This is a
phase 3 trial. Researchers hope that 24 people from the UK will agree to take part.
It is a
randomised trial. Everyone taking part is put into 1 of the following groups by computer:
- pembrolizumab, surgery and then radiotherapy (or chemoradiotherapy) and pembrolizumab (group A)
- surgery and then radiotherapy or chemoradiotherapy (group B)
Neither you nor your doctor are able to decide which group you are in.
Group A
First, you have 2 pembrolizumab treatments. You have each treatment as a
drip into your vein over 30 minutes, every 3 weeks. You then have surgery about 3 weeks after your second pembrolizumab treatment.
You have
surgery in the same way as if you weren’t taking part in this trial. Your doctor can tell you more about this.
After surgery, a specialist doctor called a pathologist looks at the tissue they took during the operation. They check the border of tissue around the tumour for cancer cells. Depending on these results, you join 1 of the following groups:
- high risk group
- low risk group
You join the high risk group if there are cancer cells close to the border of tissue taken (positive margins). Or if the cancer has spread outside the
lymph nodes 
.
People in the high risk group have the following treatments after surgery:
- chemoradiotherapy with a high dose of radiotherapy every weekday, for 6 weeks. And cisplatin as a drip into your vein every 3 weeks, for up to 6 weeks
- pembrolizumab as a drip into your vein every 3 weeks, for up 10 months
You join the low risk group if there aren’t cancer cells close to the border of tissue they took (negative margins). And the cancer hasn’t spread outside the lymph nodes.
People in the low risk group have the following treatments after surgery:
- a low dose of radiotherapy every weekday, for 6 weeks
- pembrolizumab as a drip into your vein every 3 weeks, for up to 10 months
Group B
You have surgery in the same way as if you weren’t taking part in this trial. After surgery, your doctors look at the tissue taken under the microscope. Depending on these results, you join:
- the high risk group if there are cancer cells close to the border of tissue taken. Or if the cancer has spread outside the lymph nodes
- the low risk group if there aren’t cancer cells close to the border of tissue. And the cancer hasn’t spread outside the lymph nodes
People in the high risk group have a high dose of radiotherapy every weekday, for 6 weeks. And cisplatin as a drip into your vein every 3 weeks, for 6 weeks.
People in the low risk group have a low dose of radiotherapy every weekday, for 6 weeks.
Blood tests
You have extra blood tests as part of this trial. Researchers want to look for:
- certain proteins (biomarkers
that can tell how well treatment is working
- tumour cells that have broken away from the cancer and are circulating in the blood (circulating tumour cells)
You have the extra blood tests before the start of treatment, at set times during the trial and when you finish treatment.
Tissue sample
If you have oropharyngeal cancer, the trial team will ask to use a tissue sample of cancer they took when you were diagnosed (archival tissue sample). They want to look for the human papilloma virus.
You might need to give a tissue sample (biopsy) if there isn’t a suitable sample available. If you already had the HPV test done, the trial team will check the results before you start treatment.
If you have larynx, hypopharynx or mouth cancer, the trial doctors may also ask you for a tissue sample. They want to look for certain proteins (biomarkers) called PD-L1. You have a biopsy before the start of treatment and if your cancer gets worse.
Quality of life
- at set times during treatment
- after you finish treatment
- every 3 months for up to 3 years
- then every year for up to 2 years
The questionnaires ask about how you have been feeling and what side effects you have had.