Reducing the length of immunotherapy treatment for advanced melanoma did not lead to a significant difference in disease control compared to longer treatment periods, according to findings from the UK DANTE phase III clinical trial. The trial was led by the Universities of Sheffield and Leeds, alongside Sheffield Teaching Hospitals NHS Foundation Trust, and the results were presented at the American Society of Clinical Oncology (ASCO) annual meeting in Chicago on 3 June 2025.
The study was funded by a National Institute for Health and Care Research (NIHR) Health Technology Assessment grant and is the largest prospective trial to date assessing the appropriate duration of immunotherapy treatment for inoperable stage 3 and stage 4 melanoma.
Between September 2018 and March 2023, the five-year trial enrolled 415 patients across 36 hospitals in the UK. Patients who showed no disease progression after 12 months of immunotherapy were either continued on treatment or stopped therapy. Of the 166 patients who met the criteria, 80.2 per cent who stopped treatment at 12 months maintained disease control after an additional 12 months. This outcome was comparable to the 87.6 per cent disease control rate observed in those who continued treatment beyond 12 months, based on a predefined margin for disease worsening.
Secondary analyses of the study revealed minimal differences in quality of life between the two patient groups. Further evaluation is underway to examine the cost-effectiveness of a shorter treatment duration.
Immunotherapy, including drugs such as pembrolizumab and nivolumab, has become the standard first-line treatment for patients with inoperable metastatic melanoma. Current clinical practice typically recommends treatment for at least two years or until the drugs cease to be effective. However, prolonged treatment is often associated with severe side effects, increased hospital visits, and a higher need for diagnostic testing and inpatient care. The DANTE trial aimed to address whether shorter durations could offer similar therapeutic benefit with fewer burdens on patients and the healthcare system.
Chief Investigator Professor Sarah Danson, Professor of Medical Oncology at the University of Sheffield and Honorary Consultant in Medical Oncology at Weston Park Cancer Centre, Sheffield Teaching Hospitals NHS Foundation Trust, said: “Reducing the amount of treatment is one of the hardest things to do because patients and clinical teams worry that ‘more is best’. However, more treatment may mean more side-effects, which can be a burden to patients. Through this trial, we have gained a wealth of information and important evidence on the way advanced melanoma is treated. We will now be looking at this in more detail to see if certain patients benefited more than others.”
Michelle Collinson, Associate Professor in Clinical Trials at the Leeds Cancer Research UK Clinical Trials Unit, University of Leeds, said: “Clinical trials research is essential to improve the care and outcomes for patients globally. At the University of Leeds, we are committed to finding the best ways to treat cancer and this would not be possible without the patients who take part in research. We are proud to have led delivery of the DANTE trial and hope the promising findings will inform further research into immunotherapy treatment for melanoma patients.”
Jackie Summers, a 77-year-old patient from near Lincoln, took part in the trial after being diagnosed with inoperable stage 3 melanoma in 2018. After a year of immunotherapy, she opted to enrol in the trial and stop treatment early.
“Immunotherapy had only been around seven years before I was diagnosed with advanced skin cancer, and I truly believe that if you are on the receiving end of something so fantastic – the people, the nurses and the huge team that surround you – you need to give back,” said Jackie. “It was all about the people that had gone before me on the research trials; I wanted to tap into that and help thousands of people on the same drug as I was on.”
Since participating in the trial, Jackie has seen her tumour shrink by around half. She continues to wear a compression sleeve to manage lingering swelling.
“I know the tumour is there but don’t often think about it. I’ve only had 50 per cent of the standard treatment but I’m glad I am as bolshy as I am as there’s so much to be gained from research, not just for yourself but for the information that is recouped by the hospital, and that’s so important as it will help the next cohort of people who unfortunately will have cancer like me. The staff have been absolutely wonderful.”
Despite early trial closure due to recruitment delays linked to the COVID-19 pandemic, the research has offered important data. However, because the trial did not reach its full recruitment target, continuing immunotherapy for at least two years remains the standard approach for patients with advanced melanoma.
The trial was sponsored by Sheffield Teaching Hospitals NHS Foundation Trust and conducted by the Leeds Cancer Research UK Clinical Trials Unit at the University of Leeds. The abstract, titled ‘Comparison of 1 year versus minimum 2 years of anti-PD1-immunotherapy as first-line treatment for metastatic melanoma: Results of the DANTE phase III trial’, has been selected for inclusion in the 2025 Best of ASCO programme.
The DANTE trial was designed in collaboration with patients and supported by the Melanoma Focus Charity.
“My thanks go to all patients who signed up to the trial and to everyone else who contributed,” added Professor Danson.