A Study Investigating the Efficacy and Safety of LBL-007 Plus Tislelizumab in Combination With Bevacizumab Plus Fluoropyrimidine Versus Bevacizumab Plus Fluoropyrimidine in Participants With Unresectable or Metastatic Colorectal Cancer
- Conditions
- Unresectable or Metastatic Microsatellite Stable/Mismatch Repair Proficient Colorectal Cancer
- Registration Number
- NCT05609370
- Lead Sponsor
- BeiGene
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 226
Inclusion Criteria:<br><br> - Participant must have measurable disease as defined per RECIST version 1.1<br><br> - Has a histologically confirmed colorectal adenocarcinoma with metastatic or<br> unresectable disease (Stage IV as defined by American Joint Committee on Cancer<br> [AJCC] 8th edition)<br><br> - No prior systemic therapy for colorectal cancer (CRC) in the metastatic setting<br> except for the induction treatment of first-line therapy. Note: Local regional<br> treatment performed during induction systemic treatment is allowed<br><br> - Participants who have completed the first-line induction treatment, with an overall<br> response of stable disease or better<br><br>Exclusion Criteria:<br><br> - Participants whose disease has become resectable at the investigator's discretion<br> during or after induction treatment are not eligible<br><br> - Induction treatment initiated less than 6 months from completion of any prior<br> neoadjuvant or adjuvant chemotherapy or radiotherapy which occurred later<br><br> - Participants who have been treated with anti-epidermal growth factor receptor (EGFR)<br> antibody in the induction treatment<br><br> - Any prior therapy targeting T-cell stimulation or checkpoint pathways<br><br> - Participants with B-raf proto-oncogene, serine/threonine kinase (BRAF)V600E<br> mutations<br><br> - Have locally or centrally confirmed microsatellite instability-high (MSI-H) by<br> polymerase chain reaction (PCR) method or dMMR by immunohistochemistry (IHC) method<br><br>Note: Other protocol defined criteria may apply.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Phase 1b: Number of participants with Adverse events (AE) and Serious AEs (SAE);Phase 2: Progression Free Survival (PFS) as Assessed by The Investigator in PD-L1 Positive Arms A and C
- Secondary Outcome Measures
Name Time Method