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Looking for participantsPhase2

Pembrolizumab With Olaparib as Combined Therapy in Metastatic Pancreatic Cancer

Sponsor: Cambridge University Hospitals NHS Foundation Trust

NCT ID: NCT05093231

View on ClinicalTrials.gov ↗

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).

Pancreatic Cancer

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

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

MSIPD-L1CD137

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
Inclusion Criteria: * Aged ≥ 18 years old * Written informed consent * Histologically or cytologically confirmed PDA * Confirmation that the PDA has TMB \>4 mutations/Mb, or dMMR gene mutation, or MSI-H by IHC. TMB status and dMMR can be obtained from either tissue, or blood. * Radiologically confirmed stage 4 mPDA, with measurable disease * Received no more than 1 prior systemic therapy regimen for unresectable (stage 3 or 4) PDA is allowed * Measurable disease which has not been irradiated in prior radiotherapy * Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1 * Life expectancy \>12 weeks from the date of screening assessment * Adequate bone marrow function: * Absolute neutrophil count (ANC) ≥1.5 x 109 /L * Haemoglobin (Hb) ≥ 90 g/L * Platelets ≥100 x 109 /L * Adequate liver function: * Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤2.5 x upper limit of normal range (ULN), or \<5 x ULN in the presence of liver metastases * Total bilirubin \<1.5 x ULN * Adequate renal function defined as a calculated creatinine clearance by Cockcroft - Gault of ≥50 mL/min Exclusion Criteria: * Patients with resectable or locally advanced PDA * Other invasive malignancies diagnosed within the last 2 years which have not been treated with curative intent * Prior immune checkpoint inhibitors or PARP inhibitors. This includes any prior therapy with an anti-PD-1, or anti-PD-L1, or anti-PD-L2 agent, or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g, CTLA-4, OX 40, CD137) * Requirement for non-physiological dose of daily oral steroids, or regular use of any other immunosuppressive agents; prednisolone dose of \< 10mg (or equivalent steroid dose) is allowed. Use of inhaled or topical steroids is allowed. * Significant acute or chronic medical or psychiatric condition, disease or laboratory abnormality, which in the judgment of the investigator would place the patient at undue risk or interfere with the trial. Examples include, but are not limited to: * A history of chronic obstructive pulmonary disease, interstitial lung disease, sarcoidosis, idiopathic pulmonary fibrosis, pulmonary hypersensitivity pneumonitis, cystic fibrosis or bronchiectasis affecting pulmonary function, causing breathlessness at rest * Uncontrolled ischaemic heart or other cardiovascular event (myocardial infarction, new angina, stroke transient ischaemic attack, or new congestive cardiac failure) within the last 2 months * Stable but significant cardiovascular disease defined by heart failure (New York Heart Association Functional Classification III or IV) or frequent angina * Presence of active infection * Cirrhotic liver disease, known HIV, chronic active or acute hepatitis B, or hepatitis C * History of severe allergy or hypersensitivity reactions * Autoimmune disease requiring chronic use of immunosuppressive agents. * Replacement therapy using physiological doses for adrenal or pituitary insufficiency is allowed. * Known additional malignancy that is progressing or has required active treatment within the past 3 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ, excluding carcinoma in situ of the bladder, that have undergone potentially curative therapy are not excluded. * Has known brain metastases and/or carcinomatous meningitis * Has myelodysplastic syndrome (MDS)/acute myeloid leukaemia (AML) or with features suggestive of MDS/AML. * Women who are pregnant, or plan to become pregnant or are lactating. * Women of child-bearing potential and male patients who are unwilling to adhere to the contraception requirement from informed consent until the last dose of the trial treatment and for 120 days after the last dose of trial treatment. * Patients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of the trial medication. * Concomitant use of known potent CYP3A4 inhibitors and inducers. Restrictions relating to concomitant medications are described in section 10.9. Please consider wash-out periods. * Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to screening. * Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients * Has received prior radiotherapy within 2 weeks of start of study intervention. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-CNS disease. * Has received a live vaccine or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed. * Participant received colony-stimulating factors (e.g., granulocyte colony-stimulating factor \[G-CSF\], granulocyte-macrophage colony-stimulating factor \[GM CSF\] or recombinant erythropoietin) within 28 days prior to the first dose of study intervention. * Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study intervention. * Participant has persistent toxicities (\>CTCAE Grade 2) caused by previous cancer therapy, excluding alopecia. * Has had an allogenic tissue/solid organ transplant * Judgment by the Investigator that the patient should not participate in the trial.

Where Is This Study? (15 UK sites)

Addenbrooke's Hospital

Cambridge CB2 0QQ, United Kingdom

Recruiting
Site contact (verified)
Bristi BasuPrincipal Investigator
Clinical Trial Coordinator01223348454cuh.pemola@nhs.net

Glan Clwyd Hospital

Bodelwyddan LL18 5UJ, United Kingdom

Recruiting
Site contact (verified)
Angel GarciaPrincipal Investigator
Clinical Trial Coordinator+44 (0)1223 348 454cuh.pemola@nhs.net

Velindre Cancer Centre

Cardiff CF14 2TL, United Kingdom

Recruiting
Site contact (verified)
Seema ArifPrincipal Investigator
Clinical Trial Coordinator01223 348454cuh.pemola@nhs.net

University Hospitals Coventry and Warwickshire

Coventry, United Kingdom

Recruiting
Site contact (verified)
Martin Scott-BrownPrincipal Investigator
Clinical Trial Coordinatorcuh.pemola@nhs.net

Beatson West of Scotland Cancer Centre

Glasgow, United Kingdom

Recruiting
Site contact (verified)
Fieke FroelingPrincipal Investigator
Clinical Trial Coordinatorcuh.pemola@nhs.net

St James' University Hospital

Leeds, United Kingdom

Recruiting
Site contact (verified)
Alan AnthoneyPrincipal Investigator
Clinical Trial Coordinatorcuh.pemola@nhs.net

Clatterbridge Cancer Centre

Liverpool L7 8YA, United Kingdom

Recruiting
Site contact (verified)
Daniel PalmerPrincipal Investigator
Clinical Trial Coordinator+44 (0)1223 348 454cuh.pemola@nhs.net

Guy's and St Thomas' NHS Foundation Trust

London, United Kingdom

Recruiting
Site contact (verified)
Debashis SarkerPrincipal Investigator
Clinical Trial Coordinatorcuh.pemola@nhs.net

Royal Free Hospital

London, United Kingdom

Recruiting
Site contact (verified)
Roopinder GillmorePrincipal Investigator
Clinical Trial Coordinatorcuh.pemola@nhs.net

University College London Hospitals NHS Foundation Trust

London, United Kingdom

Recruiting
Site contact (verified)
John BridgewaterPrincipal Investigator
Clinical Trial Coordinatorcuh.pemola@nhs.net

The Christie

Manchester, United Kingdom

Recruiting
Site contact (verified)
Mairead McNamaraPrincipal Investigator
Clinical Trial Coordinatorcuh.pemola@nhs.net

Milton Keynes University Hospital

Milton Keynes, United Kingdom

Recruiting
Site contact (verified)
Wasiru SakaPrincipal Investigator
Clinical Trial Coordinatorcuh.pemola@nhs.net

Norfolk and Norwich University Hospital

Norwich, United Kingdom

Recruiting
Site contact (verified)
Daniel HolyoakePrincipal Investigator
Clinical Trial Coordinatorcuh.pemola@nhs.net

Nottingham University Hospitals NHS Foundation Trust

Nottingham, United Kingdom

Recruiting
Site contact (verified)
Arvind AroraPrincipal Investigator
Clinical Trial Coordinator+44 01223 348454cuh.pemola@nhs.net

Derriford Hospital

Plymouth, United Kingdom

Recruiting
Site contact (verified)
Dominique ParslowPrincipal Investigator
Clinical Trial Coordinatorcuh.pemola@nhs.net

How to Get in Touch

Clinical Trial Coordinator

Sponsor contact

CONTACT

+44 01223348454 cuh.pemola@nhs.net

Early phase team Cambridge Clincial Trials Unit -Cancer Theme

Sponsor contact

CONTACT

01223348454 cuh.cctuep@nhs.net
Data sourced from ClinicalTrials.gov · Last verified: 2026-06