Thymosin Alpha 1 Combined With Anti-PD-1 Monoclonal Antibody in Elderly Patients With Advanced Melanoma
Objective: To evaluate the effectiveness of Thymosin Alpha-1 combined with PD-1 monoclonal antibody in elderly patients with advanced melanoma . Secondary Objective: To evaluate the safety and tolerability of adenpeptide-α1 combined with PD-1 antibody in elderly patients with advanced melanoma . Study Design：Open-label, single-arm, non-controlled clinical trial. Primary Inclusion Criteria: 1. Age ≥60 years old; 2. Pathologically confirmed as inoperable or metastatic melanoma; 3. one or more lesions evaluable by RECIST1.1 standards. 4. The Eastern Cooperative Oncology Group (ECOG) scoring system in the United States scores from 0-2; Main exclusion criteria: 1. Received treatment with a regimen containing PD-1, PD-L1, or CTLA-4 antibodies within the past 6 months; 2. Received thymosin class drug treatment within 3 months before signing the informed consent. 3. Symptomatic, untreated central nervous system metastases. Treatment： Thymosin Alpha 1 1.6mg, sc，QD，d1-7;1.6mg, sc， three times per week, d8-21. Each 21 days is considered one cycle, for a total of 12 weeks. Anti-PD-1 monoclonal antibody (Toripalimab) 240mg per dose,ivdrip，Q3W，4 cycles. Primary study endpoints: Objective Response Rate (ORR: CR+PR) Secondary study endpoints: Progression-Free Survival (PFS), Duration of Response (DOR), Overall Survival (OS) Adverse Events (AEs)
• Aged 60 years or older;
• Diagnosis of malignant melanoma confirmed by pathological histology or cytology examination.
• According to the 8th edition of AJCC staging, patients with unresectable stage III or IV melanoma;
• One or more lesions evaluable by RECIST1.1 standards.
• The Eastern Cooperative Oncology Group (ECOG) scoring system in the United States has a score range of 0-2.
• Total bilirubin ≤1.5× upper limit of normal (ULN); AST and AST \<2.5× upper limit of normal (ULN).(No liver metastasis), or \<5 times the upper limit of normal (ULN) (with liver metastasis);
• Patients with recurrent metastasis who have not previously received immunotherapy such as PD-1, PD-L1, CTLA-4 antibodies，also allowed for the enrollment of patients who had used adjuvant/neoadjuvant therapies
‣ If the adjuvant or neoadjuvant treatment plan includes PD(L)-1 or CTLA-4 monoclonal antibodies, it is required that only those who progress more than 6 months after the end of the treatment plan can be included in the study group.
⁃ If the adjuvant or neo-adjuvant treatment plan does not include PD(L)-1 or CTLA-4 monoclonal antibodies, patients who progress during the adjuvant treatment are allowed to participate in the study.
• Has signed the informed consent form, able to comply with the study protocol and follow-up plan.