EACH: Evaluating Avelumab in Combination With Cetuximab in Head and Neck Cancer
Status:
Active, not recruiting
Trial end date:
2022-10-04
Target enrollment:
Participant gender:
Summary
Head & neck (H&N) cancer is the eighth most common cancer in the UK. Advanced H&N cancer
which has come back after treatment or has spread to other parts of the body is incurable and
the average life expectancy of these patients is less than a year. New drugs called immune
checkpoint inhibitors work with the patient's own immune system to fight cancer. They are
used in the clinic to treat a number of cancers, including H&N cancer. It may be possible to
make immune checkpoint inhibitors more effective by combining drugs that work in different
ways. In effect, attacking the cancer from different angles. Cetuximab is a well-established
drug that works by blocking signals that tell cancer cells to grow and divide into more
cells. It also engages with the immune system within the tumour. The trial aims to see if
giving cetuximab along with an immune checkpoint inhibitor drug called avelumab is better at
treating advanced H&N cancer than giving avelumab on its own.
These two drugs have not been given together before, so to start with, the investigator plans
to enrol a small number of patients and give the patients avelumab + cetuximab to make sure
the combination is safe at the doses chosen. After this, the investigator plans to enrol 114
patients with advanced H&N cancer. Half the patients will be treated with avelumab alone and
the other half with avelumab + cetuximab. Both drugs are given intravenously in the hospital
once every 2 weeks.
Treatment lasts for up to a year and patients will be followed up for up to 2 years from the
time they enter the study. Patients will be recruited from around 15 hospitals in the UK.
Recruitment would be expected to start in the second quarter of 2018 and it will take about
29 months (Safety run-in: 5 months; Phase II: 24 months) to recruit all the patients.