Evidence map›Paper›PMID 38653864›Full record

Trial reportNature medicine2024

Nivolumab for mismatch-repair-deficient or hypermutated gynecologic cancers: a phase 2 trial with biomarker analyses.

Claire F Friedman, Beryl L Manning-Geist, Qin Zhou, Tara Soumerai, Aliya Holland, Arnaud Da Cruz Paula, Hunter Green, Melih Arda Ozsoy, Alexia Iasonos, Travis Hollmann and 18 more

Open access · hybridAbstract readClinical Trial, Phase II
In one paragraph

Trial report in Nature medicine, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed, 1 pooled it
8.9field-weighted citation impact, top 2% of its field
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

23 citing papers in PubMed, 1 synthesis or guideline pooled it, 21 citations in OpenAlex.

  1. Morphological and molecular characterization of epithelial ovarian cancer: SEOM-SEAP consensus guidelines for biomarker integration in clinical practice.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2026
    Guideline
  2. Review
  3. Review
  4. Article
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  6. Article
  7. Review
  8. Review
  9. Review
  10. Therapeutic targeting of mismatch repair-deficient cancers.Nature reviews. Clinical oncology · 2025
    Review
  11. Article
  12. Review
  13. Review
  14. [IGSF11: A Novel Target for Cancer Immunotherapy].Zhongguo fei ai za zhi = Chinese journal of lung cancer · 2025
    Review
  15. Review
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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

28 authors at 4 institutions in 1 country.

Claire F FriedmanGynecologic Medical Oncology Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA. friedmac@mskcc.org.ORCID 0000-0003-2621-8553
Beryl L Manning-GeistGynecology Service, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY, USA.
Qin ZhouDepartment of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, NY, USA.
Tara SoumeraiGynecologic Medical Oncology Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA.
Aliya HollandDepartment of Medicine, Weill Cornell Medical College, New York, NY, USA.
Arnaud Da Cruz PaulaGynecology Service, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY, USA.ORCID 0000-0001-7694-8760
Hunter GreenDepartment of Pathology and Laboratory Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA.ORCID 0009-0002-3944-6803
Melih Arda OzsoyGynecologic Medical Oncology Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA.
Alexia IasonosDepartment of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, NY, USA.
Travis HollmannParker Institute for Cancer Immunotherapy, Memorial Sloan Kettering Cancer Center, New York, NY, USA.
Mario M LeitaoGynecology Service, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY, USA.
Jennifer J MuellerGynecology Service, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY, USA.
Vicky MakkerGynecologic Medical Oncology Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA.
William P TewGynecologic Medical Oncology Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA.
Roisin E O'CearbhaillGynecologic Medical Oncology Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA.ORCID 0000-0001-8217-4554
Ying L LiuGynecologic Medical Oncology Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA.
Maria M RubinsteinGynecologic Medical Oncology Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA.
Tiffany Troso-SandovalGynecologic Medical Oncology Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA.
Stuart M LichtmanGynecologic Medical Oncology Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA.
Alison SchramGynecologic Medical Oncology Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA.ORCID 0000-0002-6070-2413
Chrisann KyiGynecologic Medical Oncology Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA.
Rachel N GrishamGynecologic Medical Oncology Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA.
Pamela Causa AndrieuDepartment of Radiology, Memorial Sloan Kettering Cancer Center, New York, NY, USA.
E John WherryInstitute of Immunology,University of Pennsylvania, Philadelphia, PA, USA.ORCID 0000-0003-0477-1956
Carol AghajanianGynecologic Medical Oncology Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA.
Britta WeigeltDepartment of Pathology and Laboratory Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA.ORCID 0000-0001-9927-1270
Martee L HensleyGynecologic Medical Oncology Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA.
Dmitriy ZamarinTisch Cancer Institute,Icahn School of Medicine at Mount Sinai, New York, NY, USA. dmitriy.zamarin@mssm.edu.ORCID 0000-0002-0094-0161
Memorial Sloan Kettering Cancer Center · USCornell University · USTisch Hospital · USUniversity of Pennsylvania · US

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Hongbiao Carl Lekaye · 1985 to 2026
$347.4M
Clinical and Translational Science AwardUL1TR001873 · NCATS · COLUMBIA UNIVERSITY HEALTH SCIENCES · PI REILLY, MUREDACH P · 2016 to 2025
$99.0M
Disparities in COVID Disease Severity and Outcomes in New York CityUL1TR002384 · NCATS · WEILL MEDICAL COLL OF CORNELL UNIV · PI JULIANNE L IMPERATO-MCGINLEY · 2017 to 2026
$86.2M
NCATS NIH HHS UL1 TR001873NCATS NIH HHS UL1 TR002384NCI NIH HHS P30 CA008748
6 · The paper itself

Abstract

Programmed death-1 (PD-1) inhibitors are approved for therapy of gynecologic cancers with DNA mismatch repair deficiency (dMMR), although predictors of response remain elusive. We conducted a single-arm phase 2 study of nivolumab in 35 patients with dMMR uterine or ovarian cancers. Co-primary endpoints included objective response rate (ORR) and progression-free survival at 24 weeks (PFS24). Secondary endpoints included overall survival (OS), disease control rate (DCR), duration of response (DOR) and safety. Exploratory endpoints included biomarkers and molecular correlates of response. The ORR was 58.8% (97.5% confidence interval (CI): 40.7-100%), and the PFS24 rate was 64.7% (97.5% one-sided CI: 46.5-100%), meeting the pre-specified endpoints. The DCR was 73.5% (95% CI: 55.6-87.1%). At the median follow-up of 42.1 months (range, 8.9-59.8 months), median OS was not reached. One-year OS rate was 79% (95% CI: 60.9-89.4%). Thirty-two patients (91%) had a treatment-related adverse event (TRAE), including arthralgia (n = 10, 29%), fatigue (n = 10, 29%), pain (n = 10, 29%) and pruritis (n = 10, 29%); most were grade 1 or grade 2. Ten patients (29%) reported a grade 3 or grade 4 TRAE; no grade 5 events occurred. Exploratory analyses show that the presence of dysfunctional (CD8

Indexed as

Biomarkers, TumorDNA Mismatch RepairNivolumabAdultAgedAged, 80 and overAntineoplastic Agents, ImmunologicalB7-H1 AntigenFemaleGenital Neoplasms, FemaleHumansMiddle AgedMutationOvarian NeoplasmsProgrammed Cell Death 1 ReceptorProgression-Free SurvivalAntineoplastic Agents, ImmunologicalB7-H1 AntigenBiomarkers, TumorNivolumabProgrammed Cell Death 1 Receptor

Identifiers

PMID38653864
PMCPMC11108776
OpenAlexW4395041354

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Registered trials

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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.