A randomised phase III multicentre trial to evaluate the duration of anti-PD1 monoclonal antibody monotherapy in patients with metastatic melanoma (DANTE) – Stage 1 results
Session type: Poster / e-Poster / Silent Theatre session
Immunotherapy has revolutionised the treatment of melanoma and other tumour types. In contrast to some immune checkpoint inhibitors which are given for a fixed duration of 12 weeks, the anti-PD1 antibodies pembrolizumab and nivolumab are licensed to be given every 2-6 weeks until disease progression, which can extend to several years. This is a significant burden to patients and the NHS. Many responses occur in the first year and can continue even after treatment is stopped. The optimal duration of treatment is a major research priority. We hypothesise that continuing treatment beyond 1 year is unnecessary, exposing patients to the risk of developing immune-related toxicities and incurring considerable costs.
DANTE is a randomised multi-stage phase III non-inferiority trial. Patients receiving anti-PD1 monotherapy are registered into DANTE within 1 year of starting treatment. Those who remain progression-free at 1 year are then randomised to either a) stop treatment (with the option to restart anti-PD1 therapy or commence other treatment on progression) or b) continue until disease progression/unacceptable toxicity, or for a minimum of 2 years in the absence of progression/toxicity. Participants are followed up for 4 years. The primary outcome is progression-free survival. Secondary outcomes are quality of life, overall survival, response rate and duration, safety, cost effectiveness and patient acceptance of randomisation.
The trial includes 3 interim stages to identify early lack of feasibility of recruitment or efficacy. The trial opened in September 2018 and aims to randomise 1208 participants. The results of the Stage 1 analysis of recruitment rate and patient acceptance of randomisation will be presented.
The outcomes of DANTE will be of national and international importance in melanoma and other cancers.