NCT05795244

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

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Yonsei University · Academic / Other
• Sex: Female
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Endometrial Neoplasms
• Endometrial Cancer

Interventions

Type	Name	Description
DRUG	Nivolumab	\- Nivolumab 480 mg/every 4 weeks/IV infusion/6 cycles

Timeline

• Start date: 2023-10-31
• Primary completion: 2029-12-01
• Completion: 2029-12-01
• First posted: 2023-04-03
• Last updated: 2025-05-13

Locations

1 site across 1 country: South Korea