PEACOCC
Research type
Research Study
Full title
A phase II study of pembrolizumab in patients with advanced gynaecological clear cell cancer
IRAS ID
236786
Contact name
Nick McNally
Contact email
Sponsor organisation
University College London
Eudract number
2017-004168-36
Clinicaltrials.gov Identifier
Duration of Study in the UK
6 years, 0 months, 1 days
Research summary
PEACOCC is a gynaecological cancer study using an immunotherapy drug, called Pembrolizumab. The target accrual is 48 and it will recruit in approximately 5 UK hospitals.
The patients will be women who have advanced gynaecological clear cell cancer who have received at least one previous line of chemotherapy for their disease, and whose disease has recurred or progressed.
The study will investigate the use of 3 weekly i.v infusions of the immunotherapy drug, pembrolizumab. The aim is to stop disease progressing further following failure of prior treatment.
The recruited women will receive the study treatment for up to a maximum of 2 years initially. The drug may be stopped for the following reasons; if there is an unacceptable side effect, the treating clinician’s decision, or if disease becomes worse while taking pembrolizumab. In addition, if the disease radiologically (on a scan) show it has disappeared (complete response), the treatment could be discontinued and restarted later if the disease starts to grow again. In order to be eligible for this re-treatment the woman would have to have received at least 24 weeks of pembrolizumab initially.
Women who have received the full 2 years of pembrolizumab are also eligible for a further re-treatment period if the study is still running, assuming they had stable disease or a response showing that the cancer is smaller or has disappeared whilst on initial treatment.
Patients will undergo biopsies on trial to measure biomarkers associated with treatment response or resistance.
The study will be sponsored academically, by University College London and is funded by Merck Sharpe and Dohme Limited, the pharmaceutical company who make pembrolizumab.
REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
18/YH/0329
Date of REC Opinion
16 Oct 2018
REC opinion
Further Information Favourable Opinion