China Oncology ›› 2022, Vol. 32 ›› Issue (12): 1133-1146.doi: 10.19401/j.cnki.1007-3639.2022.12.001
• Specialists' Commentary • Previous Articles Next Articles
XU Yu1(), CHEN Yong1, YANG Jilong2,3, ZHU Guannan4()
Received:
2022-11-22
Revised:
2022-12-27
Online:
2022-12-30
Published:
2023-02-02
Contact:
ZHU Guannan
CLC Number:
XU Yu, CHEN Yong, YANG Jilong, ZHU Guannan. Current status and prospect of perioperative treatment of stage Ⅲ melanoma[J]. China Oncology, 2022, 32(12): 1133-1146.
Tab. 1
On-going stage Ⅲ neoadjuvant therapy clinical trials"
NCT No. | Title | Research status | Treatment method | Main outcome indicators |
---|---|---|---|---|
NCT04207086 | A phase Ⅱ study of neoadjuvant pembrolizumab and lenvatinib for resectable stage Ⅲ melanoma (Neo PeLe) | Active, not recruiting | Pembrolizumab+lenvatinib 6 weeks; Surgery; Pembrolizumab 46 weeks | ① pCR rate; ② Anti-tumor immune response |
NCT03842943 | Neoadjuvant combination immunotherapy for stage Ⅲ melanoma | Recruiting | Talimogene laherparepvec (T-VEC)+ pembrolizumab before surgery, T-VEC is injected into the palpable lymph node once every 3 weeks for 6 months or until the target lesion is completely relieved; Pembrolizumab was used once every 3 weeks for 6 consecutive months and continued to be used for 1 year after operation | pCR rate |
NCT04330430 | Neo-adjuvant T-VEC+nivolumab combination therapy for resectable early metastatic (stage ⅢB/C/D-Ⅳ M1a) melanoma with injectable disease (NIVEC) | Recruiting | T-VEC+nivolumab before surgery | pCR rate |
NCT04331093 | Neoadjuvant SHR-1210 plus apatinib for resectable stage Ⅲ-Ⅳ acral melanoma | Recruiting | SHR-1210+apatinib before surgery | pCR rate |
NCT03618641 | CMP-001 in combination with nivolumab in stage ⅢB/C/D melanoma patients with clinically apparent lymph node disease | Active, not recruiting | Nivolumab+CMP-001 before surgery | mpCR rate |
NCT04197882 | Clinical study to evaluate OrienX010 in combination with toripalimab as neoadjuvant treatment in advanced melanoma | Active, not recruiting | OrienX010+toripalimab before surgery, toripalimab after surgery | pCR rate |
NCT05176470 | Neoadjuvant admin autologous tumor infiltrating lymphocytes and pembrolizumab for treatment of advanced melanoma patients | Recruiting | Pembrolizumab+cyclophosphamide+ fludarabine before surgery, pembrolizumab after surgery | ① Feasibility of MK-3475 and LN-144/Lifileucel as neoadjuvant therapy in patients with ⅢB-D melanoma; ② Incidence rate of grade 3 and above adverse reactions (immune-related and unrelated) |
NCT04949113 | Neoadjuvant ipilimumab plus nivolumab versus standard adjuvant nivolumab in macroscopic stage Ⅲ melanoma (NADINA) | Recruiting | Trial group: Neoadjuvant ipilimumab+ nivolumab after surgery; Control group: Nivolumab after surgery | EFS |
NCT04139902 | Neoadjuvant PD-1 inhibitor dostarlimab (TSR-042) vs combination of Tim-3 inhibitor cobolimab (TSR-022) and PD-1 inhibitor dostarlimab (TSR-042) in melanoma (Neo-MEL-T) | Recruiting | Trial group: Dostarlimab (TSR-042) before surgery combined TSR-022; Control group: Dostarlimab (TSR-042) | mpCR rate |
NCT04708418 | A study evaluating whether pembrolizumab alone or in combination with CMP-001 improves efficacy in patients with operable melanoma | Recruiting | Group 1: Pembrolizumab before surgery,pembrolizumab after surgery; Group 2: CMP-001+ pembrolizumab before surgery, pembrolizumab after surgery | pCR rate |
NCT03698019 | A study to compare the administration of pembrolizumab after surgery versus administration both before and after surgery for high-risk melanoma | Active, not recruiting | Control group: Pembrolizumab after surgery; Trial group: Pembrolizumab before surgery+pembrolizumab after surgery | EFS |
NCT03567889 | Efficacy of daromun neoadjuvant intratumoral treatment in clinical stage ⅢB/C melanoma patients (NeoDREAM) | Recruiting | Trial group: Daromun before surgery+ postoperative adjuvant therapy; Control group: Postoperative adjuvant therapy | RFS |
NCT02938299 | Neoadjuvant L19IL2/L19TNF-pivotal study | Recruiting | Trial group: Neoadjuvant therapy L19IL2/L19TNF+surgery; Control group: Surgery | RFS rate |
NCT04401995 | Study of TLR9 agonist vidutolimod (CMP-001) in combination with nivolumab vs nivolumab | Recruiting | Trial group 1: Nivolumab+vidutolimod (CMP-001) + [18F]F-AraG PET/CT; Trial group 2: Nivolumab+ [18F]F-AraG PET/CT | mpCR rate |
NCT03554083 | NeoACTIVATE: Neoadjuvant therapy for patients with high risk stage Ⅲ melanoma | Recruiting | Trial group 1: Before surgery, vemurafenib +cobimetinib+atezolizumab; Trial group 2: Before surgery, cobimetinib+ atezolizumab; Trial group 3: Before surgery, atezolizumab+tiragolumab | ① pCR rate of stage Ⅲ BRAF mutation patients (neoadjuvant therapy); ② pCR rate of stage Ⅲ BRAF wild type patients (neoadjuvant therapy); ③ Median RFS (adjuvant therapy) |
NCT02977052 | Optimal neoadjuvant combination scheme of ipilimumab and nivolumab | Active, not recruiting | Trial group 1: Before surgery, ipilimumab 3 mg/kg+nivolumab 1 mg/kg; Trial group 2: Before surgery, ipilimumab 1 mg/kg+nivolumab 3 mg/kg; Trial group 3: Before surgery, ipilimumab 3 mg/kg+nivolumab 3 mg/kg | ① Immune-related advers effects; ② Response rate (RECIST 1.1) ③ pCR rate; ④ The draining lymph node reaches pCR or npCR; ⑤ Or npCR, and 24-month RFS rate of patients who did not receive CLND; ⑥ No pCR, nivolumab after surgery+radiotherapy/BRAFV600E mutation patients recedved dabrafenib+trametinib for 24 months, RFS rate |
NCT04133948 | Multicenter phase 1b trial testing the neoadjuvant combination of domatinostat, nivolumab and ipilimumab in IFN-gamma signature-low and IFN-gamma signature-high RECIST 1.1-measurable stage Ⅲ cutaneous or unknown primary melanoma (DONIMI) | Active, not recruiting | Trial group 1: High IFN-gamma level, nivolumab before surgery; Trial group 2:High IFN-gamma level, nivolumab+domatinostat before surgery; Trial group 3: Low IFN-gamma level, nivolumab+domatinostat before surgery; Trial group 4: Low IFN-gamma level, nivolumab+ipilimumab+domatinostat before surgery | ① Security (measured by complying with the time design in the research scheme); ② Scheme feasibility is measured by complying with the time design in the research scheme) |
NCT04303169 | Substudy 02C: safety and efficacy of pembrolizumab in combination with investigational agents or pembrolizumab alone in participants with stage Ⅲ melanoma who are candidates for neoadjuvant therapy (MK-3475-02C/KEYMAKER-U02) | Recruiting | Group 1: Pembrolizumab+vibostolimab before surgery, pembrolizumab after surgery; Group 2:Pembrolizumab+V937 before surgery, pembrolizumab after surgery; Group 3: Pembrolizumab before surgery, pembrolizumab after surgery; Group 4: Pembrolizumab+MK-4830 before surgery, pembrolizumab after surgery; Group 5: Favezelimab+pembrolizumab before surgery, pembrolizumab after surgery; Group 6: Pembrolizumab+all-trans retinoic acid (ATRA) before surgery, pembrolizumab after surgery | ① Adverse reaction; ② Proportion of patients who stopped the study due to adverse reaction; ③ pCR rate |
NCT03769155 | VX15/2503 with or without ipilimumab and/or nivolumab in patients with resectable stage ⅢB-D melanoma | Recruiting | Trial group 1: VX15/2503+nivolumab before surgery +surgery; Trial group 2: VX15/2503+ipilimumab before surgery +surgery; Trial group 3: VX15/2503+nivolumab +ipilimumab before surgery+surgery; Trial group 4: Nivolumab before surgery+surgery Control group: Surgery | Analysis of biomarker parameters: infiltration degree of CD8+T cells |
NCT02231775 | Dabrafenib and trametinib before and after surgery in treating patients with stage ⅢB-C melanoma with BRAF V600 mutation | Recruiting | Treatment (dabrafenib, trametinib and surgery); Neoadjuvant therapy (dabrafenib+ trametinib)+surgery; 1 week after surgery. If no disease progression or unacceptable toxicity occurred, continue dabrafenib+trametinib for 44 weeks | RFS |
NCT01972347 | Neoadjuvant dabrafenib+ trametinib for AJCC stage ⅢB-C BRAFV600 mutation positive melanoma | Active, not recruiting | Dabrafenib+trametinib before surgery | After 12 weeks of neoadjuvant therapy, proportion of surviving melanoma tissues in lymph nodes or metastatic tumor tissues compared with baseline |
NCT04310397 | Dabrafenib, trametinib, and spartalizumab for the treatment of BRAFV600E or BRAFV600K mutation positive stage ⅢB/C/D melanoma (Neo PeLe) | Active, not recruiting | Single arm study: Neoadjuvant therapy dabrafenib+trametinib, pCR patients after surgery could be treated with dabrafenib+trametinib; non-pCR patients treated with spartalizumab+dabrafenib+ trametinib | RFS rate |
NCT04221438 | A phase Ⅱ neoadjuvant study of encorafenib with binimetinib in patients with resectable locoregional metastases from cutaneous or unknown primary melanoma (stage Ⅲ N1B/C/D) | Recruiting | 18F-FLT+encorafenib+binimetinib before surgery, encorafenib+binimetinib after surgery | ① pCR rate; ② 18F-FLT PET/CT intake changes from baseline after 2 cycles of neoadjuvant therapy |
NCT02858921 | Neoadjuvant dabrafenib, trametinib and/or pembrolizumab in BRAF mutant resectable stage Ⅲ melanoma (Neo Trio) | Active, not recruiting | Group 1: Dabrafenib+trametinib, pembrolizumab sequential therapy; Dabrafenib 150 mg orally, bid+trainenib 2 mg, qd, 1 week; Pembrolizumab (2 mg/kg) was then injected intravenously at weeks 1, 3 and 6; Surgery; Pembrolizumab (2 mg/kg) every 3 weeks from the 6th week, for 46 weeks; Group 2: Dabrafenib+trametinib, combined with pembrolizumab; Dabrafenib 150 mg orally, bid+trametinib 2 mg orally, qd+pembrolizumab 200 mg iv, every 3 weeks for 6 weeks, surgery, pembrolizumab 46 weeks after surgery; Group 3: Pembrolizumab; Pembrolizumab 200 mg iv, once every 3 weeks, surgery at the 6th week, and continue to use until the 52nd week | pCR rate treated for 6 weeks |
NCT05097378 | Perioperative encobini in BRAFV600 mutant stage Ⅲ (B/C/D) or oligometastatic stage Ⅳ melanoma (PREMIUM) | Not yet recruiting | Group 1: Before surgery, encorafeni+ binimetinib 8 weeks; Surgery; Encorafeni+binimetinib 44 weeks; Group 2: Surgery+the standard adjuvant treatment method selected by the researchers after surgery | pCR rate |
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