At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Pembrolizumab (drug), Olaparib (drug)
- How long the study runs
- Study runs about 35 months (dates as stated)
- About the drug or intervention
- Pembrolizumab — drug: Pembrolizumab is a highly selective immunoglobulin G4-kappa humanised monoclonal antibody against Programmed cell death protein 1 (PD-1) receptor. · Olaparib — drug: Olaparib is a potent inhibitor of polyadenosine 5'diphosphoribose polymerase (PARP) developed as a monotherapy as well as for combination with chemotherapy, ionising radiation and other anti-cancer agents including novel agents and immunotherapy.
- Patient visit burden
- Not specified by the sponsor
In plain English
This trial is looking at combining two drugs, pembrolizumab and olaparib, to treat pancreatic cancer that has spread to other parts of the body (stage 4). It is for people whose cancer has certain genetic features, such as high tumour mutational burden (TMB), mismatch repair deficiency (dMMR), or high microsatellite instability (MSI-H). It is run by Cambridge University Hospitals NHS Foundation Trust.
Who can take part
- Aged 18 or over, and able to give written informed consent
- Pancreatic cancer confirmed by tissue or cell testing, with certain genetic features: TMB above 4 mutations per megabase, dMMR, or MSI-H (these can be checked from tissue or blood)
- Stage 4 pancreatic cancer that has spread, confirmed by scans, with tumours that can be measured and have not previously been treated with radiotherapy
- Have had no more than one previous course of systemic (whole-body) treatment for stage 3 or 4 pancreatic cancer
- Fairly fit and well day to day (performance status score of 0 or 1), with a life expectancy of more than 12 weeks
- Healthy enough blood counts, and liver and kidney function, based on blood tests
Who may not be able to
- Pancreatic cancer that could be removed by surgery, or locally advanced disease
- Another invasive cancer diagnosed in the last 2 years that has not been treated with the aim of cure, or another cancer that is growing or needed treatment in the past 3 years (some treated skin cancers are allowed)
- Previous treatment with immune checkpoint inhibitors or PARP inhibitors (drugs like pembrolizumab that affect the immune system)
- Needing regular steroids or other drugs that suppress the immune system (low-dose steroids, and inhaled or skin steroids, are allowed)
- Serious health problems that could make taking part risky, such as lung disease causing breathlessness at rest, a recent heart attack, stroke or uncontrolled heart failure, active infection, cirrhosis of the liver, HIV, hepatitis B or C, severe allergies, or autoimmune disease needing immune-suppressing drugs
- Cancer that has spread to the brain, or cancer in the lining of the brain and spinal cord
- A blood or bone marrow condition such as myelodysplastic syndrome (MDS) or acute myeloid leukaemia (AML)
- Pregnancy, breastfeeding, or planning to become pregnant; people able to have children must use contraception during the trial and for 120 days after the last dose
- Being unable to swallow tablets, or gut problems that could stop the medicine being absorbed
- Taking certain medicines that strongly affect how the body processes drugs (CYP3A4 inhibitors or inducers)
- Cancer treatment or an experimental drug within 4 weeks before screening, radiotherapy within 2 weeks, or lasting side effects (worse than mild, apart from hair loss)
- Severe allergic reaction (grade 3 or worse) to pembrolizumab or its ingredients
- A live vaccine within 30 days before the first dose, or certain blood growth factor injections within 28 days before
- Having had a donor tissue or organ transplant
- Any other reason the doctor believes the person should not take part
What taking part involves
- • Taking the trial drugs pembrolizumab and olaparib together
- • Details of how the drugs are given (for example, drip or tablets), how often, and for how long: Not stated — ask the trial team
Time commitment: Not stated — ask the trial team. Details such as number of hospital visits, tests, and length of the trial are not included in the information provided.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 20
- Started
- 2025-02-26
- Last checked
- 2026-06
Plain English Summary
What is this study?
- • Testing a new treatment for pancreatic cancer
- • Phase2 - 20 participants
- • A phase II study combining pembrolizumab with olaparib in metastatic pancreatic adenocarcinoma patients with high tumour mutation burden
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with pancreatic cancer
Where?
- • Cambridge - Addenbrooke's Hospital
- • Bodelwyddan - Glan Clwyd Hospital
- • Cardiff - Velindre Cancer Centre
- • Coventry - University Hospitals Coventry and Warwickshire
- • +11 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
A phase II study combining pembrolizumab with olaparib in metastatic pancreatic adenocarcinoma patients with high tumour mutation burden
More detail
This is a phase II single arm, open label, prospective trial investigating the efficacy of pembrolizumab plus olaparib in metastatic pancreatic adenocarcinoma patients exhibiting high tumour mutation burden (defined as ≥4 mutations/Mb, including tumours with Mismatch Repair Deficient (MMRD) /Microsatellite Instability (MSI) high).
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
Biomarkers mentioned
What the study is looking for
- ✓Aged ≥ 18 years old
- ✓Written agreement to take part
- ✓confirmed by testing a sample PDA
- ✓Confirmation that the PDA has TMB \>4 mutations/Mb, or dMMR gene mutation, or MSI-H by IHC. TMB status and dMMR can...
- ✓Radiologically confirmed stage 4 mPDA, with cancer that can be measured on scans
Who cannot take part
- ✗Patients with resectable or that has grown locally PDA
- ✗Other invasive malignancies diagnosed within the last 2 years which have not been treated with curative intent
- ✗Uncontrolled ischaemic heart or other cardiovascular event (myocardial infarction, new angina, stroke transient...
- ✗Stable but significant cardiovascular disease defined by heart failure (New York Heart Association Functional...
- ✗Presence of active infection
See the full criteria
Where Is This Study? (15 UK sites)
Addenbrooke's Hospital
Cambridge CB2 0QQ, United Kingdom
Glan Clwyd Hospital
Bodelwyddan LL18 5UJ, United Kingdom
Velindre Cancer Centre
Cardiff CF14 2TL, United Kingdom
University Hospitals Coventry and Warwickshire
Coventry, United Kingdom
Beatson West of Scotland Cancer Centre
Glasgow, United Kingdom
St James' University Hospital
Leeds, United Kingdom
Clatterbridge Cancer Centre
Liverpool L7 8YA, United Kingdom
Guy's and St Thomas' NHS Foundation Trust
London, United Kingdom
Royal Free Hospital
London, United Kingdom
University College London Hospitals NHS Foundation Trust
London, United Kingdom
The Christie
Manchester, United Kingdom
Milton Keynes University Hospital
Milton Keynes, United Kingdom
Norfolk and Norwich University Hospital
Norwich, United Kingdom
Nottingham University Hospitals NHS Foundation Trust
Nottingham, United Kingdom
Derriford Hospital
Plymouth, United Kingdom
How to Get in Touch
Clinical Trial Coordinator
Sponsor contactCONTACT
Early phase team Cambridge Clincial Trials Unit -Cancer Theme
Sponsor contactCONTACT
