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

NCT05795244 | Recruiting Phase 2

• 1 other identifier: 4-2023-0001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Endometrial Neoplasms; Endometrial Cancer

Outcome Measures

Primary Outcomes (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.

  At 3 months

Secondary Outcomes (3)

• Objective response rate (ORR)

  At 3 months

• Progression free survival (PFS)

  1 year

• Overall survival (OS)

  Approximately up to 6 years.

Study Arms (1)

Experimental

EXPERIMENTAL

Drug: Nivolumab

Interventions

Nivolumab DRUG

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

Also known as: Opdivo

Experimental

Eligibility Criteria

• Age: 20 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Severance Hospital, Yonsei University Health System

Seoul, South Korea

RECRUITING

Related Publications (1)

• 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.

  PMID: 39530558 DERIVED

MeSH Terms

Conditions

Endometrial Neoplasms

Interventions

Nivolumab

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• JUNGYUN LEE

  Severance Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

JUNGYUN LEE

CONTACT

82)2-2228-2237; JUNGYUNLEE@yuhs.ac

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D, PhD

Study Record Dates

• First Submitted: March 21, 2023
• First Posted: April 3, 2023
• Study Start: October 31, 2023
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: May 13, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)