Extension Study-Participants-Advanced Tumors in Pembrolizumab trials
Research type
Research Study
Full title
A Multicenter, Open label, Phase III Extension Trial to Study the Long-term Safety and Efficacy in Participants with Advanced Tumors Who Are Currently on Treatment or in Follow-up in a Pembrolizumab Trial.
IRAS ID
246951
Contact name
James Larkin
Contact email
Sponsor organisation
Merck Sharp & Dohme LLC
Eudract number
2017-004417-42
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
110080, IND
Duration of Study in the UK
10 years, 0 months, 0 days
Research summary
Pembrolizumab (MK-3475) is a potent and highly selective monoclonal antibody (a type of protein made in the laboratory that can bind to substances in the body, including cancer cells) that targets and blocks the programmed cell death 1 (PD-1) receptor on the surface of certain immune cells called T-cells, which fight cancer.
Blocking PD-1 triggers the T-cells to find and kill cancer cells. The study drug, pembrolizumab, has been developed to block PD1/PDL1 interaction, thereby increasing the immune attack on cancers. Pembrolizumab is already approved in a number of countries, including the USA and UK, and available on prescription to treat several different cancers.
This study is a multi-centre, open-label, Phase III study investigating pembrolizumab in participants with advanced or spreading (metastatic) tumours.
The purpose of this trial is to allow participants who previously enrolled in pembrolizumab trials, sponsored by Merck Sharp & Dohme (MSD), including those who received pembrolizumab, pembrolizumab-based combinations or control, to rollover into an extension trial to collect long-term efficacy and safety data.
Approximately 2300 or more, male/female participants aged at least 18 years with advanced solid tumours, who previously enrolled in MSD-sponsored pembrolizumab trials, will be enrolled to continue to collect long-term information on the safety of pembrolizumab or pembrolizumab-based combinations to see how well the drug(s) work and how the body reacts to the drug(s) long term. The trial will last approximately ten years.
The study is sponsored by Merck Sharp & Dohme Limited and will take place at 6 study centres in the UK.
REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
18/EE/0248
Date of REC Opinion
13 Sep 2018
REC opinion
Further Information Favourable Opinion