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
Primary Purpose
Esophageal Squamous Cell Carcinoma
Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Tislelizumab
Ociperlimab
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Esophageal Squamous Cell Carcinoma
Eligibility Criteria
Key Inclusion Criteria:
- Histologically confirmed diagnosis of (esophageal squamous cell carcinoma) ESCC.
- Have PD during or after first-line of systemic treatment for unresectable, locally advanced, recurrent or metastatic ESCC.
- Have measurable disease as assessed by RECIST v1.1.
- Have confirmed PD-L1 TAP ≥ 10% in tumor tissues tested by the central lab.
- Eastern Cooperative Oncology Group Performance Status score of 0 or 1.
Key Exclusion Criteria:
- 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.
- Participants with evidence of fistula (either esophageal/bronchial or esophageal/aorta).
- Evidence of complete esophageal obstruction not amenable to treatment.
- Uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage (recurrence within 2 weeks after intervention).
- 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.
Sites / Locations
- Anhui Provincial Cancer Hospital
- Quanzhou First Hospital of Fujian Province
- First Affiliated Hospital of Xiamen University
- Lanzhou University Second Hospital
- Guangdong Provincial Hospital of Chinese Medicine
- Meizhou Hospital Affiliated to Sun Yat-sen University
- Hainan Third People's Hospital
- Nantong Tumor Hospital
- Affiliated Hospital of Jiangnan University
- General Hospital of Ningxia Medical University
- Qinghai Provincial People's Hospital
- Shandong Cancer Hospital
- Shanxi Provincial People's Hospital
- People's Hospital of Deyang City
- Tianjin Medical University Cancer Institute & Hospital
- The First Affiliated Hospital of Xinjiang Medical University
- Yunnan Cancer Hospital
- First Affiliated Hospital of Kunming Medical University
- Beijing Cancer Hospital
- Beijing Friendship Hospital, Capital Medical University
- Heping Hospital Affiliated to Changzhi Medical College
- The First People's Hospital of Changzhou
- Fujian Cancer Hospital
- The First Affiliated Hospital of Fujian Medical University
- Zhongshan Hospital Xiamen University
- Cancer Hospital of Shantou University Medical College
- Nanfang Hospital of Southern Medical University
- Sun Yat-sen University Cancer Center
- The First Affiliated Hospital of Guangzhou University of Chinese Medicine
- The Sixth Affiliated Hospital, Sun Yat-sen University
- Guangxi Medical University Affiliated Tumor Hospital
- Hainan General Hospital
- Affiliated Hospital of Hebei University
- The Second Hospital of Anhui Medical University
- Harbin Medical University Cancer Hospital
- Henan Cancer Hospital
- The First Affiliated Hospital of Xinxiang Medical University
- The First Affiliated Hospital of Zhengzhou University
- Hubei Cancer Hospital
- Xiangyang Central Hospital
- Hunan Cancer Hospital
- The First Affiliated Hospital of Nanchang University
- The Second Affiliated Hospital of Nanchang University
- Linyi Cancer Hospital
- Weifang People's Hospital
- Shanghai Chest Hospital
- Liaoning Cancer Hospital & Institute
- Sichuan Provincial People's Hospital
- The Affiliated Hospital of Xuzhou Medical University
- Northern Jiangsu People's Hospital
- Hangzhou Cancer Hospital
- Hwa Mei Hospital, University of Chinese Academy of Sciences
- Centre Hospitalier Universitaire d'Amiens - Hopital Sud
- Hôpital de la Timone
- Hopital Europeen Georges Pompidou - Digestive Oncology
- CHU de Poitiers
- Ajou University Hospital
- Chonnam National University Hwasun Hospital
- Asan Medical Center
- Korea University Guro Hospital
- Samsung Medical Center
- Seoul National University Hospital
- Severance Hospital, Yonsei University Health System
- The Catholic University of Korea, Seoul St. Mary's Hospital
- Hospital Clínic de Barcelona
- Hospital de la Santa Creu i Sant Pau
- Hospital Universitario Vall d'Hebron
- Institut Catala D'Oncologia
- Hospital Universitario Madrid Sanchinarro
- Hospital Universitario Ramón y Cajal
- Hospital Regional Universitario de Málaga
- Hospital Universitario Marqués de Valdecilla
- Hospital Clinico Universitario de Valencia - Incliva
- Hospital Universitario Miguel Servet
- Chiayi Chang Gung Memorial Hospital
- Kaohsiung Chang Gung Memorial Hospital
- China Medical University Hospital
- National Taiwan University Hospital
- Taipei Veterans General Hospital
- Linkou Chang Gung Memorial Hospital
- Chulabhorn Hospital
- Phramongkutklao Hospital
- Rajavithi Hospital
- Siriraj Hospital
- Maharaj Nakorn Chiang Mai Hospital, Chiang Mai University
- Songklanagarind Hospital, Prince of Songkla University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Arm A: Tislelizumab plus Ociperlimab
Arm B: Tislelizumab plus Placebo
Arm Description
Participants will receive tislelizumab (200 milligrams [mg]) plus ociperlimab (900 mg) intravenously once every 3 weeks.
Participants will receive tislelizumab (200 mg) plus placebo intravenously once every 3 weeks.
Outcomes
Primary Outcome Measures
Objective Response Rate (ORR) Assessed By The Investigator's Review Per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1
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
Overall Survival
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.
Progression-free Survival Assessed By The IRC And The Investigator Per RECIST v1.1
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.
Duration Of Response Assessed By The IRC And The Investigator Per RECIST v1.1
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.
Disease Control Rate Assessed By The IRC And The Investigator Per RECIST v1.1
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.
Clinical Benefit Rate
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).
Health -related Quality Of Life (HRQoL): European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30)
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) :
HRQoL: Dysphagia, Eating, Reflux and Pain Scales of EORTC Quality of Life Oesophageal Cancer Questionnaires 18 (QLQ-OES18)
The HRQoL will be assessed by scores in the EORTC QLQ-OES18.
Incidence of Adverse Events And Serious Adverse Events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04732494
Brief Title
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
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 31, 2021 (Actual)
Primary Completion Date
February 1, 2023 (Actual)
Study Completion Date
February 29, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BeiGene
4. Oversight
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
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Squamous Cell Carcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
125 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm A: Tislelizumab plus Ociperlimab
Arm Type
Experimental
Arm Description
Participants will receive tislelizumab (200 milligrams [mg]) plus ociperlimab (900 mg) intravenously once every 3 weeks.
Arm Title
Arm B: Tislelizumab plus Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive tislelizumab (200 mg) plus placebo intravenously once every 3 weeks.
Intervention Type
Drug
Intervention Name(s)
Tislelizumab
Other Intervention Name(s)
BGB-A317
Intervention Description
Tislelizumab is a monoclonal antibody formulated for intravenous injection.
Intervention Type
Drug
Intervention Name(s)
Ociperlimab
Other Intervention Name(s)
BGB-A1217
Intervention Description
Ociperlimab is a monoclonal antibody formulated for intravenous injection.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Ociperlimab placebo
Intervention Description
Ociperlimab placebo injection is a sterile, preservative-free solution for infusion formulated in the same buffer as ociperlimab active drug.
Primary Outcome Measure Information:
Title
Objective Response Rate (ORR) Assessed By The Investigator's Review Per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1
Description
The objective response rate will be defined as the proportion of participants who have confirmed complete response (CR) or partial response (PR).
Time Frame
Approximately 17 months
Secondary Outcome Measure Information:
Title
Overall Survival
Description
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.
Time Frame
Approximately 32 months
Title
Progression-free Survival Assessed By The IRC And The Investigator Per RECIST v1.1
Description
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.
Time Frame
Approximately 32 months
Title
Duration Of Response Assessed By The IRC And The Investigator Per RECIST v1.1
Description
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.
Time Frame
Approximately 32 months
Title
Disease Control Rate Assessed By The IRC And The Investigator Per RECIST v1.1
Description
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.
Time Frame
Approximately 32 months
Title
Clinical Benefit Rate
Description
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).
Time Frame
Approximately 32 months
Title
Health -related Quality Of Life (HRQoL): European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30)
Description
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) :
Time Frame
30 days (±7) after last dose
Title
HRQoL: Dysphagia, Eating, Reflux and Pain Scales of EORTC Quality of Life Oesophageal Cancer Questionnaires 18 (QLQ-OES18)
Description
The HRQoL will be assessed by scores in the EORTC QLQ-OES18.
Time Frame
30 days (±7) after last dose
Title
Incidence of Adverse Events And Serious Adverse Events
Time Frame
90 days (±14) after last dose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria:
Histologically confirmed diagnosis of (esophageal squamous cell carcinoma) ESCC.
Have PD during or after first-line of systemic treatment for unresectable, locally advanced, recurrent or metastatic ESCC.
Have measurable disease as assessed by RECIST v1.1.
Have confirmed PD-L1 TAP ≥ 10% in tumor tissues tested by the central lab.
Eastern Cooperative Oncology Group Performance Status score of 0 or 1.
Key Exclusion Criteria:
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.
Participants with evidence of fistula (either esophageal/bronchial or esophageal/aorta).
Evidence of complete esophageal obstruction not amenable to treatment.
Uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage (recurrence within 2 weeks after intervention).
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
BeiGene
Official's Role
Study Director
Facility Information:
Facility Name
Anhui Provincial Cancer Hospital
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230088
Country
China
Facility Name
Quanzhou First Hospital of Fujian Province
City
Quanzhou
State/Province
Fujian
ZIP/Postal Code
362002
Country
China
Facility Name
First Affiliated Hospital of Xiamen University
City
Xiamen
State/Province
Fujian
ZIP/Postal Code
361003
Country
China
Facility Name
Lanzhou University Second Hospital
City
Gansu
State/Province
Gansu
Country
China
Facility Name
Guangdong Provincial Hospital of Chinese Medicine
City
Guangzhou
State/Province
Guangdong
Country
China
Facility Name
Meizhou Hospital Affiliated to Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
Country
China
Facility Name
Hainan Third People's Hospital
City
Sanya
State/Province
Hainan
Country
China
Facility Name
Nantong Tumor Hospital
City
Nantong
State/Province
Jiangsu
ZIP/Postal Code
226000
Country
China
Facility Name
Affiliated Hospital of Jiangnan University
City
Wuxi
State/Province
Jiangsu
Country
China
Facility Name
General Hospital of Ningxia Medical University
City
Yinchuan
State/Province
Ningxia
Country
China
Facility Name
Qinghai Provincial People's Hospital
City
Qinghai
State/Province
Qinghai
Country
China
Facility Name
Shandong Cancer Hospital
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250117
Country
China
Facility Name
Shanxi Provincial People's Hospital
City
Taiyuan
State/Province
Shanxi
ZIP/Postal Code
140100
Country
China
Facility Name
People's Hospital of Deyang City
City
Deyang
State/Province
Sichuan
Country
China
Facility Name
Tianjin Medical University Cancer Institute & Hospital
City
Tianjin
State/Province
Tianjin
Country
China
Facility Name
The First Affiliated Hospital of Xinjiang Medical University
City
Ürümqi
State/Province
Xinjiang
Country
China
Facility Name
Yunnan Cancer Hospital
City
Kunming
State/Province
Yunnan
Country
China
Facility Name
First Affiliated Hospital of Kunming Medical University
City
Yunnan
State/Province
Yunnan
Country
China
Facility Name
Beijing Cancer Hospital
City
Beijing
Country
China
Facility Name
Beijing Friendship Hospital, Capital Medical University
City
Beijing
Country
China
Facility Name
Heping Hospital Affiliated to Changzhi Medical College
City
Changzhi
ZIP/Postal Code
046000
Country
China
Facility Name
The First People's Hospital of Changzhou
City
Changzhou
Country
China
Facility Name
Fujian Cancer Hospital
City
Fujian
Country
China
Facility Name
The First Affiliated Hospital of Fujian Medical University
City
Fujian
Country
China
Facility Name
Zhongshan Hospital Xiamen University
City
Fujian
Country
China
Facility Name
Cancer Hospital of Shantou University Medical College
City
Guangdong
Country
China
Facility Name
Nanfang Hospital of Southern Medical University
City
Guangdong
Country
China
Facility Name
Sun Yat-sen University Cancer Center
City
Guangdong
Country
China
Facility Name
The First Affiliated Hospital of Guangzhou University of Chinese Medicine
City
Guangdong
Country
China
Facility Name
The Sixth Affiliated Hospital, Sun Yat-sen University
City
Guangdong
Country
China
Facility Name
Guangxi Medical University Affiliated Tumor Hospital
City
Guangxi
Country
China
Facility Name
Hainan General Hospital
City
Hainan
Country
China
Facility Name
Affiliated Hospital of Hebei University
City
Hebei
Country
China
Facility Name
The Second Hospital of Anhui Medical University
City
Hefei
Country
China
Facility Name
Harbin Medical University Cancer Hospital
City
Heilongjiang
Country
China
Facility Name
Henan Cancer Hospital
City
Henan
Country
China
Facility Name
The First Affiliated Hospital of Xinxiang Medical University
City
Henan
Country
China
Facility Name
The First Affiliated Hospital of Zhengzhou University
City
Henan
Country
China
Facility Name
Hubei Cancer Hospital
City
Hubei
Country
China
Facility Name
Xiangyang Central Hospital
City
Hubei
Country
China
Facility Name
Hunan Cancer Hospital
City
Hunan
Country
China
Facility Name
The First Affiliated Hospital of Nanchang University
City
Jiangxi
Country
China
Facility Name
The Second Affiliated Hospital of Nanchang University
City
Jiangxi
Country
China
Facility Name
Linyi Cancer Hospital
City
Shandong
Country
China
Facility Name
Weifang People's Hospital
City
Shandong
Country
China
Facility Name
Shanghai Chest Hospital
City
Shanghai
Country
China
Facility Name
Liaoning Cancer Hospital & Institute
City
Shenyang
Country
China
Facility Name
Sichuan Provincial People's Hospital
City
Sichuan
Country
China
Facility Name
The Affiliated Hospital of Xuzhou Medical University
City
Xuzhou
Country
China
Facility Name
Northern Jiangsu People's Hospital
City
Yangzhou
Country
China
Facility Name
Hangzhou Cancer Hospital
City
Zhejiang
Country
China
Facility Name
Hwa Mei Hospital, University of Chinese Academy of Sciences
City
Zhejiang
Country
China
Facility Name
Centre Hospitalier Universitaire d'Amiens - Hopital Sud
City
Amiens Cedex 1
State/Province
Picardie
Country
France
Facility Name
Hôpital de la Timone
City
Marseille
Country
France
Facility Name
Hopital Europeen Georges Pompidou - Digestive Oncology
City
Paris
ZIP/Postal Code
75015
Country
France
Facility Name
CHU de Poitiers
City
Poitiers
ZIP/Postal Code
80621
Country
France
Facility Name
Ajou University Hospital
City
Gyeonggi-do
Country
Korea, Republic of
Facility Name
Chonnam National University Hwasun Hospital
City
Jeongnam
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Korea University Guro Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Severance Hospital, Yonsei University Health System
City
Seoul
Country
Korea, Republic of
Facility Name
The Catholic University of Korea, Seoul St. Mary's Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Hospital Clínic de Barcelona
City
Barcelona
Country
Spain
Facility Name
Hospital de la Santa Creu i Sant Pau
City
Barcelona
Country
Spain
Facility Name
Hospital Universitario Vall d'Hebron
City
Barcelona
Country
Spain
Facility Name
Institut Catala D'Oncologia
City
L'Hospitalet De Llobregat
Country
Spain
Facility Name
Hospital Universitario Madrid Sanchinarro
City
Madrid
Country
Spain
Facility Name
Hospital Universitario Ramón y Cajal
City
Madrid
Country
Spain
Facility Name
Hospital Regional Universitario de Málaga
City
Málaga
Country
Spain
Facility Name
Hospital Universitario Marqués de Valdecilla
City
Santander
Country
Spain
Facility Name
Hospital Clinico Universitario de Valencia - Incliva
City
Valencia
Country
Spain
Facility Name
Hospital Universitario Miguel Servet
City
Zaragoza
Country
Spain
Facility Name
Chiayi Chang Gung Memorial Hospital
City
Chiayi City
Country
Taiwan
Facility Name
Kaohsiung Chang Gung Memorial Hospital
City
Kaohsiung
Country
Taiwan
Facility Name
China Medical University Hospital
City
Taichung
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei
Country
Taiwan
Facility Name
Taipei Veterans General Hospital
City
Taipei
Country
Taiwan
Facility Name
Linkou Chang Gung Memorial Hospital
City
Taoyuan
Country
Taiwan
Facility Name
Chulabhorn Hospital
City
Bangkok
Country
Thailand
Facility Name
Phramongkutklao Hospital
City
Bangkok
Country
Thailand
Facility Name
Rajavithi Hospital
City
Bangkok
Country
Thailand
Facility Name
Siriraj Hospital
City
Bangkok
Country
Thailand
Facility Name
Maharaj Nakorn Chiang Mai Hospital, Chiang Mai University
City
Chiang Mai
Country
Thailand
Facility Name
Songklanagarind Hospital, Prince of Songkla University
City
Hat Yai
Country
Thailand
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
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
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