Melanoma
Conditions
Interventions
Combination therapy arm:Dabrafenib in Combination Trametinibwith
Sponsors
Shanghai Skin Disease Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Patients with stage III and IV melanoma confirmed by histology and unable to be treated surgically must have a survival time of more than 3 months. 2. The patient has not received systemic therapy, targeted drug therapy and radiotherapy. 3. According to the solid tumor efficacy evaluation version 1.1, there is at least one untreatable measurable lesion (excluding superficial lesions at the skin and mucosa) in addition to a single measurable lymph node lesion. 4. The patients had passed the written informed consent and voluntarily participated in the trial. The age of the informed consent was between 18 and 70 years old on the day of signing the informed consent. 5. Willing to provide tumor tissue and blood samples for gene detection. 6. The ECoG score must be 0 or 1. 7. The organ function assessment of the patients met the inclusion criteria, as shown in the following laboratory test values (within 1 month before the start of the study drug treatment). Absolute neutrophil count >=1.5 * 10^9 /L; Platelet >= 100 * 10^9/L; Hemoglobin >= 90g/L; Serum creatinine <= 1.5 * upper limit of normal (ULN); Serum total bilirubin <= 1.5 * ULN; Serum glutamic oxaloacetic transaminase and alanine aminotransferase <= 2.5 * ULN or <= 5 * ULN (patients with liver metastasis) Prothrombin time (PT), international normalized ratio (INR), activated partial thromboplastin time (APTT) <= 1.5 times ULN. 8. A fertile female patient had negative urine or serum pregnancy tests within 7 days prior to receiving the first dose of the study drug. 9. Female patients enrolled in the study must have contraception within 12 months after the last treatment.
Exclusion criteria
Exclusion criteria: 1. The patient has participated in or is currently receiving drug clinical research or medical device clinical research within 1 month before preparation for enrollment. 2. The patient is expected to require any other form of systemic or local anti-tumor therapy, systemic steroid therapy (> 10mg / kg prednisone or equivalent) or any other form of immunosuppressive drug treatment within 1 month before preparation for enrollment or during the study period. 3. The patient has a known history of hematological malignancies, primary brain tumors, sarcomas or other primary solid tumors, unless the patient has been cured and there is no evidence of recurrence within 5 years. But the cured skin basal cell carcinoma, skin squamous cell carcinoma and cervical carcinoma in situ were excluded. 4. The patient is known to have central nervous system metastasis and / or cancerous meningitis. 5. The patient had severe hypersensitivity to another targeted drug therapy in the past. 6. Patients with active autoimmune diseases requiring systematic treatment in the past 2 years (such as using glucocorticoids or immunosuppressive drugs), and related alternative therapy (such as thyroxine, insulin, or physiological glucocorticoid replacement therapy for renal or pituitary dysfunction); in addition to vitiligo, type I diabetes, childhood asthma / atopic constitution. Seven Other patients with serious and uncontrollable concomitant diseases that may affect protocol compliance or interfere with the interpretation of the results include active opportunistic infection or progressive (severe) infection, uncontrolled diabetes, cardiovascular disease (grade III or IV heart failure as defined by the New York Heart Association classification), cardiac block above grade II, myocardial infarction in the past 6 months, and no adverse events Stable arrhythmia or unstable angina pectoris, cerebral infarction within 3 months, or pulmonary disease (interstitial pneumonia, obstructive pulmonary disease and symptomatic bronchospasm); HIV positive, HCV positive; HBsAg or HBcAb positive patients simultaneously detected HBV DNA copy number positive (quantitative detection limit is 500iu / ml); or have a clear history of tuberculosis. 8. Patients received live vaccine within 4 weeks before the first dose of treatment. Patients who had received hematopoietic stimulating factors, such as colony-stimulating factor and erythropoietin, within 2 weeks before the start of treatment, and underwent major surgical operations (excluding diagnostic surgery) within 4 weeks before treatment. 9. Mental or substance abuse disorders known to interfere with the requirements for cooperative completion of the trial. 10. Pregnant or lactating women, or those who plan to become pregnant or have children during the study period. 11. According to the investigator, other severe, acute or chronic medical diseases or laboratory abnormalities that may increase the risk associated with participating in the study, or may interfere with the interpretation of the results of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| incidence and severity of adverse events;progression-free survival (PFS);clinical benefit rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate;duration of response;overall survival; | — |
Countries
China
Contacts
Public ContactYeqiang Liu
Shanghai Skin Disease Hospital
Outcome results
None listed