Tislelizumab (Anti-Programmed Cell Death Protein-1 (PD-1) Antibody) in MSI-H or dMMR Solid Tumors
- Registration Number
- NCT03736889
- Lead Sponsor
- BeiGene
- Brief Summary
In this Phase 2, Single-Arm, Multi-Center, Open-Label Study, participants with previously treated locally advanced unresectable or metastatic solid tumors with mismatched repair deficient (dMMR) or microsatellite instability-high (MSI-H) will be treated with anti-PD-1 Monoclonal Antibody Tislelizumab (BGB-A317).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 200
- Having histological confirmed diagnosis of malignancy
- Having locally advanced unresectable or metastatic solid tumors with MSI-H or dMMR
- Having received prior cancer therapy regimen(s) for advanced disease.
- At least 1 measurable lesion as defined per RECIST Version (v) 1.1
- Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1
- Adequate organ function
Key
- Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2 or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
- Active leptomeningeal disease or uncontrolled brain metastasis.
- Clinically significant pleural effusion, pericardial effusion or ascites
- Active autoimmune diseases or history of autoimmune diseases that may relapse
- Any active malignancy
- Any condition that required systemic treatment with either corticosteroids (> 10 mg daily of prednisone or equivalent) or other immunosuppressive medication ≤ 14 days before the first dose of study drug
- Having a history of interstitial lung disease, non-infectious pneumonitis, pulmonary fibrosis, acute lung diseases, or uncontrolled systemic diseases (including but not limited to diabetes, hypertension, etc.)
- Participants with uncontrolled diabetes or uncontrolled electrolyte disorders despite standard medical management
- Having severe chronic or active infections
- A known history of human immunodeficiency virus infection
- Child - Pugh B or greater cirrhosis
- Any major surgical procedure ≤ 28 days before the first dose of study drug
- Prior allogeneic stem cell transplantation or organ transplantation
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Tislelizumab (BGB-A317) Injection Tislelizumab (BGB-A317) -
- Primary Outcome Measures
Name Time Method Objective response rate assessed by Independent Review Committee per Response Evaluation Criteria in Solid Tumors Version 1.1 Up to 2 years
- Secondary Outcome Measures
Name Time Method Time to response assessed by Independent Review Committee and by investigator per Response Evaluation Criteria in Solid Tumors Version 1.1 Up to 2 years Progression-free survival assessed by Independent Review Committee and by investigator per Response Evaluation Criteria in Solid Tumors Version 1.1 Up to 2 years Duration of response assessed by Independent Review Committee and by investigator per Response Evaluation Criteria in Solid Tumors Version 1.1 Up to 2 years Disease control rate assessed by Independent Review Committee and by investigator per Response Evaluation Criteria in Solid Tumors Version 1.1 Up to 2 years Overall survival Up to 2 years Objective response rate assessed by investigator per Response Evaluation Criteria in Solid Tumors Version 1.1 Up to 2 years Safety and tolerability assessment per the number of participants experiencing Treatment-Emergent Adverse Event (TEAE) as assessed by CTCAE v5.0 Up to 2 years
Trial Locations
- Locations (29)
Cancer Hospital Chinese Academy of Medical Sciences
🇨🇳Beijing, Beijing, China
The Affiliated Hospital of Military Medical Sciences
🇨🇳Beijing, Beijing, China
Guangdong Provincial Peoples Hospital
🇨🇳Guangzhou, Guangdong, China
Nanfang Hospital of Southern Medical University
🇨🇳Guangzhou, Guangdong, China
The Sixth Affiliated Hospital, Sun Yat Sen University
🇨🇳Guangzhou, Guangdong, China
The Peoples Hospital of Hechi
🇨🇳Hechi, Guangxi, China
Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology
🇨🇳Wuhan, Hubei, China
Hubei Cancer Hospital
🇨🇳Wuhan, Hubei, China
Hunan Cancer Hospital
🇨🇳Changsha, Hunan, China
Nanjing Drum Tower Hospital,the Affiliated Hospital of Nanjing University Medical School
🇨🇳Nanjing, Jiangsu, China
Jiangsu Province Hospital
🇨🇳Nanjing, Jiangsu, China
The General Hospital of Shenyang Military
🇨🇳Shenyang, Liaoning, China
Yidu Central Hospital of Weifang
🇨🇳Weifang, Shandong, China
Fudan University Shanghai Cancer Center
🇨🇳Shanghai, Shanghai, China
The First Affiliated Hospital, Zhejiang University School of Medicine
🇨🇳Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital
🇨🇳Hangzhou, Zhejiang, China
Anhui Provincial Hospital
🇨🇳Hefei, Anhui, China
Beijing Cancer Hospital
🇨🇳Beijing, Beijing, China
Chongqing Cancer Hospital
🇨🇳Chongqing, Chongqing, China
Fujian Medical University Union Hospital
🇨🇳Fuzhou, Fujian, China
Huizhou First Hospital
🇨🇳Huizhou, Guangdong, China
Meizhou People Hospital
🇨🇳Meizhou, Guangdong, China
Affiliated Hospital of Hebei University
🇨🇳Baoding, Hebei, China
Harbin Medical University Cancer Hospital
🇨🇳Harbin, Heilongjiang, China
Henan Cancer Hospital
🇨🇳Zhengzhou, Henan, China
Jilin Cancer Hospital
🇨🇳Changchun, Jilin, China
Affiliated Zhongshan Hospital of Fudan University
🇨🇳Shanghai, Shanghai, China
The First Peoples Hospital of Yibin
🇨🇳Yibin, Sichuan, China
Zhejiang University College of Medicine Second Affiliated Hospital
🇨🇳Hangzhou, Zhejiang, China