{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,30]],"date-time":"2026-10-30T04:27:35Z","timestamp":1793334455919,"version":"4.5.0"},"reference-count":27,"publisher":"BMJ","issue":"1","license":[{"start":{"date-parts":[[2026,1,22]],"date-time":"2026-01-22T00:00:00Z","timestamp":1769040000000},"content-version":"unspecified","delay-in-days":21,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100001009","name":"Bristol Myers Squibb Foundation","doi-asserted-by":"publisher","award":["N\/A"],"award-info":[{"award-number":["N\/A"]}],"id":[{"id":"10.13039\/100001009","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["J Immunother Cancer"],"accepted":{"date-parts":[[2025,12,23]]},"published-print":{"date-parts":[[2026,1]]},"abstract":"<jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Cysteine\u2013cysteine chemokine receptors 2 (CCR2) and 5 (CCR5) contribute to immune suppression in tumor microenvironments. CCR2 and CCR5 antagonists have demonstrated antitumor activity in pancreatic ductal adenocarcinoma (PDAC) and colorectal cancer (CRC), respectively. This phase 1b\/2, open-label study evaluated BMS-813160, a CCR2\/5 dual antagonist, in combination with chemotherapy\u00b1nivolumab in advanced PDAC or metastatic CRC.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Part 1 included patients with metastatic untreated (first-line (1L)) PDAC, 1L CRC, or previously treated (second or third line (2\/3L)) microsatellite stable (MSS) CRC. Patients received 2\u2009weeks of BMS-813160 monotherapy (300\u2009mg two times a day, 600\u2009mg once daily, 300\u2009mg once daily, or 150\u2009mg once daily) and then BMS-813160+chemotherapy (gemcitabine+nab-paclitaxel (gem\/nabP; 1L PDAC), 5-fluorouracil+leucovorin+irinotecan (FOLFIRI; 1L CRC)), or nivolumab (2\/3L MSS CRC).<\/jats:p>\n                    <jats:p>Part 2 included patients with metastatic 1L PDAC or 2L CRC. Patients received BMS-813160 300\u2009mg two times a day+gem\/nabP\u00b1nivolumab (1L PDAC), BMS-813160 300\u2009mg two times a day or 150\u2009mg once daily+FOLFIRI (2L CRC), or chemotherapy alone. Primary endpoints were safety and pharmacodynamics (Part 1) and efficacy (Part 2).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>In Part 1, 22 of 75 (29%) and 54 of 72 (72%) patients experienced a treatment-related adverse event during monotherapy lead-in and overall, respectively. Two dose-limiting toxicities (rash and pericardial effusion with pericarditis, both grade 3) occurred. In Part 2, patients with 1L PDAC who received BMS-813160 300\u2009mg two times a day+gem\/nabP+nivolumab achieved an overall response rate (ORR) of 37% (13\/35); the median duration of response (DOR) was 45\u2009weeks (95%\u2009CI 26.1 to not evaluable). ORRs with BMS-813160 300\u2009mg two times a day+gem\/nabP and gem\/nabP alone were 26% (9\/35) and 28% (9\/32), respectively; median DORs were 121 and 31\u2009weeks, respectively. Progression-free survival rates at 24\u2009weeks were 56% (BMS-813160 300\u2009mg two times a day+gem\/nabP+nivolumab), 56% (BMS-813160 300\u2009mg two times a day+gem\/nabP), and 50% (gem\/nabP). ORRs in 2L CRC were 19% (6\/32; BMS-813160 300\u2009mg two times a day+FOLFIRI), 13% (4\/32; BMS-813160 150\u2009mg once daily+FOLFIRI), and 27% (7\/26; FOLFIRI).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>In 1L PDAC, BMS-813160 300 two times a day+gem\/nabP\u00b1nivolumab demonstrated durable antitumor response and was well tolerated. BMS-813160 combination regimens were tolerable in other cohorts, but clinical efficacy was not demonstrated.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT03184870\">NCT03184870<\/jats:ext-link>\n                      .\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/jitc-2024-011284","type":"journal-article","created":{"date-parts":[[2026,1,22]],"date-time":"2026-01-22T14:25:19Z","timestamp":1769091919000},"page":"e011284","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":13,"title":["Phase 1b\/2 study of BMS-813160, a CCR2\/5 dual antagonist, in combination with chemotherapy or nivolumab in patients with advanced pancreatic or colorectal cancer"],"prefix":"10.1136","volume":"14","clinical-trial-number":[{"clinical-trial-number":"nct03184870","registry":"10.18810\/clinical-trials-gov"}],"author":[{"given":"Dung T","family":"Le","sequence":"first","affiliation":[{"name":"Sidney Kimmel Cancer Center, Johns Hopkins University, Baltimore, Maryland, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gunnar","family":"Folprecht","sequence":"additional","affiliation":[{"name":"Medical Department I, TU Dresden\/Universitaetsklinikum Carl Gustav Carus, Dresden, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anna M","family":"Varghese","sequence":"additional","affiliation":[{"name":"Memorial Sloan Kettering Nassau, Uniondale, New York, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Martin","family":"Gutierrez","sequence":"additional","affiliation":[{"name":"Hackensack University Medical Center Center, Hackensack, New Jersey, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marcus","family":"Noel","sequence":"additional","affiliation":[{"name":"Lombardi Comprehensive Cancer Center, Medstar Georgetown University Hospital, Washington, DC, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nikolaos A","family":"Trikalinos","sequence":"additional","affiliation":[{"name":"Washington University School of Medicine in Saint Louis, St Louis, Missouri, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4581-8848","authenticated-orcid":false,"given":"Eric","family":"Chen","sequence":"additional","affiliation":[{"name":"Princess Margaret Hospital Cancer Centre, Toronto, Ontario, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Farshid","family":"Dayyani","sequence":"additional","affiliation":[{"name":"UC Irvine Medical Center, Orange, Florida, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"S Lindsey","family":"Davis","sequence":"additional","affiliation":[{"name":"University of Colorado Cancer Center, Denver, Colorado, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wen Wee","family":"Ma","sequence":"additional","affiliation":[{"name":"Mayo Clinic in Minnesota, Rochester, Minnesota, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Atrayee","family":"BasuMallick","sequence":"additional","affiliation":[{"name":"Thomas Jefferson University, Philadelphia, Pennsylvania, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ignacio","family":"Garrido-Laguna","sequence":"additional","affiliation":[{"name":"Huntsman Cancer Institute, Salt Lake City, Utah, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5215-9994","authenticated-orcid":false,"given":"Mayu","family":"Osawa","sequence":"additional","affiliation":[{"name":"Bristol Myers Squibb Co, Princeton, New Jersey, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shaun","family":"O\u2019Brien","sequence":"additional","affiliation":[{"name":"Bristol Myers Squibb Co, Princeton, New Jersey, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ruslan D","family":"Novosiadly","sequence":"additional","affiliation":[{"name":"Bristol Myers Squibb Co, Princeton, New Jersey, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ke","family":"Xu","sequence":"additional","affiliation":[{"name":"Bristol Myers Squibb Co, Princeton, New Jersey, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Danielle M","family":"Greenawalt","sequence":"additional","affiliation":[{"name":"Bristol Myers Squibb, Lawrenceville, New Jersey, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Santanu","family":"Dutta","sequence":"additional","affiliation":[{"name":"Biostatistics, Bristol Myers Squibb, Princeton, New Jersey, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christina","family":"Twyman Saint Victor","sequence":"additional","affiliation":[{"name":"Bristol Myers Squibb Co, Princeton, New Jersey, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Heinz-Josef","family":"Lenz","sequence":"additional","affiliation":[{"name":"USC Norris Comprehensive Cancer Center, Los Angeles, California, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2026,1,22]]},"reference":[{"key":"2026012206250553000_14.1.e011284.1","doi-asserted-by":"crossref","DOI":"10.1186\/s13045-024-01561-6","article-title":"Current and future immunotherapeutic approaches in pancreatic cancer treatment","volume":"17","author":"Farhangnia","year":"2024","journal-title":"J Hematol Oncol"},{"key":"2026012206250553000_14.1.e011284.2","doi-asserted-by":"publisher","DOI":"10.1016\/j.gastha.2023.09.007"},{"key":"2026012206250553000_14.1.e011284.3","doi-asserted-by":"publisher","DOI":"10.1038\/s41575-021-00475-9"},{"key":"2026012206250553000_14.1.e011284.4","doi-asserted-by":"crossref","first-page":"1578","DOI":"10.1002\/cam4.1386","article-title":"Strategy to targeting the immune resistance and novel therapy in colorectal cancer","volume":"7","author":"Gang","year":"2018","journal-title":"Cancer Med"},{"key":"2026012206250553000_14.1.e011284.5","doi-asserted-by":"publisher","DOI":"10.4161\/onci.21176"},{"key":"2026012206250553000_14.1.e011284.6","doi-asserted-by":"publisher","DOI":"10.1038\/s41417-021-00303-x"},{"key":"2026012206250553000_14.1.e011284.7","doi-asserted-by":"crossref","first-page":"532","DOI":"10.1002\/ijc.32982","article-title":"12-Chemokine signature, a predictor of tumor recurrence in colorectal cancer","volume":"147","author":"Tokunaga","year":"2020","journal-title":"Int J Cancer"},{"key":"2026012206250553000_14.1.e011284.8","doi-asserted-by":"publisher","DOI":"10.1158\/1078-0432.CCR-13-0525"},{"key":"2026012206250553000_14.1.e011284.9","doi-asserted-by":"publisher","DOI":"10.1158\/0008-5472.CAN-12-2731"},{"key":"2026012206250553000_14.1.e011284.10","doi-asserted-by":"publisher","DOI":"10.1093\/annonc\/mdv474"},{"key":"2026012206250553000_14.1.e011284.11","doi-asserted-by":"crossref","DOI":"10.3390\/cancers12071765","article-title":"The CCL5\/CCR5 axis in cancer progression","volume":"12","author":"Aldinucci","year":"2020","journal-title":"Cancers (Basel)"},{"key":"2026012206250553000_14.1.e011284.12","doi-asserted-by":"publisher","DOI":"10.1158\/0008-5472.CAN-11-0268"},{"key":"2026012206250553000_14.1.e011284.13","doi-asserted-by":"publisher","DOI":"10.1016\/j.ccell.2016.03.005"},{"key":"2026012206250553000_14.1.e011284.14","doi-asserted-by":"publisher","DOI":"10.1016\/S1470-2045(16)00078-4"},{"key":"2026012206250553000_14.1.e011284.15","doi-asserted-by":"crossref","first-page":"1753","DOI":"10.1021\/acsmedchemlett.1c00373","article-title":"BMS-813160: A potent CCR2 and CCR5 dual antagonist selected as a cClinical candidate","volume":"12","author":"Cherney","year":"2021","journal-title":"ACS Med Chem Lett"},{"key":"2026012206250553000_14.1.e011284.16","doi-asserted-by":"crossref","DOI":"10.3390\/ijms21144939","article-title":"Common drug pipelines for the treatment of diabetic nephropathy and hepatopathy: Can we kill two birds with one stone?","volume":"21","author":"Sumida","year":"2020","journal-title":"Int J Mol Sci"},{"key":"2026012206250553000_14.1.e011284.17","doi-asserted-by":"publisher","DOI":"10.3389\/fphar.2020.621093"},{"key":"2026012206250553000_14.1.e011284.18","doi-asserted-by":"crossref","DOI":"10.1158\/1538-7445.AM2018-CT124","article-title":"Abstract CT124: A phase Ib\/II study of BMS-813160, a CC chemokine receptor (CCR) 2\/5 dual antagonist, in combination with chemotherapy or nivolumab in patients (pts) with advanced pancreatic or colorectal cancer","volume":"78","author":"Le","year":"2018","journal-title":"Cancer Res"},{"key":"2026012206250553000_14.1.e011284.19","doi-asserted-by":"crossref","DOI":"10.3389\/fimmu.2021.686057","article-title":"Case report: Complete response to nivolumab in a patient with programmed cell death 1 ligand 1-positive and multiple gene-driven anaplastic lymphoma kinase tyrosine kinase inhibitor-resistant lung adenocarcinoma","volume":"12","author":"Dong","year":"2021","journal-title":"Front Immunol"},{"key":"2026012206250553000_14.1.e011284.20","unstructured":"Opdivo (nivolumab) . Prescribing information. Bristol Myers Squibb; 2022."},{"key":"2026012206250553000_14.1.e011284.21","doi-asserted-by":"publisher","DOI":"10.1007\/s10637-019-00830-3"},{"key":"2026012206250553000_14.1.e011284.22","doi-asserted-by":"crossref","first-page":"1221","DOI":"10.1158\/2326-6066.CIR-23-1073","article-title":"Blockade of IL1\u03b2 and PD1 with combination chemotherapy reduces systemic myeloid suppression in metastatic pancreatic cancer with heterogeneous effects in the tumor","volume":"12","author":"Oberstein","year":"2024","journal-title":"Cancer Immunol Res"},{"key":"2026012206250553000_14.1.e011284.23","doi-asserted-by":"publisher","DOI":"10.1016\/j.immuni.2017.07.014"},{"key":"2026012206250553000_14.1.e011284.24","doi-asserted-by":"crossref","DOI":"10.3389\/fimmu.2021.771210","article-title":"Targeting the CCL2\/CCR2 axis in cancer immunotherapy: One stone, three birds?","volume":"12","author":"Fei","year":"2021","journal-title":"Front Immunol"},{"key":"2026012206250553000_14.1.e011284.25","doi-asserted-by":"crossref","first-page":"521","DOI":"10.1038\/tpj.2015.14","article-title":"Variations in genes involved in immune response checkpoints and association with outcomes in patients with resected colorectal liver metastases","volume":"15","author":"Stremitzer","year":"2015","journal-title":"Pharmacogenomics J"},{"key":"2026012206250553000_14.1.e011284.26","doi-asserted-by":"publisher","DOI":"10.1038\/s41591-020-0856-x"},{"key":"2026012206250553000_14.1.e011284.27","doi-asserted-by":"publisher","DOI":"10.1158\/1078-0432.CCR-20-2790"}],"container-title":["Journal for ImmunoTherapy of Cancer"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.1136\/jitc-2024-011284","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,1,22]],"date-time":"2026-01-22T14:25:21Z","timestamp":1769091921000},"score":1,"resource":{"primary":{"URL":"https:\/\/jitc.bmj.com\/lookup\/doi\/10.1136\/jitc-2024-011284"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,1]]},"references-count":27,"journal-issue":{"issue":"1","published-online":{"date-parts":[[2026,1,22]]},"published-print":{"date-parts":[[2026,1]]}},"alternative-id":["10.1136\/jitc-2024-011284"],"URL":"https:\/\/doi.org\/10.1136\/jitc-2024-011284","relation":{},"ISSN":["2051-1426"],"issn-type":[{"value":"2051-1426","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,1]]}}}