Anti-PD-1 Antibody in the Treatment of Patients With Malignant Melanoma of the Female Genital Tract

Exclusion Criteria

• •Patients with central nervous system disease or brain metastases; patients who have received systemic, radical treatment of brain or meningeal metastases (radiotherapy or surgery), such as imaging confirmed stable has been maintained for at least 1 month, and have stopped systemic hormone therapy (dose \> 10 mg/day prednisone or other effective hormones) for more than 2 weeks, no clinical symptoms can be included;
• •Other malignant tumors occurred in the past 5 years, except for cured cervical carcinoma in situ, non-melanoma skin cancer;
• •The researchers believe that will affect the ability of subjects to receive the study program treatment, and uncontrolled serious medical diseases, such as severe medical diseases, including severe heart disease, cerebrovascular disease, uncontrolled diabetes, uncontrolled hypertension (after treatment: systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg, Based on the average of BP readings obtained by ≥ 2 measurements), uncontrolled infection, active peptic ulcer, etc.;
• •Known interstitial lung disease or history or evidence of non-infectious pneumonia treated with corticosteroids; or patients who may interfere with the detection or treatment of suspected drug-related pulmonary toxicity;
• •Known allergy, high sensitivity or intolerance to study-related drugs or their excipients;
• •received other experimental drugs or participated in other clinical studies for the purpose of anti-cancer therapy within 30 days before the first dose;
• •Serious infection occurred before the start of study treatment, including but not limited to infectious complications requiring hospitalization, bacteremia or severe pneumonia;
• •Previously received anti-programmed cell death-1 (PD-1), anti-PD-L1, anti-CD137 or anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) antibody therapy;
• •7 days before receiving the study drug, diagnosed with immunodeficiency disease or receiving systemic steroid therapy or other immunosuppressive therapy;
• •patients with active pulmonary tuberculosis;
• •syphilis patients;
• •human immunodeficiency virus (HIV) positive;
• •hepatitis B surface antigen positive (HBsAg), and peripheral blood hepatitis B virus deoxyribonucleic acid (HBV-DNA) test ≥ 1 × 103 IU/mL subjects; if HBsAg positive, and peripheral blood HBV-DNA \< 1 × 103 IU/mL, if the investigator believes that the subject is in a stable period of chronic hepatitis B and will not increase the risk of subjects, Subjects are eligible;
• •Hepatitis C virus (HCV) antibody positive and HCV RNA test positive.
• •less than 4 years before the study medication or may be vaccinated during the study;
• •the researchers determine that patients who are not suitable for this study, such as alcoholism, drug abuse, other serious diseases (including mental illness) need combined treatment, there are serious laboratory abnormalities, accompanied by family or social factors, will affect the safety of patients or data and sample collection;