Tislelizumab (Anti-Programmed Cell Death Protein-1 (PD-1) Antibody) in MSI-H or dMMR Solid Tumors (NCT03736889) | Clinical Trial Compass
RecruitingPhase 2
Tislelizumab (Anti-Programmed Cell Death Protein-1 (PD-1) Antibody) in MSI-H or dMMR Solid Tumors
China200 participantsStarted 2018-09-19
Plain-language 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).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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
Exclusion criteria
✕. 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.)
What they're measuring
1
Objective response rate assessed by Independent Review Committee per Response Evaluation Criteria in Solid Tumors Version 1.1