Study of Induction PD-1 Blockade (Nivolumab) in Patients With Surgically Complete Resectable Mismatch Repair Deficient Endometrial Cancer (NIVEC)

Exclusion Criteria

• •1. Patients with multiple primary cancers (with the exception of completely resected basal cell carcinoma, stage I squamous cell carcinoma, carcinoma in situ, intramucosal carcinoma, or superficial bladder cancer, or any other cancer that has not recurred for at least 5 years)
• •2. Patients with residual adverse effects of prior therapy or effects of surgery that would affect the safety evaluation of the investigational product in the opinion of the investigator or sub-investigator.
• •3. Patients with current or past history of severe hypersensitivity to any other antibody products
• •4. Patients with concurrent autoimmune disease or history of chronic or recurrent autoimmune disease
• •5. Patients with a current or past history of interstitial lung disease or pulmonary fibrosis diagnosed based on imaging or clinical findings. Patients with radiation pneumonitis may be randomized if the radiation pneumonitis has been confirmed as stable (beyond acute phase) without any concerns about recurrence.
• •6. Patients with concurrent diverticulitis or symptomatic gastrointestinal ulcerative disease
• •7. Patients with pericardial fluid, pleural effusion, or ascites requiring treatment
• •8. Patients with uncontrollable, tumor-related pain
• •9. Patients who have experienced a transient ischemic attack, cerebrovascular accident, thrombosis, or thromboembolism (pulmonary arterial embolism or deep vein thrombosis) within 180 days before randomization
• •10. Patients with a history of uncontrollable or significant cardiovascular disease meeting any of the following criteria:
• •* Myocardial infarction within 180 days before randomization
• •* Uncontrollable angina pectoris within 180 days before randomization
• •* New York Heart Association (NYHA) Class III or IV congestive heart failure
• •* Uncontrollable hypertension despite appropriate treatment (e.g., systolic blood pressure ≥150mmHg or diastolic blood pressure ≥ 90 mmHg lasting 24 hours or more)
• •* Arrhythmia requiring treatment
• •11. Patients receiving or requiring anticoagulant therapy for a disease. Patients receiving antiplatelet therapy including low-dose aspirin may be enrolled.
• •12. Patients with uncontrollable diabetes mellitus
• •13. Patients with systemic infections requiring treatment
• •14. Patients who have received systemic corticosteroids (except for temporary use, e.g., for examination or prophylaxis of allergic reactions) or immunosuppressants within 28 days before randomization
• •15. Patients who have received antineoplastic drugs (e.g., chemotherapy agents, molecular-targeted therapy agents, or immunotherapy agents) within 28 days before randomization
• •16. Patients who have undergone surgical adhesion of the pleura or pericardium within 28 days before randomization
• •17. Patients who have undergone surgery under general anesthesia within 28 days before randomization
• •18. Patients who have undergone surgery involving local or topical anesthesia within 14 days before randomization
• •19. Patients who have received radiotherapy within 28 days before randomization, or radiotherapy to bone metastases within 14 days before randomization
• •20. Patients who have received any radiopharmaceuticals (except for examination or diagnostic use of radiopharmaceuticals) within 56 days before randomization
• •21. Patients with a positive test result for any of the following: HIV-1 antibody, HIV-2 antibody, HTLV-1 antibody, HBs antigen, or HCV antibody
• •22. Patients with a negative HBs antigen test but a positive test result for either HBs antibody or HBc antibody with a detectable level of HBV-DNA
• •23. Women who are pregnant or breastfeeding, or possibly pregnant
• •24. Patients who have received any other unapproved drug (e.g., investigational use of drugs, unapproved combined formulations, or unapproved dosage forms) within 28 days before randomization
• •25. Patients who have previously received Nivolumab, anti-PD-1 antibody, anti-PD-L1 antibody, anti-PD L2 antibody, anti-CD137 antibody, anti-CTLA-4 antibody or other therapeutic antibodies or pharmacotherapies for regulation of T-cells
• •26. Patients judged to be incapable of providing consent for reasons such as concurrent dementia
• •27. Other patients judged by the investigator or sub-investigator to be inappropriate as subjects of this study
• •28. Patient with current or past history of hypersensitivity to Nivolumab.
• •29. WOCBP who has a positive urine pregnancy test within 72 hours prior to allocation. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.