DETECTION
Research type
Research Study
Full title
Circulating tumour DNA guidEd Therapy for stage IIB/C mElanoma after surgiCal resecTION (DETECTION)
IRAS ID
270318
Contact name
Paul Lorigan
Contact email
Eudract number
2020-000234-17
Duration of Study in the UK
9 years, 4 months, 1 days
Research summary
Research Summary:
• We are looking for new and better ways to treat melanoma.
• We have developed a blood test that tells us whether cancer cells are still present or cancer is becoming active, even if a scan looks normal.
• The test looks for pieces of DNA that are known to have come from the cancer, which we call ‘circulating tumour DNA’, or ctDNA.
• If we do not find ctDNA patients will stay on the study having blood tests either until the study ends (and we have not found ctDNA in their blood) or until we find ctDNA in the blood.
• If we find ctDNA, patients will be allocated to either receive the standard of care, which is ongoing follow up or nivolumab, an immune boosting drug which we know is effective at treating melanoma.
• Doctor will inform patients of the possible benefits and risks when taking nivolumab.
• We do not know whether treating early with nivolumab, on the evidence of ctDNA alone, is of benefit to patients, and this is what we need to find out.Summary of results:
The DETECTION study was designed at a time when patients with Stage 2b/c melanoma were followed up clinically, but there was no approved adjuvant (preventative) treatment. The Study opened in November 2021. In april 2022, the preliminary results from a large study comparing routine follow-up with adjuvant immunotherapy showed a benefit for adjuvant immunotherapy. A second study with similar design reported initially in November 2022, and showed a similar benefit. As no treatment was no longer considered standard of care, The DETECTION Trial was halted in October 2022 and a decision made to close it in January 2023. During this time, the study was redesigned. The new study included treatment as the standard of care.
A decision was made by all involved that this new protocol was a significant change from the original study and would be resubmitted to the funders and regulators.
When the study was closed, there were a small number of patients on follow-up but none had been randomised. These patients were spoken to individually. None of them were eligible for adjuvant treatment at that time. Those patients remain on standard of care follow-up.Termination of the study was declared prior to any patient being randomised which means we are unable to perform any evaluation of result or outcome.
REC name
London - Harrow Research Ethics Committee
REC reference
21/LO/0318
Date of REC Opinion
23 Jul 2021
REC opinion
Further Information Favourable Opinion