This is an international
phase 3 trial. Researchers hope that around 735 people worldwide and 30 people from the UK will agree to take part.
This trial is in 2 parts:
- induction phase
- maintenance phase
Induction phase
Everyone has one of the following treatments:
- pembrolizumab, carboplatin and paclitaxel
- pembrolizumab, carboplatin and nab-paclitaxel
Your doctor can tell you which treatment you will have.
You have treatment in
cycles of treatment that last 3 weeks. This means that after each round of treatment you have a break to allow your body to recover. You have up to 4 cycles of treatment, taking around 3 months in total.
You have each cycle of treatment in the following way. You have:
- pembrolizumab as a drip into your bloodstream on day 1
- carboplatin as a drip into your bloodstream on day 1
- paclitaxel as a drip into your bloodstream on day 1 OR nab-paclitaxel on day 1, 8 and 15
After 4 cycles of treatment, you have a scan to find out how well the treatment is working. You stop this trial if your cancer got worse (progressed) after induction treatment. Your doctor can tell which other treatments you might be able to have.
You join the second part (maintenance phase) of this trial if your cancer stayed the same, got better or disappeared.
Maintenance phase
This part of the
trial is randomised. The people taking part are put one of the following groups at random:
- pembrolizumab and olaparib
- pembrolizumab and dummy drug
Neither you nor your doctor are able to decide which group you are in.
You have pembrolizumab as a drip into your vein every 3 weeks. It takes about 30 minutes each time you have it. You continue to have pembrolizumab for as long as it helps you and the side effects aren’t too bad. You can have treatment for up to 2 years.
You have olaparib or the dummy drug as
tablets that you swallow whole, twice a day. You continue to have olaparib or the dummy drug for as long as it helps you and the side effects aren’t too bad.
Tissue sample
The trial team will ask to use a tissue sample of your cancer taken when you had surgery or a biopsy. You need to have a new sample taken if there isn’t a suitable sample available.
Researchers want to look for a protein called PD-L1 on the surface of the cancer cells.
Blood tests
You have extra blood tests as part of this trial. You have them before the start of treatment and then:
- at set times during the trial
- at the end of treatment
Doctors want to look for certain proteins (
biomarkers) 
that can help to tell how well the treatment is working. They also want to look for small amounts of cancer
DNA 
in the blood. This is called circulating tumour DNA.
Quality of life
- every 3 weeks during treatment
- at the end of treatment
- a month after finishing treatment
The questionnaires ask about how you have been feeling and what side effects you have had.