Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06553781
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-12
Brief Title:
A Single-arm Multicenter Clinical Study of Fruquintinib Combined With Cadonilimab Injection and Temozolomide in Second-line and Subsequent Treatment of Advanced Melanoma
Sponsor:
None
Organization:
None
Study Overview
Official Title:
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
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 6mgkg ivgtt q2w
Temozolomide 150200mgm2 poqd d1-5 q4W
The combined treatment lasted 6 cycles
Maintenance treatment
Fruquintinib 4mg d1-21 po qd q4w
Cadonilimab 6mgkg 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 patients disease progresses RECIST 11 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
Fruquintinib 4mg d1-21 po qd q4w
Cadonilimab 6mgkg ivgtt q2w
Temozolomide 150200mgm2 poqd d1-5 q4W
The combined treatment lasted 6 cycles
Maintenance treatment
Fruquintinib 4mg d1-21 po qd q4w
Cadonilimab 6mgkg 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 patients disease progresses RECIST 11 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None