Clinical trial NCT05116085: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Colorectal Cancer
Lead sponsor: BeiGene
Sponsor class: INDUSTRY
First posted: 2021-11-10
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Major pathological response (MPR) rate
timeFrame: approximately 16 months
Secondary outcomes:
measure: Pathological complete response (pCR) rate
timeFrame: approximately 16 months
measure: Event-free survival (EFS)
timeFrame: approximately 50 months
measure: 2-year/3-year EFS rate
timeFrame: approximately 50 months
measure: Proportion of participants expressing Potential Biomarkers in Blood
timeFrame: approximately 50 months
measure: Number of Participants With Clinically Significant Laboratory Values
timeFrame: approximately 16 months
measure: Number of Participants With Clinically Significant Vital Signs
timeFrame: approximately 16 months
measure: Number of Participants With Clinically Significant Physical Examination Findings
timeFrame: approximately 16 months
measure: Number of Participants with Treatment-emergent Adverse Events (TEAEs)
timeFrame: approximately 16 months
Other outcomes:
Locations:
city: Bengbu
country: China
facility: The First Affiliated Hospital of Bengbu Medical College
state: Anhui
city: Guangzhou
country: China
facility: Sun Yat Sen University Cancer Center
state: Guangdong
city: Wuhan
country: China
facility: Hubei Cancer Hospital
state: Hubei
city: Shenyang
country: China
facility: Liaoning Cancer Hospital and Institute
state: Liaoning
city: Jinan
country: China
facility: Shandong Cancer Hospital
state: Shandong
city: Qingdao
country: China
facility: The Affiliated Hospital of Qingdao University Branch South
state: Shandong
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute and Hospital
state: Tianjin
city: Hangzhou
country: China
facility: The Second Affiliated Hospital of Zhejiang University School of Medicine
state: Zhejiang
Study officials:
References: