Thymosin Alpha 1 Combined With Anti-PD-1 Monoclonal Antibody in Elderly Patients With Advanced Melanoma

What Was Tested

In this phase 2 trial, researchers set out to test Thymosin Alpha-1.

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.

It had 1 arm (groups): intervention group (experimental).

Thymosin Alpha 1 and anti-PD-1 monoclonal antibody.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 55 planned participants were the target.

It was open to people of any sex aged from 60 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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.

The full record lists 10 inclusion and 5 exclusion criteria; among the exclusions: received treatment involving pd-1, pd-l1, or ctla-4 antibody regimen within the past 6 months;; patients who have received treatment with thymosin, thymopentin, or thymosin a-1d within 3 months prior to enrollment.

How the Study Was Run

The set-up was single-group and open-label.

Being open-label, the Thymosin Alpha-1 study did not mask who received what.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2023-05-30 with completion listed for 2027-05-30.

It ran at 2 sites in China (2).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Objective Response Rate (time frame: up to 24 weeks).

It also tracked 4 secondary outcomes, for example Progression-Free Survival (PFS), overall survival (OS), Adverse Events (AEs) and Duration of Response (DOR),.

What This Means in Plain Language

Put simply, this is a phase 2 trial of Thymosin Alpha-1 in 55 people.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Thymosin Alpha-1 compound page, all human trials.