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

Official title

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

Overview

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).

Interventions

• Drug Tislelizumab (BGB-A317)
  Anti-PD-1 Antibody

Primary outcome measures

• Objective response rate assessed by Independent Review Committee per Response Evaluation Criteria in Solid Tumors Version 1.1 [Time frame: Up to 2 years]

Secondary outcome measures (7)

• 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]

Eligibility criteria

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.)
• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

China · 30 centers

• Anhui Provincial Hospital — Hefei
• Cancer Hospital Chinese Academy of Medical Sciences — Beijing
• The Affiliated Hospital of Military Medical Sciences — Beijing
• Beijing Cancer Hospital — Beijing
• Beijing Cancer Hospital — Beijing
• Chongqing University Cancer Hospital — Chongqing
• Fujian Medical University Union Hospital — Fuzhou
• Guangdong Provincial Peoples Hospital — Guangzhou
• … and 22 more centers

Identifiers

NCT: NCT03736889 · BGB-A317-209 · CTR20180867

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)
• NMPA/CDE CTR20180867 (chinadrugtrials.org.cn platform)

View this study on ClinicalTrials.gov ↗