drugset / Trial / NCT03396926

Pembrolizumab, Capecitabine, and Bevacizumab for Treating Colorectal Cancer

NCT03396926 ↗

Non-randomizedSequentialOpen-labelTreatment

Summary

This phase II trial studies the side effects and best dose of capecitabine when given together with pembrolizumab and bevacizumab, and investigates how well they work in treating patients with microsatellite stable colorectal cancer that has spread to nearby tissues or lymph nodes, has spread to other places in the body, or that cannot be removed by surgery. Monoclonal antibodies, such as pembrolizumab and bevacizumab, may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving capecitabine together with pembrolizumab and bevacizumab may work better in treating patients with colorectal cancer.

Timeline

Start
2018-04-18
Primary completion
2024-01-30
Completion
2024-01-30

Outcome

Missed primary endpoint

paper The overall response rate of 5% did not meet the prespecified target of ≥ 15%; PMID 41826077 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Bevacizumab Monoclonal antibody 7.5 mg/kg Intravenous
Subject Capecitabine Small molecule 1000 mg/m2 Oral
Subject Pembrolizumab Monoclonal antibody 200 mg Intravenous

Indications