Clinical trial NCT04732494: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Esophageal Squamous Cell Carcinoma
Lead sponsor: BeiGene
Sponsor class: INDUSTRY
First posted: 2021-02-01
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Key Inclusion Criteria:

1. Histologically confirmed diagnosis of esophageal squamous cell carcinoma (ESCC).
2. Have progressive disease during or after first-line of systemic treatment for unresectable, locally advanced, recurrent or metastatic ESCC.
3. Have measurable disease as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
4. Have confirmed programmed cell death protein-ligand 1 (PD-L1) tumor area positivity (TAP) ≥ 10% in tumor tissues tested by the central lab.
5. Eastern Cooperative Oncology Group (ECOG) 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.

Primary outcomes:
measure: Objective Response Rate (ORR) Assessed by the Investigator
timeFrame: Up to the primary analysis data cutoff date of 01 February 2023; median (range) time on follow-up was 7.4 (0.5 - 20.1) months in Arm A and 6.4 (0.4 - 20.2) months in Arm B.
Secondary outcomes:
measure: Overall Survival
timeFrame: From randomization to the end of the study, median (range) time on follow-up was 10.0 (0.5 - 29.9) months in Arm A and 7.8 (0.4 - 29.3) months in Arm B.
measure: Objective Response Rate Assessed by the Independent Review Committee
timeFrame: Up to the primary analysis data cutoff date of 01 February 2023; median (range) time on follow-up was 7.4 (0.5 - 20.1) months in Arm A and 6.4 (0.4 - 20.2) months in Arm B.
measure: Progression-free Survival (PFS) Assessed by the Independent Review Committee
timeFrame: From randomization up to the primary analysis data cutoff date of 01 February 2023; median (range) time on follow-up was 7.4 (0.5 - 20.1) months in Arm A and 6.4 (0.4 - 20.2) months in Arm B.
measure: Progression-free Survival (PFS) Assessed by the Investigator
timeFrame: From randomization to the end of the study, median (range) time on follow-up was 10.0 (0.5 - 29.9) months in Arm A and 7.8 (0.4 - 29.3) months in Arm B.
measure: Duration Of Response (DOR) Assessed by the Independent Review Committee
timeFrame: From randomization up to the primary analysis data cutoff date of 01 February 2023; median (range) time on follow-up was 7.4 (0.5 - 20.1) months in Arm A and 6.4 (0.4 - 20.2) months in Arm B.
measure: Duration Of Response (DOR) Assessed by the Investigator
timeFrame: From randomization to the end of the study, median (range) time on follow-up was 10.0 (0.5 - 29.9) months in Arm A and 7.8 (0.4 - 29.3) months in Arm B.
measure: Disease Control Rate Assessed by the IRC And the Investigator
timeFrame: Up to the primary analysis data cutoff date of 01 February 2023; median (range) time on follow-up was 7.4 (0.5 - 20.1) months in Arm A and 6.4 (0.4 - 20.2) months in Arm B.
measure: Clinical Benefit Rate Assessed by the IRC and the Investigator
timeFrame: Up to the primary analysis data cutoff date of 01 February 2023; median (range) time on follow-up was 7.4 (0.5 - 20.1) months in Arm A and 6.4 (0.4 - 20.2) months in Arm B.
measure: Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status (GHS)/Quality of Life (QOL) and Physical Functioning Scores
timeFrame: Baseline, Cycle 5 Day 1 and Cycle 7 Day 1 (each cycle was 3 weeks)
measure: Change From Baseline in EORTC Quality of Life Oesophageal Cancer Questionnaires 18 (QLQ-OES18) Dysphagia, Eating, Reflux and Pain Scales
timeFrame: Baseline, Cycle 5 Day 1 and Cycle 7 Day 1 (each cycle was 3 weeks)
measure: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
timeFrame: From first dose of study drug until 30 days after last dose; median duration of treatment was 3.45 months in Tislelizumab + Ociperlimab arm and 2.79 months in the Tislelizumab + Placebo arm.
Other outcomes:
Locations:
city: Hefei
country: China
facility: Anhui Provincial Cancer Hospital
state: Anhui
city: Quanzhou
country: China
facility: Quanzhou First Hospital of Fujian Province
state: Fujian
city: Xiamen
country: China
facility: First Affiliated Hospital of Xiamen University
state: Fujian
city: Gansu
country: China
facility: Lanzhou University Second Hospital
state: Gansu
city: Guangzhou
country: China
facility: Guangdong Provincial Hospital of Chinese Medicine
state: Guangdong
city: Guangzhou
country: China
facility: Meizhou Hospital Affiliated to Sun Yat-sen University
state: Guangdong
city: Sanya
country: China
facility: Hainan Third People's Hospital
state: Hainan
city: Nantong
country: China
facility: Nantong Tumor Hospital
state: Jiangsu
city: Wuxi
country: China
facility: Affiliated Hospital of Jiangnan University
state: Jiangsu
city: Yinchuan
country: China
facility: General Hospital of Ningxia Medical University
state: Ningxia
city: Qinghai
country: China
facility: Qinghai Provincial People's Hospital
state: Qinghai
city: Jinan
country: China
facility: Shandong Cancer Hospital
state: Shandong
city: Taiyuan
country: China
facility: Shanxi Provincial People's Hospital
state: Shanxi
city: Deyang
country: China
facility: People's Hospital of Deyang City
state: Sichuan
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute & Hospital
state: Tianjin
city: Ürümqi
country: China
facility: The First Affiliated Hospital of Xinjiang Medical University
state: Xinjiang
city: Kunming
country: China
facility: Yunnan Cancer Hospital
state: Yunnan
city: Yunnan
country: China
facility: First Affiliated Hospital of Kunming Medical University
state: Yunnan
city: Beijing
country: China
facility: Beijing Cancer Hospital
city: Beijing
country: China
facility: Beijing Friendship Hospital, Capital Medical University
city: Changzhi
country: China
facility: Heping Hospital Affiliated to Changzhi Medical College
city: Changzhou
country: China
facility: The First People's Hospital of Changzhou
city: Fujian
country: China
facility: Fujian Cancer Hospital
city: Fujian
country: China
facility: The First Affiliated Hospital of Fujian Medical University
city: Fujian
country: China
facility: Zhongshan Hospital Xiamen University
city: Guangdong
country: China
facility: Cancer Hospital of Shantou University Medical College
city: Guangdong
country: China
facility: Nanfang Hospital of Southern Medical University
city: Guangdong
country: China
facility: Sun Yat-sen University Cancer Center
city: Guangdong
country: China
facility: The First Affiliated Hospital of Guangzhou University of Chinese Medicine
city: Guangdong
country: China
facility: The Sixth Affiliated Hospital, Sun Yat-sen University
city: Guangxi
country: China
facility: Guangxi Medical University Affiliated Tumor Hospital
city: Hainan
country: China
facility: Hainan General Hospital
city: Hebei
country: China
facility: Affiliated Hospital of Hebei University
city: Hefei
country: China
facility: The Second Hospital of Anhui Medical University
city: Heilongjiang
country: China
facility: Harbin Medical University Cancer Hospital
city: Henan
country: China
facility: Henan Cancer Hospital
city: Henan
country: China
facility: The First Affiliated Hospital of Xinxiang Medical University
city: Henan
country: China
facility: The First Affiliated Hospital of Zhengzhou University
city: Hubei
country: China
facility: Hubei Cancer Hospital
city: Hubei
country: China
facility: Xiangyang Central Hospital
city: Hunan
country: China
facility: Hunan Cancer Hospital
city: Jiangxi
country: China
facility: The First Affiliated Hospital of Nanchang University
city: Jiangxi
country: China
facility: The Second Affiliated Hospital of Nanchang University
city: Shandong
country: China
facility: Linyi Cancer Hospital
city: Shandong
country: China
facility: Weifang People's Hospital
city: Shanghai
country: China
facility: Shanghai Chest Hospital
city: Shenyang
country: China
facility: Liaoning Cancer Hospital & Institute
city: Sichuan
country: China
facility: Sichuan Provincial People's Hospital
city: Xuzhou
country: China
facility: The Affiliated Hospital of Xuzhou Medical University
city: Yangzhou
country: China
facility: Northern Jiangsu People's Hospital
city: Zhejiang
country: China
facility: Hangzhou Cancer Hospital
city: Zhejiang
country: China
facility: Hwa Mei Hospital, University of Chinese Academy of Sciences
city: Amiens Cedex 1
country: France
facility: Centre Hospitalier Universitaire d'Amiens - Hopital Sud
state: Picardie
city: Marseille
country: France
facility: Hôpital de la Timone
city: Paris
country: France
facility: Hopital Europeen Georges Pompidou - Digestive Oncology
city: Poitiers
country: France
facility: CHU de Poitiers
city: Gyeonggi-do
country: Korea, Republic of
facility: Ajou University Hospital
city: Jeongnam
country: Korea, Republic of
facility: Chonnam National University Hwasun Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Seoul St. Mary's Hospital
city: Barcelona
country: Spain
facility: Hospital Clínic de Barcelona
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Barcelona
country: Spain
facility: Hospital Universitario Vall d'Hebron
city: L'Hospitalet De Llobregat
country: Spain
facility: Institut Catala D'Oncologia
city: Madrid
country: Spain
facility: Hospital Universitario Madrid Sanchinarro
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal
city: Málaga
country: Spain
facility: Hospital Regional Universitario de Málaga
city: Santander
country: Spain
facility: Hospital Universitario Marqués de Valdecilla
city: Valencia
country: Spain
facility: Hospital Clinico Universitario de Valencia - Incliva
city: Zaragoza
country: Spain
facility: Hospital Universitario Miguel Servet
city: Chiayi City
country: Taiwan
facility: Chiayi Chang Gung Memorial Hospital
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Taoyuan
country: Taiwan
facility: Linkou Chang Gung Memorial Hospital
city: Bangkok
country: Thailand
facility: Chulabhorn Hospital
city: Bangkok
country: Thailand
facility: Phramongkutklao Hospital
city: Bangkok
country: Thailand
facility: Rajavithi Hospital
city: Bangkok
country: Thailand
facility: Siriraj Hospital
city: Chiang Mai
country: Thailand
facility: Maharaj Nakorn Chiang Mai Hospital, Chiang Mai University
city: Hat Yai
country: Thailand
facility: Songklanagarind Hospital, Prince of Songkla University
Study officials:
affiliation: BeiGene
name: Study Director
role: STUDY_DIRECTOR
References: