PemOla
Research type
Research Study
Full title
A phase II study combining pembrolizumab with olaparib in metastatic pancreatic adenocarcinoma patients with mismatch repair deficiency or tumour mutation burden > 4 mutations/Mb
IRAS ID
1004744
Contact name
Pippa Corrie
Contact email
Sponsor organisation
Cambridge University Hospitals NHS Foundation Trust
Eudract number
2021-006652-13
ISRCTN Number
N/A
Clinicaltrials.gov Identifier
Research summary
Pancreatic adenocarcinoma (PDA) is one of the 10 most common cancer types: over 8,500 UK patients are diagnosed with this disease each year. PDA begins in the cells that line the ducts of the pancreas. Most patients present with advanced disease and may be offered treatment with chemotherapy, but benefits are modest. More effective treatments are much needed. We now know that PDA is not a single entity and different subtypes may be more likely to respond to modern interventions such as immunotherapy.
This trial is being carried out to test whether pembrolizumab combined with olaparib is an effective treatment for patients with metastatic PDA and tumour mutation burden (TMB) >4 mutations/Mb. Pembrolizumab is routinely used as an effective immunotherapy treatment for many cancer types, such as melanoma skin cancer, kidney cancer and lung cancer, but is not routinely used to treat pancreatic cancer. Olaparib is mainly used to treat certain types of ovarian and breast cancers.
20 patients will be recruited from approximately 20 participating sites. Patients must be aged ≥ 18 years old, and have confirmed stage 4 mPDA with measurable disease and TMB >4 mutations/Mb, or dMMR gene mutation, or MSI-H IHC.
All participants will receive both study drugs. Pembrolizumab will be given intravenously once every 3 weeks and olaparib will be given as a tablet twice a day. Participants will undergo routine and research tests and assessments, including CT scans, blood, urine and stool tests. The trial duration for an individual patient consists of a 28-day screening period and a treatment period until disease progression up to a maximum of 2 years. Participants that have withdrawn or completed the study will be referred back to their usual hospital doctor.
REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
23/EM/0270
Date of REC Opinion
20 Dec 2023
REC opinion
Further Information Favourable Opinion