# EORTC 1607: pembrolizumab with cisplatin and gemcitabine in biliary tract cancer

Source: https://onco.cc/trials/eortc-1607-pembro-cisgem/  
OnCo record `eortc-1607-pembro-cisgem` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A 50-patient European single-arm study that added pembrolizumab to standard chemotherapy for bile duct and gallbladder cancer at sites including three in England, run before the large KEYNOTE-966 trial reported.

## Summary

EORTC 1607 (NCT03260712) was an open-label single-arm phase 2 of cisplatin and gemcitabine combined with pembrolizumab as first-line treatment for advanced or metastatic biliary tract carcinoma, intrahepatic or extrahepatic, or gallbladder cancer. The primary endpoint was the progression-free survival rate at six months by RECIST 1.1. Fifty patients were enrolled at seven sites in Germany, Spain and the United Kingdom between January 2020 and April 2023, and the study completed in August 2023. Results were not found in Europe PMC in September 2026; the randomised KEYNOTE-966 trial has since established the combination's survival benefit.

## Fields

- Kind: Trial
- Status: completed
- Last checked: 2026-09-24
- Also known as: EORTC-1607
- Registry id: NCT03260712
- Phase: 2
- Setting: First-line advanced or metastatic biliary tract cancer including gallbladder cancer: cisplatin and gemcitabine with pembrolizumab, single arm, primary endpoint 6-month progression-free survival rate
- Sponsor: European Organisation for Research and Treatment of Cancer
- Enrolled: 50

## Notes

- UK sites (3, registry): University College Hospital (London), The Christie (Manchester), Nottingham City Hospital.

## Sources

- ClinicalTrials.gov NCT03260712: https://clinicaltrials.gov/study/NCT03260712

## Connected records

- cancers: [Biliary tract cancer (all types)](https://onco.cc/cancers/biliary-tract-cancer/), [Biliary tract cancer (cholangiocarcinoma)](https://onco.cc/cancers/cholangiocarcinoma/), [Gallbladder cancer](https://onco.cc/cancers/gallbladder/)
- technologies: [Cytotoxic chemotherapy](https://onco.cc/technologies/cytotoxic-chemotherapy/), [Immune checkpoint inhibitors](https://onco.cc/technologies/checkpoint-inhibitor/), [Platinum agents](https://onco.cc/technologies/platinum/)
- drugs: [Cisplatin](https://onco.cc/drugs/cisplatin/), [Gemcitabine](https://onco.cc/drugs/gemcitabine/), [Gemcitabine + cisplatin](https://onco.cc/drugs/gemcitabine-cisplatin/), [Pembrolizumab](https://onco.cc/drugs/pembrolizumab/)
- terms: [Gallbladder cancer in biliary tract cancer trials (eligibility and subgroups)](https://onco.cc/terms/gallbladder-cancer-in-biliary-trials/)

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