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Malignant MelanomaNCT06553781

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

A study testing Temozolomide、Fruquintinib、Cadonilimab in people with Malignant Melanoma, run by Fudan University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Malignant Melanoma
What is being tested?
Temozolomide、Fruquintinib、Cadonilimab
How many people
28 participants
Where
No sites listed yet
Study dates
1 Sep 2024to 1 Sep 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;
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  • 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;
  • endogenous creatinine clearance ≥50ml/min;
  • Women of childbearing age need to take effective contraceptive measures;
  • Good compliance, cooperate with follow-up.

Who cannot join

  • 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;
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  • 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%;
  • Active or uncontrolled severe infection (≥CTCAE v5.0 grade 2 infection);
  • Known human immunodeficiency virus (HIV) infection. A known history of clinically significant liver disease, including viral hepatitis [active HBV infection, i.e., positive HBV DNA (>1×104 copies /mL or >2000 IU/ml) must be ruled out for a known hepatitis B virus (HBV) carrier; Known hepatitis C virus infection (HCV) and HCV RNA positive (>1×103 copies /mL);
  • Unmitigated toxicity higher than CTCAE v5.0 grade 1 due to any previous anticancer therapy, excluding alopecia, lymphocytopenia, and oxaliplatin grade ≤2 neurotoxicity;
  • Women who are pregnant (positive pregnancy test before medication) or breastfeeding;
  • Received blood transfusion therapy, blood products and hematopoietic factors, such as albumin and granulocyte colony-stimulating factor (G-CSF), within 14 days before enrollment;
  • Any other medical condition, clinically significant metabolic abnormality, physical abnormality or laboratory abnormality, which, in the investigator's judgment, reasonably suspects that the patient has a medical condition or condition that is not suitable for the use of the investigational drug (such as having seizures and requiring treatment), or which would affect the interpretation of the study results or place the patient at high risk;
  • Urine routine indicated urinary protein ≥2+, and 24-hour urinary protein volume >1.0g;
  • The patients considered by the investigators to be unsuitable for inclusion in this study.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Xiaowei zhang contact

15921521116

dongfangzhizizhxw@aliyun.com

About this study

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.

Read the 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.

Being tested
Temozolomide、Fruquintinib、Cadonilimab
Medical subject headings
Melanoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Temozolomide、Fruquintinib、CadonilimabDrug

    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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 5 months

Secondary outcomes (4)

  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

    Measured: two years

  2. 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,

    Measured: two years

  3. 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

    Measured: 5 months

  4. 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

    Measured: two years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Aug 2024
  2. Study start1 Sep 2024 (estimated)
  3. Primary completion1 Sep 2025 (estimated)
  4. Study completion1 Sep 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
28 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06553781
Sponsor's protocol ID
2407299-2
Status last verified
Aug 2024
First submitted
12 Aug 2024
Last updated
14 Aug 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Temozolomide、Fruquintinib、Cadonilimab in people with Malignant Melanoma, run by Fudan University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 14 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Xiaowei zhang (15921521116, dongfangzhizizhxw@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ORR（objective response rate） (time frame: 5 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06553781.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2024.

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