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Leading Pancreatic Cancer Research

The Precision-Panc platform’s pancreatic cancer research is diverse, focusing on translating basic scientific discoveries into the clinic. These include defining the genetic characteristics of pancreatic cancer, developing biomarkers of prognosis and response to treatment, and understanding why some cancers are resistant to drugs, in order to develop new treatments.

Advances in technology give the pancreatic cancer research teams the unparalleled ability to test pancreatic cancers in new ways, vastly increasing our understanding and leading to better, safer, more effective, personalised therapies. Building an accessible database is key and much of the information for this is based on data from the International Cancer Genome Consortium, as well as from the Cancer Genome Atlas. Precision-Panc researchers are networked with cancer researchers in more than 30 countries around the world, bringing together the information that is needed to improve current treatments and develop new ones.

Master Protocol

The Precision-Panc Master Protocol is a “portal” protocol for patients with known or suspected pancreatic cancer.  Patients can be screened and registered to Precision-Panc to allow some of their tissue and blood to be molecularly profiled, these results may by used to inform enrolment into PRIMUS (Pancreatic canceR Individualised Multi-arm Umbrella Study), examining different treatment regimens and/or biomarker development.

The overall aim of this research study is to improve the outcomes of patients with pancreatic cancer. It is designed to achieve this by studying of the make up of the cancer, in order to find out what the most effective treatment for each individual patient might be. It also aims to learn more about when, how and why people develop pancreatic cancer. We also hope to be able to predict which people are at risk of developing pancreatic cancer.

The main eligibility criteria for the Master Protocol is:

  • You must be at least 16 years of age
  • You must have either a mass highly suspicious of primary pancreatic cancer or histologically or cytologically confirmed pancreatic ductal adenocarcinoma and its variants
  • You must be willing to undergo tumour biopsy if this is required
  • You must be deemed suitable to receive chemotherapy or radiotherapy or surgery for their disease
  • You must be eligible for a currently open PRIMUS trial
  • You must sign screening and registration consent for the study

The Precision-Panc Master Protocol is currently open at 21 sites around the UK, with more due to open in the coming months.

Current Open Sites

  • Aberdeen Royal Infirmary
  • Addenbrooke’s Hospital, Cambridge
  • Bristol Haematology and Oncology Centre
  • Castle Hill Hospital, Hull
  • The Christie NHS Foundation Trust, Manchester
  • Glasgow Royal Infirmary
  • Imperial College Healthcare NHS Trust
  • King’s College Hospital NHS Foundation Trust
  • Manchester Royal Infirmary
  • Ninewells Hospital, Dundee
  • Nottingham University Hospitals NHS Trust
  • Oxford University NHS Foundation Trust
  • Poole Hospital NHS Foundation Trust
  • Queen Elizabeth Hospital, Birmingham
  • Royal Free London NHS Foundation Trust
  • Royal Marsden NHS Foundation Trust
  • St George’s Hospital, London
  • St James’s University Hospital
  • University College London Hospitals
  • University Southampton NHS Foundation Trust
  • Weston Park Hospital, Sheffield

PRIMUS 001 – A PRECISION PANC CLINICAL STUDY

PRIMUS 001 is a phase II study looking at two different chemotherapy regimens FOLFOX-A and AG in patients with metastatic pancreatic cancer.  As part of the study we are looking at biomarkers to see if we can tell which patients will do better on which treatment.

PRIMUS 001 will open at approximately 20 sites in the UK.  Patients are randomised to one of the two treatments and as part of the study translational work including in-depth molecular profiling and biomarker discovery/development will take place.

The main inclusion criterial for PRIMUS 001 is below but please see protocol for full eligibility details

  • Patient must have enrolled in the Precision-Panc Master Protocol
  • Patient must be at least 16 years old
  • Patient must have histologically confirmed metastatic pancreatic ductal adenocarcinoma and its variants with measurable metastatic lesions according to RECIST 1.1
  • ECOG performance status of 0 or 1
  • Patient must not have had previous treatment for metastatic disease
  • Patient must not be pregnant
  • Patient must have adequate liver and bone marrow functions

The main exclusion criterial for PRIMUS 001 is below but please see protocol for full eligibility details

  • Patient must not have had prior treatment with nab-paclitaxel or oxaliplatin
  • Patient must not have an active infection
  • Patient must not have neuropathy of equal to or more than grade 2
  • Patient must not have significant heart disease
  • Patient must not have uncontrolled brain metastases
  • Patient must not have severe diarrhoea (grade 3 despite best supportive care)

PRIMUS 001 is currently open at 16 sites around the UK, with more due to open in the coming months.

Current Open Sites

  • Aberdeen Royal Infirmary
  • Addenbrooke’s Hospital, Cambridge
  • Beatson West of Scotland Cancer Centre, Glasgow
  • Bristol Haematology and Oncology Centre
  • The Christie NHS Foundation Trust, Manchester
  • Imperial College Healthcare Trust, London
  • Ninewells Hospital, Dundee
  • Nottingham University Hospitals NHS Trust
  • Oxford University Hospitals NHS Foundation Trust
  • Queen Elizabeth Hospital, Birmingham
  • Royal Free London NHS Foundation Trust
  • Royal Marsden NHS Foundation Trust
  • St George’s Hospital, London
  • University College London Hospitals
  • University Southampton NHS Foundation Trust
  • Weston Park Hospital, Sheffield

PRIMUS 002 – A PRECISION PANC CLINICAL STUDY

An umbrella phase II study examining two neo-adjuvant regimens (FOLFOX-A and AG) in resectable and borderline resectable Pancreatic Ductal AdenoCarcinoma (PDAC), focusing on biomarker and liquid biopsy development

PRIMUS 002 is a non-randomised, phase II trial of 2 neo-adjuvant regimens (FOLFOX-A and AG) assessing efficacy and toxicity with integrated translational work. The study is powered on testing a proposed DNA damage response deficient biomarker for responsiveness in patients treated with FOLFOX-A; patients being treated with AG are recruited concurrently. The study has a prospective safety assessment of neo-adjuvant chemotherapy and neo-adjuvant chemotherapy followed by CRT consisting of conventional radiotherapy with concomitant capecitabine. This safety assessment will include all patients (FOLFOX-A and AG)

The main inclusion criterial for PRIMUS 002 is below but please see protocol for full eligibility details

  • Patient must have enrolled in the Precision-Panc Master Protocol
  • Patient must be at least 16 years old
  • Patient must have resectable or borderline resectable pancreatic cancer as defined by NCCN criteria
  • Measurable disease as per RECIST 1.1
  • Histologically or cytologically proven pancreatic ductal adenocarcinoma
  • ECOG performance status of 0 or 1
  • Patient must not be pregnant
  • Patient must have adequate liver and bone marrow functions

The main exclusion criterial for PRIMUS 002 is below but please see protocol for full eligibility details

  • Patient must not have metastatic disease
  • Patient must not have had prior chemotherapy or chemo-radiotherapy for pancreatic cancer
  • Patient must not have an active infection
  • Patient must not have neuropathy of equal to or more than grade 2
  • Patient must not have significant heart disease
  • Patient’s BMI must not be over 35
  • Patient must not have severe diarrhoea (grade 3 despite best supportive care)

PRIMUS 002 opened in Glasgow in March 2019 and will open in other UK sites later in the year.

PRIMUS 003 – A PRECISION PANC CLINICAL STUDY

A phase Ib and II Open-Label, Multi-Center Study of MEDI4736 Evaluated in Different Combinations in Patients with Metastatic Pancreatic Ductal Adenocarcinoma. PRIMUS 003, also known as the Everest study, was sponsored by AstraZeneca and is now closed to recruitment. The database has been locked and the samples are due to be sent to Glasgow for analysis in the very near future. Any publications arising from the PRIMUS 003 study will be added to the website.

PRIMUS 004 – A PRECISION PANC CLINICAL STUDY

A multi-arm, non-comparative signal seeking phase II umbrella trial of marker-directed novel second-line treatments in metastatic pancreatic cancer. PRIMUS 004 is currently under development. AstraZeneca have agreed to supply study drug and provide an educational grant and CRUK have endorsed the study. We hope to open PRIMUS 004 by the end of 2019.

Research Studies

We carry out a wide range of basic and translational research studies to help us generally improve our understanding of how pancreatic cancer behaves and grows. Over the coming months and years, we will post more details of our projects so you can follow our activities and understand how we are working actively to fight pancreatic cancer. Our experienced team of clinicians, researchers, bioinformaticians and lab staff work tirelessly with one thing in mind: improving patient outcomes.

© 2019 Precision Panc
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