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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03419897
Recruitment Status : Active, not recruiting
First Posted : February 5, 2018
Last Update Posted : November 18, 2019
Sponsor:
Information provided by (Responsible Party):
BeiGene

Study Description
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Brief Summary:
This is 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.

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma (HCC) Drug: BGB-A317 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 228 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: RATIONALE-208: 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
Actual Study Start Date : April 9, 2018
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : September 2021
Arms and Interventions
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Arm Intervention/treatment
Experimental: BGB-A317
BGB-A317: 200 mg once every 3 weeks (Q3W), intravenous dosing (IV)
 Drug: BGB-A317
Anti-PD-1 ANTIBODY


Outcome Measures
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Primary Outcome Measures :
  1. Objective Response Rate (ORR) assessed by Independent Review Committee (IRC) [ Time Frame: From date of enrollment up to 4 years, approximately ]

Secondary Outcome Measures :
  1. Duration of Response (DOR) [ Time Frame: From first determination of an objective response up to 4 years, approximately ]
  2. Progression-free survival (PFS) [ Time Frame: From date of enrollment up to 4 years, approximately ]
  3. Disease Control Rate (DCR) [ Time Frame: From first dose of study treatment up to 4 years, approximately ]
  4. Clinical benefit rate (CBR) [ Time Frame: From first dose of study treatment up to 4 years, approximately. ]
  5. Overall Survival [ Time Frame: From date of enrollment up to 4 years, approximately. ]
  6. Percentage of patients with adverse events [ Time Frame: From date of enrollment up to 4 years, approximately. ]
  7. Health-Related Quality of Life (HRQoL) [ Time Frame: At screening or baseline up to 4 years, approximately ]
  8. Percentage of Participants With Clinically Significant Changes in Vital Signs Findings [ Time Frame: At screening or baseline up to 4 years, approximately ]
  9. Percentage of Participants With Clinically Significant Changes in Physical Examination Findings [ Time Frame: At screening or baseline up to 4 years, approximately ]
  10. Percentage of Participants With Clinically Significant Changes in Clinical Laboratory Results Findings [ Time Frame: At screening or baseline up to 4 years, approximately ]
  11. Percentage of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Findings [ Time Frame: At screening or baseline up to 4 years, approximately ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Histologically confirmed HCC
  2. Patients 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

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, acute lung diseases, etc

  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. Patient 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03419897


Locations
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Sponsors and Collaborators
BeiGene
Investigators
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Principal Investigator: Ann-Lii Cheng, PhD National Taiwan University Hospital
More Information
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Responsible Party: BeiGene
ClinicalTrials.gov Identifier: NCT03419897    
Other Study ID Numbers: BGB-A317-208
2017-003983-10 ( EudraCT Number )
CTR20171257 ( Registry Identifier: Center for drug evaluation, CFDA )
First Posted: February 5, 2018    Key Record Dates
Last Update Posted: November 18, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by BeiGene:
Advanced liver cancer
RATIONALE-208
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
 Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases