OncoMatch/Clinical Trials/NCT06529523
Tislelizumab in People With Colorectal Cancer
Is NCT06529523 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Tislelizumab for colorectal cancer.
Treatment: Tislelizumab — The researchers are doing this study to find out whether tislelizumab is an effective treatment for people with colorectal cancer who are living in Nigeria. The researchers will also look at the safety of the study drug. All participants in this study will be treatment naïve (they have not yet received treatment for their cancer), and their cancer will be mismatch repair deficient (dMMR). dMMR cancer can happen when your cells are unable to repair mistakes made during the cell division process.
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Biomarker criteria
Required: MSH2 deficient mismatch repair (dMMR) by immunohistochemistry
Confirmation of dMMR by immunohistochemistry
Required: MLH1 deficient mismatch repair (dMMR) by immunohistochemistry
Confirmation of dMMR by immunohistochemistry
Required: MSH6 deficient mismatch repair (dMMR) by immunohistochemistry
Confirmation of dMMR by immunohistochemistry
Required: PMS2 deficient mismatch repair (dMMR) by immunohistochemistry
Confirmation of dMMR by immunohistochemistry
Disease stage
Required: Stage METASTATIC (COHORT 1), II, III (AJCC 8th edition (for rectal cancer))
Radiologically measurable metastatic disease as per RECIST 1.1, not eligible for potentially curative surgery (Cohort 1); Rectal cancer stage II or III per AJCC 8 th edition criteria (Cohort 2)
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: immunotherapy
Prior immunotherapy for metastatic colorectal cancer (Cohort 1); Prior immunotherapy for localized rectal cancer (Cohort 2)
Cannot have received: chemotherapy
Exception: adjuvant therapy of prior localized tumor is allowable as long as it was completed at least 6 months prior to cycle 1 day 1
Prior chemotherapy for metastatic colorectal cancer (Cohort 1); Prior chemotherapy for localized rectal cancer (Cohort 2)
Cannot have received: radiation therapy
Exception: adjuvant therapy of prior localized tumor is allowable as long as it was completed at least 6 months prior to cycle 1 day 1
Prior radiation therapy for metastatic colorectal cancer (Cohort 1); Prior radiation therapy for localized rectal cancer (Cohort 2)
Cannot have received: surgery
Exception: adjuvant therapy of prior localized tumor is allowable as long as it was completed at least 6 months prior to cycle 1 day 1
Prior surgery for metastatic colorectal cancer (Cohort 1); Prior surgery for localized rectal cancer (Cohort 2)
Cannot have received: immune checkpoint inhibitor
Has received prior therapy with an immune checkpoint inhibitor
Lab requirements
Blood counts
Absolute neutrophil count (ANC) ≥1,500 /mm^3; Platelets ≥100,000 / mcL; Hemoglobin >9 g/dL or ≥5.6 mmol/L
Kidney function
Serum creatinine OR measured or calculated creatinine clearance (GFR can also be used in place of creatinine or CrCl) ≤1.5 × upper limit of normal (ULN) OR ≥30 mL/min for subject with creatinine levels > 1.5 × institutional ULN
Liver function
Serum total bilirubin ≤ 1.5 × ULN OR Direct bilirubin ≤ ULN for subjects with total bilirubin levels > 1.5 ULN; AST (SGOT) and ALT (SGPT) ≤ 2.5 × ULN (< 5 x ULN if hepatic metastases are present in cohort 1)
Demonstration of adequate organ function below within 14 days of cycle 1 day 1; see detailed criteria
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Memorial Sloan Kettering Cancer Center · New York, New York
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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