Evidence map›Paper›PMID 41759531›Full record

Trial reportCell reports. Medicine2026

Neoadjuvant Fc-enhanced anti-CTLA-4 targets Tregs to augment androgen deprivation in high-risk prostate cancer: A randomized phase I trial.

Casey R Ager, Aleksandar Obradovic, Patrick McCann, Matthew Chaimowitz, Alexander L E Wang, Neha Shaikh, Parin Shah, Samuel S Pan, Caroline J Laplaca, Renu K Virk and 16 more

Registry-linked trialAbstract readRandomized Controlled TrialClinical Trial, Phase I
In one paragraph

Trial report in Cell reports. Medicine, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04301414 (A Pilot Study of Neoadjuvant Non-fucosylated Anti-CTLA-4), which is not on this map. Cited by 5 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 2 pooled it
–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.

NCT04301414 early_phase1completednot on this map

A Pilot Study of Neoadjuvant Non-fucosylated Anti-CTLA-4 (BMS-986218) + Degarelix Acetate vs. Degarelix Acetate Alone in Men With High-risk Localized Prostate Cancer

TypeinterventionalSponsorColumbia UniversityRan2020 to 2025Enrolled26ConditionsProstate CancerArmsBMS-986218 and Degarelix, Degarelix
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Article
  4. Article
  5. 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

26 authors.

Casey R AgerDepartment of Medicine, Division of Hematology and Oncology, Columbia University Irving Medical Center, New York, NY 10032, USA; Columbia Center for Translational Immunology, Columbia University Irving Medical Center, New York, NY 10032, USA; Department of Immunology, Mayo Clinic Arizona, Phoenix, AZ 85054, USA; Department of Urology, Mayo Clinic Arizona, Phoenix, AZ 85054, USA. Electronic address: ager.casey@mayo.edu.
Aleksandar ObradovicDepartment of Systems Biology, Vagelos College of Physicians and Surgeons, Columbia University Irving Medical Center, New York, NY 10032, USA.
Patrick McCannDepartment of Radiation Oncology, Columbia University Irving Medical Center, New York, NY 10032, USA; Genitourinary Oncology Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY 10065, USA.
Matthew ChaimowitzColumbia Center for Translational Immunology, Columbia University Irving Medical Center, New York, NY 10032, USA.
Alexander L E WangDepartment of Systems Biology, Vagelos College of Physicians and Surgeons, Columbia University Irving Medical Center, New York, NY 10032, USA.
Neha ShaikhHerbert Irving Comprehensive Cancer Center, Columbia University Irving Medical Center, New York, NY 10032, USA.
Parin ShahHerbert Irving Comprehensive Cancer Center, Columbia University Irving Medical Center, New York, NY 10032, USA.
Samuel S PanHerbert Irving Comprehensive Cancer Center, Columbia University Irving Medical Center, New York, NY 10032, USA.
Caroline J LaplacaDepartment of Urology, Columbia University Irving Medical Center, New York, NY 10032, USA.
Renu K VirkDepartment of Pathology, Columbia University Irving Medical Center, New York, NY 10032, USA.
Jessica C HillDepartment of Immunology, Mayo Clinic Arizona, Phoenix, AZ 85054, USA.
Collin JuglerDepartment of Immunology, Mayo Clinic Arizona, Phoenix, AZ 85054, USA.
Grace DeFrancoDepartment of Immunology, Mayo Clinic Arizona, Phoenix, AZ 85054, USA.
Nilika BhattacharyaDepartment of Immunology, Mayo Clinic Arizona, Phoenix, AZ 85054, USA.
Kade R CoppleDepartment of Immunology, Mayo Clinic Arizona, Phoenix, AZ 85054, USA.
Phuong NguyenDepartment of Immunology, Mayo Clinic Arizona, Phoenix, AZ 85054, USA.
Howard I ScherGenitourinary Oncology Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY 10065, USA.
Guarionex Joel DeCastroDepartment of Urology, Columbia University Irving Medical Center, New York, NY 10032, USA.
Christopher B AndersonDepartment of Urology, Columbia University Irving Medical Center, New York, NY 10032, USA.
James M McKiernanDepartment of Urology, Columbia University Irving Medical Center, New York, NY 10032, USA.
Catherine S SpinaDepartment of Radiation Oncology, Columbia University Irving Medical Center, New York, NY 10032, USA.
Mark N SteinDepartment of Medicine, Division of Hematology and Oncology, Columbia University Irving Medical Center, New York, NY 10032, USA.
Karie RuncieDepartment of Medicine, Division of Hematology and Oncology, Columbia University Irving Medical Center, New York, NY 10032, USA.
Charles G DrakeDepartment of Medicine, Division of Hematology and Oncology, Columbia University Irving Medical Center, New York, NY 10032, USA; Department of Urology, Columbia University Irving Medical Center, New York, NY 10032, USA.
Andrea CalifanoDepartment of Systems Biology, Vagelos College of Physicians and Surgeons, Columbia University Irving Medical Center, New York, NY 10032, USA; Herbert Irving Comprehensive Cancer Center, Columbia University Irving Medical Center, New York, NY 10032, USA; Department of Biochemistry & Molecular Biophysics, Vagelos College of Physicians and Surgeons, Columbia University Irving Medical Center, New York, NY 10032, USA; Department of Medicine, Vagelos College of Physicians and Surgeons, Columbia University Irving Medical Center, New York, NY 10032, USA; Department of Biomedical Informatics, Vagelos College of Physicians and Surgeons, Columbia University Irving Medical Center, New York, NY 10032, USA; Chan Zuckerberg Biohub New York, New York, NY 10027, USA.
Matthew C DallosDepartment of Medicine, Division of Hematology and Oncology, Columbia University Irving Medical Center, New York, NY 10032, USA; Genitourinary Oncology Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY 10065, USA. Electronic address: dallosm@mskcc.org.

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI SELWYN M VICKERS · 1985 to 2026
$347.4M
Predicting Cancer Cell Response to Endogenous and Exogenous Perturbations at the Single Cell LevelR35CA197745 · NCI · COLUMBIA UNIVERSITY HEALTH SCIENCES · PI ANDREA CALIFANO · 2015 to 2026
$11.5M
Studying the evolution of drug resistance in prostate cancer at the single cell levelU54CA274506 · NCI · COLUMBIA UNIVERSITY HEALTH SCIENCES · PI Peter Alan Sims · 2023 to 2026
$9.1M
NCI NIH HHS P30 CA008748NCI NIH HHS R35 CA197745NCI NIH HHS U54 CA274506
6 · The paper itself

Abstract

Despite high rates of post-surgical recurrence in men with high-risk localized prostate cancer (PCa), there is currently no role for neoadjuvant therapy. Tumor infiltrating regulatory T cells (TI-Tregs) limit the antitumor effects of presurgical androgen deprivation therapy (ADT). We present a neoadjuvant clinical trial testing whether an afucosylated anti-CTLA-4 antibody (BMS-986218) with ADT is safe, feasible, and reduces TI-Treg frequencies. This single-center, two-arm, open-label study randomizes 24 men with high-risk localized PCa to ADT with or without BMS-986218 prior to radical prostatectomy. Treatment is well tolerated and feasible. Mechanistic studies reveal reductions in TI-Treg frequencies correlate with CD16a/FCGR3A on tumor macrophages, dendritic cell (DC) modulation, and augmented T cell priming following BMS-986218 treatment. Depth of Treg inhibition and increased DC frequencies are associated with improved clinical outcomes. Overall, this study supports the feasibility and biological activity of neoadjuvant ADT + Fc-enhanced anti-CTLA-4 in high-risk PCa. Trial is registered at clinicaltrials.gov (NCT04301414).

Indexed as

Androgen AntagonistsCTLA-4 AntigenNeoadjuvant TherapyProstatic NeoplasmsT-Lymphocytes, RegulatoryAgedDendritic CellsHumansMaleMiddle AgedAndrogen AntagonistsCTLA-4 AntigenCTLA4 protein, humanCTLA-4CyTOFdendritic cellsneoadjuvant immunotherapyprostate cancerregulatory T cellssingle-cell RNA sequencingtumor-associated macrophages

Identifiers

PMID41759531
PMCPMC13006393

What OpenQuestion holds

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LicenceCC BY-NC
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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.