Tislelizumab (Anti-Programmed Cell Death Protein-1 (PD-1) Antibody) in MSI-H or dMMR Solid Tumors

Study Overview
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Brief Summary
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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).

Official Title
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A Single-Arm, Multi-Center, Open-Label, Phase 2 Study to Evaluate Efficacy and Safety of Tislelizumab (BGB-A317), an Anti-PD-1 Monoclonal Antibody, as Monotherapy in Patients With Previously-Treated Locally Advanced Unresectable or Metastatic Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Solid Tumors

Conditions
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MSI-H/dMMR Solid Tumors

Intervention / Treatment
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* Drug: Tislelizumab (BGB-A317)


Participation Criteria
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Eligibility Criteria
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Key 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 Key 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.) 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tislelizumab (BGB-A317) Injection<br> | Drug: Tislelizumab (BGB-A317)<br>* Anti-PD-1 Antibody<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MSI-H/dMMR, Solid tumors, PD-1