advanced melanoma
Conditions
Interventions
treatment group:reRNA-Melanoma Vaccine/ PD-1 Terepril Monoclonal Antibody Injection
Sponsors
The First Affiliated Hospital of Nanyang Medical College
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Male or female,18 years = 1.5×10^9/L; platelet count (PLT) >= 75×10^9/L; hemoglobin content (HGB) >= 80g/L. No use of granulocyte colony-stimulating factor (G-CSF), granulocyte-macrophage colony-stimulating factor (GM-CSF), red blood cell transfusion and platelet transfusion within 14 days before the examination. (2) Liver function: Subjects without liver metastasis require serum total bilirubin (TBIL) <= 1.5 × upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <= 2.5×ULN. Requirements for subjects with liver metastases: TBIL <=1.5×ULN; ALT and AST <=5×ULN. (3) Renal function: serum creatinine (Scr) <= 1.5× ULN. (4) Sufficient coagulation function, defined as the international normalized ratio (INR) <= 1.5 or prothrombin time (PT) <= 1.5 times ULN; if the subject is receiving anticoagulant therapy, as long as PT is within the prescribed range of anticoagulant drugs can; 7. Sign the written informed consent, and be able to abide by the visits and related procedures stipulated in the plan; 8. Qualified patients (male and female) with reproductive potential must agree to use reliable contraceptive methods (hormone or barrier method or abstinence) during the study.
Exclusion criteria
Exclusion criteria: 1. Have a history of severe allergy to biological products; 2. Those who are pregnant or breastfeeding; 3. Primary ocular melanoma; 4. Diagnosed with other malignant tumors within the past 5 years, except for radically treated, locally curable cancers, such as: basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast; 5. Those who have undergone major surgery within 4 weeks after signing the informed consent form, or plan to undergo major surgery during the study period; 6. Received radiotherapy, chemotherapy, biological therapy, endocrine therapy, immunotherapy and other anti-tumor drug treatments within 4 weeks before the first administration; 7. Currently, recently (within 28 days before starting the study treatment) receiving any other study drug treatment or participating in another anti-tumor treatment clinical study; 8. Patients with active CNS metastases and/or cancerous meningitis, known or detected during screening. However, the following subjects are allowed to enroll: 1) Patients with asymptomatic brain metastases (that is, no progressive central nervous system symptoms caused by brain metastases, and do not need to use corticosteroids) can participate. 2) Subjects who have been treated and have stable brain metastases for at least 2 months, without evidence of new or enlarged brain metastases; 9. In addition to hearing loss, hair loss and fatigue, the adverse reactions of previous anti-tumor therapy have not recovered to NCI CTCAE v5.0 grade evaluation = grade 1; 10. Patients after splenectomy; 11. Cardiovascular and cerebrovascular diseases meet any of the following: a. Poorly controlled hypertension (systolic blood pressure >= 160 mmHg or diastolic blood pressure >= 100 mmHg); b. Cardiac function >= grade 2 congestive heart failure (New York Heart Association (NYHA) classification); c. Arrhythmias requiring clinical intervention (including QTc >= 450ms (male), QTc >= 470ms (female)); d. Serious arterial and venous thromboembolic events, including myocardial infarction, unstable angina, cerebrovascular accident or transient cerebral ischemic attack, pulmonary embolism, deep vein thrombosis or any other serious thromboembolism (excluding the investigators) Intermuscular venous thrombosis that can be included in the evaluation); 12. Accompanied by uncontrolled third space effusion that needs repeated drainage, such as pleural effusion, ascites, pericardial effusion, etc. (patients who do not need to drain effusion or have no significant increase in effusion after stopping drainage for 3 days can be enrolled); 13. Systemic active infection requiring treatment; 14. HIV, HCV, syphilis, CMV (cytomegalovirus) infected patients; patients with active replication of hepatitis B virus (DNA>500 cps/mL); 15. With active autoimmune disease or inflammatory disease (including inflammatory bowel disease [such as ulcerative colitis or Crohn's disease], diverticulitis [except diverticular disease], celiac disease, systemic lupus erythematosus, Sarcoidosis syndrome or Wegener's syndrome [granulomatous polyangiitis], Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc.) or a history of the disease within 2 years (systematic Subjects with treated vitiligo, psoriasis, alopecia, or Graves' disease, hypothyroidism requiring only thyroid hormone replacement therapy, and type 1 diabetes requiring only insulin replacement therapy can be enrolled). Known history of primary im
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse event; | — |
Secondary
| Measure | Time frame |
|---|---|
| overall response rate;disease response rate;Progression Free Survival;Overall Survival;the immunoreactivity;the immunogenicity;Pharmacokinetics characteristics;the viral shedding; | — |
Countries
China
Contacts
Public ContactCheng Peng
The First Affiliated Hospital of Nanyang Medical College
Outcome results
None listed