This is a
phase 2 study. It is taking place at St George’s University Hospital in London.
The study is divided into 2 groups:
- group A is for people who haven’t had treatment for advanced melanoma
- group B is for people whose advanced melanoma got worse during immunotherapy treatment
The researchers need 18 people to join group A and 8 people to join group B.
Everyone has IMM-101 and nivolumab. Some patients in group B may change to IMM-101 and ipilimumab during the study.
IMM-101
IMM-101 is an injection into your upper arm. You have IMM-101 as follows:
- 1 injection once every 2 weeks for the first 3 doses
- no injections for 4 weeks
- 1 injection once every 2 weeks for the next 3 doses
- 1 injection once every 4 weeks after that
The study team will monitor you for 2 hours after the first injection to check you don’t have a bad reaction. They check your blood pressure, pulse and temperature at regular intervals.
Nivolumab
You have treatment for as long as it is working, and the side effects aren’t too bad. The longest you can have treatment for on this study is 18 months.
You stop treatment if your cancer gets worse. In group B, some people might change from nivolumab to ipilimumab if their cancer gets worse and you haven’t already had this. You have up to 4 doses of ipilimumab and then you can continue with IMM-101 on its own. The study team can tell you more if this applies. If not, your doctor will talk to you about other treatment options.
Samples for research
You give some extra blood samples during treatment. You give the samples at specific times and the study team will give you more information about this. They plan to use the samples to:
- see how well the treatment is working
- look for biomarkers to predict who will benefit from treatment
The study team will ask you to give an extra tissue sample (biopsy) at 3 months if you join group A.
They will also ask for some extra tissue samples if you join group B. But you don’t have to agree to this if you don’t want to. You can still take part in the study.