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.
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 Studies), 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 more than 30 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
• Guy’s Hospital
• Huddersfield Royal Infirmary
• Imperial College Healthcare NHS Trust
• Milton Keynes University Hospital
• Morriston’s Hospital, Swansea
• Ninewells Hospital, Dundee
• Norfolk and Norwich NHS Trust
• Northern Ireland Cancer Centre, Belfast
• Nottingham University Hospitals NHS Trust
• Oxford University NHS Foundation Trust
• Poole Hospital NHS Foundation Trust
• Queen Elizabeth Hospital, Birmingham
• Raigmore Hospital, Inverness
• Royal Albert, Edward Infirmary, Wigan
• Royal Cornwall Hospital
• Royal Free London NHS Foundation Trust
• Royal Liverpool University Hospital
• Royal Marsden NHS Foundation Trust
• St Bart’s
• St George’s Hospital, London
• St James’s University Hospital, Leeds
• University College London Hospitals
• University Hospital Coventry
• University Southampton NHS Foundation Trust
• Western General, Edinburgh
• 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.
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 more than 30 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
• Freeman Hospital, Newcastle
• Glasgow Royal Infirmary
• Guy’s Hospital
• Huddersfield Royal Infirmary
• Imperial College Healthcare NHS Trust
• Milton Keynes University Hospital
• Morriston’s Hospital, Swansea
• Ninewells Hospital, Dundee
• Norfolk and Norwich NHS Trust
• Northern Ireland Cancer Centre, Belfast
• Nottingham University Hospitals NHS Trust
• Oxford University NHS Foundation Trust
• Poole Hospital NHS Foundation Trust
• Queen Elizabeth Hospital, Birmingham
• Raigmore Hospital, Inverness
• Royal Albert, Edward Infirmary, Wigan
• Royal Cornwall Hospital
• Royal Free London NHS Foundation Trust
• Royal Liverpool University Hospital
• Royal Marsden NHS Foundation Trust
• St Bart’s
• St George’s Hospital, London
• St James’s University Hospital, Leeds
• University College London Hospitals
• University Southampton NHS Foundation Trust
• Western General, Edinburgh
• Weston Park Hospital, Sheffield
PRIMUS 005 – A PRECISION PANC CLINICAL STUDY (Trial now closed to recruitment)
A phase IIb randomised clinical trial repurposing ATRA as a stromal targeting agent in a novel drug combination for pancreatic cancer.
Patients with locally advanced pancreatic ductal adenocarcinoma will be randomised to receive either gemcitabine and nab-paclitaxol or gemcitabine, nab-paclitaxol and ATRA.
PLEASE NOTE THAT PRIMUS 005 IS CURRENTLY SUSPENDED TO RECRUITMENT
PRIMUS 006 – A PRECISION-PANC CLINICAL STUDY
PRIMUS 006 is a phase II trial of gemcitabine, pembrolizumab and IMM-101 as first line treatment in patients with metastatic pancreatic cancer
Patients with metastatic pancreatic ductal adenocarcinoma with performance status 1 who, in the opinion of the investigator, are not sufficiently fit to potentially tolerate regimens consisting of two or more cytotoxic chemotherapy agents are eligible for PRIMUS 002
All Patients will receive IMM-101, pembrolizumab and gemcitabine.
The main inclusion criterial for PRIMUS 006 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 18 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 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 006 is below but please see protocol for full eligibility details
• Patient must not have had prior treatment with IMM-101 or an immune checkpoint inhibitor
• Patient must not be using or have used immunosuppressive medication within 14 days of first dose of study drug
• Patient must not have an active autoimmune disorder
• Patient must not have significant heart disease
• Patient must not have an active infection
PRIMUS 006 is open to recruitment in Glasgow (Beatson West of Scotland Cancer Centre) but will open at other UK sites soon
PRIMUS 002 – A PRECISION PANC CLINICAL STUDY (Trial now closed to recruitment)
PRIMUS 002 was looking at two different chemotherapy regimens (FOLFOX-A and AG) for patients whose cancer is suitable or potentially suitable for surgery. Approximately 3 months of chemotherapy was given in the neo-adjuvant setting prior to surgery.
The study was focusing on biomarker and liquid biopsy development.
PRIMUS 002 registered younger and fitter patients to receive FOLFOX-A and older or less fit patients received AG.
The study was powered on testing a proposed DNA damage response deficient biomarker for responsiveness in patients treated with FOLFOX-A; patients being treated with AG were recruited concurrently.
PRIMUS 003 – A PRECISION PANC CLINICAL STUDY (Trial now closed to recruitment)
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 have been sent to Glasgow for analysis in the very near future.
Any publications arising from the PRIMUS 003 study will be added to the website.
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.