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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age20+
SponsorYonsei University

About this trial

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.

Eligibility criteria

Qualifiers

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)

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Nivolumab

Treatment groups

30 Participants
are divided into 1 treatment group

Sponsors and collaborators