Evidence map›Paper›PMID 40125795›Full record

Trial reportClinical cancer research : an official journal of the American Association for Cancer Research2025

Neoadjuvant BMS-813160, Nivolumab, Gemcitabine, and Nab-Paclitaxel for Patients with Pancreatic Cancer.

Patrick M Grierson, Crystal Wolf, Rama Suresh, Andrea Wang-Gillam, Benjamin R Tan, Lee Ratner, Peter Oppelt, Olivia Aranha, Ashley Frith, Katrina S Pedersen and 10 more

Registry-linked trialAbstract readClinical Trial, Phase IClinical Trial, Phase II
In one paragraph

Trial report in Clinical cancer research : an official journal of the American Association for Cancer Research, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03496662 (A Phase I/II Study to Evaluate the Tolerability and Efficacy of BMS-813160), which is not on this map. Cited by 18 papers.

0numbers the graph read from it
0cells of the map it votes in
18citing 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.

NCT03496662 phase1 / phase2completednot on this map

A Phase I/II Study to Evaluate the Tolerability and Efficacy of BMS-813160 (CCR2/5 Inhibitor) With Nivolumab and Gemcitabine and Nab-paclitaxel in Borderline Resectable and Locally Advanced Pancreatic Ductal Adenocarcinoma (PDAC)

TypeinterventionalSponsorWashington University School of MedicineRan2018 to 2024Enrolled40ConditionsPancreatic Ductal AdenocarcinomaArmsBMS-813160, Nivolumab, Gemcitabine, Nab-paclitaxel, Biopsy
3 · Its place in the literature

Who cites it

18 citing papers in PubMed.

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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

20 authors.

Patrick M GriersonDivision of Medical Oncology, Department of Internal Medicine, Washington University, St. Louis, Missouri.ORCID 0000-0002-0624-6699
Crystal WolfDivision of Medical Oncology, Department of Internal Medicine, Washington University, St. Louis, Missouri.ORCID 0009-0000-7302-807X
Rama SureshDivision of Medical Oncology, Department of Internal Medicine, Washington University, St. Louis, Missouri.ORCID 0000-0003-1637-9994
Andrea Wang-GillamDivision of Medical Oncology, Department of Internal Medicine, Washington University, St. Louis, Missouri.ORCID 0000-0003-0458-7614
Benjamin R TanDivision of Medical Oncology, Department of Internal Medicine, Washington University, St. Louis, Missouri.ORCID 0000-0003-1838-1182
Lee RatnerDivision of Medical Oncology, Department of Internal Medicine, Washington University, St. Louis, Missouri.ORCID 0000-0003-2744-7294
Peter OppeltDivision of Medical Oncology, Department of Internal Medicine, Washington University, St. Louis, Missouri.ORCID 0000-0002-3557-8449
Olivia AranhaDivision of Medical Oncology, Department of Internal Medicine, Washington University, St. Louis, Missouri.ORCID 0000-0003-3405-5694
Ashley FrithDivision of Medical Oncology, Department of Internal Medicine, Washington University, St. Louis, Missouri.ORCID 0000-0001-9507-4122
Katrina S PedersenDivision of Medical Oncology, Department of Internal Medicine, Washington University, St. Louis, Missouri.ORCID 0000-0003-2793-6901
Jennifer SpannDivision of Medical Oncology, Department of Internal Medicine, Washington University, St. Louis, Missouri.ORCID 0009-0003-4858-3073
Nicholas BoiceDivision of Medical Oncology, Department of Internal Medicine, Washington University, St. Louis, Missouri.ORCID 0000-0002-3615-5325
Amberly BrownDivision of Medical Oncology, Department of Internal Medicine, Washington University, St. Louis, Missouri.ORCID 0000-0001-8300-5701
John M BaerDivision of Medical Oncology, Department of Internal Medicine, Washington University, St. Louis, Missouri.ORCID 0000-0002-8758-0030
Emily G ButkaDivision of Medical Oncology, Department of Internal Medicine, Washington University, St. Louis, Missouri.ORCID 0000-0003-2615-3454
Faiz AhmadDivision of Medical Oncology, Department of Internal Medicine, Washington University, St. Louis, Missouri.ORCID 0000-0002-0450-042X
Yifei XuDivision of Public Health Sciences, Department of Surgery, Washington University, St. Louis, Missouri.ORCID 0009-0008-6333-8224
Jingxia LiuDivision of Public Health Sciences, Department of Surgery, Washington University, St. Louis, Missouri.ORCID 0000-0002-9434-7907
David G DeNardoDivision of Medical Oncology, Department of Internal Medicine, Washington University, St. Louis, Missouri.ORCID 0000-0002-3655-5783
Kian-Huat LimDivision of Medical Oncology, Department of Internal Medicine, Washington University, St. Louis, Missouri.ORCID 0000-0002-2766-200X

Funding

Washington University SPORE in Pancreatic CancerP50CA196510 · NCI · WASHINGTON UNIVERSITY · PI HAWKINS, WILLIAM G · 2016 to 2020
$10.9M
Washington University SPORE in Pancreatic CancerP50CA272213 · NCI · WASHINGTON UNIVERSITY · PI David G DeNardo, WILLIAM G HAWKINS · 2023 to 2026
$10.7M
Washington University (WU) ROBIN Center: MicroEnvironment and Tumor Effects Of Radiotherapy (METEOR)U54CA274318 · NCI · WASHINGTON UNIVERSITY · PI Clifford Grant Robinson, Julie Kristina Schwarz · 2023 to 2026
$7.7M
The Impact of Macrophage Origin on the Pathogenesis and Treatment Resistance of Pancreatic CancerR01CA177670 · NCI · WASHINGTON UNIVERSITY · PI DENARDO, DAVID G · 2014 to 2023
$3.3M
Stomal Senescence Regulator of Tumor Immunity and ProgressionR01CA286615 · NCI · WASHINGTON UNIVERSITY · PI David G DeNardo, Paolo Provenzano · 2024 to 2026
$3.2M
Re-wiring PDAC Tumor Immunity Through Dendritic CellsR01CA262506 · NCI · WASHINGTON UNIVERSITY · PI DENARDO, DAVID G, DESELM, CARL · 2021 to 2025
$2.8M
Targeting Focal Adhesion Kinase to Improve RT-inducted Tumor ImmunityR01CA248917 · NCI · WASHINGTON UNIVERSITY · PI DENARDO, DAVID G, KIM, HYUN · 2020 to 2024
$2.5M
The Impact of Metastatic Site On Dendritic Cell-Driven Tumor ImmunityU01CA284086 · NCI · WASHINGTON UNIVERSITY · PI David G DeNardo, Li Ding · 2023 to 2026
$2.3M
Exploiting Integrin Signaling to Overcome Resistance to ImmunotherapyR01CA244938 · NCI · WASHINGTON UNIVERSITY · PI DENARDO, DAVID G, GUPTA, VINEET · 2020 to 2024
$2.2M
National Cancer Institute (NCI) P50CA196510National Institues of Health/National Cancer Institute P50CA196510National Institues of Health/National Cancer Institute P50CA272213NCI NIH HHS P50 CA196510NCI NIH HHS P50 CA272213NCI NIH HHS R01 CA177670NCI NIH HHS R01 CA244938NCI NIH HHS R01 CA248917NCI NIH HHS R01 CA262506NCI NIH HHS R01 CA286615NCI NIH HHS U01 CA284086NCI NIH HHS U54 CA274318
6 · The paper itself

Abstract

purposeTargeting tumor-associated macrophages through C-C chemokine receptor type 2 (CCR) in pancreatic ductal adenocarcinoma (PDAC) improves the efficacy of chemotherapy and restores T-cell immunity in preclinical models. PATIENTS AND

methodsWe conducted a phase I/II single-institution study (NCT03496662) combining chemotherapy gemcitabine and nab-paclitaxel (GnP), CCR2/5 inhibitor BMS-813160, and nivolumab for four 28-day cycles for patients with borderline resectable (BR) or locally advanced (LA) PDAC. The recommended phase II dose of BMS-813160 was established in the 3 + 3 design. Primary endpoints were safety and objective response rate (ORR). Secondary endpoints included resection rate, median progression-free survival, and median overall survival.

resultsEight patients were treated with GnP alone (control arm), and 32 patients (29 response evaluable) were treated at the recommended phase II dose. One instance each of grade 3 diarrhea and QTc prolongation occurred which were atrributed solely to BMS-813160. After four cycles of study treatment (N = 22), the ORR was 42% and 20% among patients with BR and LA PDAC, respectively, compared with 0% of control patients. A total of 83.3% of patients with BR and 20% of patients with LA PDAC who completed study treatment underwent surgical resection. For intent-to-treat analyses, patients with BR PDAC had a median progression-free survival and median overall survival of 11.9 and 18.2 months, respectively, whereas patients with LA PDAC had 14.7 and 17 months, respectively. Biomarker analyses showed decreased intratumoral monocytes and macrophages and enhanced T-cell proliferation and effector gene expression.

conclusionsNeoadjuvant BMS-813160/nivolumab/GnP was well tolerated and seems to achieve comparable ORR and resectability with historical data; however, with prolonged PFS and OS in LA-PDAC patients, warranting a larger phase II study with a more efficacious CCR2-targeted therapeutic.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsCarcinoma, Pancreatic DuctalPancreatic NeoplasmsAdultAgedAlbuminsDeoxycytidineFemaleGemcitabineHumansMaleMiddle AgedNeoadjuvant TherapyNivolumabPaclitaxel130-nm albumin-bound paclitaxelAlbuminsDeoxycytidineGemcitabineNivolumabPaclitaxel

Identifiers

PMID40125795
PMCPMC12402776

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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.