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

• ClinicalTrials.gov Identifier: NCT03736889
• Recruitment Status: Recruiting
• First Posted: November 9, 2018
• Last Update Posted: December 15, 2022
• Sponsor: BeiGene
• Information provided by (Responsible Party): BeiGene

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).

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

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 200 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: November 2026
• Estimated Study Completion Date: September 2027

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 [ 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 ]

Eligibility Criteria

• 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 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

Contacts

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

Locations

China, Beijing

Beijing Cancer Hospital; Recruiting

Beijing, Beijing, China, 100142

Sponsors and Collaborators

BeiGene

Investigators

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

More Information

• 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
• Last Update Posted: December 15, 2022
• Last Verified: December 2022

• 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:

Neoplasms; Tislelizumab; Antineoplastic Agents, Immunological; Antineoplastic Agents