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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
200
Anti-PD-1 Antibody
Objective response rate assessed by Independent Review Committee per Response Evaluation Criteria in Solid Tumors Version 1.1
Time frame: 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
Time frame: Up to 2 years
Time to response assessed by Independent Review Committee and by investigator per Response Evaluation Criteria in Solid Tumors Version 1.1
Time frame: 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
Time frame: 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
Time frame: Up to 2 years
Overall survival
Time frame: Up to 2 years
Objective response rate assessed by investigator per Response Evaluation Criteria in Solid Tumors Version 1.1
Time frame: 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
Time frame: Up to 2 years
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Anhui Provincial Hospital
Hefei, Anhui, China
RECRUITINGCancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
COMPLETEDThe Affiliated Hospital of Military Medical Sciences
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Beijing, Beijing Municipality, China
RECRUITINGChongqing Cancer Hospital
Chongqing, Chongqing Municipality, China
RECRUITINGFujian Medical University Union Hospital
Fuzhou, Fujian, China
RECRUITINGGuangdong Provincial Peoples Hospital
Guangzhou, Guangdong, China
COMPLETEDNanfang Hospital of Southern Medical University
Guangzhou, Guangdong, China
COMPLETEDThe Sixth Affiliated Hospital, Sun Yat Sen University
Guangzhou, Guangdong, China
COMPLETEDHuizhou First Hospital
Huizhou, Guangdong, China
RECRUITING...and 19 more locations