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

NCT06553781 | Not Yet Recruiting

• 1 other identifier: 2407299-2
• Study Type: interventional
• Target: 28
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Malignant Melanoma

Outcome Measures

Primary Outcomes (1)

• 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.

  5 months

Secondary Outcomes (4)

• OS Overall survival

  two years

• DCR Disease control rate

  two years

• PFS Progression-free survival

  5 months

• Safety

  two years

Interventions

Temozolomide、Fruquintinib、Cadonilimab DRUG

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.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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;
• Platelet ≥100×109/L;
• Hemoglobin ≥90g/L;
• Total bilirubin \< 1.5 ULN;
• ALT and/or AST \< 1.5 times ULN;
• Serum creatinine \< 1.5 ULN;

You may not qualify if:

• 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;
• Poorly controlled diabetes mellitus was present before enrollment (fasting glucose concentration ≥CTCAE level 2 after formal treatment);
• Had any disease or condition affecting drug absorption before enrollment, or the patient could not take the drug orally;
• Gastrointestinal diseases such as active ulcer of stomach and duodenum, ulcerative colitis, or active bleeding of unresectable tumors, or other conditions that may cause gastrointestinal bleeding or perforation as determined by researchers before enrollment;
• Patients with evidence or history of significant bleeding tendency within 3 months prior to enrollment (bleeding within 3 months \> 30 mL, hematemesis, stool, stool blood), hemoptysis (within 4 weeks \>; 5 mL of fresh blood) or had a thromboembolic event (including stroke events and/or transient ischemic attacks) within 12 months;
• Clinically significant cardiovascular disease, including but not limited to acute myocardial infarction, severe/unstable angina pectoris, or coronary artery bypass grafting within 6 months prior to enrollment; New York Heart Association (NYHA) Grades for Congestive Heart Failure \>Level 2; Ventricular arrhythmias requiring medical treatment; LVEF (Left ventricular Ejection Fraction) \< 50%;

Sponsors & Collaborators

• Fudan University: lead

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Xiaowei zhang

CONTACT

15921521116; dongfangzhizizhxw@aliyun.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician of Medical oncology

Study Record Dates

• First Submitted: August 12, 2024
• First Posted: August 14, 2024
• Study Start: September 1, 2024
• Primary Completion: September 1, 2025
• Study Completion (Estimated): September 1, 2027
• Last Updated: August 14, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share