BGB-A317-208: BGB-A317 in Hepatocellular Unresectable Carcinoma
Research type
Research Study
Full title
A Phase 2, Open-label, Multicenter Study to Investigate the Efficacy, Safety, and Pharmacokinetics of the Anti-PD-1 Monoclonal Antibody BGB-A317 in Patients with Previously Treated Hepatocellular Unresectable Carcinoma
IRAS ID
240385
Contact name
Paul Ross
Contact email
Sponsor organisation
BeiGene, Ltd., c/o BeiGene USA, Inc.
Eudract number
2017-003983-10
Duration of Study in the UK
1 years, 10 months, 1 days
Research summary
Research Summary:
This study will investigate the Efficacy (how well the drug works), Safety, and Pharmacokinetics (how much drug is in the body) of the Anti-PD-1 (programmed cell death protein-1) Monoclonal Antibody BGB-A317 in Patients with Previously Treated Hepatocellular Unresectable Carcinoma (cancer of the liver that cannot be removed by surgery).
Patients will receive the study drug, BGB-A317 intravenously (through a vein) once every 3 weeks. Each treatment cycle will be 21 days in duration. The study consists of a Screening phase of up to 28 days, a Treatment phase, a Safety Follow-up visit which will occur 30 days after the last dose of study drug and Survival Follow-up visits which will occur every 3 months after the Safety Follow-up visit.
Approximately 228 patients will receive the study drug. Of the 228 patients, at least 100 patients will be enrolled who have had only 1 type of previous treatment for their liver cancer and at least 100 patients will be enrolled who have had at least 2 types of previous treatment.
Study treatment is to be continually given until unacceptable side effects, withdrawal of informed consent, or if the investigator determines that the patient is no longer benefiting from the study drug, whichever should occur first.Summary of Research:
"Measuring ORR(Overall Response Rate) is one way to determine how well a new treatment works. The
percentage of patients with HCC (hepatocellular carcinoma)who no longer had evidence of cancer or had
an improvement in the signs and symptoms of cancer after treatment is shown
below. A total of 249 patients were included in this analysis.The results from this study will help researchers understand more about how
tislelizumab works in patients with HCC and may provide additional treatment
options for patients in the future. More studies with tislelizumab are ongoing
and planned."REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
18/NE/0029
Date of REC Opinion
3 May 2018
REC opinion
Further Information Favourable Opinion