 |
|
|
Huang et al,14 2019 | Single arm, phase 1B | Pembrolizumab, 200-mg single dose, in neoadjuvant setting; surgery; and adjuvant therapy with pembrolizumab | 29 | Clinical stage III, resectable stage IV | Cutaneous; excluded mucosal or uveal | 29 | Response trAE; biomarkers |
|
Rozeman et al,15 2019 | Randomized clinical trial, phase 2 |
|
89 | Stage III | NR | NR | trAE within first 12 wk; radiologic response at 6 wk; pathologic response at 6 wk |
|
Amaria et al,16 2022 | Single arm | Nivolumab, 480 mg + relatlimab, 160 mg intravenously 4 wk for 2 doses; surgery; and 10 doses of nivolumab, 480 mg + relatlimab, 160 mg, every 4 wk | 30 | IIIB to IIID, M1a (completely resected) | NR | 29 (1 Patient received BRAF/MEK inhibitors before this study) |
|
|
Reijers et al,17 2022 | Single arm | Ipilimumab, 1 mg/kg, and nivolumab, 3 mg/kg for 3 wk, 2 cycles Pathologic assessment of ILND, TLND, and adjuvant therapy based on pathologic response |
99 | Stage III with clinically palpable nodes | NR | NR |
|
|
Patel et al,18 2023 | Randomized clinical trial, phase 2 |
|
313 | Stage IIIB to IIID, and IV (completely resected) | Cutaneous (296 patients); mucosal (4 patients); and acral (9 patients) | NR |
|
|
Abbreviations: DCPI, dual checkpoint inhibition; DFS, disease-free survival; DMFS, distant metastasis-free survival; EFS, event-free survival; HRQoL, health-related quality of life; IFN-γ, interferon-gamma; ILND, index lymph node dissection; MPR, major pathologic response; NR, not reported; OS, overall survival; pCR, pathologic complete response; pnCR, pathologic near-complete response; pNR, pathologic nonresponse; RFS, relapse-free survival; T-reg, regulatory T cells; TLND, total lymph node dissection; TMB, tumor mutation burden; trAE, treatment-related adverse events.
No systemic treatment history.