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

Sponsor
BeiGene (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05116085
Collaborator
(none)
38
Enrollment
8
Locations
1
Arm
58.2
Anticipated Duration (Months)
4.8
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
38 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Jan 26, 2022
Anticipated Primary Completion Date :
May 1, 2023
Anticipated Study Completion Date :
Dec 1, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: Tislelizumab

Tislelizumab administered intravenously before surgery during the neo-adjuvant phase

Drug: Tislelizumab
Administered intravenously
Other Names:
  • BGB-A317

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Major pathological response (MPR) rate [approximately 16 months]

      MPR rate is defined as the percentage of participants with ≤ 10% residual viable tumor

    Secondary Outcome Measures

    1. Pathological complete response (pCR) rate [approximately 16 months]

      Percentage of participants with absence of residual tumor

    2. Event-free survival (EFS) [approximately 50 months]

      Time from first dose until disease progression

    3. 2-year/3-year EFS rate [approximately 50 months]

      Percentage of participants free from EFS events at 2 years and 3 years estimated using the Kaplan-Meier method.

    4. Number of Participants With Clinically Significant Laboratory Values [approximately 16 months]

      Laboratory parameters include hematology , chemistry, coagulation and urinalysis

    5. Number of Participants With Clinically Significant Vital Signs [approximately 16 months]

      Vital signs include pulse rate and blood pressure

    6. Number of Participants With Clinically Significant Physical Examination Findings [approximately 16 months]

      A full physical examination includes head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, gastrointestinal and musculoskeletal systems

    7. Number of Participants with Treatment-emergent Adverse Events (TEAEs) [approximately 16 months]

      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.

    Eligibility Criteria

    Criteria

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

    1. ECOG Performance status of 0 or 1.

    2. Pathologically (histologically) confirmed diagnosis of potentially resectable Stage II or Stage III CRC with MSI-H confirmed by sponsor designated central 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 14 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The First Affiliated Hospital of Bengbu Medical College Bengbu Anhui China 233004
    2 Shandong Cancer Hospital Jinan Shandong China 250117
    3 The Affiliated Hospital of Qingdao University Qingdao Shandong China 266000
    4 Tianjin Medical University Cancer Institute & Hospital Tianjin Tianjin China
    5 The Second Affiliated Hospital of Zhejiang University School of Medicine Hangzhou Zhejiang China 310009
    6 Sun Yat-sen University Cancer Center Guangdong China
    7 Hubei Cancer Hospital Hubei China
    8 Liaoning Cancer Hospital & Institute Shenyang China

    Sponsors and Collaborators

    • BeiGene

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    BeiGene
    ClinicalTrials.gov Identifier:
    NCT05116085
    Other Study ID Numbers:
    • BGB-A317-214
    First Posted:
    Nov 10, 2021
    Last Update Posted:
    Apr 5, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Colorectal Neoplasms

    Study Results

    No Results Posted as of Apr 5, 2022