Study of the Combination of CM082 With JS001 in Patients With Advanced Mucosal Melanoma.

Exclusion Criteria

• •Patients who have previously received anti-PD-1, anti-PD-L1, anti-PD-L2 therapy, or VEGFR TKI therapy.
• •Patients currently receiving anti-tumor treatment
• •Patients who participated in or were participating in other drug/therapy clinical trials within 4 weeks prior to the first dose of the study drug.
• •Patients who received large surgery within 4 weeks before the first dose of the test drug or has not recovered from the side effects of this operation, received live vaccination or immunotherapy within 4 weeks before the first dose of the test drug, and radiotherapy was performed within 2 weeks.
• •In the past 5 years, there have been history of malignant tumors other than mucosal melanoma, except for cured skin basal cell carcinoma, cutaneous squamous cell carcinoma, early prostate cancer, and cervical carcinoma in situ.
• •Hematopoietic stimulating factors were received within 1 week prior to the first dose of the study drug, such as granulocyte colony-stimulating factor (G-CSF) and erythropoietin.
• •HIV antibody or Treponema pallidum antibody test results are positive.
• •If HBsAg or HBcAb is positive, HBV DNA should be tested.Patients should be excluded if the measurement is above the upper limit of the normal range.If HCV antibody is positive, HCV DNA should be tested.Patients should be excluded if the measurement is above the upper limit of the normal range.
• •Those known to be allergic to recombinant humanized PD-1 monoclonal antibody drugs and their components; those known to be allergic to CM-082 and any of its excipients.
• •A large amount of pleural or ascites with clinical symptoms and requiring symptomatic treatment.
• •Active lung disease (eg, interstitial pneumonia, pneumonia, obstructive pulmonary disease, asthma) or a history of active tuberculosis.
• •Have any clinical problems out of control, including but not limited to:
• •* Persistent or active (severe) infection;
• •* Hypertension that is not effectively controlled (blood pressure lasts greater than 150/90mmHg);
• •* Diabetes that is not effectively controlled;
• •* Heart disease, defined as grade III/IV congestive heart failure or heart block defined by the New York Heart Association
• •* Having a history of or suspected of having an autoimmune disease;Having a history of any kind of disease requiring treatment with a steroid/immunosuppressive, such as: pituitary inflammation, colitis, hepatitis, nephritis, hyperthyroidism, Hypothyroidism, etc.;
• •* The following situation occurred within 6 months before the first dose:
• •* Deep vein thrombosis or pulmonary embolism;
• •* myocardial infarction;
• •* severe or unstable arrhythmia or angina;
• •* percutaneous coronary intervention, acute coronary syndrome, coronary artery bypass grafting;
• •* Cerebrovascular accident, transient ischemic attack, and cerebral embolism.
• •The patient has any condition that affects the swallowing of the drug, as well as any conditions that affect the course of treatment (absorption, distribution, metabolism, or excretion) of the test drug, including any type of gastrointestinal resection or surgical history.
• •Have received a stem cell transplant or an organ transplant.
• •Has a history of psychotropic substance abuse which is unable to quit or has a history of mental disorders.
• •Patients who need to use during the study or have used or the following drugs within 14 days prior to the first dose: CYP3A4 strong inhibitor or strong inducer; warfarin or any other coumarin derivative anticoagulant.
• •The investigator judges other severe, acute or chronic medical illness or laboratory abnormalities that may increase the risk associated with the study or may interfere with the interpretation of the findings.
• •The investigator judged that the patient's compliance was poor or that there were other conditions that were not suitable for the trial.