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Endometrial NeoplasmsPhase 2NCT05795244

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

A Phase 2 study testing Nivolumab in people with Endometrial Neoplasms and Endometrial Cancer, run by Yonsei University at 1 site in South Korea.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 20 years and older, women only
Conditions the study is for
Endometrial Neoplasms, Endometrial Cancer
What is being tested?
Nivolumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteSouth Korea
Study dates
31 Oct 2023to Dec 2029
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Explicit and voluntary consent to participation in the trial obtained by signing and dating a consent form that clearly and completely describes the purpose, potential risks, and other important issues related to the trial.
  • Sex: female
  • Age (at the time of informed consent): 20 years and older
  • Subjects with histologically-or cytologically-confirmed endometrial cancer or carcinosarcoma(Mixed Mullerian Tumor)
  • Clinical stage: Stage I - IIIC2 and surgically completely resectable
  • No evidence of distant metastases
Show all 20Show fewer
  • MMRd or MSI-H subtype (defined by either deficient/loss expression of mismatch repair (MMR) proteins MLH1, PMS2, MSH2, MSH6 or microsatellite instability-high (MSI-H) by polymerase chain reaction assay for 5 microsatellite markers)
  • ECOG Performance Status Score 0 or 1
  • Patients with a life expectancy of at least 3 months
  • Patients whose latest laboratory data meet the below criteria within 7 days before first dose. If the date of the laboratory tests at the time of enrollment is not within 7 days before the first dose of the investigational product, testing must be repeated within 7 days before the first dose of the investigational product, and these latest laboratory tests must meet the following criteria. Of note, laboratory data will not be valid if the patient has received a granulocyte colony-stimulating factor (G CSF) or blood transfusion within 14 days before testing.
  • White blood cells ≥2,000/mm3 and neutrophils ≥1,500/mm3
  • Platelets ≥100,000/mm3
  • Hemoglobin ≥9.0 g/dL
  • 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
  • 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
  • Women of childbearing potential (including women with chemical menopause or no menstruation for other medical reasons)#1 must agree to use contraception#2 from the time of informed consent until 5months or more after the last dose of the investigational product. Also, women must agree not to breastfeed from the time of informed consent until 5 months or more after the last dose of the investigational product.
  • Women of childbearing potential are defined as all women after the onset of menstruation who are not postmenopausal and have not been surgically sterilized (e.g., hysterectomy, bilateral tubal ligation, bilateral oophorectomy). Post-menopause is defined as amenorrhea for ≥12 consecutive months without specific reasons. Women using oral contraceptives, intrauterine devices, or mechanical contraception such as contraceptive barriers are regarded as having childbearing potential.
  • The subject must consent to use any one of the following methods of contraception: a condom for the subject's partner (male), an intrauterine device (IUD) for female subjects, or skin implantation of a rod contraceptive (Implanon).
  • Complete sexual abstinence is also acceptable: Sexual abstinence is considered highly effective only if it is defined as abstaining from sexual intercourse with the opposite sex for the entire duration of the trial treatment-related risks. The reliability of sexual abstinence in relation to the duration of the trial needs to be evaluated, and sexual abstinence should be a preferred and routine lifestyle of the subjects.

Who cannot join

  • Patients with multiple primary cancers (with the exception of completely resected basal cell carcinoma, stage I squamous cell carcinoma, carcinoma in situ, intramucosal carcinoma, or superficial bladder cancer, or any other cancer that has not recurred for at least 5 years)
  • Patients with residual adverse effects of prior therapy or effects of surgery that would affect the safety evaluation of the investigational product in the opinion of the investigator or sub-investigator.
  • Patients with current or past history of severe hypersensitivity to any other antibody products
  • Patients with concurrent autoimmune disease or history of chronic or recurrent autoimmune disease
  • Patients with a current or past history of interstitial lung disease or pulmonary fibrosis diagnosed based on imaging or clinical findings. Patients with radiation pneumonitis may be randomized if the radiation pneumonitis has been confirmed as stable (beyond acute phase) without any concerns about recurrence.
  • Patients with concurrent diverticulitis or symptomatic gastrointestinal ulcerative disease
Show all 34Show fewer
  • Patients with pericardial fluid, pleural effusion, or ascites requiring treatment
  • Patients with uncontrollable, tumor-related pain
  • Patients who have experienced a transient ischemic attack, cerebrovascular accident, thrombosis, or thromboembolism (pulmonary arterial embolism or deep vein thrombosis) within 180 days before randomization
  • Patients with a history of uncontrollable or significant cardiovascular disease meeting any of the following criteria:
  • Myocardial infarction within 180 days before randomization
  • Uncontrollable angina pectoris within 180 days before randomization
  • New York Heart Association (NYHA) Class III or IV congestive heart failure
  • Uncontrollable hypertension despite appropriate treatment (e.g., systolic blood pressure ≥150mmHg or diastolic blood pressure ≥ 90 mmHg lasting 24 hours or more)
  • Arrhythmia requiring treatment
  • Patients receiving or requiring anticoagulant therapy for a disease. Patients receiving antiplatelet therapy including low-dose aspirin may be enrolled.
  • Patients with uncontrollable diabetes mellitus
  • Patients with systemic infections requiring treatment
  • Patients who have received systemic corticosteroids (except for temporary use, e.g., for examination or prophylaxis of allergic reactions) or immunosuppressants within 28 days before randomization
  • Patients who have received antineoplastic drugs (e.g., chemotherapy agents, molecular-targeted therapy agents, or immunotherapy agents) within 28 days before randomization
  • Patients who have undergone surgical adhesion of the pleura or pericardium within 28 days before randomization
  • Patients who have undergone surgery under general anesthesia within 28 days before randomization
  • Patients who have undergone surgery involving local or topical anesthesia within 14 days before randomization
  • Patients who have received radiotherapy within 28 days before randomization, or radiotherapy to bone metastases within 14 days before randomization
  • Patients who have received any radiopharmaceuticals (except for examination or diagnostic use of radiopharmaceuticals) within 56 days before randomization
  • Patients with a positive test result for any of the following: HIV-1 antibody, HIV-2 antibody, HTLV-1 antibody, HBs antigen, or HCV antibody
  • Patients with a negative HBs antigen test but a positive test result for either HBs antibody or HBc antibody with a detectable level of HBV-DNA
  • Women who are pregnant or breastfeeding, or possibly pregnant
  • Patients who have received any other unapproved drug (e.g., investigational use of drugs, unapproved combined formulations, or unapproved dosage forms) within 28 days before randomization
  • 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
  • Patients judged to be incapable of providing consent for reasons such as concurrent dementia
  • Other patients judged by the investigator or sub-investigator to be inappropriate as subjects of this study
  • Patient with current or past history of hypersensitivity to Nivolumab.
  • WOCBP who has a positive urine pregnancy test within 72 hours prior to allocation. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

JUNGYUN LEE contact

82)2-2228-2237

JUNGYUNLEE@yuhs.ac

South Korea1 site, 1 recruiting

  • Severance Hospital, Yonsei University Health System

    Seoul

    JUNGYUN LEE, 82)2-2228-2237, JUNGYUNLEE@yuhs.ac

    Recruiting

Other trials in South Korea

About this study

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

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.

Read the 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.

Being tested
Nivolumab
Medical subject headings
Endometrial Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NivolumabDrug

    Also called Opdivo

    • Nivolumab 480 mg/every 4 weeks/IV infusion/6 cycles
Study groups in NCT05795244
Study groupRoleWhat they receive
ExperimentalExperimentalNot described
Receives: Drug: Nivolumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. pathologic complete response

    Tumor response evaluation will be conducted based on imaging tests and pathological response of the endometrium. The evaluation of endometrium should be performed using Dilatation \& Currettage or hysteroscopic biopsy every 3 cycles.

    Measured: At 3 months

Secondary outcomes (3)

  1. Objective response rate (ORR)

    Objective response rate is defined according to RECIST v1.1 or iRECIST.

    Measured: At 3 months

  2. Progression free survival (PFS)

    PFS is defined as the time from treatment start until the first documented sign of disease progression or death from any cause.

    Measured: 1 year

  3. Overall survival (OS)

    OS is defined as the time from first treatment until death from any cause.

    Measured: Approximately up to 6 years.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Apr 2023
  2. Study start31 Oct 2023
  3. Primary completionDec 2029 (estimated)
  4. Study completionDec 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05795244
Sponsor's protocol ID
4-2023-0001
Status last verified
May 2025
First submitted
21 Mar 2023
Last updated
13 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Lee YJ, Lee YY, Park JY, Cho HW, Lim MC, Kim MK, Lee JM, Lee JY. A phase II study of induction PD-1 blockade (nivolumab) in patients with surgically completely resectable mismatch repair deficient endometrial cancer (NIVEC). J Gynecol Oncol. 2025 May;36(3):e35. doi: 10.3802/jgo.2025.36.e35. Epub 2024 Oct 23.

    PubMed 39530558

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Nivolumab in people with Endometrial Neoplasms and Endometrial Cancer, run by Yonsei University at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 13 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact JUNGYUN LEE (82)2-2228-2237, JUNGYUNLEE@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

pathologic complete response (time frame: At 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05795244, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2025.

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