Melanoma
Conditions
Sponsors
Shanghai Sixth People's Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. were fully informed about the study and voluntarily signed an informed consent form; 2. patients >=14 years old, age =1.5m^2; 3. Patients with histologically or cytologically confirmed unresectable stage III-IV melanoma; 4. patients need to have at least one measurable lesion (RECIST 1.1) 5. ECOG PS score: 0-1 (PS 0-2 for patients with amputation); 6. expected survival >= 3 months; 7. patients have experienced at least one prior line of systemic treatment failure, defined as: disease progression during treatment or within 6 months of final treatment; or intolerable toxicities during treatment. (Note: Pre-existing neoadjuvant or adjuvant therapy is permitted, and neoadjuvant or adjuvant therapy is considered to be a first-line standard treatment failure for progressive disease if disease progression/relapse occurs during or within 6 months of the end of neoadjuvant or adjuvant therapy). 8. Normal major organ function, i.e., the following criteria are met: (1) Routine blood tests (without blood transfusion within 14 days and without correcting the state with haematopoietic stimulating factor drugs): haemoglobin (Hb) >= 90g/L; absolute neutrophil count (ANC) >= 1.5 x 10^9/L; platelet (PLT) >= 100 x 10^9/L; white blood cell count (WBC) >= 3.0 x 10^9/L; (2) Biochemical tests: alanine aminotransferase (ALT) and glutamine aminotransferase (AST) = 50ml /min; (3) Coagulation: activated partial thromboplastin time (APTT), international normalised ratio (INR), prothrombin time (PT) = 50%; 9. Women of childbearing potential must agree to use contraception (such as an intrauterine device [IUD], oral contraceptives, or condoms) during the study period and for six months thereafter; they must have a negative serum pregnancy test within seven days prior to study enrolment and must not be breastfeeding; male participants must agree to use contraception during the study period and for six months following its conclusion; 10. Prior to initiating any study-related procedures, the parents/guardians of young patients must be capable of understanding, consenting to, and signing the study informed consent form (ICF). Subjects may provide consent with parental/guardian assent where applicable.
Exclusion criteria
Exclusion criteria: 1. prior treatment with an immune checkpoint inhibitor (including, but not limited to, pembrolizumab, navulizumab monotherapy) or lenvatinib 2. anticancer therapy within 28 days (or 5 times the half-life, whichever is shorter) prior to the first dose of study drug therapy, or any study drug therapy within 30 days; 3. major surgery, open biopsy, or major trauma within 4 weeks prior to the start of enrolment; 4. have used immunosuppressive medications, excluding transnasal and inhaled corticosteroids or physiological doses of systemic steroids (i.e., prednisolone at a daily dose of no more than 10 mg or equivalent physiological doses of other corticosteroids) within 14 days prior to initiation of treatment 5. any active autoimmune disease or history of autoimmune disease (including, but not limited to: autoimmune hepatitis, interstitial pneumonitis, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, hypothyroidism; subjects with vitiligo or asthma that may have completely resolved in childhood and do not currently require medical intervention, or history of allogeneic organ transplantation or allogeneic (history of haematopoietic stem cell transplantation); 6. International Normalised Ratio (INR) >1.5 or Partially Activated Prothrombin Time (APTT) >1.5 x ULN; 7. Patients with current medically uncontrolled hypertension, defined as systolic blood pressure >= 140 mmHg and/or diastolic blood pressure >= 90 mmHg; 8. participants with proteinuria greater than 1+ on urinalysis will undergo 24 hour urine collection for quantitative assessment of proteinuria, and screeners with urinary protein >= 1 g/24 hours will not be eligible to participate in the study. 9. patients with any current disease or condition that interferes with drug absorption, or patients who are unable to take lenvatinib orally; 10. patients with current gastrointestinal disease such as active gastric and duodenal ulcers, ulcerative colitis, or active bleeding from unresected tumours, or other conditions that may cause gastrointestinal bleeding or perforation as determined by the investigator; 11. patients with evidence or history of significant bleeding tendency within 3 months prior to enrolment (bleeding >30 mL within 3 months, vomiting blood, black stool, blood in stool), haemoptysis (>5 mL of fresh blood within 4 weeks) or a thromboembolic event (including stroke event and/or transient ischaemic attack) within 12 months; 12. clinically significant cardiovascular disease including, but not limited to, acute myocardial infarction, severe/unstable angina, or coronary artery bypass grafting within 6 months prior to enrolment; congestive heart failure New York Heart Association (NYHA) classification >2; ventricular arrhythmia requiring pharmacological treatment; LVEF (left ventricular ejection fraction) = CTCAE v5.0 grade 2 infection) 15. known human immunodeficiency virus (HIV) infection; known history of clinically significant liver disease, including viral hepatitis [known hepatitis B virus (HBV) carriers must be excluded from active HBV infection, i.e., HBV DNA positive (greater than the lower limit of normal detection; >1 x 10^4 copies/mL or >2000 IU/ml); known hepatitis C virus infection ( HCV) and HCV RNA positive (>1×10^3
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| DCR;Time to relief;Duration of relief;Objective Response Rate;Overall survival;Incidence of adverse events (AEs) and serious adverse events (SAEs);Severity of adverse events (AEs) and serious adverse events (SAEs);Abnormal laboratory values;Dose interruption rate caused by AE;Dose reduction rate caused by AE;Dose discontinuation rate due to AE;Mortality caused by AE; | — |
Countries
China
Contacts
Public ContactHu Haiyan
Shanghai Sixth People's Hospital
Outcome results
None listed