Pembrolizumab vs chemotherapy in Subjects with Oesophageal Cancer
Research type
Research Study
Full title
A Phase III Randomized Open-label Study of Single Agent Pembrolizumab vs Physicians’ Choice of Single Agent Docetaxel, Paclitaxel, or Irinotecan in Subjects with Advanced/Metastatic Adenocarcinoma and Squamous Cell Carcinoma of the Esophagus that have Progressed after First-Line Standard Therapy (KEYNOTE-181)
IRAS ID
196596
Contact name
Ildiko Csiki
Contact email
Sponsor organisation
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Eudract number
2015-002782-32
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 2 months, 1 days
Research summary
Summary of Research
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 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 (malignant tumour that develops at the expense of glandular tissue) has been gradually increasing in men of all ethnic backgrounds and in women. Squamous cell carcinoma (cancer with uncontrolled growth of abnormal cells in the skin) seems to respond better to treatment, but the long-term outcome is the same, 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 ligands 1 and 2 (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 and highly selective humanized monoclonal antibody developed to block PD1/PDL1 interaction, thereby increasing the immune attack on cancers.
Approximately 600 male/female subjects older than 18 with cancer of the oesophagus or oesophagogastric junction who failed after first line therapy will be enrolled in this phase II study which will last approximately 24 months. The purpose of this study is to demonstrate the superiority of pembrolizumab as compared to investigator’s choice of paclitaxel, docetaxel or irinotecan, evaluating Progression Free Survival (PFS) and Overall Survival (OS).
Subjects will receive pembrolizumab on Day 1 of each 3-week dosing cycle.
The study is funded by Merck Sharp & Dohme Limited and will take place at 4 study centres in the UK.Summary of Results
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REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
16/NW/0084
Date of REC Opinion
4 Apr 2016
REC opinion
Further Information Favourable Opinion