{"entity":{"id":"paper-royal-ipilimumab-pancreatic-j-immunother-2010","kind":"paper","name":"Phase 2 trial of single agent ipilimumab (anti-CTLA-4) for locally advanced or metastatic pancreatic adenocarcinoma","aka":[],"tldr":"The first checkpoint inhibitor trial in pancreatic cancer gave ipilimumab to 27 patients and not one tumour shrank by the standard measure, though one patient regressed later after apparent progression.","summary":"Adults with locally advanced or metastatic pancreatic adenocarcinoma, measurable disease, good performance status and minimal comorbidity received intravenous ipilimumab 3.0 mg/kg every 3 weeks, four doses per course, for up to two courses. Twenty-seven were enrolled (20 metastatic, 7 locally advanced), median age 55. Three had grade 3 or higher immune-mediated adverse events (colitis, encephalitis, hypophysitis). There were no responders by RECIST, although one subject had a delayed response after initial progression, with regression of the primary and 20 hepatic metastases and normalisation of tumour markers.","asOf":"2026-09-24","links":[{"label":"Royal et al., J Immunother 2010: ipilimumab in 27 patients, no RECIST response","url":"https://doi.org/10.1097/CJI.0b013e3181eec14c"},{"label":"PubMed","url":"https://pubmed.ncbi.nlm.nih.gov/20842054/"}],"tags":[],"related":[],"cancers":["pancreatic","metastatic-pdac","locally-advanced-pdac"],"sections":[],"technologies":[],"targets":["ctla4"],"drugs":["ipilimumab"],"companies":[],"institutions":["nci-ccr"],"pathways":["pd1-checkpoint"],"terms":["cold-vs-hot"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"journal":"Journal of Immunotherapy","year":2010,"doi":"10.1097/CJI.0b013e3181eec14c","pmid":"20842054","authors":"Royal RE, Levy C, Turner K, et al.","paperType":"rct","findings":["No RECIST responses to single-agent ipilimumab in 27 patients.","One delayed regression after apparent progression."],"whatItMeans":"The first of the negative checkpoint trials that define pancreatic cancer as immunologically cold, with a single anecdote that kept the field going.","caveats":["Single-arm, 27 patients, no biomarker selection.","Predates the MSI-high exception."],"changedPractice":false,"participants":27},"route":"/key-papers/paper-royal-ipilimumab-pancreatic-j-immunother-2010/","neighbours":{"cancer":[{"id":"locally-advanced-pdac","kind":"cancer","name":"Locally advanced unresectable pancreatic ductal adenocarcinoma","route":"/cancers/locally-advanced-pdac/"},{"id":"metastatic-pdac","kind":"cancer","name":"Metastatic pancreatic ductal adenocarcinoma","route":"/cancers/metastatic-pdac/"},{"id":"pancreatic","kind":"cancer","name":"Pancreatic ductal adenocarcinoma","route":"/cancers/pancreatic/"}],"target":[{"id":"ctla4","kind":"target","name":"CTLA-4","route":"/targets/ctla4/"}],"drug":[{"id":"ipilimumab","kind":"drug","name":"Ipilimumab","route":"/drugs/ipilimumab/"}],"institution":[{"id":"nci-ccr","kind":"institution","name":"NCI Center for Cancer Research (intramural programme)","route":"/institutions/nci-ccr/"}],"pathway":[{"id":"pd1-checkpoint","kind":"pathway","name":"PD-1 / PD-L1 immune checkpoint & T-cell activation","route":"/pathways/pd1-checkpoint/"}],"term":[{"id":"cold-vs-hot","kind":"term","name":"Hot vs cold tumours","route":"/terms/cold-vs-hot/"}]}}