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

Esophageal Squamous Cell Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04732494
• Other study ID #: BGB-A317-A1217-203
• Secondary ID: 2020-004658-32
• Status: Completed
• Phase: Phase 2
• Start date: March 31, 2021
• Est. completion date: December 26, 2023

Study information

• Verified date: April 2024
• Source: BeiGene
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: December 26, 2023
• Est. primary completion date: February 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Esophageal Squamous Cell Carcinoma

Intervention

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

Locations

Country	Name	City	State
China	Beijing Cancer Hospital	Beijing
China	Beijing Friendship Hospital, Capital Medical University	Beijing
China	Heping Hospital Affiliated to Changzhi Medical College	Changzhi
China	The First People's Hospital of Changzhou	Changzhou
China	People's Hospital of Deyang City	Deyang	Sichuan
China	Fujian Cancer Hospital	Fujian
China	The First Affiliated Hospital of Fujian Medical University	Fujian
China	Zhongshan Hospital Xiamen University	Fujian
China	Lanzhou University Second Hospital	Gansu	Gansu
China	Cancer Hospital of Shantou University Medical College	Guangdong
China	Nanfang Hospital of Southern Medical University	Guangdong
China	Sun Yat-sen University Cancer Center	Guangdong
China	The First Affiliated Hospital of Guangzhou University of Chinese Medicine	Guangdong
China	The Sixth Affiliated Hospital, Sun Yat-sen University	Guangdong
China	Guangxi Medical University Affiliated Tumor Hospital	Guangxi
China	Guangdong Provincial Hospital of Chinese Medicine	Guangzhou	Guangdong
China	Meizhou Hospital Affiliated to Sun Yat-sen University	Guangzhou	Guangdong
China	Hainan General Hospital	Hainan
China	Affiliated Hospital of Hebei University	Hebei
China	Anhui Provincial Cancer Hospital	Hefei	Anhui
China	The Second Hospital of Anhui Medical University	Hefei
China	Harbin Medical University Cancer Hospital	Heilongjiang
China	Henan Cancer Hospital	Henan
China	The First Affiliated Hospital of Xinxiang Medical University	Henan
China	The First Affiliated Hospital of Zhengzhou University	Henan
China	Hubei Cancer Hospital	Hubei
China	Xiangyang Central Hospital	Hubei
China	Hunan Cancer Hospital	Hunan
China	The First Affiliated Hospital of Nanchang University	Jiangxi
China	The Second Affiliated Hospital of Nanchang University	Jiangxi
China	Shandong Cancer Hospital	Jinan	Shandong
China	Yunnan Cancer Hospital	Kunming	Yunnan
China	Nantong Tumor Hospital	Nantong	Jiangsu
China	Qinghai Provincial People's Hospital	Qinghai	Qinghai
China	Quanzhou First Hospital of Fujian Province	Quanzhou	Fujian
China	Hainan Third People's Hospital	Sanya	Hainan
China	Linyi Cancer Hospital	Shandong
China	Weifang People's Hospital	Shandong
China	Shanghai Chest Hospital	Shanghai
China	Liaoning Cancer Hospital & Institute	Shenyang
China	Sichuan Provincial People's Hospital	Sichuan
China	Shanxi Provincial People's Hospital	Taiyuan	Shanxi
China	Tianjin Medical University Cancer Institute & Hospital	Tianjin	Tianjin
China	The First Affiliated Hospital of Xinjiang Medical University	Ürümqi	Xinjiang
China	Affiliated Hospital of Jiangnan University	Wuxi	Jiangsu
China	First Affiliated Hospital of Xiamen University	Xiamen	Fujian
China	The Affiliated Hospital of Xuzhou Medical University	Xuzhou
China	Northern Jiangsu People's Hospital	Yangzhou
China	General Hospital of Ningxia Medical University	Yinchuan	Ningxia
China	First Affiliated Hospital of Kunming Medical University	Yunnan	Yunnan
China	Hangzhou Cancer Hospital	Zhejiang
China	Hwa Mei Hospital, University of Chinese Academy of Sciences	Zhejiang
France	Centre Hospitalier Universitaire d'Amiens - Hopital Sud	Amiens Cedex 1	Picardie
France	Hôpital de la Timone	Marseille
France	Hopital Europeen Georges Pompidou - Digestive Oncology	Paris
France	CHU de Poitiers	Poitiers
Korea, Republic of	Ajou University Hospital	Gyeonggi-do
Korea, Republic of	Chonnam National University Hwasun Hospital	Jeongnam
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Korea University Guro Hospital	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Severance Hospital, Yonsei University Health System	Seoul
Korea, Republic of	The Catholic University of Korea, Seoul St. Mary's Hospital	Seoul
Spain	Hospital Clínic de Barcelona	Barcelona
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona
Spain	Hospital Universitario Vall d'Hebron	Barcelona
Spain	Institut Catala D'Oncologia	L'Hospitalet De Llobregat
Spain	Hospital Universitario Madrid Sanchinarro	Madrid
Spain	Hospital Universitario Ramón y Cajal	Madrid
Spain	Hospital Regional Universitario de Málaga	Málaga
Spain	Hospital Universitario Marqués de Valdecilla	Santander
Spain	Hospital Clinico Universitario de Valencia - Incliva	Valencia
Spain	Hospital Universitario Miguel Servet	Zaragoza
Taiwan	Chiayi Chang Gung Memorial Hospital	Chiayi City
Taiwan	Kaohsiung Chang Gung Memorial Hospital	Kaohsiung
Taiwan	China Medical University Hospital	Taichung
Taiwan	National Taiwan University Hospital	Taipei
Taiwan	Taipei Veterans General Hospital	Taipei
Taiwan	Linkou Chang Gung Memorial Hospital	Taoyuan
Thailand	Chulabhorn Hospital	Bangkok
Thailand	Phramongkutklao Hospital	Bangkok
Thailand	Rajavithi Hospital	Bangkok
Thailand	Siriraj Hospital	Bangkok
Thailand	Maharaj Nakorn Chiang Mai Hospital, Chiang Mai University	Chiang Mai
Thailand	Songklanagarind Hospital, Prince of Songkla University	Hat Yai

Sponsors (1)

Lead Sponsor	Collaborator
BeiGene

Countries where clinical trial is conducted

China,  France,  Korea, Republic of,  Spain,  Taiwan,  Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Approximately 17 months
Secondary	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.	Approximately 32 months
Secondary	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.	Approximately 32 months
Secondary	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.	Approximately 32 months
Secondary	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.	Approximately 32 months
Secondary	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).	Approximately 32 months
Secondary	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) :	30 days (±7) after last dose
Secondary	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.	30 days (±7) after last dose
Secondary	Incidence of Adverse Events And Serious Adverse Events		90 days (±14) after last dose