OncoMatch/Clinical Trials/NCT07644897
Thymosin Alpha 1 Combined With Anti-PD-1 Monoclonal Antibody in Elderly Patients With Advanced Melanoma
Is NCT07644897 recruiting? Yes, currently enrolling (Jul 2026). This Phase 2 trial studies Thymosin Alpha 1 and Anti-PD-1 monoclonal antibody for melanoma.
Treatment: Thymosin Alpha 1 and Anti-PD-1 monoclonal antibody — Primary 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)
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Melanoma
Disease stage
Required: Stage III, IV
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Demographics
Lab requirements
Liver function
Total bilirubin ≤1.5× ULN; AST and AST <2.5× ULN (no liver metastasis), or <5× ULN (with liver metastasis)
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);
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT07644897 currently recruiting?
Yes, this trial is currently recruiting patients.
What disease stage is eligible?
Stage III or IV is required.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
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