Back to resultsEfficacy and Safety of Tislelizumab (BGB-A317) as Neo-Adjuvant Treatment in Patients With Colorectal Cancer
Primary Purpose
Colorectal Cancer
Status
Active
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Tislelizumab
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Cancer
Eligibility Criteria
Inclusion Criteria:
- ECOG Performance status of 0 or 1.
- Pathologically (histologically) confirmed diagnosis of potentially resectable Stage II or Stage III Colon/Rectal Cancer (CRC) with MSI-H confirmed by sponsor designated central laboratory or known MSI-H status by local laboratory. Participants should be eligible for an R0 resection with curative intent.
- Evaluable or measurable disease as assessed by the investigator per RECIST v1.1.
- Adequate hematologic and organ function, defined by protocol-specified laboratory test results, obtained within 7 days before first dose.
Exclusion Criteria:
- Any prior therapy for current CRC, including chemotherapy or radiotherapy or immunotherapy.
- Any condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone or equivalent) or other immunosuppressive medications within 14 days before first dose.
- Active autoimmune diseases or history of autoimmune diseases that may relapse.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Sites / Locations
- The First Affiliated Hospital of Bengbu Medical College
- Sun Yat Sen University Cancer Center
- Hubei Cancer Hospital
- Liaoning Cancer Hospital and Institute
- Shandong Cancer Hospital
- The Affiliated Hospital of Qingdao University Branch South
- Tianjin Medical University Cancer Institute and Hospital
- Zhejiang University College of Medicine Second Affiliated Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Tislelizumab
Arm Description
Tislelizumab administered intravenously before surgery during the neo-adjuvant phase
Outcomes
Primary Outcome Measures
Major pathological response (MPR) rate
MPR rate is defined as the percentage of participants with ≤ 10% residual viable tumor in the resected primary tumor
Secondary Outcome Measures
Pathological complete response (pCR) rate
Percentage of participants with absence of residual tumor
Event-free survival (EFS)
Time from first dose until disease progression
2-year/3-year EFS rate
Percentage of participants free from EFS events at 2 years and 3 years estimated using the Kaplan-Meier method.
Proportion of participants expressing Potential Biomarkers in Blood
Potential biomarkers include immune cell infiltration, PD-L1 expression, tumor mutational burden (TMB) and DNA mutation, gene expression profile (GEP)
Number of Participants With Clinically Significant Laboratory Values
Laboratory parameters include hematology , chemistry, coagulation and urinalysis
Number of Participants With Clinically Significant Vital Signs
Vital signs include pulse rate and blood pressure
Number of Participants With Clinically Significant Physical Examination Findings
A full physical examination includes head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, gastrointestinal and musculoskeletal systems
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Number of participants with one or more TEAE, including serious adverse events and immune-mediated adverse events, graded according to NCI-CTCAE Version 5.0.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05116085
Brief Title
Efficacy and Safety of Tislelizumab (BGB-A317) as Neo-Adjuvant Treatment in Patients With Colorectal Cancer
Official Title
A Single-Arm, Multicenter, Open-Label, Phase 2 Study to Investigate the Efficacy and Safety of Tislelizumab (BGB-A317) as Neo-Adjuvant Treatment in Patients With Early-Stage (Stage II-III) Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Colorectal Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 26, 2022 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
January 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BeiGene
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will evaluate the safety, and tolerability of neo-adjuvant treatment with tislelizumab in participants with early-stage (Stage II-III) Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) colorectal cancer.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tislelizumab
Arm Type
Experimental
Arm Description
Tislelizumab administered intravenously before surgery during the neo-adjuvant phase
Intervention Type
Drug
Intervention Name(s)
Tislelizumab
Other Intervention Name(s)
BGB-A317
Intervention Description
Administered intravenously
Primary Outcome Measure Information:
Title
Major pathological response (MPR) rate
Description
MPR rate is defined as the percentage of participants with ≤ 10% residual viable tumor in the resected primary tumor
Time Frame
approximately 16 months
Secondary Outcome Measure Information:
Title
Pathological complete response (pCR) rate
Description
Percentage of participants with absence of residual tumor
Time Frame
approximately 16 months
Title
Event-free survival (EFS)
Description
Time from first dose until disease progression
Time Frame
approximately 50 months
Title
2-year/3-year EFS rate
Description
Percentage of participants free from EFS events at 2 years and 3 years estimated using the Kaplan-Meier method.
Time Frame
approximately 50 months
Title
Proportion of participants expressing Potential Biomarkers in Blood
Description
Potential biomarkers include immune cell infiltration, PD-L1 expression, tumor mutational burden (TMB) and DNA mutation, gene expression profile (GEP)
Time Frame
approximately 50 months
Title
Number of Participants With Clinically Significant Laboratory Values
Description
Laboratory parameters include hematology , chemistry, coagulation and urinalysis
Time Frame
approximately 16 months
Title
Number of Participants With Clinically Significant Vital Signs
Description
Vital signs include pulse rate and blood pressure
Time Frame
approximately 16 months
Title
Number of Participants With Clinically Significant Physical Examination Findings
Description
A full physical examination includes head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, gastrointestinal and musculoskeletal systems
Time Frame
approximately 16 months
Title
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Description
Number of participants with one or more TEAE, including serious adverse events and immune-mediated adverse events, graded according to NCI-CTCAE Version 5.0.
Time Frame
approximately 16 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
ECOG Performance status of 0 or 1.
Pathologically (histologically) confirmed diagnosis of potentially resectable Stage II or Stage III Colon/Rectal Cancer (CRC) with MSI-H confirmed by sponsor designated central laboratory or known MSI-H status by local laboratory. Participants should be eligible for an R0 resection with curative intent.
Evaluable or measurable disease as assessed by the investigator per RECIST v1.1.
Adequate hematologic and organ function, defined by protocol-specified laboratory test results, obtained within 7 days before first dose.
Exclusion Criteria:
Any prior therapy for current CRC, including chemotherapy or radiotherapy or immunotherapy.
Any condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone or equivalent) or other immunosuppressive medications within 14 days before first dose.
Active autoimmune diseases or history of autoimmune diseases that may relapse.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Facility Information:
Facility Name
The First Affiliated Hospital of Bengbu Medical College
City
Bengbu
State/Province
Anhui
ZIP/Postal Code
233004
Country
China
Facility Name
Sun Yat Sen University Cancer Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Facility Name
Hubei Cancer Hospital
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430079
Country
China
Facility Name
Liaoning Cancer Hospital and Institute
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110042
Country
China
Facility Name
Shandong Cancer Hospital
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250117
Country
China
Facility Name
The Affiliated Hospital of Qingdao University Branch South
City
Qingdao
State/Province
Shandong
ZIP/Postal Code
266000
Country
China
Facility Name
Tianjin Medical University Cancer Institute and Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300060
Country
China
Facility Name
Zhejiang University College of Medicine Second Affiliated Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310009
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Efficacy and Safety of Tislelizumab (BGB-A317) as Neo-Adjuvant Treatment in Patients With Colorectal Cancer
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