Advanced cutaneous and acral melanoma
Conditions
Interventions
Experimental group:Ipilimumab in combination with bevacizumab
Sponsors
Henan Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Age over 18 years old, male or female; 2.Patients with unresectable or unwilling to undergo surgery for stage III-IV (Eighth Edition) cutaneous and acral melanoma confirmed by pathohistology or cytology; 3.No prior systemic or local anti-tumor therapy (such as radiotherapy, chemotherapy, targeted therapy, immunotherapy, cell therapy, etc.); 4.At least one measurable lesion according to RECIST v1.1 for solid tumour efficacy evaluation; 5.ECOG PS score of 0-1 within one week before enrollment; 6.Expected survival >= 12 weeks; 7.Voluntarily sign the informed consent form, understand and comply with the requirements of the study, and cooperate with the follow-up. 8.If the patient has hepatitis b virus (HBV) infection: patients with positive hepatitis B surface antigen (HBsAg) should receive anti-HBV treatment for at least 14 days before randomization, and be willing to receive anti-viral treatment throughout the study period (treatment based on the diagnostic and treatment guidelines) and be regularly monitored; Hepatitis C virus (HCV) ribonucleic acid (RNA)Patients with positive results should receive antiviral treatment according to the diagnostic and treatment guidelines and have liver function within CTCAE grade 1; 9.Women of childbearing potential must have a negative pregnancy test (serum) within 7 days prior to randomization and be willing to practice adequate birth control from the time of signing the informed consent form; men of childbearing potential must agree to practice adequate birth control from the time of signing the informed consent form; The time limit was from signing the informed consent to 3 months after the last dose.
Exclusion criteria
Exclusion criteria: 1.Patients with contraindications to bevacizumab treatment; 2.Patients with a history of allergy to active or excipient ingredients of elpercatopilumab; 3.BRAF V600E mutation; 4.Have active brain metastasis or have brain metastasis with uncontrolled clinical symptoms; 5.had other neoplasm malignant in the past 5 years, had other malignant neoplasm within 5 years (except for cured skin basal cell carcinoma, carcinoma in situ of prostate, cervix carcinoma in situ, and superficial bladder neoplasm [Ta, Tis, T1], and digestive tract carcinoma in situ/precancerous lesion); 6.History of immunodeficiency, or other acquired or congenital immunodeficiency diseases, or history of organ transplantation; 7.Markedly abnormal hepatic and renal function, meeting any of the following criteria: aminotransferase (AST or ALT) > 5 times the upper limit of normal, alkaline phosphatase (ALP) > 2.5 times the upper limit of normal, significantly elevated bilirubin total > 3 times the upper limit of normal, Serum albumin (ALB) 1.5 times the upper limit of normal;Blood routine neutrophil count (NEUT) = 40 g/d, female >= 20 g/d) (ethanol amount (g) conversion formula: alcohol consumption (m1) × ethanol content (%) × 0.8) and/or psychoactive substances, Drug abuse and dependence; 12.Neoplasm invades major blood vessels; 13.Patients who are not suitable for participation in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| EORTC QLQ-C30;Progress Free Survival;Disease Control Rate; | — |
Countries
China
Contacts
Public ContactYong Zhang
Henan Cancer Hospital
Outcome results
None listed