malignant melanoma
Conditions
Interventions
Experimental group:Encore combined with PD-1 monoclonal antibody (Treprizumab)
Control group:PD-1 monoclonal antibody (Treprizumab, 240mg/bottle)
Sponsors
Shanghai Skin Disease Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Aged 18 to 75 years old; (2) Diagnosed as malignant melanoma by histopathology (only skin and extremities); (3) Previous treatment failed or could not tolerate chemotherapy, and at most received 2-line system therapy (never received PD-1 and PD-L1 monoclonal antibody treatment in the past); (4) There must be an injectable lesion, and the lesion must meet the requirements of RECIST 1.1 and iRECIST measurable target lesions; (5) The longest diameter of the injectable lesions must be 10 to 80mm, and the sum of the longest diameters of the total metastatic lesions =4.0x10^9/L, absolute neutrophil count >=1.5x10^9/L, platelet count >=100x10^9/L, hemoglobin >=90g/L; INR=50ml/min; (8) The interval between the date of the first treatment in this study and the date of the last anti-tumor treatment >=14 days, and the adverse reaction of the previous anti-tumor treatment has recovered to baseline or below grade 1 (Common Adverse Event Evaluation Criteria (CTCAE) Version 5.0) (Except for hair loss and grade 2 anemia); (9) Sign the informed consent form voluntarily; Female patients with reproductive potential (including early menopause, menopause <2 years and non-surgical sterilization), male patients and male patients partners must agree to use effective contraceptive measures during the study period: surgical sterilization, oral contraceptives, intrauterine contraception Contraceptives, sexual restraint, or barrier contraception combined with spermicide; and must continue contraception for 6 months after receiving the last treatment.
Exclusion criteria
Exclusion criteria: (1) Injectable lesions have received ablation, intervention, Haifu knife and other local treatments in the past; (2) Have received oncolytic virus drugs or similar drugs (such as T-VEC) in the past; (3) The local lesion cannot meet the requirement of intratumoral injection volume or is not suitable for intratumoral injection; (4) Accompanied by malignant pleural fluid and ascites; (5) Have received antiviral therapy, such as acyclovir, ganciclovir, vanaiclovir, vidarabine, etc. within 4 weeks before the first administration of the trial treatment; (6) Known to be allergic to research drugs or their active ingredients, excipients or anti-PD-1 monoclonal antibody drugs and their components; (7) Hepatitis B surface antigen (HBsAg) is positive and clinically judged as active hepatitis B; (8) Hepatitis C virus (HCV) antibody, Treponema pallidum (TP) antibody, and human immunodeficiency virus (HIV) antibody are positive; (9) There is a history of other (including unknown primary) malignant tumors within 5 years before the first administration of the trial treatment, except for the following: ? Cured non-melanoma skin malignancies ? Cervical carcinoma in situ ? Stage I uterine cancer that has been cured ? Radical ductal carcinoma in situ or lobular carcinoma in situ of the breast, currently not receiving any systemic treatment ? Limited prostate cancer that has undergone radical surgery and is currently considered cured ?Solid tumors over 5 years have been cured without any signs of recurrence (10) The patient is accompanied by any unstable systemic diseases, including but not limited to: severe infection, uncontrolled diabetes, unstable angina, cerebrovascular accident or transient cerebral ischemia, myocardial infarction, congestive heart failure, Severe arrhythmia, liver, kidney or metabolic diseases that require medication; (11) Suffer from autoimmune diseases; (12) The patient's accompanying diseases (such as mental illness, etc.) or conditions (such as alcohol or drug abuse, etc.) will increase the patient's risk of receiving experimental drug treatment or affect the patient's compliance with the trial requirements, or may confuse the research results; (13) In the 14 days before receiving the treatment in this study, the patient had received any other experimental drug treatment or participated in another interventional clinical trial; (14) Women who are pregnant or breastfeeding or who intend to become pregnant or breastfeeding during the study period; men or women who are unwilling to take effective contraceptive measures; (15) There is evidence of central nervous system metastasis at baseline; The investigator judges that the patient is not suitable for other conditions in the clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS;ORR; | — |
Countries
China
Contacts
Public ContactChen Jianhua
Shanghai Skin Disease Hospital
Outcome results
None listed