Cardiff

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Overview

Our Centre

Our ECMC uniquely unites our translational research strengths in both solid tumours and haematological malignancies, bringing together our established track records in shared focus areas including novel trial design, Stratified Medicine and drug development and longitudinal biobanking to deliver innovative, translationally rich biomarker driven adaptive trials to a diverse range of cancer patients.

We have an expanding early phase trial portfolio of both commercial and academically sponsored partnerships, leading national and international multi-centre studies and attracting investment.

The ECMC Haematology network group is co-ordinated from Cardiff and connects across the whole ECMC network, bringing active pharma engagement and collaborative research opportunities.

Cardiff ECMC is closely integrated with and aligned to our all Wales Cancer Research Strategy (CReST) which is strengthened by close links with the Clinical Trials Unit, Wales Cancer Research Centre, Wales Cancer Bank and the Cardiff University Medicines Discovery Unit. Early phase trial activity in Cardiff benefits from internationally recognised state of the art imaging facilities at the all Wales research and diagnostic PET Imaging Centre (PETIC) and the CUBRIC MRI Imaging Centre.

Cardiff ECMC supports a large cancer community within Wales, creating a vibrant translational environment of dedicated cancer researchers from across the spectrum of clinical, scientific, nursing and allied healthcare professionals to develop research careers in early phase trials. Our ECMC-funded research nurses support Phase 1 trials in both haematological malignancies and solid tumours.

Our Patient Population

As the only ECMC in Wales, Cardiff ECMC provides access to a population of more than 3 million people to innovative treatments under a devolved health authority NHS Wales. 20,000 patients present with cancer each year, with a steady increase in incidence of bowel and lung cancers over the last decade, highlighting the need for prevention, early diagnostic and novel treatment studies.

Cardiff ECMC has a growing portfolio of early phase trials with an average number of 26 open trials per year over the last 5 years, 60% of which are commercially funded. We have seen a year on year increase in trial recruitment in both solid and haematological malignancies and high uptake from a patient population keen to engage and participate in these essential research studies.

Organisations affiliated with the Cardiff ECMC:

Our location

ECMC Cardiff is situated in South Wales and easily accessible from across the UK through a major rail network hub and good motorway links. Cardiff international airport is located 13 miles from the city centre, connecting visitors with over 900 destinations and serviced by frequent bus and train amenities.

Contact the Centre Manager:

Angela Harris

harrisa28@cardiff.ac.uk or CardiffECMC@cardiff.ac.uk

Address

Room 1TB2 31, First Floor Main Building
Division of Cancer & Genetics
Cardiff University
University Hospital of Wales
Heath Park
Cardiff
CF14 4XN

Team Members

Professor Oliver Ottmann

Centre Co-Lead

ottmanno@cf.ac.uk

+44 (0) 292 074 2375

Professor Oliver Ottmann is Joint Lead of Cardiff ECMC and Head of Haematology at the Institute of Cancer and Genetics, Cardiff University School of Medicine, which he joined in 2015 after heading the experimental haematology and Early Phase Trials Unit at the Johann Wolfgang Goethe University in Frankfurt, Germany. As a clinical trialist with over 30 years experience, Prof. Ottmann´s professional clinical research interests involve the development of novel targeted therapies for blood cancer including molecularly targeted small molecules, immunotherapy and Advanced Cellular approaches. His translational research focuses on leukaemic stem cells and leukaemogenesis, mechanisms by which blood cancers become resistant to therapy and the development of predictive molecular biomarkers to guide therapy. At Cardiff University, working together with his NHS colleagues, Prof. Ottmann has been instrumental in broadening the Cardiff ECMC Haematological early phase portfolio, establishing the Cardiff-led ECMC Haematology Network and leads as Clinical Lead for Wales on the INNOVATE UK Wales-Midlands Advanced Therapy Treatment Centre Consortium. He has published over 270 original articles in peer-reviewed journals and is member of numerous national and international cooperative working groups and haematology societies.

Dr Rob Jones

Centre Co-Lead

Robert.Hugh.Jones@wales.nhs.uk

Dr Rob Jones is Speciality Lead for Cancer in Wales, Lead for Phase 1 trials in Wales, and Clinical Research Director at the Velindre NHS Trust. He comes from a research background having carried out a PhD in Cancer Research before studying Medicine in Oxford. Having completed Oncology training, he carried out a CRUK Clinician Scientist post before being appointed as Senior Lecturer in Medical Oncology in Cardiff. Since opening Wales’ first ‘First in Human’ trial approximately 8 years ago, Rob has led the development of the portfolio and has been Principal Investigator around 25 Phase 1 trials being delivered through the Velindre Cancer Research Trials Unit. He is also Chief Investigator on two other Investigator Led trials ‘FAKTION’ and ‘FURVA’. FAKTION was reported orally at ASCO 2019 and was published in Lancet Oncology in 2020 and FURVA reported orally at ESMO 2020. He also sits on the NCRI Strategy Advisory Group and is a member of the NCRI Colorectal and Early Phase Clinical Study Groups. Rob was also been a member CRUK Combinations Alliance Committee until April 2020.

Dr Steve Knapper

Deputy Lead

KnapperS@cardiff.ac.uk

Dr Steve Knapper is an academic clinical haematologist and combines the role of Clinical Reader in the Institute of Cancer and Genetics at Cardiff University School of Medicine with clinical work as a Consultant Haematologist at the University Hospital of Wales where he serves as haematological cancer lead clinician. Steve's clinical practice is predominantly in myeloid haematological cancers, particularly acute myeloid leukaemia, the myeloproliferative neoplasms and myelodysplastic syndromes. His chief research interest lies in the development of targeted therapeutic agents in myeloid malignancies including 'back-to-bench' laboratory projects running alongside clinical trials. He serves as principal investigator for an evolving portfolio of early and later phase clinical studies. Steve is extensively involved in the development of clinical research at a national level through activities within the UK NCRI AML and Myeloproliferative Neoplasms Clinical Study Groups. His other roles include Cardiff lead for the Trials Acceleration Programme (now funded by Cure Leukaemia) and lead of Cardiff School of Medicine medical undergraduate haematology teaching.

Julie Hepburn

PPIE (Patient and Public Involvement and Engagement) Lead

Julie Hepburn is the PPI&E Lead for both the Cardiff ECMC and the Wales Cancer Research Centre (WCRC) and was recently awarded an honorary post as Research Associate for Cardiff University. She has 6 years of experience in PPI&E following surgery and treatment for bowel cancer and has sat on a number of Governance Bodies as well as Trial Management Groups and Steering Committees within Wales. Her experience at UK level includes membership of two NICE Guideline Committees, two James Lind Alliance Priority Setting Partnerships, the NCRI Consumer Involvement Advisory Group and a UKCRC Data Sharing Group.

Collaborative and clinical, scientific and patient community highlighted through our dedicated commitment within our centre towards PPI&E and patient Quality of life assessments. Our experienced research partners frequently contribute to the National ECMC Network Meetings developing PPI frameworks, working on ways to record impact and contributing to national NICE guidelines and open access publications. Our team of researchers is uniquely supported from an early stage in training, funding and delivering public involvement according to UK Public Involvement Standards through the Wales Cancer Research Centre Lay Faculty and the Enabling Involvement Fund run by Health and Care Research Wales, allowing rapid recruitment and connecting ECMC researchers with a population-wide cancer community in Wales.

Adult Expertise

Treatment Modalities

Gene therapy

Immunotherapy

Small Molecules

Surgery

Radioimmunotherapy

Chemoradiotherapy

Facilities/Translational Research

CQC registered oncology trials unit
Dedicated 24 hour stay facilities (including weekends)
Radiopharmacy
On-site pharmacy
PK testing facility
Biobanking facilities
Dedicated research staff
Snap freezing facilities
On-site ITU (intensive treatment unit)
On-site central lab

Cancer Types

We have expertise in both solid tumours and haematological malignancies.

Cardiff has a special interest and international reputation for innovative trial design and delivery of clinical trials in the areas of Breast, Colorectal and Haematological malignancies, particularly Acute myeloid Leukaemia (AML).

Our expertise encompasses:

Molecular characterisation and monitoring of tumours and circulating biomarkers.
Evaluation of novel small molecule and immunotherapies and Advanced Therapies, with JACIE accreditation for the delivery of ATMPs. We have strong academic links with world leading immune-oncology and viral therapy experts.
Patient stratification and precision medicine.
Reverse translation for informative development of our translational pipelines.
Large scale biobanking of diagnostic and longitudinal samples from cells, RNA, miRNA, DNA, plasma and FFPE/frozen sections for over 20,000 cancer patients.
Combination Drug: Radiotherapy trial expertise with RadNet alignment and a strong track record in providing critical infrastructure to support delivery of RADNet trials.

Drug/Treatment Modalities

Advanced cellular therapies
Combination therapies
Oncolytic viral therapy

Radiotherapy

We have regular access to proton radiotherapy (as part of approved NHS clinical indications) and photon radiotherapy.

We have specific research expertise in

Intensity Modulated Radiotherapy (IMRT)
Image Guided Radiotherapy (IGRT)
4-Dimensional Radiotherapy (4DRT)
Stereotactic Radiotherapy (SBRT/SABRT)
Internal Radiotherapy

Automated radiotherapy planing software and development of automated contouring software with expertise in radiotherapy quality assurance.

Molecular Diagnostic Testing

We have the following available on a routine basis to our patients:

Single gene testing
Disease specific NGS panel testing (next generation sequencing)
Large NGS panel testing
WGS (whole genome sequencing)

This is available for tumours and for ctDNA (circulating tumour DNA)

The Department of Haematology’s Trial Sample Team provide biobanking and molecular analysis to support the current NCRI Acute Myeloid Leukaemia (AML) clinical trials; AML18, AML19 and LI1, as well as supporting local studies in AML and Multiple Myeloma. The molecular diagnostic screening supplies mutation status for the key genes in AML, FLT3 and NPM1 within 1 week to enable risk stratification, minimal residual disease (MRD) suitability and mutation specific treatment randomisations. The data from the previous AML trial in younger patients (>60 years) AML17 has changed the standard of care for AML patients, both on and off current trials, by modifying individual patient risk, improving the stratification and personalising the treatment pathway.

The All Wales Genetics Laboratory is commissioned by WHSCC to deliver genetic services for the Welsh population. The Solid Tumour service identifies key non-inherited changes in genes found in patient tumours that have strong evidence for use in precision medicine, as well as providing supportive diagnostic and prognostic information on tissue biopsies or on blood via the extraction of circulating tumour DNA (ctDNA) where no biopsy is available (Lung and Colorectal), according to ACGS professional reporting guidelines.

Next generation sequencing is increasingly used to detect both DNA and RNA variants and provides a service for a wide range of cancers (e.g. Colorectal cancer, NonSmall Cell Lung cancer, Gastrointestinal cancer, Melanoma, Glioma, Sarcoma, Breast cancer). All NHS patients across Wales have access to this diagnostic testing. In addition, the laboratory has successfully supported molecular DNA testing for various clinical trials (e.g. FAKTION, CRUK SMP2 etc), and early access to treatments through collaborations with pharma companies.

The All Wales Medical Genomics Service is only one of three other NHS diagnostic services across the UK that have invested in the powerful NovaSeq 6000 screening platform, enabling high capacity, high-throughout screening, with the potential to bring large scale screening ability and data linkage at the population level as part of our Precision Medicine Strategy.

Case Study

Case Studies

TACTICC

Despite advances in potentially-curative therapies, bowel cancer remains one of the leading causes of death from cancer. Researchers at Cardiff ECMC are looking for ways to improve standard treatment.

TACTICC is a randomised trial looking at how the TroVax vaccine and cyclophosphamide affect the immune system in people with advanced bowel cancer. The trial was designed in Cardiff, based on local lab data and recruitment was successfully completed with patients from Cardiff.

Eligible patients had stable or responding disease, following completion of an initial 12 weeks of palliative chemotherapy, and were randomised to one of four groups:

Group 1: Watch and wait, i.e. no additional treatment unless clinically indicated.
Group 2: Metronomic cyclophosphamide only.
Group 3: Vaccination with TroVax^® (intra-muscular administration) only
Group 4: Metronomic cyclophosphamide, followed by TroVax^®vaccination.

A total of 54 patients were randomised: 9 to each of groups 1 and 2 and 18 to each of groups 3 and 4.

The study was not powered to compare survival, but investigated immune response, following administration of the therapies, and clinical outcome.

The trial has successfully completed in March 2016, and follow-up data will be collected until February 2017. Preliminary results are not yet ready for release, but are suggestive of a positive correlation between specific anti-cancer immune responses and both increased Progression Free and Overall Survival. Potential future randomised Phase II/III trials look likely with survival end-points which, if positive, would potentially change clinical practice.

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