melanoma
Conditions
Interventions
Experimental group:QL1706 (5 mg/kg, IV, Q3W) and lenvatinib (12 mg, PO, QD) were administered in 3-week treatment cycles. Two cycles were completed preoperatively, followed by curative surgery schedul
Sponsors
Fujian Provincial Tumor Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years; 2. ECOG PS score of 0-1; 3. patients with histologically or cytologically confirmed melanoma of the extremities or mucosa, with clear stage III or IV expected to be completely resectable (M1a) on imaging etc.; and patients with local recurrence more than 12 weeks after primary treatment or adjuvant therapy after radical surgery. 4. Subjects must have at least 1 unresectable non-bone lesion that can be measured radiologically (based on Response Evaluation Criteria in Solid Tumours [RECIST] 1.1) and subjects agree to biomarker testing such as PD-L1; 5. life expectancy of at least 3 months; and 6. Other major organs (liver, kidneys, haematology, etc.) are functioning well: Haemoglobin >= 9.0 g/dL (can be maintained or exceeded by blood transfusion); Red blood cell count >= 2.0 x 10^9/L White blood cells >= 2.0 x 10^9/L Absolute neutrophil count (ANC) >= 1.5 x 10^9/L; Platelet count >= 100 x 10^9/L; Total bilirubin is within normal limits. L; Total bilirubin within normal limits; Glutamine aminotransferase, glutamine aminotransferase, and alkaline phosphatase = 50 ml/min; International Normalised Ratio (INR) of Prothrombin Time (INR) <= 1.5 and Partial Prothromboplastin Time (APTT) <= 1.5 times ULN for those who have not been on anticoagulation therapy. 1.5 times ULN Patients receiving full or parenteral anticoagulant therapy may enter the clinical trial as long as the dose of anticoagulant has been stable for at least 2 weeks prior to entry into the clinical study and the results of the coagulation assay tests are within the limits imposed by local therapy; 7. Not taking immunosuppressive drugs within 6 months prior to study entry; 8. Good lung function to tolerate surgical treatment; 9. women of childbearing potential (WOCBP) must be using an appropriate method of contraception, women of childbearing potential must have had a negative serum or urine pregnancy test (minimum sensitivity of 25 IU/L or equivalent units of HCG) within 7 days prior to the start of the study and must have agreed to the continued use of an adopted method of contraception for a period of 120 days following the last dose of study drug; 10. men who have sex with WOCBP during the treatment period up to 120 days after the last dose of study drug must use any contraceptive method with a failure rate of less than 1 % per year; 11. the patient understands and complies with the protocol requirements and has signed an informed consent form.
Exclusion criteria
Exclusion criteria: 1. Received any systemic anticancer therapy for melanoma within the past 12 weeks, including radical resection, local radiotherapy, cytotoxic drug therapy, targeted drug therapy, or experimental treatment; 2. Presence of systemic metastases; 3. History of other malignancies, except for: adequately treated localized basal cell carcinoma; cervical carcinoma in situ; adequately treated, papillary, non-invasive bladder cancer; other adequately treated Stage I-II cancers currently in complete remission; or any other cancer in complete remission for at least 2 years; 4. Currently participating in an interventional clinical trial, or having received another investigational drug or device within 4 weeks prior to the first dose; 5. Major surgery (craniotomy, thoracotomy, or laparotomy) within 8 weeks prior to first dose, or presence of unhealed wounds, ulcers, or fractures; 6. Clinically uncontrolled pleural effusion/ascites (patients requiring no drainage or with no significant increase in effusion volume within 3 days after drainage cessation may be eligible); 7. Symptomatic central nervous system metastases; 8. Concurrent unstable systemic diseases, such as uncontrolled hypertension or severe arrhythmias; 9. Active autoimmune disease requiring systemic therapy (e.g., disease-modifying antirheumatic drugs, glucocorticoids, or immunosuppressants) within 2 years prior to the first study dose; 10. Receiving systemic glucocorticoid therapy (excluding intranasal, inhaled, or other topical glucocorticoids) or any other form of immunosuppressive therapy within 4 weeks prior to the first study dose; 11. Receiving a live attenuated vaccine within 4 weeks prior to the first study dose; 12. Known allogeneic organ transplantation (excluding corneal transplantation) or allogeneic hematopoietic stem cell transplantation; 13. Allergy to the study drug; 14. History or current presence of interstitial lung disease; 15. Known history of human immunodeficiency virus (HIV) infection; 16. Untreated active hepatitis B (defined as HBsAg positive with detectable HBV-DNA copy number > ULN) and active HCV infection (HCV antibody positive with HCV-RNA level > ULN); 17. Pregnant or lactating women; 18. Individuals with neurological or psychiatric disorders rendering them unable to cooperate; 19. History or evidence of disease, treatment, or abnormal laboratory values that may interfere with study results or prevent full participation in the study, or other conditions deemed ineligible by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Major Pathological response; | — |
Secondary
| Measure | Time frame |
|---|---|
| Partial Pathological response;Objective Response Rate;Radical surgical resection rate;Event free survival;Recurrence Free Survival;Treatment Emergent Adverse Events; | — |
Countries
China
Contacts
Public ContactYu Chen
Fujian Provincial Tumor Hospital
Outcome results
None listed