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

Sponsor
BeiGene (Industry)
Overall Status
Recruiting
CT.gov ID
NCT03736889
Collaborator
(none)
80
1
1
50.4
1.6

Study Details

Study Description

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
  • Drug: Tislelizumab (BGB-A317)
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
80 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 :
Sep 19, 2018
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Tislelizumab (BGB-A317) Injection

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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. : 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]

  2. 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]

  3. 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]

  4. 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]

  5. Overall survival [Up to 2 years]

  6. Objective response rate assessed by investigator per Response Evaluation Criteria in Solid Tumors Version 1.1 [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 [Up to 2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Beijing Cancer Hospital Beijing Beijing China 100142

Sponsors and Collaborators

  • BeiGene

Investigators

  • Principal Investigator: Lin Shen, PhD, Peking University Cancer Hospital & Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
BeiGene
ClinicalTrials.gov Identifier:
NCT03736889
Other Study ID Numbers:
  • BGB-A317-209
  • CTR20180867
First Posted:
Nov 9, 2018
Last Update Posted:
Mar 25, 2022
Last Verified:
Mar 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by BeiGene
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 25, 2022