Clinical Trials

Doctor with stethoscope and patient in bed

We develop new tools for diagnosing and treating cancer. The CRUK Clinical Trials Unit works together with clinicians to take advances in medicine and surgery forward to the clinic. We translate cutting edge science into improved patient care through the design of large multi-centre/international randomised trials as well as more data intensive Phase I trials of novel therapies.

Theme Lead

Pamela KearnsPamela Kearns

Professor of Clinical Paediatric Oncology

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Research groups

 

CRUK Clinical Trials Unit
Researcher Research area
Professor Lucinda Billingham Biostatistics and Clinical trials
Simon Gates Clinical trials
Piers Gaunt Clinical trials
Susanne Gatz Clinical trials
Aimee Jackson Clinical trials
Professor Pamela Kearns Paediatric oncology/Clinical trials
Sarah Pirrie Clinical trials
Professor Daniel Rea Breast cancer treatment
Haematology and Oncology
Researcher Research area
Dr Manoj Raghavan Myeloid malignancies

Spotlight on COVID-19 vaccination and outcomes in immuno-suppressed patients

Nature Medicine doi.org/10.1038/s41591-023-02414-4 (2023). Eleanor Barnes, Carl S. Goodyear, Michelle Willicombe, Charlotte Gaskell, Stefan Siebert, Thushan I de Silva, Sam M. Murray, Daniel Rea, John A. Snowden, Miles Carroll, Sarah Pirrie, Sarah J. Bowden, Susanna J. Dunachie, Alex Richter, Zixiang Lim, Jack Satsangi, Gordon Cook, Ann Pope, Ana Hughes, Molly Harrison, Sean H. Lim, Paul Miller, Paul Klenerman, PITCH consortium, Neil Basu, Ashley Gilmour, Sophie Irwin, Georgina Meacham, Thomas Marjot, Stavros Dimitriadis, Peter Kelleher, Maria Prendecki, Candice Clarke, Paige Mortimer, Stacey McIntyre, Rachael Selby, Naomi Meardon, Dung Nguyen, Tom Tipton, Stephanie Longet, Stephen Laidlaw, Kim Orchard, Georgina Ireland, David Thomas, Pamela Kearns, Amanda Kirkham, Iain B. McInnes and The OCTAVE Collaborative Group. SARS-CoV-2-specific immune responses and clinical outcomes after COVID-19 vaccination in patients with immune-suppressive disease.  

coronavirus

This study from the OCTAVE trial followed up on the outcomes of immuno-suppressed patients following COVID-19 vaccination. This ongoing trial is a collaboration between CRUK Clinical Trial Unit, led by Professor Pam Kearns, and the Universities of Glasgow and Oxford, and a consortium of other leading UK institutions. It reports on data from 20 hospital sites across the UK who enrolled 2686 patients with reduced function of their immune systems.

This new publication from the OCTAVE trial shows, for the first time, the real-world vaccine responses and infection outcomes in clinically at-risk patients with a range of immunocompromised or immunosuppressed conditions. Overall, it found that 12% patients failed to develop anti-spike antibodies, and 17% of patients became ill with COVID-19 up to one year after the date of their first vaccination. Most infections (90%) were mild in severity, including some asymptomatic cases. Severe cases requiring hospitalisation or death was reported in 9.8% of infections and occurred predominantly in patients with renal disease.

Spotlight on Lung Cancer

583:807-812 (2020). Middleton G, P Fletcher, S Popat, J Savage, Y Summers, A Greystoke, . . .and L Billingham. The National Lung Matrix Trial of personalized therapy in lung cancer.

Lung cancer image

A pioneering lung cancer study, led by the University of Birmingham’s Cancer Research UK Clinical Trials Unit, has highlighted important factors that will need to be considered in the next wave of precision medicine studies particularly in treating genomically complicated cancers.

The National Lung Matrix Trial (NLMT) is the world’s largest precision medicine clinical trial for non-small-cell lung cancer (NSCLC) patients.

Selected highlights from this research theme

Nature Medicine doi.org/10.1038/s41591-023-02414-4 (2023). Barnes E, CS Goodyear, M Willicombe, C Gaskell, . . . . . . Thomas D, Kearns P, Kirkham A, McInnes IB, and The OCTAVE Collaborative Group. SARS-CoV-2-specific immune responses and clinical outcomes after COVID-19 vaccination in patients with immune-suppressive disease. 

BMJ 376:e068177 (2022). Homer V, C Yap, S Bond, J Holmes, D Stocken, K Walker, . . . P Gaunt. Early phase clinical trials extension to guidelines for the content of statistical analysis plans.

J Clin Oncol JCO2200033 (2022). De Wilde B, E Barry, E Fox, D Karres, M Kieran, J Manlay, . . . P Kearns. The Critical Role of Academic Clinical Trials in Pediatric Cancer Drug Approvals: Design, Conduct, and Fit for Purpose Data for Positive Regulatory Decisions.

Arch Dis Child 107:186-188 (2022). Millen GC, R Arnold, JB Cazier, H Curley, R Feltbower, A Gamble, . . . P Kearns. COVID-19 in children with haematological malignancies.

British J Cancer 124:754-759 (2021). Millen GC, R Arnold, JB Cazier, H Curley, RG Feltbower, A Gamble, . . . C Varnai, PR Kearns. Severity of COVID-19 in children with cancer: Report from the United Kingdom Paediatric Coronavirus Cancer Monitoring Project.

iScience 24:103215 (2021). Syrimi E, E Fennell, A Richter, P Vrljicak, R Stark, S Ott, . . . P Kearns, GS Taylor. The immune landscape of SARS-CoV-2-associated Multisystem Inflammatory Syndrome in Children (MIS-C) from acute disease to recovery.

Nature 583:807-812 (2020). Middleton G, P Fletcher, S Popat, J Savage, Y Summers, A Greystoke, . . . L Billingham. The National Lung Matrix Trial of personalized therapy in lung cancer. 

Lancet Respir Med 8:895-904 (2020). Middleton G, K Brock, J Savage, R Mant, Y Summers, J Connibear, . . . L Billingham. Pembrolizumab in patients with non-small-cell lung cancer of performance status 2 (PePS2): a single arm, phase 2 trial