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AdvanTIG-203: Anti-PD-1 Monoclonal Antibody Tislelizumab (BGB-A317) Combined With or Without Anti-TIGIT Monoclonal Antibody Ociperlimab (BGB-A1217) in Participants With Recurrent or Metastatic Esophageal Squamous Cell Carcinoma

Sponsor
BeiGene (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04732494
Collaborator
(none)
120
Enrollment
86
Locations
2
Arms
35
Anticipated Duration (Months)
1.4
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

A study of tislelizumab (BGB-A317) plus ociperlimab versus tislelizumab plus placebo as second-line treatment in participants with programmed cell death protein-ligand 1 (PD-L1) tumor area positivity (TAP) ≥ 10% unresectable, locally advanced, recurrent or metastatic esophageal squamous cell carcinoma.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
A Phase 2, Multicenter, Randomized, Placebo-Controlled Study to Compare the Efficacy of Anti-PD-1 Monoclonal Antibody Tislelizumab (BGB-A317) Plus Anti-TIGIT Monoclonal Antibody Ociperlimab (BGB-A1217) Versus Tislelizumab Plus Placebo as Second-Line Treatment in Patients With PD-L1 Tumor Area Positivity (TAP) ≥ 10% Unresectable, Locally Advanced, Recurrent or Metastatic Esophageal Squamous Cell Carcinoma
Actual Study Start Date :
Mar 31, 2021
Anticipated Primary Completion Date :
Nov 1, 2023
Anticipated Study Completion Date :
Mar 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Arm A: Tislelizumab plus Ociperlimab

Participants will receive tislelizumab (200 milligrams [mg]) plus ociperlimab (900 mg) intravenously once every 3 weeks.

Drug: Tislelizumab
Tislelizumab is a monoclonal antibody formulated for intravenous injection.
Other Names:
  • BGB-A317

    • Drug: Ociperlimab
    Ociperlimab is a monoclonal antibody formulated for intravenous injection.
    Other Names:
  • BGB-A1217

    		•
    Placebo Comparator: Arm B: Tislelizumab plus Placebo

    Participants will receive tislelizumab (200 mg) plus placebo intravenously once every 3 weeks.

    Drug: Tislelizumab
    Tislelizumab is a monoclonal antibody formulated for intravenous injection.
    Other Names:
  • BGB-A317

    • Drug: Placebo
    Ociperlimab placebo injection is a sterile, preservative-free solution for infusion formulated in the same buffer as ociperlimab active drug.
    Other Names:
  • Ociperlimab placebo

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Objective Response Rate (ORR) Assessed By The Investigator's Review Per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1 [Approximately 17 months]

      The objective response rate will be defined as the proportion of participants who have confirmed complete response (CR) or partial response (PR).

    Secondary Outcome Measures

    1. Overall Survival [Approximately 32 months]

      Overall survival will be defined as the time from the date of randomization until the date of death due to any cause in all randomized participants.

    2. Progression-free Survival Assessed By The IRC And The Investigator Per RECIST v1.1 [Approximately 32 months]

      Progression-free survival will be defined as the time from the date of randomization to the date of first documentation of PD assessed by both the IRC and the investigator per RECIST v1.1 or death, whichever occurs first.

    3. Duration Of Response Assessed By The IRC And The Investigator Per RECIST v1.1 [Approximately 32 months]

      Duration of response will be defined as the time from the first determination of an objective response until the first documentation of PD as assessed by both the IRC and the investigator per RECIST v1.1, or death, whichever comes first.

    4. Disease Control Rate Assessed By The IRC And The Investigator Per RECIST v1.1 [Approximately 32 months]

      Disease Control Rate will be defined as the proportion of participants who have confirmed CR, PR, and stable disease assessed by both the IRC and the investigator per RECIST v1.

    5. Clinical Benefit Rate [Approximately 32 months]

      The clinical benefit rate will be defined as the proportion of participants who achieve confirmed complete response, partial response, and durable stable disease (stable disease ≥ 24 weeks).

    6. Health -related Quality Of Life (HRQoL): European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) [30 days (±7) after last dose]

      The HRQoL will be assessed by scores in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-30) :

    7. HRQoL: Dysphagia, Eating, Reflux and Pain Scales of EORTC Quality of Life Oesophageal Cancer Questionnaires 18 (QLQ-OES18) [30 days (±7) after last dose]

      The HRQoL will be assessed by scores in the EORTC QLQ-OES18.

    8. Incidence of Adverse Events And Serious Adverse Events [90 days (±14) after last dose]

    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 diagnosis of (esophageal squamous cell carcinoma) ESCC.

    2. Have PD during or after first-line of systemic treatment for unresectable, locally advanced, recurrent or metastatic ESCC.

    3. Have measurable disease as assessed by RECIST v1.1.

    4. Have confirmed PD-L1 TAP ≥ 10% in tumor tissues tested by the central lab.

    5. Eastern Cooperative Oncology Group Performance Status score of 0 or 1.

    Key Exclusion Criteria:

    1. Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, T-cell immunoreceptor with immunoglobulin and immunoreceptor tyrosine-based inhibitory motif domains, or any other antibody or drug specifically targeting T-cell costimulation or checkpoint pathways.

    2. Participants with evidence of fistula (either esophageal/bronchial or esophageal/aorta).

    3. Evidence of complete esophageal obstruction not amenable to treatment.

    4. Uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage (recurrence within 2 weeks after intervention).

    5. Has received any chemotherapy, immunotherapy (eg, interleukin, interferon, thymosin, etc) or any investigational therapies within 14 days or 5 half-lives (whichever is longer) before the first dose of study drug. Or has received palliative radiation treatment or other local regional therapies within 14 days before the first dose of study drug.

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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Anhui Provincial Cancer Hospital Hefei Anhui China 230088
    2 Quanzhou First Hospital of Fujian Province Quanzhou Fujian China 362002
    3 First Affiliated Hospital of Xiamen University Xiamen Fujian China 361003
    4 Lanzhou University Second Hospital Gansu Gansu China
    5 Guangdong Provincial Hospital of Chinese Medicine Guangzhou Guangdong China
    6 Meizhou Hospital Affiliated to Sun Yat-sen University Guangzhou Guangdong China
    7 Hainan Third People's Hospital Sanya Hainan China
    8 Nantong Tumor Hospital Nantong Jiangsu China 226000
    9 Affiliated Hospital of Jiangnan University Wuxi Jiangsu China
    10 General Hospital of Ningxia Medical University Yinchuan Ningxia China
    11 Qinghai Provincial People's Hospital Qinghai Qinghai China
    12 Shandong Cancer Hospital Jinan Shandong China 250117
    13 Shanxi Provincial People's Hospital Taiyuan Shanxi China 140100
    14 People's Hospital of Deyang City Deyang Sichuan China
    15 Tianjin Medical University Cancer Institute & Hospital Tianjin Tianjin China
    16 The First Affiliated Hospital of Xinjiang Medical University Ürümqi Xinjiang China
    17 Yunnan Cancer Hospital Kunming Yunnan China
    18 First Affiliated Hospital of Kunming Medical University Yunnan Yunnan China
    19 Beijing Cancer Hospital Beijing China
    20 Beijing Friendship Hospital, Capital Medical University Beijing China
    21 Heping Hospital Affiliated to Changzhi Medical College Changzhi China 046000
    22 The First People's Hospital of Changzhou Changzhou China
    23 Fujian Cancer Hospital Fujian China
    24 The First Affiliated Hospital of Fujian Medical University Fujian China
    25 Zhongshan Hospital Xiamen University Fujian China
    26 Cancer Hospital of Shantou University Medical College Guangdong China
    27 Nanfang Hospital of Southern Medical University Guangdong China
    28 Sun Yat-sen University Cancer Center Guangdong China
    29 The First Affiliated Hospital of Guangzhou University of Chinese Medicine Guangdong China
    30 The Sixth Affiliated Hospital, Sun Yat-sen University Guangdong China
    31 Guangxi Medical University Affiliated Tumor Hospital Guangxi China
    32 Hainan General Hospital Hainan China
    33 Affiliated Hospital of Hebei University Hebei China
    34 The Second Hospital of Anhui Medical University Hefei China
    35 Harbin Medical University Cancer Hospital Heilongjiang China
    36 Henan Cancer Hospital Henan China
    37 The First Affiliated Hospital of Xinxiang Medical University Henan China
    38 The First Affiliated Hospital of Zhengzhou University Henan China
    39 Hubei Cancer Hospital Hubei China
    40 Xiangyang Central Hospital Hubei China
    41 Hunan Cancer Hospital Hunan China
    42 The First Affiliated Hospital of Nanchang University Jiangxi China
    43 The Second Affiliated Hospital of Nanchang University Jiangxi China
    44 Linyi Cancer Hospital Shandong China
    45 Weifang People's Hospital Shandong China
    46 Shanghai Chest Hospital Shanghai China
    47 Liaoning Cancer Hospital & Institute Shenyang China
    48 Sichuan Provincial People's Hospital Sichuan China
    49 The Affiliated Hospital of Xuzhou Medical University Xuzhou China
    50 Northern Jiangsu People's Hospital Yangzhou China
    51 Hangzhou Cancer Hospital Zhejiang China
    52 Hwa Mei Hospital, University of Chinese Academy of Sciences Zhejiang China
    53 Centre Hospitalier Universitaire d'Amiens - Hopital Sud Amiens Cedex 1 Picardie France
    54 Hôpital de la Timone Marseille France
    55 Hopital Europeen Georges Pompidou - Digestive Oncology Paris France 75015
    56 CHU de Poitiers Poitiers France 80621
    57 Ajou University Hospital Gyeonggi-do Korea, Republic of
    58 Chonnam National University Hwasun Hospital Jeongnam Korea, Republic of
    59 Asan Medical Center Seoul Korea, Republic of
    60 Korea University Guro Hospital Seoul Korea, Republic of
    61 Samsung Medical Center Seoul Korea, Republic of
    62 Seoul National University Hospital Seoul Korea, Republic of
    63 Severance Hospital, Yonsei University Health System Seoul Korea, Republic of
    64 The Catholic University of Korea, Seoul St. Mary's Hospital Seoul Korea, Republic of
    65 Hospital Clínic de Barcelona Barcelona Spain
    66 Hospital de la Santa Creu i Sant Pau Barcelona Spain
    67 Hospital Universitario Vall d'Hebron Barcelona Spain
    68 Institut Catala D'Oncologia L'Hospitalet De Llobregat Spain
    69 Hospital Universitario Madrid Sanchinarro Madrid Spain
    70 Hospital Universitario Ramón y Cajal Madrid Spain
    71 Hospital Regional Universitario de Málaga Málaga Spain
    72 Hospital Universitario Marqués de Valdecilla Santander Spain
    73 Hospital Clinico Universitario de Valencia - Incliva Valencia Spain
    74 Hospital Universitario Miguel Servet Zaragoza Spain
    75 Chiayi Chang Gung Memorial Hospital Chiayi City Taiwan
    76 Kaohsiung Chang Gung Memorial Hospital Kaohsiung Taiwan
    77 China Medical University Hospital Taichung Taiwan
    78 National Taiwan University Hospital Taipei Taiwan
    79 Taipei Veterans General Hospital Taipei Taiwan
    80 Linkou Chang Gung Memorial Hospital Taoyuan Taiwan
    81 Chulabhorn Hospital Bangkok Thailand
    82 Phramongkutklao Hospital Bangkok Thailand
    83 Rajavithi Hospital Bangkok Thailand
    84 Siriraj Hospital Bangkok Thailand
    85 Maharaj Nakorn Chiang Mai Hospital, Chiang Mai University Chiang Mai Thailand
    86 Songklanagarind Hospital, Prince of Songkla University Hat Yai Thailand

    Sponsors and Collaborators

    • BeiGene

    Investigators

    • Study Director: Study Director, BeiGene

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    BeiGene
    ClinicalTrials.gov Identifier:
    NCT04732494
    Other Study ID Numbers:
    • BGB-A317-A1217-203
    • 2020-004658-32
    First Posted:
    Feb 1, 2021
    Last Update Posted:
    Aug 22, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    Carcinoma
    Carcinoma, Squamous Cell
    Esophageal Squamous Cell Carcinoma

    Study Results

    No Results Posted as of Aug 22, 2022