Study of BGB-A317 in Participants With Previously Treated Unresectable HCC

BeiGene

Status and phase: Completed; Phase 2

Conditions: Hepatocellular Carcinoma (HCC)

Treatments: Drug: Tislelizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT03419897

2017-003983-10 (EudraCT Number)

BGB-A317-208

CTR20171257 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 249 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

1. Histologically confirmed HCC
2. 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
3. Has received at least 1 line of systemic therapy for unresectable HCC
4. Has at least 1 measurable lesion as defined per RECIST v1.1
5. Child-Pugh score A
6. Easter Cooperative Oncology Group (ECOG) Performance Status ≤ 1
7. Adequate organ function

Key Exclusion Criteria:

1. Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC histology

2. Prior therapies targeting PD-1 or PD-L1

3. Has known brain or leptomeningeal metastasis

4. Tumor thrombus involving main trunk of portal vein or inferior vena cava

5. Loco-regional therapy to the liver within 4 weeks before enrollment

6. Medical history of interstitial lung disease, non-infectious pneumonitis or uncontrolled systemic diseases, including diabetes, hypertension, pulmonary fibrosis, or acute lung diseases

7. Has received:

   1. 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
   2. Within 14 days of the first study drug administration: sorafenib, regorafenib, or any Chinese herbal medicine or Chinese patent medicines used to control cancer

8. Active autoimmune diseases or history of autoimmune diseases that may relapse

9. Participant with any condition requiring systemic treatment with either corticosteroids (> 10 mg daily of prednisone or equivalent) or other immunosuppressive medication within 14 days before study drug administration

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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249 participants in 1 patient group

Tislelizumab

Experimental group

Description:

200 milligrams once every 3 weeks

Treatment:

Drug: Tislelizumab