Chemoradiotherapy +/- Pembrolizumab for LACC
Research type
Research Study
Full title
A Randomized, Phase 3, Double-Blind Study of Chemoradiotherapy With or Without Pembrolizumab for the Treatment of High-risk, Locally Advanced Cervical Cancer (KEYNOTE-A18 / ENGOT-cx11)
IRAS ID
1003213
Contact name
Susan Lalondrelle
Contact email
Eudract number
2019-003152-37
Research summary
Cervical cancer is one of the most frequently diagnosed malignancies and cause of cancer related death among women. Worldwide, there are an
estimated 569,847 newly diagnosed cases of cervical cancer and an estimated 311,365 deaths per year. Women with Locally advanced cervical
cancer (LACC) (Stage IB2 to IVA) have higher disease recurrence rates than those with earlier stages of disease.
Rate of recurrence worsen by stage, and benefits of Standard of Care (SOC) treatment are greater with earlier versus more advanced stages of
disease. Data from previous studies provides clear evidence of a larger unmet medical need for patients with Stage III-IVA despite standard of
care treatment.
Standard of care treatment is concurrent chemoradiation (CCRT) followed by brachytherapy. Chemotherapy is cisplatin given weekly (40 mg/m2)
along with Radiotherapy (RT) for 5 weeks. Radiotherapy is delivered to the pelvis. Brachytherapy is mainly administered in an effort to maximize
the local control of the tumour, using applicators inserted into the uterus or vagina, or directly into the tumour.
Pembrolizumab is a type of immunotherapy that stimulates the body's immune system to fight cancer cells. Pembrolizumab targets and blocks a
protein called PD-1 on the surface of certain immune cells called T-cells. Blocking PD-1 triggers the T-cells to find and kill cancer cells.
Immunotherapy is emerging as a potential strategy to enhance traditional cervical cancer treatments. Pembrolizumab monotherapy demonstrated
durable antitumour activity and manageable safety in patients with advanced cervical cancer .
This multicentre phase 3 study will recruit approximately 980 female (18+) participants. The purpose of this study is to compare current
chemoradiotherapy with or without placebo with respect to progression-free survival and overall survival in patients with LACC.
The study is funded sponsored by Merck Sharp & Dohme Limited and will take place at 4 study centres in the UK.REC name
London - Surrey Borders Research Ethics Committee
REC reference
21/LO/0033
Date of REC Opinion
16 Feb 2021
REC opinion
Further Information Favourable Opinion