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

  • STATUS
    Recruiting
  • days left to enroll
    70
  • participants needed
    80
  • sponsor
    BeiGene
Updated on 5 April 2022

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). Efficacy and safety will be assessed. A short description of the clinical study, including a brief statement of the clinical study's hypothesis, written in language intended for the lay public.

Details
Condition MSI-H/dMMR Solid Tumors
Treatment Tislelizumab (BGB-A317)
Clinical Study IdentifierNCT03736889
SponsorBeiGene
Last Modified on5 April 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Having histological confirmed diagnosis of malignancy
Having locally advanced unresectable or metastatic solid tumors with MSI-H or dMMR
Having received or refused 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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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