A NEW study has explored the effects of combining nivolumab, an immunotherapy drug, with hypofractionated radiotherapy in patients with advanced melanoma. Radiotherapy is believed to enhance anti-tumour immunity, particularly when delivered in a multisite manner. This phase 2 multicentre trial aimed to determine whether this combination could improve survival outcomes.
The study enrolled 64 patients with treatment-naïve metastatic melanoma between March 2017 and July 2019. Participants received nivolumab (240 mg every two weeks) alongside radiotherapy, which was administered in three 6 Gy fractions starting on day 15. When possible, one tumour from each organ was irradiated, ensuring that not all tumour sites were targeted. The primary focus was on one-year overall survival (OS), with additional assessments of progression-free survival (PFS) and treatment-related adverse events.
With a median follow-up of 23.5 months, the study reported a 2-year OS rate of 65.2% and a 1-year PFS rate of 56%. These results were not significantly different from those observed in historical cohorts, such as the Checkmate 066 study, which reported OS and PFS rates of 58% and 43%, respectively. Notably, patients with better baseline performance status (ECOG-PS 0) experienced improved survival outcomes. Additionally, irradiating multiple tumour sites and targeting a smaller cumulative tumour volume appeared to correlate with better prognoses.
Regarding safety, 21.9% of patients experienced grade 3–4 treatment-related adverse events, though no grade 5 events were reported. While the study confirmed the feasibility of combining immunotherapy with radiotherapy, it did not demonstrate a clear survival advantage compared to existing treatment strategies.
The findings highlight the need for optimising radiotherapy protocols to enhance therapeutic benefits. Future research may focus on refining dose scheduling and patient selection to improve clinical outcomes for individuals with advanced melanoma.
Katie Wright, EMJ
Reference
Doyen J et al. Nivolumab and hypofractionated radiotherapy in patients with advanced melanoma: a phase 2 trial. Eur J Cancer. 2025;217:115256.
