NEPTUNES
Research type
Research Study
Full title
Nivolumab and ipilimumab treatment in prostate cancer with an immunogenic signature
IRAS ID
218189
Contact name
Mark Linch
Contact email
Sponsor organisation
UCL Joint Research Office
Eudract number
2016-004091-21
Clinicaltrials.gov Identifier
Duration of Study in the UK
6 years, 5 months, 30 days
Research summary
Prostate cancer is the most common cause of cancer in men. Prostate cancer that has spread to other parts of the body (metastatic) is incurable and is often fatal. New drugs called immune checkpoint inhibitors work with the patient’s own immune system to fight the cancer. These drugs look promising in other cancers but have not been as successful in prostate cancer. However, we and others have done research which showed that it may be possible to pick out people more likely to respond to these types of drugs by looking at certain features of the cancer tissue. If the cancer tissue contains a lot of DNA mutations, show deficiencies in its ability to repair DNA, or if we see a lot of cells from the immune system in the tissue, we say it has a positive immunogenic signature (ImS +ve) and we think it is more likely to respond to treatment with immune checkpoint inhibitor drugs.\nWe plan to enrol patients with metastatic prostate cancer. Patients with ImS +ve cancer could go on to have treatment with a combination of two immune checkpoint inhibitors, nivolumab (Nivo) and ipilimumab (Ipi). About 1 in 4 prostate cancer patients will have ImS +ve disease. We plan to test around 175 men for the ImS to identify 35 with ImS +ve cancer who will go on to have the study treatment.\nThe main aim is to see if these men do better on treatment with Nivo and Ipi than we would expect if they were having routine treatment.\nBoth drugs are given intravenously in the hospital every 3-4 weeks. Treatment lasts for up to a year and patients will be followed up for up to 5 years after registration in the main study. The study will recruit patients from around 15 sites in the UK. We expect recruitment to start in the fourth quarter of 2017 and it will take about 18 months to recruitment.\n
REC name
South Central - Berkshire Research Ethics Committee
REC reference
17/SC/0369
Date of REC Opinion
23 Aug 2017
REC opinion
Favourable Opinion