# Phase 2 trial of single agent ipilimumab (anti-CTLA-4) for locally advanced or metastatic pancreatic adenocarcinoma

Source: https://onco.cc/key-papers/paper-royal-ipilimumab-pancreatic-j-immunother-2010/  
OnCo record `paper-royal-ipilimumab-pancreatic-j-immunother-2010` (Key paper). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

## Fields

- Kind: Key paper
- Last checked: 2026-09-24
- Journal: Journal of Immunotherapy
- Year: 2010
- DOI: 10.1097/CJI.0b013e3181eec14c
- Authors: Royal RE, Levy C, Turner K, et al.
- Findings: No RECIST responses to single-agent ipilimumab in 27 patients.; One delayed regression after apparent progression.
- What it means: 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.

## Sources

- Royal et al., J Immunother 2010: ipilimumab in 27 patients, no RECIST response: https://doi.org/10.1097/CJI.0b013e3181eec14c
- PubMed: https://pubmed.ncbi.nlm.nih.gov/20842054/

## Connected records

- cancers: [Locally advanced unresectable pancreatic ductal adenocarcinoma](https://onco.cc/cancers/locally-advanced-pdac/), [Metastatic pancreatic ductal adenocarcinoma](https://onco.cc/cancers/metastatic-pdac/), [Pancreatic ductal adenocarcinoma](https://onco.cc/cancers/pancreatic/)
- targets: [CTLA-4](https://onco.cc/targets/ctla4/)
- drugs: [Ipilimumab](https://onco.cc/drugs/ipilimumab/)
- institutions: [NCI Center for Cancer Research (intramural programme)](https://onco.cc/institutions/nci-ccr/)
- pathways: [PD-1 / PD-L1 immune checkpoint & T-cell activation](https://onco.cc/pathways/pd1-checkpoint/)
- terms: [Hot vs cold tumours](https://onco.cc/terms/cold-vs-hot/)

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