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New treatment option for Melanoma
Official title Thymosin Alpha 1 Combined With Anti-PD-1 Monoclonal Antibody in Elderly Patients With Advanced Melanoma
ClinicalTrials.gov ID: NCT07644897
What this study is testing
What is Thymosin Alpha 1 and Anti-PD-1 monoclonal antibody?
Thymosin Alpha 1 and Anti-PD-1 monoclonal antibody is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for melanoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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 .
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 60 and older
You may be able to join if
- 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.
You likely can't join if
- 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 people with previously treated CNS metastases...
- Patients with active systemic autoimmune diseases requiring systemic treatment (i.e., using immunomodulators, corticosteroids, or...
- Has a history of immunodeficiency, including testing positive for HIV, or suffering from other acquired or congenital immunodeficiency diseases, or...
See the full eligibility 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
- 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...
- 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.
- 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 people with previously treated CNS metastases, if the subject's condition is stable (no evidence of radiographic...
- Patients with active systemic autoimmune diseases requiring systemic treatment (i.e., using immunomodulators, corticosteroids, or immunosuppressants). Replacement therapies (such as thyroxine, insulin, or physiological...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, China
- Shenzhen, Guangdong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 60 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Guangdong, China; Shenzhen, Guangdong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.