A Single-arm, Multicenter Clinical Study of Fruquintinib Combined With Cadonilimab Injection and Temozolomide in Second-line and Subsequent Treatment of Advanced Melanoma
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Malignant Melanoma
- Sponsor
- Fudan University
- Enrollment
- 28
- Primary Endpoint
- ORR（objective response rate）
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
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 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.
Investigators
Zhiguo Luo, MD, PhD
Chief physician of Medical oncology
Fudan University
Eligibility Criteria
Inclusion Criteria
- •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.
- •4 weeks or more since the last systematic treatment before enrollment;
- •ECOG physical condition 0-1 score;
- •Expected survival ≥3 months;
- •Must have at least one measurable lesion (RECIST version 1.1);
- •The functions of vital organs meet the following requirements (the use of any blood components and cell growth factors within 14 days prior to enrollment is not allowed) :
- •Absolute neutrophil count ≥1.5×109/L;
Exclusion Criteria
- •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;
- •Severe cardiovascular disease, including unstable angina pectoris or myocardial infarction, in the 6 months prior to enrollment;
- •Subjects who are allergic to the investigational drug or any of its adjuncts;
- •Participated in other domestic unapproved or unmarketed drug clinical trials and accepted the corresponding experimental drug treatment within 4 weeks before enrollment;
- •International Standardized Ratio (INR) \>1.5 or partially activated prothrombin time (APTT) \>1.5×ULN;
- •The investigator identified clinically significant electrolyte abnormalities;
- •Hypertension that could not be controlled by drugs before enrollment was defined as: systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg;
Outcomes
Primary Outcomes
ORR（objective response rate）
Time Frame: 5 months
Defined as percentage of participants achieving assessed complete response (CR) and partial response (PR) by the investigator according to the RECIST 1.1.
Secondary Outcomes
- PFS Progression-free survival(5 months)
- OS Overall survival(two years)
- DCR Disease control rate(two years)
- Safety(two years)