Evidence map›Paper›PMID 39530558›Full record

ArticleJournal of gynecologic oncology2025

A phase II study of induction PD-1 blockade (nivolumab) in patients with surgically completely resectable mismatch repair deficient endometrial cancer (NIVEC).

Yong Jae Lee, Yoo-Young Lee, Jeong-Yeol Park, Hyun-Woong Cho, Myong Cheol Lim, Mi Kyung Kim, Jong-Min Lee, Jung-Yun Lee

Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in Journal of gynecologic oncology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05795244 (A Phase II Study of Induction PD-1 Blockade), which is not on this map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05795244 phase2recruitingnot on this map

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

TypeinterventionalSponsorYonsei UniversityRan2023 to 2029Enrolled30ConditionsEndometrial Neoplasms, Endometrial CancerArmsNivolumab
3 · Its place in the literature

Who cites it

7 citing papers in PubMed.

  1. Review
  2. Updates and evolving care paradigms for pre-menopausal patients with endometrial cancer.International journal of gynecological cancer : official journal of the International Gynecological Cancer Society · 2026
    Review
  3. Review
  4. Review
  5. Review
  6. Review
  7. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

Yong Jae LeeDepartment of Obstetrics and Gynecology, Institute of Women's Life Medical Science, Yonsei University College of Medicine, Seoul, Korea.ORCID 0000-0003-0297-3116
Yoo-Young LeeGynecologic Cancer Center, Department of Obstetrics and Gynecology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.ORCID 0000-0001-5902-9877
Jeong-Yeol ParkDepartment of Obstetrics and Gynecology, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea.ORCID 0000-0003-2475-7123
Hyun-Woong ChoDepartment of Obstetrics and Gynecology, Korea University College of Medicine, Seoul, Korea.ORCID 0000-0002-7114-6301
Myong Cheol LimCenter for Gynecologic Cancer, National Cancer Center, Goyang, Korea.ORCID 0000-0001-8964-7158
Mi Kyung KimDepartment of Obstetrics and Gynecology, Ewha Womans University College of Medicine, Seoul, Korea.ORCID 0000-0001-6829-332X
Jong-Min LeeDepartment of Obstetrics and Gynecology, Kyung Hee University School of Medicine, Kyung Hee University Hospital at Gangdong, Seoul, Korea.ORCID 0000-0002-0562-5443
Jung-Yun LeeDepartment of Obstetrics and Gynecology, Institute of Women's Life Medical Science, Yonsei University College of Medicine, Seoul, Korea. jungyunlee@yuhs.ac.ORCID 0000-0001-7948-1350

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundMismatch repair deficient (MMRd) tumors are known to be highly immunogenic and of great interest for immune checkpoint inhibitor. However, there is no data about the complete response (CR) rate of programmed cell death protein 1 (PD-1) blockade and surgery in subjects with MMRd surgically resectable endometrial cancer. In this regard, we suggest a window of opportunity study of induction PD-1 blockade (nivolumab) in patients with surgically resectable MMRd endometrial cancer.

methodsThis is a multicenter, single-arm phase II trial. A total of 30 surgically resectable MMRd endometrial cancer patients will be enrolled. Inclusion criteria include clinical stage I-IIIC2, tumor specimen that demonstrates MMRd by immunohistochemistry or microsatellite instability. Exclusion criteria include multiple primary cancers, residual adverse effects of prior therapy or effects of surgery. Patients are treated with nivolumab 480 mg intravenously every 4 weeks up to 6 months followed by standard surgery and/or adjuvant treatment. The primary endpoint of the study is clinical CR rate or pathological CR rate after treatment of nivolumab. Secondary endpoints include objective response rate, progression-free survival, overall survival, and adverse events. Correlative studies include genomic characterization of tumors, assessment of immune infiltration of tumor microenvironment, and serial circulating cell-free DNA and immune biomarkers.

trial registrationClinicalTrials.gov Identifier: NCT05795244.

Indexed as

Antineoplastic Agents, ImmunologicalEndometrial NeoplasmsImmune Checkpoint InhibitorsNivolumabProgrammed Cell Death 1 ReceptorAgedBrain NeoplasmsClinical Trials, Phase II as TopicColorectal NeoplasmsDNA Mismatch RepairFemaleHumansMicrosatellite InstabilityMiddle AgedNeoplastic Syndromes, HereditaryAntineoplastic Agents, ImmunologicalImmune Checkpoint InhibitorsNivolumabPDCD1 protein, humanProgrammed Cell Death 1 ReceptorEndometrial CancerMismatch Repair DeficiencyPD-L1 Inhibitor

Identifiers

PMID39530558
PMCPMC12099038

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.