BGB-A317-305: Tislelizumab (BGB-A317) in Patients with Gastric Cancer
Research type
Research Study
Full title
A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Clinical Study Comparing the Efficacy and Safety of Tislelizumab (BGB-A317) plus Platinum and Fluoropyrimidine Versus Placebo plus Platinum and Fluoropyrimidine as First-Line Treatment in Patients with Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma
IRAS ID
260693
Contact name
Elisa Fontana
Contact email
Sponsor organisation
Beigene Ltd
Eudract number
2018-000312-24
Duration of Study in the UK
4 years, 8 months, 15 days
Research summary
Gastric cancer (GC) is the fifth most common cancer and the second leading cause of cancer death. Generally patients with newly diagnosed inoperable GC or disease that has spread (metastatic) receive chemotherapy containing a platinum and a fluoropyrimidine with or without a third cytotoxic drug. Response rates for this chemotherapy are 30%-50% with 5 to 7 months of progression-free survival. Overall survival is less than 12 months, and <10% of patients are alive after 5 years.
Tislelizumab is an antibody which acts on PD-1 (programmed cell death-1). Antibodies find and destroy bacteria, viruses, and other foreign molecules. At present, several antibodies have been approved for the treatment of cancer. PD-1, is a protein present on the surface of immune cells. PD-1 signalling stops the body’s immune cells from killing tumour cells. This happens when PD-1 binds to a molecule called PD-L1. Tislelizumab can block PD-1 and PD-L1 from binding together, thereby allowing the immune cells to kill the tumour cells.
The purpose of this study is to compare the effectiveness and safety of tislelizumab plus chemotherapy to placebo (an inactive substance) plus chemotherapy on inoperable or metastatic gastric or gastroesophageal junction adenocarcinoma (GEJ). Patients will therefore receive either tislelizumab plus chemotherapy or placebo plus chemotherapy.
During the study neither the doctor nor the patient will know whether they are receiving tislelizumab or placebo. Patients will be assigned to receive tislelizumab or placebo by chance and will have a 50:50 chance (like flipping a coin) of being in each of the groups.
Patients will receive tislelizumab or placebo once every 3 weeks given as a continuous slow injection into a vein, they will also receive chemotherapy chosen by the study doctor. Patients will receive the study treatment until they are no longer benefitting from them or they wish to stop.
REC name
East of England - Cambridge East Research Ethics Committee
REC reference
19/EE/0189
Date of REC Opinion
23 Jul 2019
REC opinion
Further Information Favourable Opinion