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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03736889
Recruitment Status : Recruiting
First Posted : November 9, 2018
Last Update Posted : December 24, 2019
Sponsor:
Information provided by (Responsible Party):
BeiGene

Brief 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.

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 : 79 participants
Allocation: N/A
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 participants experiencing Treatment-Emergent Adverse Event (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

Key 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. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1
  6. Adequate organ function

Key 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. Participants 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

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.


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: BeiGene +1-877-828-5568 clinicaltrials@beigene.com

Locations
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China, Beijing
Beijing Cancer Hospital Recruiting
Beijing, Beijing, China, 100142
Sponsors and Collaborators
BeiGene
Investigators
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Principal Investigator: Lin Shen, PhD Beijing Cancer Hospital
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Responsible Party: BeiGene
ClinicalTrials.gov Identifier: NCT03736889    
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: December 24, 2019
Last Verified: December 2019

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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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Neoplasms