Study of Cadonilimab (AK104) Plus Lenvatinib in Patients With Advanced Endometrial Cancer

Exclusion Criteria

• •1. Histologic types of carcinoma other than endometrial carcinoma.
• •2. Known or suspected allergy to any of study drugs.
• •3. Prior exposure to any anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4, or small molecule anti-angiogenic agent.
• •4. Has an active autoimmune disease requiring systemic therapy (i.e., with use of disease modifying drugs, corticosteroids or immunosuppressive drugs) in past 2 years. Subjects with vitiligo or resolved childhood asthma/atopy would be an exception to this rule. Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is permitted.
• •5. Concurrent medical condition requiring the use of systemic steroid therapy (dose \>10 mg/day of prednisone or equivalent) or any other form of immunosuppressive therapy within 2 weeks prior to the first dose of study intervention.
• •6. Has received anti-tumor treatment within 28 days, including but not limited to chemotherapy and radiotherapy or targeted therapy.
• •7. Any unresolved toxicities from prior therapy, greater than Common Terminology Criteria for Adverse Events (CTCAE) grade 1 at the time of starting study treatment, with exception of alopecia and anemia.
• •8. Has an active infection requiring systemic therapy.
• •9. Clinically significant cardiovascular diseases, including but not limited to congestive heart failure (New York heart association \[NYHA\] class \>2), unstable or severe angina, severe acute myocardial infarction within 6 months before enrollment, supraventricular or ventricular arrhythmia which need medical intervention, or QT interval male ≥ 450 ms, female ≥ 470 ms.
• •10. Hypertension that can not be well controlled through antihypertensive drugs (systolic pressure ≥140 mmHg and/or diastolic pressure ≥90 mmHg).
• •11. Received major surgery with 28 days before the first medication.
• •12. Coagulation abnormalities (INR \>2.0, PT \>16s), with bleeding tendency or are receiving thrombolytic or anticoagulant therapy.
• •13. Proteinuria ≥ (++) or 24 hours total urine protein \>1.0g.
• •14. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures.
• •15. Has known active hepatitis B disease (hepatitis B virus \[HBV\] DNA ≥1×104/ml) or hepatitis C disease (hepatitis C virus \[HCV\] RNA ≥1×103/ml).
• •16. History of another malignancy in the previous 3 years, with a disease-free interval of \<3 years. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy.
• •17. Has known active central nervous system metastases.
• •18. Has a known history of immunodeficiency including human immunodeficiency virus (HIV), or other acquired or congenital immune-deficient disease.
• •19. Has received a live vaccine within 30 days prior to the first dose of trial treatment. Note: Injection of inactivated viral vaccines against seasonal influenza are allowed.
• •20. Any other medical, psychiatric, or social condition deemed by the investigator to be likely to interfere with a subject's rights, safety, welfare, or ability to sign informed consent, cooperate, and participate in the study or would interfere with the interpretation of the results.