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

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Trial Identification

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

Official Title: A Phase II Study of Induction PD-1 Blockade (Nivolumab) in Patients With Surgically Complete Resectable Mismatch Repair Deficient Endometrial Cancer (NIVEC)

Study ID: NCT05795244

Interventions

Nivolumab

Study Description

Brief Summary: 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.

Detailed Description: Multi-center, non-randomized, open-label, A Phase II study of induction PD-1 blockade (nivolumab) in patients with surgically completely resectable mismatch repair deficient endometrial cancer. A total of 30 subjects from 7 institutions in Korea will be enrolled in this trial. Patients will be administered Nivolumab 480mg intravenously every 4 weeks for a total 6 cycles. After the 6 cycles of anti-cancer therapy, surgical resection will be performed. If clinical and pathological complete response is confirmed, it is possible to observe the patient's progress without surgical treatment.

Keywords

Eligibility

Minimum Age: 20 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

Severance Hospital, Yonsei University Health System, Seoul, , Korea, Republic of

Contact Details

Name: JUNGYUN LEE

Affiliation: Severance Hospital

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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