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Pancreatic CancerPhase 2NCT05093231

Pembrolizumab With Olaparib as Combined Therapy in Metastatic Pancreatic Cancer

A Phase 2 study testing Pembrolizumab and Olaparib in people with Pancreatic Cancer, run by Cambridge University Hospitals NHS Foundation Trust at 17 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

A phase II study combining pembrolizumab with olaparib in metastatic pancreatic adenocarcinoma patients with high tumour mutation burden Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pancreatic Cancer
What is being tested?
Pembrolizumab and Olaparib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
17 sitesin 2 countries
Study dates
26 Feb 2025to 30 Jul 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
Show all 29Show fewer
  • 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.

Trial locations and contacts

17 sites in 2 countries.

17 sites in 2 countries

United Kingdom15 sites

  • Glan Clwyd Hospital

    Bodelwyddan, LL18 5UJ

  • Addenbrooke's Hospital

    Cambridge, Cambridgeshire, CB2 0QQ

  • Velindre Cancer Centre

    Cardiff, CF14 2TL

  • University Hospitals Coventry and Warwickshire

    Coventry

  • Beatson West of Scotland Cancer Centre

    Glasgow

  • St James' University Hospital

    Leeds

  • Clatterbridge Cancer Centre

    Liverpool, L7 8YA

  • Guy's and St Thomas' NHS Foundation Trust

    London

  • Royal Free Hospital

    London

  • University College London Hospitals NHS Foundation Trust

    London

  • The Christie

    Manchester

  • Milton Keynes University Hospital

    Milton Keynes

  • Norfolk and Norwich University Hospital

    Norwich

  • Nottingham University Hospitals NHS Foundation Trust

    Nottingham

  • Derriford Hospital

    Plymouth

Other trials in United Kingdom

Australia2 sites

  • Monash Health

    Melbourne, 3168

  • Epworth Healthcare

    Richmond, 3121

Other trials in Australia

About this study

Official title: A Phase II Study Combining Pembrolizumab With Olaparib in Metastatic Pancreatic Adenocarcinoma (PDA) Patients With Mismatch Repair Deficiency or Tumour Mutation Burden > 4 Mutations/Mb

A phase II study combining pembrolizumab with olaparib in metastatic pancreatic adenocarcinoma patients with high tumour mutation burden

Read the detailed description

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).

Being tested
Pembrolizumab, Olaparib
Keywords
High tumour burden, molecular profiling, confirmed MMRD or MSI-H IHC, pancreatic cancer
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PembrolizumabDrug

    Also called Keytruda, MK-3475

    Pembrolizumab is a highly selective immunoglobulin G4-kappa humanised monoclonal antibody against Programmed cell death protein 1 (PD-1) receptor. It was generated by grafting the variable sequences of a very high-affinity mouse antihuman PD-1 antibody onto a human IgG4-kappa isotype with the containing a stabilizing Serine 228 to Proline Fc mutation.

  • OlaparibDrug

    Also called Lynparza, AZD2281, KU-0059436

    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.

Study groups in NCT05093231
Study groupRoleWhat they receive
Pembrolizumab and olaparibExperimentalPembrolizumab will be given as a fixed dose of 200mg standard dose on Day 1 (+/-3 days) of every 3 weeks cycle , administered intravenously as a ~30 minute infusion, as per standard clinical practice. Olaparib dose is 300mg given orally, twice daily, from Day 1 to Day 21 continuously of each 3-week cycle. Dosing will start on day 1 of each cycle.
Receives: Drug: Pembrolizumab; Drug: Olaparib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective Response Rate (ORR)

    ORR assessed by (RECIST) version 1.1 and CT scanning every 9 weeks for the first 9 cycles (27 weeks), then 12 weekly

    Measured: Through study completion, an average of 2 years

Secondary outcomes (6)

  1. Incidence of adverse events (Safety and toxicity)

    Safety and toxicity using NCI CTCAE version 5.0

    Measured: Through study completion, an average of 2 years

  2. Duration of Response (DOR)

    DOR: the time (in days) from the first documentation of objective response (complete response or partial response, confirmed or unconfirmed, whichever status was recorded first, using RECIST criteria) until the first documented disease progression, or death (if before progression

    Measured: Through study completion, an average of 2 years

  3. Progression Free Survival (PSF)

    PFS: the time from registration to disease progression, or death, whichever occurs first, assessed by the treating investigators. Patients who remained alive without disease progression at the time of data analyses are censored at their last date of clinical follow-up for progression. Median, 1 year and 2 year PFS rates will be measured

    Measured: through study completion, a maximum of 2 years

  4. Overall survival (OS)

    OS: the time from registration to death. Patients who remain alive are censored at their last contact date for OS. Median, 1 year and 2 year OS rates will be measured.

    Measured: through study completion, a maximum of 2 year

  5. European Organisation for Research and Treatment of Cancer Quality of Life of Cancer Patients questionnaire (EORTC QLQC30)

    EORTC QLQC30 quality of life questionnaire. Min score 28, maximum score 112. Higher scores equal worse outcome. (Extra 2 questions: min score 1, max score 7 each. Higher scores equals better outcomes.)

    Measured: Every 9 weeks during the first 27 weeks and then every 12 weeks until death or maximum of 2 years

  6. European Organisation for Research and Treatment of Cancer Pancreatic Cancer Quality of Life Questionnaire (EORTC PAN26)

    EORTC PAN26 quality of life questionnaire. Min score 26, maximum score 104. Higher scores equals worse outcomes.

    Measured: Every 9 weeks during the first 27 weeks and then every 12 weeks until death or maximum of 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Oct 2021
  2. Study start26 Feb 2025
  3. Primary completion30 Nov 2026 (estimated)
  4. Study completion30 Jul 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05093231
Sponsor's protocol ID
PemOla
Status last verified
Oct 2026
First submitted
3 Jun 2021
Last updated
30 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pembrolizumab and Olaparib in people with Pancreatic Cancer, run by Cambridge University Hospitals NHS Foundation Trust at 17 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in United Kingdom, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) (time frame: Through study completion, an average of 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05093231.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026; AzTrials last refreshed its copy on 8 Nov 2026.

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