RecruitingPhase 2NCT05093231

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


Sponsor

Cambridge University Hospitals NHS Foundation Trust

Enrollment

20 participants

Start Date

Feb 26, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of two cancer drugs — pembrolizumab (an immunotherapy) and olaparib (a PARP inhibitor that blocks cancer cell DNA repair) — for people with advanced pancreatic cancer whose tumors have specific genetic features that may make them more responsive to these treatments. **You may be eligible if...** - You have been diagnosed with metastatic pancreatic cancer (stage 4) - Your tumor has a specific genetic marker: high mutation burden (TMB > 4), a mismatch repair gene mutation (dMMR), or microsatellite instability (MSI-H) - You have received no more than one prior treatment for unresectable or metastatic pancreatic cancer - You are 18 or older in reasonably good health (ECOG 0 or 1) - Your blood counts, liver, and kidney function are adequate **You may NOT be eligible if...** - Your cancer is still potentially resectable (removable by surgery) - You have active brain metastases - You have active autoimmune disease - You are pregnant or breastfeeding - Your tumor does not have the required genetic features Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPembrolizumab

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.

DRUGOlaparib

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.


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

Norfolk and Norwich University Hospital

Norwich, United Kingdom

Nottingham University Hospitals NHS Foundation Trust

Nottingham, United Kingdom

Derriford Hospital

Plymouth, United Kingdom

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT05093231


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