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Pembrolizumab With Olaparib as Combined Therapy in Metastatic Pancreatic Cancer | Clinical Trials | Clareo Health

RECRUITINGPHASE2

Pembrolizumab With Olaparib as Combined Therapy in Metastatic Pancreatic Cancer

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

NCT05093231•Cambridge University Hospitals NHS Foundation Trust

View on ClinicalTrials.gov

Summary

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

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).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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:
+7 more criteria

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
+19 more criteria

Locations (13)

Addenbrooke's Hospital

Cambridge, Cambridgeshire, United Kingdom

Velindre Cancer Centre

Cardiff, 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

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

Key Dates

Start Date

February 26, 2025

Primary Completion Date

July 31, 2027

Completion Date

January 1, 2028

Last Updated

September 18, 2025

Enrollment

ESTIMATED participants

Conditions

Pancreatic Cancer

Interventions

Pembrolizumab

DRUG

Olaparib

DRUG

Contacts

Clinical Trial Coordinator

CONTACT

+44 01223348454 cuh.pemola@nhs.net

Early phase team Cambridge Clincial Trials Unit -Cancer Theme

CONTACT

01223348454 cuh.cctuep@nhs.net

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 18, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Pembrolizumab With Olaparib as Combined Therapy in Metastatic Pancreatic Cancer

Inclusion Criteria

Exclusion Criteria

Testing A New Anti-cancer Drug Combination, Entinostat and ZEN003694, for Advanced and Refractory Solid Tumors

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

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