CI

At a glance

ClinicalIndex Comparison Record
Phase 2Recruiting· 30 target
Drug / intervention
Nivolumabdrug
Likely dose
Nivolumab 480 mgfrom record
Key inclusion· 8
  • ✓Histologically or cytologically confirmed endometrial cancer or carcinosarcoma
  • ✓Clinical stage I-IIIC2 and surgically completely resectable
  • ✓No evidence of distant metastases
  • ✓MMRd or MSI-H subtype (MMR proteins MLH1, PMS2, MSH2, MSH6 deficiency/loss or MSI-H by PCR)
Key exclusion· 27
  • ✕Multiple primary cancers (except resected basal/squamous cell carcinoma, carcinoma in situ, intramucosal carcinoma, superficial bladder cancer, or cancer without recurrence ≥5 years)
  • ✕Residual adverse effects of prior therapy or surgery affecting safety evaluation
  • ✕Severe hypersensitivity to antibody products or Nivolumab
  • ✕Concurrent or history of chronic/recurrent autoimmune disease

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05795244
NCT05795244Phase 2RecruitingOn TrackUpdated 13mo ago
CompareCT.gov

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

Yonsei University·interventional·Posted Apr 3, 2023·Updated May 13, 2025

In Brief

A Phase 2 clinical trial evaluating Nivolumab for Endometrial Neoplasms and Endometrial Cancer. Currently recruiting, targeting 30 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEndometrial Neoplasms, Endometrial Cancer
CountriesSouth Korea
Collaborators--

Timeline

Phase 2Recruiting
2024202520262027202820292030
First PostedApr 3, 2023
Enrollment StartOct 31, 2023
Primary CompletionDec 1, 2029
TodayJul 2, 2026
Enrollment to primary: 6.1 yearsPosted 3.2 years agoPrimary completion in 3.4 years

Interventions

Nivolumabdrug

\- Nivolumab 480 mg/every 4 weeks/IV infusion/6 cycles