MK-3475 with chemo vs placebo with chemo in Esophageal carcinoma
Research type
Research Study
Full title
A Randomized, Double-Blind, Placebo-Controlled Phase III Clinical Trial of Pembrolizumab (MK-3475) in Combination with Cisplatin and 5-Fluorouracil versus Placebo in Combination with Cisplatin and 5-Fluorouracil as First-Line Treatment in Subjects with Advanced/Metastatic Esophageal Carcinoma (KEYNOTE-590)
IRAS ID
226871
Contact name
Was Mansoor
Contact email
Sponsor organisation
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Eudract number
2017-000958-19
Duration of Study in the UK
3 years, 2 months, 23 days
Research summary
Research Summary
Oesophageal cancer is the sixth most common cause of cancer deaths in the world and is more prevalent in men than in women.
The majority of patients are diagnosed with advanced/metastatic cancer (cancer which has spread), and in this setting, response to chemotherapy 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.
This is a phase III, randomised, double blind, placebo controlled trial of a study drug pembrolizumab in combination with cisplatin and 5-fluorouracil compared to placebo (dummy drug) in combination with cisplatin and 5-fluorouracil as first-line treatment for oesophageal cancer.
The purpose of the trial is to evaluate how effective and safe pembrolizumab is in combination with chemotherapy compared with placebo and chemotherapy.
Programmed cell death 1 (PD1) is a protein present on the surface of immune (attacking) cells which fight cancer. When immune cells come upon 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. Interaction between these ligands and the receptors present on the immune cells prevents the immune cells from attacking the cancer cells. The study drug pembrolizumab has been developed to block PD1/PDL1 interaction, thereby increasing the immune attack on cancers.
The study will last approximately 40 months and will recruit 700 men/women older than 18. Each participant will take part in the trial for approximately 2 years and will receive up to 35 administrations of pembrolizumab or placebo combined with chemotherapy. After the treatment, participants will be followed up for overall survival.The study is funded by Merck Sharp & Dohme Limited and will take place at 2 study centres in the UK.
Summary of Results
https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fclick.pstmrk.it%2F3ts%2Fclinicaltrials.gov%252Fstudy%252FNCT03189719%253Fterm%253D3475-590%2526rank%253D1%2526tab%253Dresults%2FNBTI%2FVsW1AQ%2FAQ%2Fa2f27c5c-9d92-430c-8346-446f4d4cec59%2F2%2FqMoG8-2yuK&data=05%7C02%7Cedgbaston.rec%40hra.nhs.uk%7C7facdf701a1e4c3844b308dc8481303b%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638530937592103755%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=EMNDve9h6ZVUxKEibL8wb%2BXKXx14Al3A19cAXcm28Ws%3D&reserved=0
REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
17/WM/0267
Date of REC Opinion
27 Sep 2017
REC opinion
Further Information Favourable Opinion