Phase 3 Pembrolizumab/Chemo vs Placebo/Chemo in Advanced BTC
Research type
Research Study
Full title
A Phase 3 Randomized, Double Blind Study of Pembrolizumab Plus Gemcitabine/Cisplatin versus Placebo Plus Gemcitabine/Cisplatin as First-Line Therapy in Participants with Advanced and/or Unresectable Biliary Tract Carcinoma
IRAS ID
269837
Contact name
John Bridgewater
Contact email
Sponsor organisation
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Eudract number
2019-000944-82
Duration of Study in the UK
3 years, 10 months, 0 days
Research summary
Biliary tract cancer (BTC), which comprises cancers of the intra- and extrahepatic bile ducts and gallbladder, is a rare but aggressive form of cancer with limited treatment options. . Gemcitabine in combination with cisplatin is the current standard of care but despite advances in supportive care along with combination chemotherapy, median progression free survival is approximately 6 to 7 months, and the median survival of advanced BTC patients remains dismal at approximately 12 months. As a result, there is an unmet medical need for more effective therapies.
Programmed cell death 1 (PD1) is a protein present on the surface of immune (attacking) cells which fight cancer. When immune cells meet 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 die thus stopping them from attacking the cancer. The study drug pembrolizumab has been developed to block PD1/PDL1 interaction, thereby increasing the immune attack on cancers.
This phase 3 study will last approximately 46 months from the time the first participant signs the informed consent until the last participant’s last study related contact. The study will recruit approximately 788 male and female participants who are at least 18 years of age and who have not had previous systemic therapy for advanced/ unresectable BCT. The purpose of the study is to assess the effectiveness and safety of pembrolizumab in combination cisplatin/gemcitabine as a first line therapy in participants with advanced and/or unresectable BCT. Participants will be assigned randomly in 1:1 ratio to one of two treatment arms to receive either pembrolizumab plus cisplatin/gemcitabine or placebo plus cisplatin/gemcitabine.
The study is funded by Merck Sharp & Dohme Limited and will take place at 11 study centres in the UK.
REC name
London - Fulham Research Ethics Committee
REC reference
19/LO/1449
Date of REC Opinion
15 Nov 2019
REC opinion
Further Information Favourable Opinion