Actively Recruiting
Study of Induction PD-1 Blockade (Nivolumab) in Patients With Surgically Complete Resectable Mismatch Repair Deficient Endometrial Cancer (NIVEC)
Led by Yonsei University · Updated on 2025-05-13
30
Participants Needed
1
Research Sites
317 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study of Induction PD-1 Blockade (Nivolumab) in Patients With Surgically Complete Resectable Mismatch Repair Deficient Endometrial Cancer (NIVEC)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide voluntary consent by signing a consent form
- Female sex
- Age 20 years or older at consent
- Histologically or cytologically confirmed endometrial cancer or carcinosarcoma
- Clinical stage I to IIIC2 and tumor completely resectable by surgery
- No distant metastases
- Mismatch repair deficient (MMRd) or microsatellite instability-high (MSI-H) subtype confirmed
- ECOG Performance Status of 0 or 1
- Life expectancy of at least 3 months
- Laboratory values within 7 days before first dose meeting specific blood counts and organ function criteria
- Women of childbearing potential agree to use effective contraception from consent until 5 months after last dose
- Women of childbearing potential agree not to breastfeed from consent until 5 months after last dose
You will not qualify if you...
- Multiple primary cancers except certain completely resected or non-recurrent cancers
- Residual adverse effects from prior therapy or surgery affecting safety
- History of severe hypersensitivity to antibody products
- Current or past autoimmune disease or recurrent autoimmune disease
- History of interstitial lung disease or pulmonary fibrosis
- Concurrent diverticulitis or symptomatic gastrointestinal ulcerative disease
- Pericardial fluid, pleural effusion, or ascites needing treatment
- Uncontrollable tumor-related pain
- Recent transient ischemic attack, stroke, thrombosis, or thromboembolism within 180 days
- Uncontrollable or significant cardiovascular disease including recent myocardial infarction, angina, heart failure, hypertension, or arrhythmia
- Receiving or requiring anticoagulant therapy (except antiplatelet therapy including low-dose aspirin)
- Uncontrollable diabetes mellitus
- Systemic infections needing treatment
- Recent systemic corticosteroids or immunosuppressants within 28 days
- Recent antineoplastic drugs within 28 days
- Recent surgery or radiotherapy within specified timeframes
- Positive tests for HIV, HTLV-1, hepatitis B or C
- Pregnancy or breastfeeding
- Recent use of unapproved drugs within 28 days
- Previous treatment with Nivolumab or certain immunotherapies
- Inability to provide informed consent
- History of hypersensitivity to Nivolumab
- Positive pregnancy test within 72 hours prior to allocation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Severance Hospital, Yonsei University Health System
Seoul, South Korea
Actively Recruiting
Research Team
J
JUNGYUN LEE
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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