Melanoma
Conditions
Interventions
Experimental group:The study used the YMN-V115 formulation in combination with a PD-1 inhibitor: YMN-V115 was administered via subcutaneous injection at low, medium, or high doses, with a single treat
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) Pathological diagnosis of malignant melanoma; (2) Age >= 18 years and = 1.5 × 10^9/L, platelet count >= 80 × 10^9/L, and hemoglobin >= 90 g/L; (8) International normalized ratio (INR) =50 mL/min; (10) Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) = 55% as assessed by Doppler echocardiography; (12) For female patients of childbearing potential who are not surgically sterilized, a negative serum or urine pregnancy test (HCG) within 7 days prior to study enrollment is required, and they must be willing to use appropriate contraception during the trial and for 3 months after the last dose of study drug. For male patients, they must either agree to use appropriate contraception during the trial and for 3 months after the last dose of study drug, or be surgically sterilized; (13) The last treatment (chemotherapy, targeted therapy, radiotherapy, surgery, interventional therapy, ablation, etc.) must be at least 4 weeks or at least 5 half-lives before the first dose of study drug. The last immunotherapy must be at least 3 weeks before the first dose of study drug. Immunotherapy includes but is not limited to immune checkpoint inhibitors, tumor-infiltrating lymphocyte (TIL) therapy, dendritic cell (DC) therapy, natural killer (NK) cell therapy, chimeric antigen receptor T-cell (CAR-T) therapy, T-cell receptor-engineered T-cell (TCR-T) therapy, Toll-like receptor agonists, cancer vaccines, proprietary Chinese medicines with anti-tumor indications, or immunomodulatory agents (including thymosin, interferon, interleukin, etc.). (14) Sign the informed consent form.
Exclusion criteria
Exclusion criteria: (1) Concurrent diagnosis of another malignancy; (2) Patients with uveal melanoma or leptomeningeal melanoma; (3) Prior treatment with IL-12-related agents; (4) Prior treatment-related adverse events not recovered to Grade 1 alopecia, hyperpigmentation, vitiligo, well-controlled hypertension, or endocrine disorders who may be enrolled; (5) Active infections, such as HIV infection, hepatitis B virus DNA >= 1 × 10^3 copies/mL, hepatitis C virus RNA above the upper limit of normal, active tuberculosis, etc.; (6) Lactating or pregnant women; (7) Severe cardiovascular or cerebrovascular diseases: myocardial ischemia or myocardial infarction greater than Grade II, poorly controlled arrhythmias (including QTc interval >= 450 ms for males and >= 470 ms for females); New York Heart Association (NYHA) Class III–IV cardiac insufficiency, or left ventricular ejection fraction (LVEF) < 55% on echocardiography; (8) Hypersensitivity to the active ingredient or excipients of the study drug; (9) History of psychiatric disorders: schizophrenia, anxiety disorder, depression, bipolar disorder, etc., or other mental illnesses currently receiving treatment or intervention; (10) Autoimmune diseases (e.g., autoimmune hepatitis, systemic lupus erythematosus, etc.), history of stem cell or organ transplantation, or diseases requiring long-term treatment with glucocorticoids or immunosuppressive agents; (11) Occurrence of arterial/venous thromboembolic events within 6 months, such as cerebrovascular accident, deep vein thrombosis, or pulmonary embolism; (12) Clinically uncontrollable pleural effusion/ascites (patients who do not require drainage or whose effusion does not increase significantly after 3 days of drainage cessation may be enrolled); (13) Other factors deemed by the investigator to make the patient unsuitable for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety;Adverse reactions; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Response Rate (ORR);Disease control rate,DCR;Progression-Free Survival ;Overall Survival;Computed tomography;Stool routine;Urinalysis; | — |
Countries
China
Contacts
Public ContactYu Jiang/Xiawei Wei
West China Hospital, Sichuan University
Outcome results
None listed