Evidence map›Paper›PMID 38355777›Full record

ArticleNature cancer2024

Entinostat, nivolumab and ipilimumab for women with advanced HER2-negative breast cancer: a phase Ib trial.

Evanthia T Roussos Torres, Won J Ho, Ludmila Danilova, Joseph A Tandurella, James Leatherman, Christine Rafie, Chenguang Wang, Adam Brufsky, Patricia LoRusso, Vincent Chung and 17 more

Registry-linked trialOpen access · greenAbstract readClinical Trial, Phase I
In one paragraph

Article in Nature cancer, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02453620 (A Phase 1 Study Evaluating Safety, Tolerability, and Preliminary Antitumor Activity of Entinostat and Nivolumab With or Without Ipilimumab in Advanced Solid Tumors), which is not on this map. Cited by 35 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
35citing papers in PubMed, 1 pooled it
11.9field-weighted citation impact, top 1% 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.

NCT02453620 phase1active not recruitingnot on this map

A Phase 1 Study Evaluating Safety, Tolerability, and Preliminary Antitumor Activity of Entinostat and Nivolumab With or Without Ipilimumab in Advanced Solid Tumors

TypeinterventionalSponsorNational Cancer Institute (NCI)Ran2016 to 2026Enrolled57ConditionsAnatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8, Breast Adenocarcinoma, Invasive Breast CarcinomaArmsBiopsy Procedure, Blood Sample, Bone Scan, Computed Tomography, Entinostat
3 · Its place in the literature

Who cites it

35 citing papers in PubMed, 1 synthesis or guideline pooled it, 42 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. The immunology of human breast cancer.Nature reviews. Immunology · 2026
    Review
  5. Epigenetic plus cytokine therapy induces stem-like CD8Journal for immunotherapy of cancer · 2026
    Article
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  14. Clinical progress and functional modalities of HDAC inhibitor-based combination therapies in cancer treatment.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2026
    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

27 authors at 8 institutions in 2 countries.

Evanthia T Roussos TorresSidney Kimmel Comprehensive Cancer Center, Johns Hopkins School of Medicine, Baltimore, MD, USA. evanthia.roussostorres@med.usc.edu.ORCID http://orcid.org/0000-0002-0740-5102
Won J HoSidney Kimmel Comprehensive Cancer Center, Johns Hopkins School of Medicine, Baltimore, MD, USA.ORCID http://orcid.org/0000-0003-2644-5086
Ludmila DanilovaSidney Kimmel Comprehensive Cancer Center, Johns Hopkins School of Medicine, Baltimore, MD, USA.
Joseph A TandurellaSidney Kimmel Comprehensive Cancer Center, Johns Hopkins School of Medicine, Baltimore, MD, USA.ORCID http://orcid.org/0000-0002-5806-6681
James LeathermanSidney Kimmel Comprehensive Cancer Center, Johns Hopkins School of Medicine, Baltimore, MD, USA.
Christine RafieSidney Kimmel Comprehensive Cancer Center, Johns Hopkins School of Medicine, Baltimore, MD, USA.
Chenguang WangSidney Kimmel Comprehensive Cancer Center, Johns Hopkins School of Medicine, Baltimore, MD, USA.
Adam BrufskyUniversity of Pittsburgh Cancer Institute and UPMC Cancer Center, Pittsburgh, PA, USA.ORCID http://orcid.org/0000-0001-8080-7960
Patricia LoRussoYale Cancer Center, New Haven, CT, USA.ORCID http://orcid.org/0000-0001-7144-036X
Vincent ChungCity of Hope, Duarte, CA, USA.
Yuan YuanCedars-Sinai Cancer, Los Angeles, CA, USA.
Melinda DownsSidney Kimmel Comprehensive Cancer Center, Johns Hopkins School of Medicine, Baltimore, MD, USA.
Ashley O'ConnorSidney Kimmel Comprehensive Cancer Center, Johns Hopkins School of Medicine, Baltimore, MD, USA.
Sarah M ShinSidney Kimmel Comprehensive Cancer Center, Johns Hopkins School of Medicine, Baltimore, MD, USA.
Alexei HernandezSidney Kimmel Comprehensive Cancer Center, Johns Hopkins School of Medicine, Baltimore, MD, USA.
Elizabeth L EngleSidney Kimmel Comprehensive Cancer Center, Johns Hopkins School of Medicine, Baltimore, MD, USA.ORCID http://orcid.org/0000-0002-6375-9060
Richard PiekarzCancer Therapy Evaluation Program (CTEP), National Cancer Institute, Bethesda, MD, USA.
Howard StreicherCancer Therapy Evaluation Program (CTEP), National Cancer Institute, Bethesda, MD, USA.
Zahra TalebiDivision of Pharmaceutics and Pharmacology, The Ohio State University, Columbus, OH, USA.ORCID http://orcid.org/0000-0001-9166-5160
Michelle A RudekSidney Kimmel Comprehensive Cancer Center, Johns Hopkins School of Medicine, Baltimore, MD, USA.ORCID http://orcid.org/0000-0001-5739-6868
Qingfeng ZhuSidney Kimmel Comprehensive Cancer Center, Johns Hopkins School of Medicine, Baltimore, MD, USA.ORCID http://orcid.org/0000-0001-7871-3359
Robert A AndersSidney Kimmel Comprehensive Cancer Center, Johns Hopkins School of Medicine, Baltimore, MD, USA.ORCID http://orcid.org/0000-0002-2363-9072
Ashley Cimino-MathewsSidney Kimmel Comprehensive Cancer Center, Johns Hopkins School of Medicine, Baltimore, MD, USA.ORCID http://orcid.org/0000-0002-0638-7969
Elana J FertigSidney Kimmel Comprehensive Cancer Center, Johns Hopkins School of Medicine, Baltimore, MD, USA.ORCID http://orcid.org/0000-0003-3204-342X
Elizabeth M JaffeeSidney Kimmel Comprehensive Cancer Center, Johns Hopkins School of Medicine, Baltimore, MD, USA.ORCID http://orcid.org/0000-0003-3841-6549
Vered StearnsSidney Kimmel Comprehensive Cancer Center, Johns Hopkins School of Medicine, Baltimore, MD, USA.
Roisin M ConnollySidney Kimmel Comprehensive Cancer Center, Johns Hopkins School of Medicine, Baltimore, MD, USA. roisin.connolly@ucc.ie.ORCID http://orcid.org/0000-0003-0056-1070
Johns Hopkins University · USNational Cancer Institute · USCedars-Sinai Medical Center · USCity of Hope · USThe Ohio State University · USUniversity of Southern California · USUPMC Hillman Cancer Center · USYale Cancer Center · US

Funding

Translational Research Central ServicesP30CA006973 · NCI · JOHNS HOPKINS UNIVERSITY · PI WILLIAM George NELSON · 1985 to 2026
$208.6M
USC/NORRIS COMPREHENSIVE CANCER CENTER (CORE) SUPPORTP30CA014089 · NCI · UNIVERSITY OF SOUTHERN CALIFORNIA · PI MYLES G COCKBURN · 1985 to 2026
$181.4M
VECTOR CORE FACILITYP30CA047904 · NCI · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI JOHN C. BYRD · 1988 to 2026
$158.0M
Yale Clinical and Translational Science Award (U Component)UL1TR001863 · NCATS · YALE UNIVERSITY · PI John H. Krystal, LUCILA OHNO-MACHADO · 2016 to 2026
$102.9M
Institute for Clinical and Translational ResearchUL1TR001079 · NCATS · JOHNS HOPKINS UNIVERSITY · PI FORD, DANIEL ERNEST · 2013 to 2017
$60.1M
ViKTriY-PC Consortium Phase II SupplementUM1CA186689 · NCI · YALE UNIVERSITY · PI Patricia M. LoRusso · 2014 to 2026
$22.2M
The Johns Hopkins Translational Science Team for the ET-CTNUM1CA186691 · NCI · JOHNS HOPKINS UNIVERSITY · PI Jan Hendrik Beumer, Michael A Carducci · 2014 to 2026
$21.9M
Phase I Molecular and Clinical Pharmacodynamic Trials ETCTNUM1CA186717 · NCI · BECKMAN RESEARCH INSTITUTE/CITY OF HOPE · PI A. Dimitrios Colevas, Alexey V. Danilov · 2014 to 2026
$19.8M
NCI ET-CTN with Phase i Emphasis at UPCIUM1CA186690 · NCI · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI JOHN C. BYRD, Farshid Dayyani · 2014 to 2026
$9.1M
The Chesapeake-Ohio Pharmacokinetics Core for The ETCTNU24CA247648 · NCI · JOHNS HOPKINS UNIVERSITY · PI Jan Hendrik Beumer, Mitch A Phelps · 2020 to 2026
$3.6M
UPLC with Tandem MS for Sensitive Quantitative Analysis of Small MoleculesS10RR026824 · NCRR · JOHNS HOPKINS UNIVERSITY · PI RUDEK, MICHELLE A · 2010 to 2010
$429k
NCATS NIH HHS UL1 TR001079NCATS NIH HHS UL1 TR001863NCI NIH HHS P30 CA006973NCI NIH HHS P30 CA014089NCI NIH HHS P30 CA047904NCI NIH HHS U24 CA247648NCI NIH HHS UM1 CA186689NCI NIH HHS UM1 CA186690NCI NIH HHS UM1 CA186691NCI NIH HHS UM1 CA186717NCRR NIH HHS S10 RR026824U.S. Department of Health & Human Services | NIH | National Cancer Institute (NCI) P30CA006973U.S. Department of Health & Human Services | NIH | National Cancer Institute (NCI) P30CA014089U.S. Department of Health & Human Services | NIH | National Cancer Institute (NCI) UM1CA186689U.S. Department of Health & Human Services | NIH | National Cancer Institute (NCI) UM1CA186690U.S. Department of Health & Human Services | NIH | National Cancer Institute (NCI) UM1CA186691U.S. Department of Health & Human Services | NIH | National Cancer Institute (NCI) UM1CA186717
6 · The paper itself

Abstract

We report the results of 24 women, 50% (N = 12) with hormone receptor-positive breast cancer and 50% (N = 12) with advanced triple-negative breast cancer, treated with entinostat + nivolumab + ipilimumab from the dose escalation (N = 6) and expansion cohort (N = 18) of ETCTN-9844 ( NCT02453620 ). The primary endpoint was safety. Secondary endpoints were overall response rate, clinical benefit rate, progression-free survival and change in tumor CD8:FoxP3 ratio. There were no dose-limiting toxicities. Among evaluable participants (N = 20), the overall response rate was 25% (N = 5), with 40% (N = 4) in triple-negative breast cancer and 10% (N = 1) in hormone receptor-positive breast cancer. The clinical benefit rate was 40% (N = 8), and progression-free survival at 6 months was 50%. Exploratory analyses revealed that changes in myeloid cells may contribute to responses; however, no correlation was noted between changes in CD8:FoxP3 ratio, PD-L1 status and tumor mutational burden and response. These findings support further investigation of this treatment in a phase II trial.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsBenzamidesErb-b2 Receptor Tyrosine KinasesIpilimumabNivolumabPyridinesAdultAgedBreast NeoplasmsFemaleHumansMiddle AgedProgression-Free SurvivalTriple Negative Breast NeoplasmsBenzamidesentinostatERBB2 protein, humanErb-b2 Receptor Tyrosine KinasesIpilimumabNivolumabPyridines

Identifiers

PMID38355777
PMCPMC11552660
OpenAlexW4391814503

What OpenQuestion holds

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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.