Experimental drug trial seeks to improve treatment for head and neck cancer

A trial designed and co-ordinated by the University of Birmingham’s Cancer Research UK Clinical Trials Unit to test an experimental drug in patients with head and neck cancer has launched today through the Combinations Alliance – a joint initiative between Cancer Research UK and the Experimental Cancer Medicine Centres (ECMC) Network.

The trial, called WISTERIA, is the first Combinations Alliance clinical trial to be sponsored by the University of Birmingham and will be conducted at five centres across the UK – Queen Elizabeth Hospital, Birmingham; Clatterbridge Cancer Centre, Wirral; University College London; The Institute of Cancer Research, London; and Beatson West of Scotland Cancer Centre, Glasgow.

Researchers want to find out whether using Astra Zeneca’s AZD1775 experimental compound, in combination with chemotherapy before surgery or with chemotherapy and radiotherapy after surgery, is more effective and reduces the risk of the cancer returning.

They also want to find out if the combination of AZD1775 and chemotherapy before surgery decreases the need for further treatment after surgery.

The phase 1 trial will determine whether it is safe to combine AZD1775 with pre-surgery cisplatin chemotherapy and post-surgery cisplatin chemotherapy and radiotherapy in patients with head and neck cancer, and what dose is best. AZD1775 acts as a potent inhibitor of WEE1, a protein which regulates the cell cycle, and it has been shown to increase the effectiveness of both cisplatin chemotherapy and radiotherapy in pre-clinical studies. It is one of AstraZeneca’s portfolio of DNA Damage Response compounds.

There will be two groups of up to 21 patients taking part in the trial co-ordinated by the Cancer Research UK Clinical Trials Unit at the University of Birmingham. The first group will receive AZD1775 with chemotherapy before surgery and the second will receive AZD1775 in addition to chemotherapy and radiotherapy after surgery.

Standard treatment for high-risk head and neck cancer is surgery followed by cisplatin chemotherapy and radiotherapy. While this treatment is the most effective option for patients, survival is still poor and the treatment often has a significant impact on quality of life for survivors.

Professor Hisham Mehanna, of the Institute of Cancer and Genomic Studies at the University of Birmingham, said: “Many patients diagnosed with aggressive types of head and neck cancer are at a high risk of relapse after surgery, so we urgently need to find new ways to treat the disease and reduce the risk of it returning.

“We hope that combining this drug with chemotherapy will mean that treatment is more effective helping more people survive, and that those cured will have a better quality of life after treatment.”

Anthony Johnson, VP Early Clinical Development, Innovative Medicines and Early Development Biotech Unit at AstraZeneca, said: “We are excited about this new clinical trial evaluating AZD1775 in combination with chemotherapy and radiation in head and neck cancer patients. There is a strong scientific rationale for running this trial and we hope that this will bring clinical benefit to patients.”

Researchers on this window-of-opportunity trial are accepting treatment naïve patients between the age of 18 and 70 with cancer of the mouth, throat and voice box and are due to undergo surgery.

Dr Ian Walker, Cancer Research UK’s director of clinical research, said: “We’re excited to have the opportunity to trial this new drug through our Combinations Alliance initiative. The initiative allows us to bring together combinations of treatments, using drugs that are in development, that wouldn’t otherwise be possible. And we look forward to seeing if this drug can improve treatment options for patients with head and neck cancer.”

For media enquiries please contact:

Kathryn Ingham in the Cancer Research UK press office on +44 (0)20 3469 5475 or, out-of-hours, the duty press officer on +44 (0)7050 264 059.

Emma McKinney, Communications Manager (Health Sciences), University of Birmingham, tel: +44 (0) 121 414 6681. For out of hours enquiries contact the Press Office by calling +44 (0) 7789 921 165.

• The University of Birmingham is ranked amongst the world’s top 100 institutions. Its work brings people from across the world to Birmingham, including researchers, teachers and more than 5,000 international students from over 150 countries.
• The Cancer Research UK Clinical Trials Unit (CRCTU), at the University of Birmingham, translates cutting edge science into improved patient care, both rapidly and safely, through the design and conduct of large multi-centre/international randomised trials as well as smaller more data intensive phase I trials of novel therapies.
• Institute of Head and Neck Studies and Education, a collaboration between the University of Birmingham, University Hospitals Birmingham NHS Foundation Trust and Heart of England NHS Foundation Trust, runs a large portfolio of research in head and neck cancer, from translational and fundamental science to large multinational clinical trials. It currently holds over £10m in research grants and has 20 staff members.
• The Combinations Alliance initiative supports research into drug combinations to bring cancer patients more treatment options that otherwise may not happen.
• The Experimental Cancer Medicine Centres (ECMC) network is an initiative funded in partnership by Cancer Research UK and the four health departments of England, Scotland, Northern Ireland and Wales. Launched in 2007 with a total investment by the funders of over £100million, this infrastructure award supports a network of 18 adult centres (of excellence) and 11 paediatric locations throughout the UK. By bringing together world-class scientific and clinical expertise the ECMC network advances the boundaries of cancer care, with over 3,000 patients recruited onto over 400 ECMC-supported trials in 2016-17. Collaboration with Industry is key to the success of the ECMC – in 2016/17 alone, ECMCs leveraged over £80 million from their commercial partnerships.
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