OncoMatch/Clinical Trials/NCT05795244
Study of Induction PD-1 Blockade (Nivolumab) in Patients With Surgically Complete Resectable Mismatch Repair Deficient Endometrial Cancer (NIVEC)
Is NCT05795244 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Nivolumab for endometrial neoplasms.
Treatment: Nivolumab — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Endometrial Cancer
Biomarker criteria
Required: MLH1 loss of expression
deficient/loss expression of mismatch repair (MMR) proteins MLH1, PMS2, MSH2, MSH6
Required: PMS2 loss of expression
deficient/loss expression of mismatch repair (MMR) proteins MLH1, PMS2, MSH2, MSH6
Required: MSH2 loss of expression
deficient/loss expression of mismatch repair (MMR) proteins MLH1, PMS2, MSH2, MSH6
Required: MSH6 loss of expression
deficient/loss expression of mismatch repair (MMR) proteins MLH1, PMS2, MSH2, MSH6
Disease stage
Required: Stage I, II, IIIA, IIIB, IIIC1, IIIC2
Clinical stage: Stage I - IIIC2 and surgically completely resectable
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: antineoplastic drugs
Patients who have received antineoplastic drugs (e.g., chemotherapy agents, molecular-targeted therapy agents, or immunotherapy agents) within 28 days before randomization
Cannot have received: immunotherapy (Nivolumab)
Patients who have previously received Nivolumab, anti-PD-1 antibody, anti-PD-L1 antibody, anti-PD L2 antibody, anti-CD137 antibody, anti-CTLA-4 antibody or other therapeutic antibodies or pharmacotherapies for regulation of T-cells
Lab requirements
Blood counts
white blood cells ≥2,000/mm3 and neutrophils ≥1,500/mm3; platelets ≥100,000/mm3; hemoglobin ≥9.0 g/dl
Kidney function
creatinine ≤1.5-fold the uln of the study site or creatinine clearance (either the measured or estimated value using the cockcroft-gault equation) >45 ml/min
Liver function
ast (got) and alt (gpt) ≤3.0-fold the upper limit of normal (uln) of the study site (or ≤5.0-fold the uln of the study site in patients with liver metastases); total bilirubin ≤1.5-fold the uln of the study site
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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