# Durvalumab with or without tremelimumab for patients with metastatic pancreatic ductal adenocarcinoma: a phase 2 randomized clinical trial

Source: https://onco.cc/key-papers/paper-oreilly-durvalumab-tremelimumab-pancreatic-jama-oncol-2019/  
OnCo record `paper-oreilly-durvalumab-tremelimumab-pancreatic-jama-oncol-2019` (Key paper). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Giving 65 patients with advanced pancreatic cancer a PD-L1 antibody alone or with a CTLA-4 antibody shrank tumours in 3% and 0%, so the trial was stopped before its second stage.

## Summary

Part A of a two-part phase 2 randomised trial was a lead-in safety, open-label study with planned expansion pending an efficacy signal. Between November 2015 and March 2017, 65 patients with metastatic pancreatic ductal adenocarcinoma who had received one prior fluorouracil- or gemcitabine-based line were enrolled at 21 sites in 6 countries and randomised to durvalumab 1500 mg every 4 weeks plus tremelimumab 75 mg every 4 weeks for 4 cycles then durvalumab, or durvalumab monotherapy. Grade 3 or higher treatment-related adverse events occurred in 22% and 6%. Objective response rate was 3.1% for combination and 0% for monotherapy; the 10% threshold for expansion was not met and part B did not open. Patient numbers limited any association with PD-L1 expression or microsatellite instability.

## Fields

- Kind: Key paper
- Last checked: 2026-09-24
- Journal: JAMA Oncology
- Year: 2019
- DOI: 10.1001/jamaoncol.2019.1588
- Authors: O'Reilly EM, Oh DY, Dhani N, et al.
- Findings: Objective response 3.1% with durvalumab plus tremelimumab and 0% with durvalumab alone.; Trial did not expand: the 10% efficacy threshold was not met.
- What it means: Dual checkpoint blockade, which rescued other cold tumours, does not work in unselected pancreatic cancer; combinations must change the microenvironment first.
- Caveats: Second-line population with rapidly progressing disease.; No biomarker selection and small numbers.

## Sources

- O'Reilly et al., JAMA Oncol 2019: durvalumab with or without tremelimumab in 65 metastatic patients: https://doi.org/10.1001/jamaoncol.2019.1588
- PubMed: https://pubmed.ncbi.nlm.nih.gov/31318392/

## Connected records

- cancers: [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/), [PD-L1](https://onco.cc/targets/pdl1/)
- drugs: [Durvalumab](https://onco.cc/drugs/durvalumab/)
- institutions: [Memorial Sloan Kettering Cancer Center](https://onco.cc/institutions/mskcc/)
- 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/)
- people: [Eileen M. O'Reilly](https://onco.cc/people/eileen-oreilly/)
- journals: [JAMA Oncology](https://onco.cc/journals/jama-oncology/)

---
JSON: https://onco.cc/api/v1/entities/paper-oreilly-durvalumab-tremelimumab-pancreatic-jama-oncol-2019.json