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 (Jun 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
Treatments studied
Immunotherapy
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)
Demographics
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.
Frequently asked questions
Is NCT05795244 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior antineoplastic drugs, immunotherapy disqualifies patients from enrollment.
Does this trial require MLH1?
Yes, MLH1 loss of expression is a required biomarker for enrollment.
Does this trial require PMS2?
Yes, PMS2 loss of expression is a required biomarker for enrollment.
Does this trial require MSH2?
Yes, MSH2 loss of expression is a required biomarker for enrollment.
What disease stage is eligible?
Stage I or II or IIIA or IIIB or IIIC1 or IIIC2 is required.
Is this trial open to male patients?
No. This trial enrolls female patients only.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages