Compare Efficacy of BGB-A317 vs Chemotherapy in Partients with ESCC
Research type
Research Study
Full title
A Randomised, Controlled, Open-label, Global Phase 3 Study Comparing the Efficacy of the anti-PD-1 Antibody BGB-A317 versus Chemotherapy as Second Line Treatment in Partients with Advanced Unresectable/Metastatic Esophageal Squamous Cell Carcinoma
IRAS ID
242092
Contact name
Arkenau Hendrik-Tobias
Contact email
Eudract number
2017-003699-30
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 8 months, days
Research summary
This is an open-label, multicenter Phase 3 study for second line treatment in subjects with Advanced Unresectable/Metastatic Esophageal Squamous Cell Carcinoma(ESCC). Eligible participants will be randomised to receive either BGB-A317 (also known as tislelizumab) or Investigator Chosen Chemotherapy (ICC).
tislelizumab is a monoclonal antibody acting on PD-1. A monoclonal antibody is a type of protein made in the laboratory which can be “programmed” to bind to specific substances in the body or on cells, like cancer cells. PD-1, called programmed cell death -1, is a protein present on the surface of immune cells. After binding to its ligand, PD-1 can inhibit the killing of tumour cells by immune cells. Tislelizumab can act on PD-1, thereby eliminating its inhibitory effect on the immune cells, so that immune cells can attack tumour cells.
The ICC drugs that the participant may receive in this research study are called paclitaxel, docetaxel, and irinotecan. All three of these drugs are considered the standard of care in the UK for participants with advanced unresectable or metastatic ESCC who have failed one regimen of systemic anti-cancer treatment.
All participants will receive study treatment until intolerable toxicity, withdrawal of informed consent, or the time point at which the participant, in the opinion of the investigator, is no longer benefiting from study therapy. Participants will be followed for survival and subsequent anticancer therapies.This study is taking place in the UK and other countries. The Sponsor of the study is BeiGene, Ltd. Around 450 participants are expected to be involved in the trial.
Lay summary of study results
https://www.beigene.com/clinical-trials/a-study-of-tislelizumab-bgb-a317-versus-chemotherapy-as-second-line-treatment-in-participants-with-advanced-esophageal-squamous-cell-carcinoma/REC name
London - Riverside Research Ethics Committee
REC reference
18/LO/1567
Date of REC Opinion
29 Nov 2018
REC opinion
Further Information Favourable Opinion