Cervical cancer patients receiving treatment at Cork University Hospital (CUH) will be among the first in Ireland and the UK to take part in a potentially groundbreaking international clinical trial that could transform treatment and outcomes.
The CUH cancer unit is the first site in either country to enrol patients onto the Keynote-A18 clinical trial that will investigate if a new combination of treatments can cure cervical cancer in women with a stage two or stage three diagnosis.
The study will assess the potential of combining immunotherapy drug Pembrolizumab with chemotherapy and radiotherapy to improve the cure rate, and prevent relapses of the disease in women with high-risk, locally advanced cervical cancer.
Ireland is the only country in Europe where the Government covers the cost of the drug known as Pembro — around €5,000 per month — for women with advanced or stage four cervical cancer, following a campaign by patient advocate Vicky Phelan and the 221 Plus group.
Pembro, manufactured by Merck, can manage the disease in some women with advanced cervical cancer — but it is now hoped that using the drug in combination with chemotherapy and radiotherapy could cure women diagnosed at an earlier stage of the disease.
Around 260 women are diagnosed with cervical cancer each year in Ireland, with most diagnosed at stages one, two, or three of the disease, before it spreads to other parts of the body.
CUH oncologist Dr Dearbhaile Collins, lead investigator on the Keynote-A18 study team, said the “amazing” trial could change how cervical cancer is treated around the globe.
“We’re hoping that the addition of Pembrolizumab to chemotherapy and radiation will make a big difference and cure patients of this cancer,” said Dr Collins. "It has the potential to change practice all around the world."
Around 60% of patients with stage two or three cervical cancer can relapse, but the treatment combination may prevent that from happening in the future. Dr Collins said:
A handful of other Irish hospital sites are expected to take part in the international study in the coming months, and at least 10 patients will be enrolled on to the study nationally.
“We will be trying to put every single patient that comes our way onto this study,” said Dr Collins, adding that the hospital was keen to enrol patients from across the country while trials in other hospital sites come onstream.
It could be two to three years before any “significant results” emerge from the study.
Cancer Trials Ireland CEO Eibhlín Mulroe said: “It’s over three years since 221 Irish women were affected by the results of a cervical cancer screening audit.
"At that time, we worked hard in Cancer Trials Ireland to get support to do more trials in this disease area. Thanks to our EU partners in Engot [European Network for Gynaecological Oncological Trial groups], we are thrilled to announce Cork’s selection to open the trial.”
There are now 69 clinical trials for cancer open to enrolment.
Visit cancertrials.ie to learn more.