What this means
This trial will test whether adding thymosin alpha-1 to an immune drug shrinks melanoma in people 60 and older. It has not started reporting results, so we do not yet know if it works.
Plain-English summary written by an AI model from the registry listing.
- Status
- Recruiting
- Who can join
- Ages 60 and over
- Where
- 2 sites
The science
- Registered title
- Thymosin Alpha 1 Combined With Anti-PD-1 Monoclonal Antibody in Elderly Patients With Advanced Melanoma
- Trial ID
- NCT07644897 ↗
- Phase
- PHASE 2
- Study type
- interventional
- Conditions
- Melanoma, Immune-related Adverse Event, Immune Checkpoint Inhibitor
- What is tested
- Thymosin Alpha 1 and Anti-PD-1 monoclonal antibody
- Sponsor
- Sun Yat-sen University
- Ages
- 60 Years to no maximum
- Dates
- First posted Jun 12, 2026 · updated Jun 12, 2026
Registry summary
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:
- Age ≥60 years old;
- Pathologically confirmed as inoperable or metastatic melanoma;
- one or more lesions evaluable by RECIST1.1 standards.
- The Eastern Cooperative Oncology Group (ECOG) scoring system in the United States scores from 0-2;
Main exclusion criteria:
- Received treatment with a regimen containing PD-1, PD-L1, or CTLA-4 antibodies within the past 6 months;
- Received thymosin class drug treatment within 3 months before signing the informed consent.
- 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)
Sites (2)
- Sun yat-sen uniersity, Guangzhou, Guangdong, China
- Nanshan hospital, Shenzhen, Guangdong, China