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RecruitingPHASE2INTERVENTIONAL

Pembrolizumab With Olaparib as Combined Therapy in Metastatic Pancreatic Cancer

This study is exploring a new combination treatment for pancreatic cancer that has spread to other parts of the body. Researchers are looking at how effective two drugs, pembrolizumab and olaparib, are when given together. This trial is specifically for patients whose pancreatic cancer has a high number of genetic changes (called a 'high tumour mutation burden'). These changes can sometimes make cancers more responsive to certain treatments. Pembrolizumab works by helping the body's own immune system fight cancer, while olaparib is a targeted drug that can damage cancer cells with specific weaknesses. By combining these treatments, doctors hope to find a more powerful way to tackle this challenging cancer. The study aims to see if this combined approach can improve outcomes for patients with these particular genetic markers.

At a glance

Status
Recruiting
Phase
PHASE2
Sponsor
Cambridge University Hospitals NHS Foundation Trust
Enrolment target
20
Start
26 Feb 2025
Estimated completion
01 Jan 2028

What is this study about?

This study is an important step in finding new ways to treat pancreatic cancer that has spread. Pancreatic cancer can be very challenging to treat, and doctors are always looking for more effective options. This trial is focusing on a specific group of patients whose cancer has particular genetic features – a 'high tumour mutation burden'. This means their cancer cells have a large number of changes in their DNA, which can sometimes make the cancer respond differently to certain treatments.

The study combines two different types of drugs: pembrolizumab and olaparib. Pembrolizumab is an 'immunotherapy' drug. It works by essentially taking the brakes off your immune system, allowing your body's natural defenses to recognise and fight cancer cells more effectively. Olaparib is a 'targeted therapy' that works by interfering with the repair mechanisms of cancer cells, especially those with certain genetic weaknesses, causing them to die. By using these two drugs together, researchers hope to achieve a stronger anti-cancer effect.

This trial is a 'Phase II' study, which means it's one of the earlier stages of drug development where researchers are primarily looking at how well the treatment works and its safety in a larger group of patients, having already checked for basic safety in smaller groups. For patients with metastatic pancreatic cancer and these specific genetic markers, this trial aims to see if this new combination could offer a more promising path forward. It's about finding treatments that are more tailored to the individual characteristics of a patient's cancer.

Key takeaways

  • This study is for metastatic pancreatic cancer with specific genetic changes.
  • It combines two drugs: immunotherapy (pembrolizumab) and targeted therapy (olaparib).
  • Doctors are looking for new, more tailored treatments.
  • Participation involves regular clinic visits, tests, and taking the study drugs.
  • It's a Phase II study, checking effectiveness and safety.
  • You can discuss potential benefits and risks with the study team.

Who may be eligible?

To be considered for this study, you would need to be at least 18 years old and have pancreatic cancer that has spread to other parts of your body. An important requirement is that your cancer must show a high number of specific genetic changes, or a particular type of genetic fault, which will be checked by doctors.

You should generally be in good health, with important organs like your bones, liver, and kidneys working well within acceptable limits. You should also not have received too much prior treatment – usually no more than one previous chemotherapy or other similar treatment for your advanced cancer. Additionally, you cannot have had certain types of immunotherapy or PARP inhibitor drugs before.

The medical team will carefully review all your health information and test results to make sure this study is the right fit for you and that it's safe for you to take part. This ensures the study is conducted responsibly and focuses on gathering valuable information for patients who might benefit most.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Do I have pancreatic cancer that has spread?
  2. Has my doctor confirmed my cancer has specific genetic changes?
  3. Am I at least 18 years old?
  4. Have I had no more than one previous chemotherapy or similar treatment for my advanced cancer?
  5. Am I generally well enough to participate in a study?
Answer every question to see your result.

What does participation involve?

If you join this study, you will receive both pembrolizumab and olaparib. Pembrolizumab is given as a drip into a vein, while olaparib is taken as tablets. The exact schedule for these medications will be explained by the study team. You will have regular visits to the clinic for medical check-ups, blood tests, and scans to monitor your health and how the treatment is working. These assessments are important to track the cancer, manage any side effects, and ensure your safety.

The study is ongoing, meaning there isn't a fixed total duration for every patient. Treatment will continue as long as it is benefiting you and you are tolerating it well, unless you or your doctor decide to stop. There will also be follow-up appointments after treatment ends to see how you are doing in the longer term.

Potential risks and benefits

Participating in this study might offer the potential benefit of a new treatment approach for your pancreatic cancer with specific genetic markers, which could be more effective than standard options. However, like all medications, pembrolizumab and olaparib can cause side effects. These can range from mild, like tiredness or nausea, to more serious reactions, which the study team will monitor closely and manage carefully. There is also no guarantee that the treatment will be effective for everyone. It's important to remember that you are free to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (13)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Addenbrooke's Hospital
    Verified postcode
    Cambridge, United Kingdom· Recruiting
  • Velindre Cancer Centre
    Verified postcode
    Cardiff, United Kingdom· Recruiting
  • University Hospitals Coventry and Warwickshire
    Verified postcode
    Coventry, United Kingdom· Recruiting
  • Beatson West of Scotland Cancer Centre
    Verified postcode
    Glasgow, United Kingdom· Recruiting
  • St James' University Hospital
    Verified postcode
    Leeds, United Kingdom· Recruiting
  • Guy's and St Thomas' NHS Foundation Trust
    Verified postcode
    London, United Kingdom· Recruiting
  • Royal Free Hospital
    Verified postcode
    London, United Kingdom· Recruiting
  • University College London Hospitals NHS Foundation Trust
    Verified postcode
    London, United Kingdom· Recruiting
  • The Christie
    Verified postcode
    Manchester, United Kingdom· Recruiting
  • Milton Keynes University Hospital
    Verified postcode
    Milton Keynes, United Kingdom· Recruiting
  • Norfolk and Norwich University Hospital
    Verified postcode
    Norwich, United Kingdom· Recruiting
  • Nottingham University Hospitals NHS Foundation Trust
    Verified postcode
    Nottingham, United Kingdom· Recruiting

Common questions

What is 'metastatic pancreatic cancer'?

This means pancreatic cancer that has spread from where it started in the pancreas to other parts of your body.

What is a 'high tumour mutation burden'?

This refers to cancer cells that have a large number of genetic changes in their DNA. It can sometimes mean the cancer is more likely to respond to certain treatments, like the ones in this study.

What do pembrolizumab and olaparib do?

Pembrolizumab is an immunotherapy that helps your immune system fight cancer. Olaparib is a targeted drug that damages cancer cells with specific weaknesses.

What does being in a 'Phase II' study mean?

Phase II studies are an earlier stage of research that check how well a new treatment works and its safety in a group of patients, after initial safety checks.

Will I get these drugs if I don't join the study?

These specific drugs in combination, for this particular type of pancreatic cancer, are currently part of a research study. They may not be available outside of a clinical trial at this time.

How to find out more

Clinical Trial Coordinator

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "Pembrolizumab With Olaparib as Combined Therapy in Metastati…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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