DANTE (Duration of Anti-PD1 therapy for melanoma)
Research type
Research Study
Full title
DANTE: A randomised phase III trial to evaluate the Duration of ANti-PD1 monoclonal antibody Treatment in patients with metastatic mElanoma
IRAS ID
230556
Contact name
Sue Bell
Contact email
Sponsor organisation
Sheffield Teaching Hospitals NHS Foundation Trust
Eudract number
2017-002435-42
Duration of Study in the UK
10 years, 0 months, 0 days
Research summary
Metastatic melanoma has a poor prognosis if untreated. Recently, two types of drugs which activate the immune system have been shown to extend survival. The most active are those which target a molecule known as PD1. Two anti-PD1 drugs, pembrolizumab and nivolumab, are licensed to treat metastatic melanoma and are becoming the initial treatment of choice, in the UK and worldwide. Pembrolizumab and nivolumab are given as intravenous infusions every 2 or 3 weeks for as long as there is benefit.
Anti-PD1 drugs are given continuously because that is how they were given in trials, but there is no biological evidence for this. Up to 40% of patients remain on treatment after 1-2 years. The drugs seem to make most difference within the first year of treatment. There is no evidence that continuing treatment beyond 1 year brings any benefit. It is possible that shorter durations may be equally effective, with fewer side-effects. Continuing treatment exposes patients to potentially severe immune-related side-effects. Also, the burden of continuous treatment is significant, as patients must attend clinic before each treatment for safety checks. There is evidence that some patients continue to respond even after treatment has stopped.
This study will assess whether treatment with anti-PD1 drugs can be stopped after 1 year. Consenting patients will, after 12 months of treatment, be randomly allocated to stop treatment, or to continue for as long as there is benefit (the current standard). All patients will be closely monitored for response and to assess and manage side-effects. The main goal is to compare how long patients in the two groups live without melanoma re-growing.
If the trial shows that anti-PD1 drugs can be given for a shorter time compared with standard recommendations, without compromising their effectiveness and safety, these findings will change clinical practice worldwide.
REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
17/EM/0440
Date of REC Opinion
18 Jan 2018
REC opinion
Further Information Favourable Opinion