NCT06553781

A Single-arm, Multicenter Clinical Study of Fruquintinib Combined With Cadonilimab Injection and Temozolomide in Second-line and Subsequent Treatment of Advanced Melanoma

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 28 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Combination 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. The study was divided into three stages: screening period, treatment period and follow-up period. The treatment period is a treatment cycle every 4 weeks. During the treatment period, imaging methods will be used to evaluate the tumor status every 8 weeks (±7 days) until the patient's disease progresses (RECIST 1.1) or death (during the treatment of the patient) or toxicity becomes intolerable. The tumor treatment status and survival status of the patient after disease progression should be recorded. Safety indicators include adverse events, laboratory tests, vital signs, and changes in electrocardiogram and cardiac ultrasound.

Conditions

• Malignant Melanoma

Interventions

Type	Name	Description
DRUG	Temozolomide、Fruquintinib、Cadonilimab	Combination 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.

Timeline

• Start date: 2024-09-01
• Primary completion: 2025-09-01
• Completion: 2027-09-01
• First posted: 2024-08-14
• Last updated: 2024-08-14