Study of Pembrolizumab in Previously Treated Oesophagael Cancer
Research type
Research Study
Full title
A Phase II Study of Pembrolizumab Monotherapy in Third-line Previously Treated Subjects with Advanced/Metastatic Adenocarcinoma or Squamous Cell Carcinoma of the Oesophagus or Advanced/Metastatic Siewert Type I Adenocarcinoma of the Oesophagogastric Junction (KEYNOTE -180)
IRAS ID
194617
Contact name
Ildiko Csiki
Contact email
Sponsor organisation
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Eudract number
2015-002427-26
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 6 months, 29 days
Research summary
Research Summary
Oesophageal cancer is the 6th most common cancer in the world and is more frequent in men than women. The majority of patients are diagnosed with advanced/metastatic cancer (cancer which has spread) and in this setting response to chemotherapeutic agents is poor.
Given the high incidence and mortality worldwide and lack of good therapeutic options oesophageal cancer patients represent a high unmet need for drug development.
Adenocarcinoma has been gradually increasing in men of all ethnic backgrounds and also in women. Squamous cell carcinoma (SCC) seems to respond better to treatment than adenocarcinoma, but the long-term outcome is the same for both types thus emphasizing the need for better improved therapies.
Programmed cell death 1 (PD1) is a protein present on the surface of immune cells which fight cancer. When immune cells encounter cancer cells, PD1 becomes activated by programmed cell death ligand 1 (PDL1) and PDL2 which are proteins on the surface of cancer cells. The activated immune cells become exhausted or die thus stopping them from attacking the cancer. The study drug pembrolizumab is a potent & highly selective humanized monoclonal antibody developed to block PD1/PDL1 interaction, thereby increasing the immune attack on cancers.Approximately 100 male/ female subjects over the age of 18 with advanced/metastatic adenocarcinoma or SCC of the oesophagus or advanced/metastatic Siewert type 1 adenocarcinoma of the oesophagogastric Junction (EGJ) who failed on 2 previous lines of therapy will be enrolled in this phase II open-label study which will last approximately 24 months. The purpose of this study is to determine the overall response rate (ORR) of pembrolizumab given as monotherapy.
Subjects will receive pembrolizumab beginning on Day 1 of each 3-week dosing cycle.
The study is funded by Merck Sharp & Dohme Limited and will take at 2 study centres in the UK.
Summary of Results
https://clinicaltrials.gov/ct2/show/study/NCT02559687
REC name
London - City & East Research Ethics Committee
REC reference
16/LO/0122
Date of REC Opinion
16 Mar 2016
REC opinion
Further Information Favourable Opinion