Efficacy and Safety of Tislelizumab (BGB-A317) as Neo-Adjuvant Treatment in Patients With Colorectal Cancer

Colorectal Cancer Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05116085
• Other study ID #: BGB-A317-214
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: January 26, 2022
• Est. completion date: January 2027

Study information

• Verified date: January 2024
• Source: BeiGene
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 33
• Est. completion date: January 2027
• Est. primary completion date: September 26, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. ECOG Performance status of 0 or 1.

2. 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.

3. Evaluable or measurable disease as assessed by the investigator per RECIST v1.1.

4. Adequate hematologic and organ function, defined by protocol-specified laboratory test results, obtained within 7 days before first dose.

Exclusion Criteria:

1. Any prior therapy for current CRC, including chemotherapy or radiotherapy or immunotherapy.

2. Any condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone or equivalent) or other immunosuppressive medications within 14 days before first dose.

3. Active autoimmune diseases or history of autoimmune diseases that may relapse. Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Drug:
• Tislelizumab
Administered intravenously

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Bengbu Medical College	Bengbu	Anhui
China	Sun Yat Sen University Cancer Center	Guangzhou	Guangdong
China	Zhejiang University College of Medicine Second Affiliated Hospital	Hangzhou	Zhejiang
China	Shandong Cancer Hospital	Jinan	Shandong
China	The Affiliated Hospital of Qingdao University Branch South	Qingdao	Shandong
China	Liaoning Cancer Hospital and Institute	Shenyang	Liaoning
China	Tianjin Medical University Cancer Institute and Hospital	Tianjin	Tianjin
China	Hubei Cancer Hospital	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
BeiGene

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major pathological response (MPR) rate	MPR rate is defined as the percentage of participants with = 10% residual viable tumor in the resected primary tumor	approximately 16 months
Secondary	Pathological complete response (pCR) rate	Percentage of participants with absence of residual tumor	approximately 16 months
Secondary	Event-free survival (EFS)	Time from first dose until disease progression	approximately 50 months
Secondary	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.	approximately 50 months
Secondary	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)	approximately 50 months
Secondary	Number of Participants With Clinically Significant Laboratory Values	Laboratory parameters include hematology , chemistry, coagulation and urinalysis	approximately 16 months
Secondary	Number of Participants With Clinically Significant Vital Signs	Vital signs include pulse rate and blood pressure	approximately 16 months
Secondary	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	approximately 16 months
Secondary	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.	approximately 16 months