This is a
phase 1/2 trial. It is taking place in the UK. It is in 2 parts. The researchers hope to find about 52 people in total. Everyone has CXD101 and nivolumab.
Part 1
Part 1 is now open. In part 1, researchers are looking at the best dose of CXD101 to have in combination with nivolumab. The researchers need about 12 people to join part 1.
The first few people taking part will have a low dose of CXD101 alongside a standard dose of nivolumab. The next few people will have a higher dose if there weren’t serious side effects in the earlier patients at the lower dose.
Part 2
Part 2 isn’t open to people yet. But it will be by early 2019. In part 2, the researchers plan to test the best dose of CXD101 alongside nivolumab in a larger number of people. They hope about 37 people will join part 2.
Treatment
CXD101 is a white capsule. You take them twice a day, for five days in a row as directed.
You have nivolumab as a
drip into a vein. Everyone has the same dose of nivolumab.
You have treatment in cycles. The first day of each
treatment cycle is called day 1. For CXD101, day 1 is every three weeks (or 21 days). For nivolumab it is every two weeks (or 14 days).
You:
- take CXD101 on day 1 to 5
- have a break from day 6 to 21
You complete a medication diary and record the days you take CXD101 and how many you take.
You have nivolumab every 2 weeks on day:
You have treatment for as long as it is working and the side effects aren’t too bad. You stop treatment if your cancer gets worse. Your doctor will talk to you about other treatment options.
Samples for biomarker research
The researchers will look at tumour tissue samples from past surgeries or biopsies. The trial team will ask you to give another sample if you haven’t had a biopsy in the last year. They plan to use these to look for biomarkers. Biomarkers are diagnostic test results which if they can be linked to drug effects, could be used to predict in future the best treatment for a patient (precision medicine).