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

BeiGene

Status and phase: Completed; Phase 2

Conditions: Colorectal Cancer

Treatments: Drug: Tislelizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT05116085

CTR20212779 (Other Identifier)

BGB-A317-214

Details and patient eligibility

About

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.

Enrollment: 33 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

33 participants in 1 patient group

Tislelizumab

Experimental group

Description:

Tislelizumab administered intravenously before surgery during the neo-adjuvant phase

Treatment:

Drug: Tislelizumab