Actively Recruiting
Pembrolizumab With Olaparib as Combined Therapy in Metastatic Pancreatic Cancer
Led by Cambridge University Hospitals NHS Foundation Trust · Updated on 2025-09-18
20
Participants Needed
13
Research Sites
148 weeks
Total Duration
On this page
Sponsors
C
Cambridge University Hospitals NHS Foundation Trust
Lead Sponsor
N
National Institute for Health Research, United Kingdom
Collaborating Sponsor
AI-Summary
What this Trial Is About
A phase II study combining pembrolizumab with olaparib in metastatic pancreatic adenocarcinoma patients with high tumour mutation burden
CONDITIONS
Official Title
Pembrolizumab With Olaparib as Combined Therapy in Metastatic Pancreatic Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Provided written informed consent
- Histologically or cytologically confirmed pancreatic adenocarcinoma
- Tumor mutation burden greater than 4 mutations per megabase, or confirmed mismatch repair deficiency or microsatellite instability-high status by immunohistochemistry
- Radiologically confirmed stage 4 metastatic pancreatic adenocarcinoma with measurable disease
- Received no more than one prior systemic therapy regimen for unresectable pancreatic cancer
- Measurable disease not previously treated with radiotherapy
- Eastern Cooperative Oncology Group Performance Status of 0 or 1
- Life expectancy greater than 12 weeks from screening
- Adequate bone marrow function with neutrophil count ≥1.5 x 10^9/L, hemoglobin ≥90 g/L, and platelets ≥100 x 10^9/L
- Adequate liver function with AST or ALT ≤2.5 times upper limit of normal or <5 times if liver metastases are present, and total bilirubin <1.5 times upper limit of normal
- Adequate kidney function with creatinine clearance ≥50 mL/min
You will not qualify if you...
- Patients with resectable or locally advanced pancreatic adenocarcinoma
- Other invasive cancers diagnosed within the last 2 years not treated with curative intent
- Prior treatment with immune checkpoint inhibitors or PARP inhibitors
- Need for high-dose daily oral steroids or regular use of other immunosuppressive agents (low-dose steroids allowed)
- Significant acute or chronic medical or psychiatric conditions posing undue risk or interfering with the trial, including severe lung disease, recent cardiovascular events, active infections, liver cirrhosis, HIV or hepatitis B or C, severe allergies, autoimmune disease requiring immunosuppression, active additional malignancies within 3 years, brain metastases, or myelodysplastic syndrome/acute myeloid leukemia
- Pregnancy, plans to become pregnant, or lactation
- Unwillingness to use contraception during and for 120 days after treatment
- Inability to swallow oral medication or gastrointestinal conditions affecting absorption
- Use of strong CYP3A4 inhibitors or inducers
- Previous systemic anti-cancer therapy or investigational agents within 4 weeks prior to screening
- Severe hypersensitivity to pembrolizumab or its components
- Recent radiotherapy within 2 weeks before study treatment
- Live vaccine within 30 days before first dose
- Recent use of colony-stimulating factors within 28 days
- Participation in other investigational studies within 4 weeks
- Persistent grade 2 or higher toxicities from prior cancer therapy (except hair loss)
- History of allogenic tissue or solid organ transplant
- Investigator judgment deeming participation unsafe or inappropriate
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 13 locations
1
Addenbrooke's Hospital
Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ
Actively Recruiting
2
Velindre Cancer Centre
Cardiff, United Kingdom, CF14 2TL
Actively Recruiting
3
University Hospitals Coventry and Warwickshire
Coventry, United Kingdom
Actively Recruiting
4
Beatson West of Scotland Cancer Centre
Glasgow, United Kingdom
Actively Recruiting
5
St James' University Hospital
Leeds, United Kingdom
Actively Recruiting
6
Guy's and St Thomas' NHS Foundation Trust
London, United Kingdom
Actively Recruiting
7
Royal Free Hospital
London, United Kingdom
Actively Recruiting
8
University College London Hospitals NHS Foundation Trust
London, United Kingdom
Actively Recruiting
9
The Christie
Manchester, United Kingdom
Actively Recruiting
10
Milton Keynes University Hospital
Milton Keynes, United Kingdom
Actively Recruiting
11
Norfolk and Norwich University Hospital
Norwich, United Kingdom
Actively Recruiting
12
Nottingham University Hospitals NHS Foundation Trust
Nottingham, United Kingdom
Actively Recruiting
13
Derriford Hospital
Plymouth, United Kingdom
Actively Recruiting
Research Team
C
Clinical Trial Coordinator
CONTACT
E
Early phase team Cambridge Clincial Trials Unit -Cancer Theme
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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