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Tislelizumab (Anti-PD-1 Antibody) in MSI-H or dMMR Solid Tumors

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ClinicalTrials.gov Identifier: NCT03736889
Recruitment Status : Recruiting
First Posted : November 9, 2018
Last Update Posted : July 19, 2019
Sponsor:
Information provided by (Responsible Party):
BeiGene

Brief Summary:
In this Phase 2, Single-Arm, Multi-Center, Open-Label Study, patients 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.

Condition or disease Intervention/treatment Phase
MSI-H/dMMR Solid Tumors Drug: Tislelizumab (BGB-A317) Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : September 19, 2018
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : May 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Tislelizumab (BGB-A317) Injection Drug: Tislelizumab (BGB-A317)
Anti-PD-1 Antibody




Primary Outcome Measures :
  1. 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 :
  1. : 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]
  5. Overall survival [ Time Frame: Up to 2 years ]
  6. Objective response rate assessed by investigator per Response Evaluation Criteria in Solid Tumors Version 1.1 [ Time Frame: Up to 2 years ]
  7. Safety and tolerability assessment per the number of patients experiencing TEAE as assessed by CTCAE v5.0 [ Time Frame: Up to 2 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Having histological confirmed diagnosis of malignancy
  2. Having locally advanced unresectable or metastatic solid tumors with MSI-H or dMMR
  3. Having received or refused prior cancer therapy regimen(s) for advanced disease.
  4. At least 1 measurable lesion as defined per RECIST Version (v) 1.1
  5. ECOG Performance Status ≤ 1
  6. Adequate organ function

Exclusion Criteria:

  1. 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
  2. Active leptomeningeal disease or uncontrolled brain metastasis.
  3. Clinically significant pleural effusion, pericardial effusion or ascites
  4. Active autoimmune diseases or history of autoimmune diseases that may relapse
  5. Any active malignancy
  6. 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
  7. 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.)
  8. Patients with uncontrolled diabetes or uncontrolled electrolyte disorders despite standard medical management
  9. Having severe chronic or active infections
  10. A known history of human immunodeficiency virus infection
  11. Child - Pugh B or greater cirrhosis
  12. Any major surgical procedure ≤ 28 days before the first dose of study drug
  13. Prior allogeneic stem cell transplantation or organ transplantation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03736889


Contacts
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Contact: Zhezhen Li +86 10 5895 8000 clinicaltrials@beigene.com

Locations
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China, Beijing
Beijing Cancer Hospital Recruiting
Beijing, Beijing, China, 100142
Contact: Guangxia Zhu         
Principal Investigator: Lin Shen, MD         
Sponsors and Collaborators
BeiGene

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Responsible Party: BeiGene
ClinicalTrials.gov Identifier: NCT03736889     History of Changes
Other Study ID Numbers: BGB-A317-209
CTR20180867 ( Registry Identifier: Center for drug evaluation, CFDA )
First Posted: November 9, 2018    Key Record Dates
Last Update Posted: July 19, 2019
Last Verified: November 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by BeiGene:
MSI-H/dMMR
Solid tumors
PD-1

Additional relevant MeSH terms:
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Microsatellite Instability
Genomic Instability
Pathologic Processes
Antibodies
Immunologic Factors
Physiological Effects of Drugs