phase 2 clinical trial to confirm the pathological complete response rate of PD-1 blocker use in patients with Mismatch Repair Deficiency(MMRd) endometrial cancer that can be completely resected surgically.
Explicit and voluntary consent to participation in the trial obtained by signing and dating a consent form that clearly and completely describes the purpose, potential risks, and other important issues related to the trial.
Sex: female
Age (at the time of informed consent): 20 years and older
Subjects with histologically-or cytologically-confirmed endometrial cancer or carcinosarcoma(Mixed Mullerian Tumor)
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)
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.
Patients with current or past history of severe hypersensitivity to any other antibody products
Patients with concurrent autoimmune disease or history of chronic or recurrent autoimmune disease
Single group
Nivolumab
Drug\- Nivolumab 480 mg/every 4 weeks/IV infusion/6 cycles
pathologic complete response
Tumor response evaluation will be conducted based on imaging tests and pathological response of the endometrium. The evaluation of endometrium should be performed using Dilatation \& Currettage or hysteroscopic biopsy every 3 cycles.
Objective response rate (ORR)
Objective response rate is defined according to RECIST v1.1 or iRECIST.
Progression free survival (PFS)
PFS is defined as the time from treatment start until the first documented sign of disease progression or death from any cause.
Overall survival (OS)
OS is defined as the time from first treatment until death from any cause.
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