Thymosin Alpha 1 Combined With Anti-PD-1 Monoclonal Antibody in Elderly Patients With Advanced Me… (NCT07644897) | Clinical Trial Compass
RecruitingPhase 2
Thymosin Alpha 1 Combined With Anti-PD-1 Monoclonal Antibody in Elderly Patients With Advanced Melanoma
China55 participantsStarted 2023-05-30
Plain-language 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:
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)
Who can participate
Age range
60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Has signed the informed consent form, able to comply with the study protocol and follow-up plan.
Exclusion criteria
. 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.
. Presence of symptomatic central nervous system (CNS) metastases and/or carcinomatous meningitis. For subjects with previously treated CNS metastases, if the subject's condition is stable (no evidence of radiographic progression for at least weeks prior to the first administration of the study intervention, and all neurological symptoms have returned to baseline), repeat radiographic examination confirms no evidence of new brain metastases or enlargement of existing brain metastases, and no need for steroid treatment for at least 14 days prior to the first administration of the study intervention, they may participate in the study.
. Patients with active systemic autoimmune diseases requiring systemic treatment (i.e., using immunomodulators, corticosteroids, or immunosuppressants). Replacement therapies (such as thyroxine, insulin, or physiological corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) are not considered systemic treatment.
. Has a history of immunodeficiency, including testing positive for HIV, or suffering from other acquired or congenital immunodeficiency diseases, or has a history of organ transplantation and bone marrow transplantation.