Melanoma
Conditions
Interventions
experimental group:The study used the YMN-V117 formulation in combination with a PD-1 inhibitor: YMN-V117 was administered via intratumoral 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?/L, platelets >=80×10?/L, and hemoglobin >=90 g/L; 8. International normalized ratio =50 mL/min; 10. ALT and AST =55% assessed by Doppler echocardiography; 12. For female patients of childbearing potential who are not surgically sterile, serum or urine HCG test results must be negative within 7 days prior to study enrollment, and they must be willing to use appropriate contraceptive methods during the study period and for 3 months after the last dose of study drug. Male patients must either agree to use appropriate contraceptive methods during the study period and for 3 months after the last dose of study drug or be surgically sterile; 13. The interval between the last treatment (chemotherapy, targeted therapy, radiotherapy, surgery, interventional therapy, ablation therapy, etc.) and the first dose of study drug must be at least 4 weeks or at least 5 half-lives; the interval between the last immunotherapy and the first dose of study drug must be at least 3 weeks. Immunotherapy includes, but is not limited to, immune checkpoint inhibitors, tumor-infiltrating lymphocyte therapy, dendritic cell therapy, natural killer cell therapy, CAR-T, TCR-T, Toll-like receptor agonists, cancer vaccines, Chinese patent medicines with anti-tumor indications, or immunomodulatory drugs (e.g., thymosin, interferon, interleukin, etc.); 14. Signed informed consent.
Exclusion criteria
Exclusion criteria: 1. Concurrent presence of other malignant tumors; 2. Patients with uveal melanoma or leptomeningeal melanoma; 3. Prior treatment with anti-CTLA-4 agents or anti-TGF-ß agents; 4. Prior treatment-related adverse events not recovered to Grade 1 alopecia, hyperpigmentation, vitiligo, well-controlled hypertension, or endocrine disorders may be enrolled; 5. Active infections, such as HIV infection, HBV DNA >=1×10³ copies/mL, HCV RNA copy number 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 Grade II or above, poorly controlled arrhythmias (including QTc interval >=450 ms in males, >=470 ms in females); heart failure Class III–IV according to NYHA criteria, or left ventricular ejection fraction (LVEF) <55% on echocardiography; 8. Allergy to the active ingredient or excipients of the study drug; 9. History of psychiatric disorders: schizophrenia, anxiety disorder, depression, bipolar disorder, etc., as well as other mental illnesses currently receiving treatment or intervention; 10. Autoimmune diseases (e.g., autoimmune hepatitis, systemic lupus erythematosus, etc.), stem cell or organ transplantation, or diseases requiring long-term treatment with glucocorticoids or immunosuppressants; 11. Arterial/venous thrombotic events within 6 months, such as cerebrovascular accidents, deep vein thrombosis, or pulmonary embolism; 12. Clinically uncontrolled pleural effusion/ascites (patients who do not require drainage or have no significant increase in fluid after stopping drainage for 3 days 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;Computerized tomography (CT) scan;Stool routine;Urinalysis; | — |
Countries
China
Contacts
Public ContactYu Jiang/ Xiawei Wei
West China Hospital, Sichuan University
Outcome results
None listed