Clinical trials – Birmingham Health Partners

New vaccine trial for head and neck cancer patients

Written by Louise Stanley on 02/09/2025. Posted in Cancer outcomes, Clinical trials, Experimental medicine.

Patients in Birmingham who have advanced head and neck cancers may be eligible to take part in a new clinical trial of a potential cancer vaccine, supported by the NHS Cancer Vaccine Launch Pad (CVLP).

Queen Elizabeth Hospital Birmingham, part of BHP founder-members University Hospitals Birmingham NHS Foundation Trust (UHB), is one of 15 sites across the country aiming to recruit more than 100 patients over the next year.

The investigational cancer vaccine in this latest trial on the platform uses mRNA technology to help the immune system recognise and kill cancer cells which express human papillomavirus (HPV) proteins.

The first head and neck cancer patients in England have received the investigational mRNA cancer vaccine in the clinical trial, known as AHEAD-MERIT (BNT113-01), with more patients to soon be enrolled at their nearest NHS hospital.

More than 11,000 new head and neck cancer cases are diagnosed in England every year, with cancers typically developing in the mouth, throat or voice box.

Despite advances in care for patients with head and neck cancer, the advanced form of the disease is difficult to treat and has high rates of recurrence, with two-year survival rates at under 50%.

The investigational cancer vaccine is designed to encode two proteins that are frequently found in head and neck squamous cell cancers associated with human papillomavirus (HPV-16). This is the most common type of head and neck cancer, accounting for 95% of these types of cancers, and the vaccine aims to train the immune system to fight the cancer.

NHS England is partnering with life sciences company BioNTech to help identify potentially eligible patients to refer to NHS hospitals running the clinical trial.

Dr Paul Sanghera, Consultant Oncologist and Principal Investigator of the trial at Queen Elizabeth Hospital Birmingham, said: “This clinical trial marks an important step forward in the search for better treatments for advanced head and neck cancers, which remain a significant challenge in oncology.

“These cancers are notoriously difficult to treat, and access to this investigational vaccine could offer patients a potential new option in their treatment journey. While we are still in the early stages, the hope is that this trial will pave the way for improved outcomes for those living with these challenging conditions.”

Matthew Metcalfe, Hospital Executive Director at Queen Elizabeth Hospital Birmingham, said: “We are incredibly proud to be one of the 15 sites across the country taking part in this important clinical trial. It reflects our ongoing commitment to driving forward research aimed at improving outcomes for patients in Birmingham and beyond, offering new hope to those facing these challenging diagnoses.”

Dr Iain Foulkes, Executive Director of Research and Innovation at Cancer Research UK, said: “It’s great to see more clinical trials of vaccines for head and neck cancer supported by the Cancer Research UK-funded Southampton Clinical Trials Unit.

“Research into personalised cancer treatments is vital. There are over 200 different types of cancer and it’s unlikely there will ever be a single cure that works for everyone. That’s why it’s vital that we support a wide range of research, so that more people can live longer, better lives, free from the fear of cancer.”

More cancer vaccines news from across BHP

Birmingham academic appointed Clinical Lead of new NIHR network

Written by Louise Stanley on 01/09/2025. Posted in Birmingham Health Partners, Clinical trials.

The National Institute for Health and Care Research (NIHR) has awarded £6.5 million, funded jointly through a public-private partnership with the pharmaceutical industry, to establish a UK-wide Commercial Research Delivery Centre (CRDC) Network. The Network is hosted by University Hospitals of Leicester NHS Trust (UHL), with Birmingham Health Partners’ Managing Director Professor Lorraine Harper as its Clinical Lead, and will commence formally on 1 September 2025.

The new Network will provide strategic coordination of all 21 CRDCs across the the UK. It will play a key role in building research capacity, streamlining the interface between industry and the UK clinical trials delivery infrastructure, and enhancing efficiency to deliver commercial clinical research through harmonised processes, in line with the Government’s call to turbocharge medical research earlier this year.

The Network will:

Provide strategic leadership and national coordination across the 21 CRDCs across the UK
Offer a central point of contact for industry sponsors
Facilitate study feasibility, placement and setup across the UK
Foster collaboration with regulators, wider NIHR and UK-wide delivery infrastructure, and other key stakeholders to advance UK Clinical Research Delivery
Support workforce development, inclusion, and public involvement
Facilitate the integration of the Primary Care CRDCs (PC-CRDCs) in England in autumn 2025, adopting them into the Network

By aligning CRDC efforts and offering a cohesive offer to industry, the Network will ensure that the CRDCs deliver against industry expectations for faster, more efficient set up and delivery of commercial research in the UK.

Lorraine Harper, Professor of Nephrology at the University of Birmingham and Managing Director of Birmingham Health Partners, is the Director of the Central and North West Midlands CRDC and has been appointed Clinical Lead of the new Network. She said: “The vision of the Network is to ensure equitable access, diverse recruitment and a much more efficient model of trial delivery, improving NHS and patient access to trials. With Birmingham Health Partners already leading a regional programme to reduce bureaucracy in clinical trials, and BHP member Birmingham Women’s and Children’s Hospitals hosting the Central and North West Midlands CRDC, this is an exciting opportunity to align all our work and deliver a ‘gold standard’ for commercial clinical trials.”

BHP founding member Birmingham Women’s and Children’s Hospitals NHS Foundation Trust hosts the £7m Central and West North Midlands (C&NWM) CRDC, working closely with regional partners Midlands Partnership University NHS Foundation Trust – host of Staffordshire and Shropshire, Telford and Wrekin Health Research Partnership (SSHERPA) – and the Black Country Provider Collaborative.

The C&NWM region, home to 4.2 million people, includes many of the UK’s most economically deprived communities who face significant health inequalities and higher rates of serious illness. The CRDC will focus on addressing these inequities by increasing access to clinical trials for patients who have the greatest need – dovetailing with BHP’s strategic focus on addressing health inequalities and giving greater opportunities for residents to participate in research.

Professor Melanie Davies, Professor of Diabetes Medicine at the University of Leicester and Honorary Consultant Diabetologist for University Hospitals of Leicester NHS Trust, and Director of the CRDC Network, said: “We are really proud that University Hospitals of Leicester NHS Trust has been awarded this funding to host this federated CRDC Network across the four nations of the UK. We are fully committed to working with our partners across the UK to deliver faster, more efficient set up and delivery of commercial research. We want to drive increased investment from industry and enable even more people to take part in studies that can lead to the future approval of new medicines and devices for the benefit of patients in the UK.”

Dr Maria Koufali, NIHR Life Sciences Industry Director, said: “The UK CRDC Network is a critical part of our national effort to transform UK clinical research delivery. By streamlining trial set-up and expanding access into community and underserved settings, it will help make the UK one of the most attractive destinations globally for commercial research. This means faster access to innovative treatments for patients, greater investment in the NHS and a stronger life sciences sector that boosts the health and wealth of the nation.”

Adding dendritic cell vaccine to liver cancer therapy slows disease progression

Written by Louise Stanley on 29/08/2025. Posted in Clinical trials, Experimental medicine.

Patients with intermediate-stage primary liver cancer who received a vaccine of dendritic cells (DC) alongside their cancer therapy saw a longer time without tumour progression in response to standard treatment – found a study by BHP founding-member the University of Birmingham, funded by the National Institute for Health and Care Research (NIHR).

The results of the ImmunoTACE trial, the first clinical trial of its kind, published in Clinical Cancer Research, found improved progression-free survival (PFS) for patients with hepatocellular carcinoma (HCC) who received the cell-based vaccine expanded from their own white blood cells. The vaccine was administered alongside usual treatment with tumour chemoembolisation, a treatment for blood vessels that feed the tumour, plus chemotherapy.

The collaborative trial between the University of Birmingham, fellow BHP members University Hospitals Birmingham, Nottingham University Hospitals NHS Trust and Aintree University Hospital and Clatterbridge saw 48 patients recruited to receive either standard treatment alone or standard treatment plus a cellular vaccine using dendritic cells loaded with cancer antigens to stimulate immune responses against the cancer.

In the experimental arm of the trial the average time to progression of the tumour was 18 months compared with only 10 months in the group who only received standard treatment.

Professor David Adams, Chief Investigator of the study, Emeritus Professor of Hepatology at the University of Birmingham and past Director of BHP, said: “The results from this phase 2 trial are very promising and offer a potential new treatment option for patients with primary liver cancer, one of the highest causes of cancer-related death worldwide.

“As far as we know, ImmunoTACE is the first controlled clinical trial to show that a cell-based vaccine using lab-grown dendritic cells can improve patient outcomes with liver cancer. The results warrant further investigation and could in future offer much needed hope and a better treatment option for patients.”

The vaccine is made with dendritic cells (DC) which help orchestrate the immune system’s response to diseases including cancer by activating immune killer cells to recognise and destroy cancer cells.

The dendritic cells used in the study were expanded from the patients’ own white blood cells by growing them in a purpose-built laboratory for eight days with proteins taken from cancer cells. The cells allow the immune system to see these proteins and then to mount an immune attack on the cancer cells that bear them.

Patients received the DC vaccine at the same time as standard treatment with chemo-embolisation and then monthly for a further three months.

While dendritic cells are produced naturally in the body, studies have shown that in patients with cancer they can become “exhausted” and get stuck within the tumour rather than carrying cellular information back to the lymph nodes where they can activate immune killer cells. The idea of DC vaccine is to restore and uncover immune responses to the cancer. The current trial design reports that this therapy can be both affordable and effective.

Dr Yuk Ting Ma, lead author of the study and Associate Clinical Professor at the University of Birmingham, and an Honorary Consultant in Hepatobiliary Oncology at the University Hospitals Birmingham NHS Foundation Trust said: “These are very promising findings that demonstrate the potential use of dendritic cell vaccines in a widely prevalent and hard to treat cancer. With our approach to developing the vaccine, focusing on stimulation with multiple tumour antigens, we have shown a strong signal that we believe warrants testing in larger trials in patients with liver cancer.

“Dendritic cell vaccines also represent a potential additional immune therapy to add to current checkpoint inhibitors. Future studies will look at whether adding DC vaccination to standard immunotherapy can derive better outcomes for patient with HCC who show only modest responses to current checkpoint inhibitor drugs.”

New trial to test novel diagnostic for bladder cancer recurrence

Written by Louise Stanley on 28/08/2025. Posted in Clinical trials, Early diagnosis and detection.

Nonacus, an early cancer testing company, has announced two West Midlands-based trials to assess a new way of monitoring for recurrence of bladder cancer, using a novel test developed in collaboration with researchers from BHP founding-member the University of Birmingham.

The at-home urine test uses Nonacus’ highly-sensitive liquid biopsy technology, which was developed in conjunction with a panel of biomarkers developed by researchers from the University’s Bladder Cancer Research Centre.

Called Galeas Bladder, the test was developed while the company based itself at the University’s bio-incubator, the BioHub Birmingham, and a previous Cancer Research UK-funded study has already shown that it can accurately and consistently detect the presence of bladder cancer from a urine sample.

Professor Rik Bryan, Director of the Bladder Cancer Research Centre, said: “These trials are the culmination of eight years of collaborative research and development between the University of Birmingham and Nonacus, which has the potential to help the millions of patients at higher risk of bladder cancer across our country and worldwide.”

Tony Hickson, Chief Business Officer at Cancer Research UK said: “As funders of much of the world-class, cutting-edge cancer research happening in the UK, we offer unique opportunities to commercial partners looking for early involvement in new discoveries. Having Nonacus on board to help transform promising findings in the lab into a new non-invasive test to diagnosis bladder cancer is a testament to how commercial collaborations have the potential to transform the lives of patients. We are looking forward to seeing the next steps as the test is developed and rolled out to the UK and beyond.”

Jeannie Rigby, CEO of Action Bladder Cancer, said ” Bladder cancer can often be diagnosed late and has a high level of recurrence – which can lead to poor outcomes for patients – and bladder cancer has been neglected in terms of new research in the past. Action Bladder Cancer UK, bladder cancer patients and their families, welcome this exciting development in improving testing for bladder cancer.”

Richard Parker, Mayor of the West Midlands, commented: “Health-tech is about better care for patients, shorter waiting times and more good jobs here in the West Midlands. Through my Growth Plan we are making this one of the best places in the country to develop and roll out new treatments – from expanding our innovation clusters to supporting local medtech businesses to grow and export. The technology I’ve seen today is proof that when we back science, patients and the economy both win.”

Peter Kyle, Secretary of State for Science, Innovation and Technology, added: “In a region renowned for engineering, with Richard Parker as Mayor, the West Midlands is setting the pace for medical technology. Nonacus’ innovative approach to testing for bladder cancer will help save patients time and the NHS money. Life sciences is a growth sector for the West Midlands and the UK as a whole combining the power of our universities, the creativity of our businesses and the strength of our NHS.”

Research patient recruitment reaches record high at Good Hope

Written by Louise Stanley on 04/07/2025. Posted in Clinical trials.

The research team at Good Hope Hospital – operated by BHP founder-member University Hospitals Birmingham – has marked a major milestone, achieving a phenomenal 1,000% increase in patient recruitment over the past six years.

In 2019, only 50 patients were successfully recruited to research studies at the hospital. In 2024-2025, this has soared to a remarkable 573, testament to the hospital’s growing research capabilities supported by the wider Trust.

The expansion began in August 2019, when Good Hope Hospital appointed its first research nurse with a vision to build a diverse non-cancer research portfolio. At the time, the hospital had a limited research presence, with just 1.5 full-time equivalent research nurses who were focused solely on cancer studies.

Since then, the team has grown to include three research nurses – Heather Willis, Abi Roberts and Asha Clement – and a portfolio support officer, Daniel Lenton.

**L-R:** Daniel Lenton, Portfolio Support Officer; Abi Roberts, Clinical Research and Development Nurse; Heather Willis, Senior Clinical Research and Development Nurse; Asha Clement, Clinical Research and Development Nurse

With an expanded team and a stronger research infrastructure, the hospital has developed a broad research portfolio, increasing opportunities for patient participation across various specialties.

The team faced setbacks during the COVID-19 pandemic as the hospital had to rapidly establish COVID-related studies – which while raising public awareness of research’s importance caused the normal research portfolio to be temporarily paused, as staff were redeployed.

Since then, research activity has continued to thrive post-pandemic, and the team has been recognised by study sponsors for their high levels of recruitment.

With research now a significant part of Good Hope Hospital’s long-term strategy, the team has ambitious plans, including creating a designated research facility on-site, developing a commercial research portfolio and ensuring research remains self-sustaining and not a cost burden.

As the hospital moves forward with its strategy, its commitment to fostering a future-proof research workforce and expanding patient access to life-changing clinical studies remains key.

Largest ever UK surgical trial aims to reduce post-surgery infections

Written by Louise Stanley on 03/03/2025. Posted in Clinical trials.

More than £10m of funding from the National Institute for Health and Care Research (NIHR) has been awarded to BHP founder-member the University of Birmingham to run an ambitious trial which aims to recruit 26,000 patients from 100 sites across the UK in the next five years.

ROSSINI-Platform is a large multi-arm, multi-stage platform trial, led by Professor Thomas Pinkney and the Birmingham Clinical Trials Unit, that will help experts understand how to reduce wound infections that can occur following operations.

Wound infections, also referred to as Surgical Site Infections (SSI), are the commonest complication after surgery and affect up to one in four patients undergoing surgery each year. These infections carry an estimated cost to the NHS of at least £700m each year.

Professor Thomas Pinkney from the School of Health Sciences at the University of Birmingham, and Chief Investigator of the ROSSINI-Platform trial said: “An adult living in the UK will have an average of four operations during their lifetime. Up to a quarter of operations may result in a surgical site infection (SSI) – a post-operative infection of the wound – which can have significant negative impacts on patient recovery.

“We know that infections at different operation sites can cause different types of challenges. For example, an infection following a caesarean section can impact on the mothers’ ability to bond with their newborn. An infection following amputation could mean that the patient is no longer suitable to be fitted for a prosthetic, meaning they might become a wheelchair user.

“Post pandemic the waiting lists for surgeries are higher than ever, so an evidence-based approach to improving recovery times and reducing preventable complications and their associated risk of readmissions has never been more necessary.”

ROSSINI-Platform will look at various interventions to reduce the rates of surgical site infection, and the design of the trial will enable the team to focus on those that show evidence of benefit.

In total, 18 interventions are being assessed in the trial, with examples including:

using state-of-the-art wound cleaning solutions during surgery
using special wound dressings after surgery,
applying antibiotics differently during surgery,
changing gloves and instruments at certain points during surgery,
waxing or epilation around the surgical site

In addition, the trial will test these interventions across multiple operation types areas such as heart surgery, brain surgery, caesarean section and leg amputation, to find what works best to reduce infection in each setting.

Sue’s story

Sue Blackwell, 49, from Liverpool, has faced health issues over the years connected with inflammatory bowel disease and has had a total of 13 operations. Several operations have resulted in SSIs requiring antibiotics, but one infection led to unexpected complications that impacted Sue’s life for years.

Following a planned completion proctectomy, Sue developed a serious infection leading to being housebound for six months and losing control of her bladder for ten weeks.

Sue had to wait for district nurses to come and change her dressings twice each day, and this had a significant impact on her life. To add to the ordeal, Sue had to undergo additional surgeries to address the complications and experienced problems with wound draining for two years. The seemingly never-ending round of surgeries and treatments continued, and it took a total of eleven years for the wound to fully heal.

Sue is currently doing a PhD at the University of Birmingham and will use her lived experience to inform the ROSSINI-Platform trial as a public involvement representative.

Speaking of her involvement in both developing and delivering the study, Sue said:

“A lot of patients think that someone somewhere along the line is at fault, which isn’t usually the case. SSIs are very common and we don’t know enough about what we can do to stop them. With this trial, all the interventions are already in use, we know they are all safe, we’re just testing them against each other in a smart way, similar to a world cup tournament, to see which comes out on top.”

In addition to delaying or impeding patient recovery, SSIs are responsible for extending hospital stays and hospital readmissions. SSIs are a significant problem for the NHS, due to increased treatment costs and resource usage both in hospital and in the community. SSI is now the most common healthcare associated infection and costs the NHS at least £700million per year. It is therefore a priority for patients and the health service.

The trial team hope that the findings will help countries around the world to implement the most effective ways to prevent SSI following different types of common surgeries. This will help speed up recovery, get patients discharged from hospital sooner freeing up bed space, and in many countries around the world will save countless lives.