This single-arm, multicenter clinical study enrolled patients with advanced malignant melanoma who had failed previous first-line therapy (cutaneous melanoma patients were excluded), and patients with BRAF V600 mutations required targeted therapy.
Have fully understood the study and voluntarily signed the informed consent;
Age 18-75 years old (including 18 and 75 years old), gender is not limited;
Stage IV melanoma determined by pathology or cytology;
Patients with advanced malignant melanoma who have failed previous first-line therapy (cutaneous melanoma patients are excluded) and patients with BRAF V600 mutations need to be admitted after targeted therapy.
Failure to comply with the study protocol or study procedure;
Patients with active brain metastases;
Received organ surgery 6 weeks before enrollment;
Had other malignant tumors within 5 years prior to admission, except basal cell or squamous cell carcinoma of the skin after radical surgery, or carcinoma in situ of the cervix;
Single group
Temozolomide、Fruquintinib、Cadonilimab
DrugCombination treatment period: Fruquintinib: 4mg d1-21, po qd q4w; Cadonilimab 6mg/kg, ivgtt q2w; Temozolomide: 150\~200mg/m2, poqd, d1-5, q4W; The combined treatment lasted 6 cycles. Maintenance treatment: Fruquintinib: 4mg d1-21, po qd q4w; Cadonilimab 6mg/kg, ivgtt q2w; The maximum duration of maintenance treatment is not more than 2 years.
ORR（objective response rate）
Defined as percentage of participants achieving assessed complete response (CR) and partial response (PR) by the investigator according to the RECIST 1.1.
OS Overall survival
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first
DCR Disease control rate
From date of randomization until the end of treatment or the date of first documented progression or date of death from any cause, whichever came first,
PFS Progression-free survival
PFS were defined as from date of randomization until the date of first documented progression or date of death from any cause, whichever came first
Safety
Adverse events as assessed by NCI CTCAE v5.0overall incidence of adverse events (AE); incidence of grade 3 or higher AE; incidence of severe adverse events (SAE); incidence of AEs leading to discontinuation of drug use; incidence of AEs leading to suspension of drug use
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