A Multicenter, Randomized, Controlled, Open-label, Phase II Trial on Autologous Tumor Infiltrating Lymphocyte Injection (LM103 TILs) for the Treatment of Advanced Melanoma

INTERVENTION: Control group:Comparator drugs include dacarbazine, temozolomide, paclitaxel, and carboplatin/cisplatin. They can be used as monotherapy or in combination chemother;Experimental group:LM103 Injection; CONDITION: Melanoma PRIMARY OUTCOME: IRC‐assessed PFS; SECONDARY OUTCOME: Related to adverse events;Investigator‐assessed PFS according to RECIST 1.1;Overall survival;Objective response rate as assessed by the IRC and investigators according to RECIST 1.1;Disease control rates as assessed by the IRC and investigators according to RECIST 1.1;Duration of response as assessed by the IRC and investigators according to RECIST 1.1; INCLUSION CRITERIA: 1. Must be aged >=18 and <=75 at the time of signing the informed consent form, applicable to both men and women; 2. Expected survival period >= 3 months; 3. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1; 4. Patients with unresectable recurrent/metastatic melanoma (except uveal melanoma) who failed to respond to at least two lines of standard therapy: (1) failed to respond to or were intolerant to PD‐1 antibody therapy. Details of treatment failures are provided in Appendi X4. Intolerance was defined as the occurrence of immune‐related adverse events (irAE) of grade >=3 after PD‐1 antibody treatment leading to the discontinuation of PD‐1 antibody. (2) If BRAF V600 mutation is positive, BRAF±MEK inhibitor therapy should be failed; (3) If NRAS mutation is positive, treatment failure with tollatinib is required. 5. Have a needle that can be used for surgical resection (> 1.0cm3) or biopsy (needle specimen: 16G>=4, 18G>=6, and