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

BeiGene54 sites in 8 countries249 target enrollmentApril 9, 2018

ConditionsHepatocellular Carcinoma (HCC)

InterventionsTislelizumab

DrugsTislelizumab

Overview

Phase: Phase 2
Intervention: Tislelizumab
Conditions: Hepatocellular Carcinoma (HCC)
Sponsor: BeiGene
Enrollment: 249
Locations: 54
Primary Endpoint: Objective Response Rate (ORR) Assessed by Independent Review Committee (IRC)
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This study investigated the efficacy, safety, and pharmacokinetics of the anti-PD-1 monoclonal antibody BGB-A317 in participants with previously treated hepatocellular unresectable carcinoma.

Registry

clinicaltrials.gov

Start Date

April 9, 2018

End Date

July 6, 2022

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

BeiGene

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Histologically confirmed HCC
•Participants with Barcelona Clinic Liver Cancer (BCLC) Stage C, or BCLC stage B not amenable to locoregional therapy or relapsed after locoregional therapy, and not amenable to a curative treatment approach
•Has received at least 1 line of systemic therapy for unresectable HCC
•Has at least 1 measurable lesion as defined per RECIST v1.1
•Child-Pugh score A
•Easter Cooperative Oncology Group (ECOG) Performance Status ≤ 1
•Adequate organ function

Exclusion Criteria

•Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC histology
•Prior therapies targeting PD-1 or PD-L1
•Has known brain or leptomeningeal metastasis
•Tumor thrombus involving main trunk of portal vein or inferior vena cava
•Loco-regional therapy to the liver within 4 weeks before enrollment
•Medical history of interstitial lung disease, non-infectious pneumonitis or uncontrolled systemic diseases, including diabetes, hypertension, pulmonary fibrosis, or acute lung diseases
•Has received:
•Within 28 days or 5 half-lives (whichever is shorter) of the first study drug administration: any chemotherapy, immunotherapy (eg, interleukin, interferon, thymoxin) or any investigational therapies
•Within 14 days of the first study drug administration: sorafenib, regorafenib, or any Chinese herbal medicine or Chinese patent medicines used to control cancer
•Active autoimmune diseases or history of autoimmune diseases that may relapse

Arms & Interventions

Tislelizumab

200 milligrams once every 3 weeks

Intervention: Tislelizumab

Outcomes

Primary Outcomes

Objective Response Rate (ORR) Assessed by Independent Review Committee (IRC)

Time Frame: From date of first dose to primary analysis data cut-off date of 30-June-2021 (up to approximately 3 years and 3 months)

ORR is defined as the percentage of participants with complete response (CR) and partial response (PR) as the best overall response, as determined by an IRC using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. CR is defined as disappearance of all target lesions and PR is defined as at least a 30% decrease in the sum of diameters of target lesions.

Secondary Outcomes

Progression-free Survival (PFS) Assessed by IRC(From date of first dose to end of study (up to approximately 4 years and 3 months))
PFS Assessed by Investigator(From date of first dose to end of study (up to approximately 4 years and 3 months))
DCR Assessed by Investigator(From date of first dose to end of study (up to approximately 4 years and 3 months))
Duration of Response (DOR) Assessed by IRC(From date of first dose to end of study (up to approximately 4 years and 3 months))
DOR Event-Free Rate Assessed by Investigator(From date of first dose to end of study (up to approximately 4 years and 3 months); Months 12 and 24 reported)
EORTC QLQ - Hepatocellular Carcinoma 18 Questions (HCC18): Index Scores(Baseline to Cycle 6 Day 1 and Cycle 12 Day 1 (each cycle is 21 days))
ORR Assessed by Investigator(From date of first dose to end of study (up to approximately 4 years and 3 months))
DOR Assessed by Investigator(From date of first dose to end of study (up to approximately 4 years and 3 months))
Clinical Benefit Rate (CBR) Assessed by IRC(From date of first dose to end of study (up to approximately 4 years and 3 months))
CBR Assessed by Investigator(From date of first dose to end of study (up to approximately 4 years and 3 months))
European Quality of Life 5 Dimensions 5 Level Version (EQ-5D-5L) Visual Analogue Score (VAS)(Baseline to Cycle 6 Day 1 and Cycle 12 Day 1 (each cycle is 21 days))
Overall Survival (OS)(From date of first dose to end of study (up to approximately 4 years and 3 months))
European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Global Health Status(Baseline to Cycle 6 Day 1 and Cycle 12 Day 1 (each cycle is 21 days))
DOR Event-Free Rate Assessed by IRC(From date of first dose to end of study (up to approximately 4 years and 3 months); Months 12 and 24 reported)
Disease Control Rate (DCR) Assessed by IRC(From date of first dose to end of study (up to approximately 4 years and 3 months))
Number of Participants With Adverse Events(From first dose up to 30 days after the last dose of study drug; up to approximately 4 years and 3 months)