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

Sponsor
BeiGene (Industry)
Overall Status
Completed
CT.gov ID
NCT03419897
Collaborator
(none)
249
Enrollment
65
Locations
1
Arm
50.8
Actual Duration (Months)
3.8
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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 Participants with Previously Treated Hepatocellular Unresectable Carcinoma.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
249 participants
Allocation:
N/A
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 :
Apr 9, 2018
Actual Primary Completion Date :
Jun 30, 2021
Actual Study Completion Date :
Jul 4, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Tislelizumab

200 mg once every 3 weeks (Q3W), intravenous dosing (IV)

Drug: Tislelizumab
Anti-PD-1 ANTIBODY
Other Names:
  • BGB-A317

    		•

    Outcome Measures

    Primary Outcome Measures

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

    Secondary Outcome Measures

    1. Duration of Response (DOR) [From first determination of an objective response up to 4 years, approximately]

    2. Progression-free survival (PFS) [From date of enrollment up to 4 years, approximately]

    3. Disease Control Rate (DCR) [From first dose of study treatment up to 4 years, approximately]

    4. Clinical benefit rate (CBR) [From first dose of study treatment up to 4 years, approximately.]

    5. Overall Survival [From date of enrollment up to 4 years, approximately.]

    6. Percentage of participants with adverse events [From date of enrollment up to 4 years, approximately.]

    7. Health-Related Quality of Life (HRQoL) [At screening or baseline up to 4 years, approximately]

    8. Percentage of Participants With Clinically Significant Changes in Vital Signs Findings [At screening or baseline up to 4 years, approximately]

    9. Percentage of Participants With Clinically Significant Changes in Physical Examination Findings [At screening or baseline up to 4 years, approximately]

    10. Percentage of Participants With Clinically Significant Changes in Clinical Laboratory Results Findings [At screening or baseline up to 4 years, approximately]

    11. Percentage of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Findings [At screening or baseline up to 4 years, approximately]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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, acute lung diseases, etc

    7. Has received:

    8. 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

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

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

    11. 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Anhui Provincial Hospital Hefei Anhui China 230071
    2 The Second Hospital of Anhui Medical Hospital Hefei Anhui China 230601
    3 302 Military Hospital of China Beijing Beijing China 100039
    4 Beijing Cancer Hospital Beijing Beijing China 100142
    5 Cancer Hospital Chinese Academy of Medical Sciences Beijing Beijing China
    6 Fujian Medical University Union Hospital Fuzhou Fujian China 350001
    7 Sun Yat-Sen Memorial Hospital,Sun Yat-Sen University Guangzhou Guangdong China 510288
    8 Nanfang Hospital of Southern Medical University Guangzhou Guangdong China 510515
    9 Peking University Shenzhen Hospital Shenzhen Guangdong China 518036
    10 Harbin Medical University Cancer Hospital Harbin Heilongjiang China 150081
    11 Henan Cancer Hospital Zhengzhou Henan China 450008
    12 Union Hospital Tongji Medical College Huazhong University of Science and Technology Wuhan Hubei China 430022
    13 Hubei Cancer Hospital Wuhan Hubei China 430079
    14 Xuzhou Central Hospital Xuzhou Jiangsu China 221009
    15 The Second Affiliated Hospital of Nanchang University Nanchang Jiangxi China 330006
    16 The First affiliated hospital of Nanchang University Nanchang Jiangxi China
    17 Jilin Cancer Hospital Changchun Jilin China 130012
    18 The First Hospital of Jilin University Changchun Jilin China 130021
    19 Weifang People's Hospital Weifang Shandong China 261000
    20 Shanghai Cancer Hospital, Fudan University Shanghai Shanghai China 200032
    21 Zhongshan Hospital Fudan University Shanghai Shanghai China 200032
    22 Tianjin Medical University Cancer Institute & Hospital Tianjin Tianjin China 300060
    23 The First Affiliated Hospital, Zhejiang University Hangzhou Zhejiang China 310003
    24 The Second Affiliated Hospital of Zhejiang University School of Medicine Hangzhou Zhejiang China 310009
    25 Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine Hangzhou Zhejiang China 310016
    26 Zhejiang Cancer Hospital Hangzhou Zhejiang China 310022
    27 The First Affiliated Hospital of Wenzhou Medical University Wenzhou Zhejiang China 325000
    28 Chinese PLA General Hospital Medical School of Chinese PLA Beijing China 100853
    29 CHU Nice - Hôpital de l'Archet 2 Nice Cedex 3 Alpes Maritimes France 06202
    30 Groupe Hospitalier Sud - Hôpital Haut Lévêque Pessac Cedex Gironde France 33604
    31 Hopital Saint Eloi Montpellier Herault France 34295
    32 CRLCC Eugene Marquis Rennes cedex Ille Et Vilaine France 35042
    33 Hopital Beaujon Clichy Paris France 92210
    34 Centre Hospitalier de la Croix Rousse Lyon Rhone France 69004
    35 Centre Hospitalier de la Croix Rousse Lyon Rhone France 69317
    36 Institut Gustave Roussy Villejuif cedex Val De Marne France 94805
    37 CHU Poitiers - Hôpital la Milétrie Poitiers Cedex Vienne France 8600
    38 Kliniken Essen-Mitte Essen Nordrhein Westfalen Germany 45136
    39 Universitätsmedizin der Johannes Gutenberg-Universität Mainz Mainz Rheinland Pflaz Germany 55131
    40 Universitaetsklinikum Hamburg-Eppendorf Hamburg Germany 20246
    41 Istituto Clinico Humanitas Rozzano Milano Italy 20089
    42 Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni XXIII) Bergamo Italy 24127
    43 Azienda Ospedaliero Universitaria Pisana Pisa Italy 56126
    44 Università Campus Bio-Medico di Roma Roma Italy 00128
    45 Centrum Badan Klinicznych Piotr Napora Lekarze Spolka Partnerska Warszawa Poland 02-034
    46 Centrum Onkologii-Instytut im. M. Sklodowskiej Curie Wroclaw Poland 51-162
    47 ICO l'Hospitalet - Hospital Duran i Reynals L'Hospitalet de Llobregat Barcelona Spain 08908
    48 Hospital Universitari Vall d'Hebron Barcelona Spain 08035
    49 Hospital Universitario Reina Sofia Córdoba Spain 14004
    50 Hospital Universitario Ramón Y Cajal Madrid Spain 28034
    51 Hospital Universitario La Paz Madrid Spain 28046
    52 Hospital Universitario HM Madrid Sanchinarro Madrid Spain 28050
    53 Chiayi Chang Gung Memorial Hospital of the Chang Gung Medical Foundation Chiayi City Taiwan
    54 E-Da Cancer Hospital Kaohsiung Taiwan 803
    55 Chang Gung Memorial Hospital, Kaohsiung Kaohsiung Taiwan 833
    56 National Cheng Kung University Hospital Tainan Taiwan 70403
    57 National Taiwan University Hospital Taipei Taiwan 100
    58 Taipei Veterans General Hospital Taipei Taiwan 11217
    59 Chang Gung Memorial Hospital, Linkou Taoyuan Taiwan 333
    60 The Christie NHS Foundation Trust Manchester England United Kingdom M20 4BX
    61 Royal Free Hospital London Greater London United Kingdom NW3 2QG
    62 King's College Hospital London Greater London United Kingdom SE5 9RS
    63 Beatson West of Scotland Cancer Centre Glasgow Strathclyde United Kingdom G12 OYN
    64 Queen Elizabeth Hospital Birmingham West Midlands United Kingdom B15 2TH
    65 Freeman Hospital Newcastle Upon Tyne United Kingdom NE7 7DN

    Sponsors and Collaborators

    • BeiGene

    Investigators

    • Principal Investigator: Ann-Lii Cheng, PhD, National Taiwan University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    BeiGene
    ClinicalTrials.gov Identifier:
    NCT03419897
    Other Study ID Numbers:
    • BGB-A317-208
    • 2017-003983-10
    • CTR20171257
    First Posted:
    Feb 5, 2018
    Last Update Posted:
    Jul 26, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    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:
    Carcinoma

    Study Results

    No Results Posted as of Jul 26, 2022