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Faster, more accessible clinical trial initiative being piloted in pancreatic cancer

A pancreatic cancer trial led from Addenbrooke’s Hospital, Cambridge, is piloting a new scheme intended to make clinical trials faster and more accessible for patients in line with the NHS 10-year plan.

The trial is investigating using immunotherapy as a precision medicine for people with pancreatic cancer, one of the hardest to treat forms of cancer.

With ‘Just in Time’, we hope to enable more pancreatic cancer patients to have access to immunotherapy through the PemOla trial and benefit from the convenience of being treated by their local team.

Dr Pippa Corrie, consultant medical oncologist at Addenbrooke’s Hospital and a researcher at the Department of Oncology, University of Cambridge

The ‘Just in Time’ scheme run by the National Institute for Health and Care Research (NIHR), could reduce the time needed to set up a clinical trial from months to only days. If successful, the scheme could allow more patients to benefit from access to clinical trials at hospitals closer to home.

For the first time, the scheme is being piloted in the PemOla trial, a precision medicine study exploring a combination immunotherapy using pembrolizumab and olaparib to treat pancreatic cancers that have a large number of genetic changes.

The trial is being led by Dr Pippa Corrie, consultant medical oncologist at Addenbrooke’s Hospital and a researcher at the Department of Oncology, University of Cambridge.

Pippa Corrie facing the camera in a clinical room

We are excited to be testing a novel precision immunotherapy treatment, which we hope will have a transformative effect for the group of patients that we think could benefit.

Dr Pippa Corrie

Pancreatic cancer is one of the hardest cancers to diagnose and treat. Despite much research, there has been little progress in improving patient outcomes in the last 50 years. It is one of the ten most common forms of cancer, but only 1 in 5 patients diagnosed in the early stages of the disease and only 5% of pancreatic cancer patients survive more than 10 years beyond diagnosis.

Precision medicine has transformed the treatment of many cancers, yet little has changed for people with pancreatic cancer.

Treatments beyond standard surgery and chemotherapy aimed at combatting the disease are very limited. Precision medicines, including immunotherapies, are proving effective in helping treat many types of cancer and use scientific analysis of cancer cells to identify biological weaknesses that can be targeted with specific treatments.

We welcome this new trial, which aims to test a personalised approach to immunotherapy for the disease. By using genomics to identify which patients are most likely to benefit from treatment, this study has the potential to increase the effectiveness of treatment, allowing patients to spend more precious time with their families.

Dr Chris Macdonald, Head of Research at Pancreatic Cancer UK

Immunotherapy aims to activate the body’s own immune system, causing it to attack and destroy cancer cells. Immunotherapy drugs can be highly effective if given to the right patients as precision medicines.

A key challenge when testing new precision medicines is finding patients who are most likely to benefit from a new treatment. Often this might be a small fraction of those people diagnosed with a certain type of cancer.

The ‘Just In Time’ scheme will enable a hospital to join a trial when they know they have a patient who is eligible for it. Reducing the time to set up a site from several months to a matter of days. So, more hospitals will be able to participate and more patients will be able to access clinical trials and be treated closer to home.

We hope the ‘Just in Time’ scheme will help people get the care they need faster and closer to home, so that they are given the best chance to respond to therapies while being surrounded by their loved ones.

Prof Nick Lemoine, Strategic Development Director at the NIHR Research Delivery Network (RDN)

If successful, ‘Just In Time’ will accelerate patient recruitment, speed up the time it takes to complete clinical trials and get results more quickly. At the same time, it will reduce the work involved in setting up new trials. This could be a dramatic leap forward in the development of new precision medicines designed to help rare patient groups.

It also aligns with the NHS 10-year plan ambition to help more people benefit from innovative medicines by speeding up clinical trials and making them more a part of routine patient care.

The need for new treatments for patients with pancreatic cancer makes PemOla an ideal test case for ‘Just in Time’.

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The PemOla trial is funded by the Efficacy and Mechanism Evaluation (EME) Programme, a partnership between the NIHR and the Medical Research Council, and supported by Merck, Sharp & Dohme, the manufacturer of pembrolizumab and olaparib, which is providing the drugs for the trial patients. The trial is being run from the Cambridge Clinical Trials Unit and sponsored by Cambridge University Hospitals NHS Foundation Trust, and has additional support from Addenbrooke’s Charitable Trust.

Improvements to clinical trial processes will be further enabled in Cambridge through the closer working of clinicians and researchers within the planned Cambridge Cancer Research Hospital, which is being designed to lead the development and delivery of pioneering care and novel precision medicines.