Trial results for a combination therapy of pembrolizumab, capecitabine, and bevacizumab in colorectal cancer were posted on ClinicalTrials.gov on 2025-02-28. The Phase 2 study reported an Overall Response Rate (ORR) of 5 percentage of participants and a Disease Control Rate (DCR) of 25 percentage of participants in the ASaT population.
Background
Pembrolizumab is an immune checkpoint inhibitor, while bevacizumab is a monoclonal antibody targeting vascular endothelial growth factor. Capecitabine is a chemotherapy agent. This combination was investigated for treating microsatellite stable (MSS), mismatch repair protein proficient (pMMR) colorectal cancer, specifically Stage III, IIIB, or IIIC.
Trial design
This completed Phase 2 trial (NCT03396926) enrolled 44 participants. The study investigated the combination of pembrolizumab, capecitabine, and bevacizumab in patients with microsatellite stable, mismatch repair protein proficient, Stage III, IIIB, or IIIC colorectal cancer.
Key results
The trial reported several key measurements for the combination therapy:
- The proportion of participants with treatment-related, dose-limiting toxicities (DLT) in the safety lead-in cohort was 0.33 proportion of participants.
- The Overall Response Rate (ORR) in the ASaT population was 5 percentage of participants.
- The Disease Control Rate (DCR) in the ASaT population was 25 percentage of participants.
- The median Duration of Response (DOR) in the ASaT population was 13.5 months.
- The median Overall Survival (OS) in the ASaT population was 10.1 months.
- The median Progression-Free Survival (PFS) in the ASaT population was 4.29 months.
What this means
The results from this Phase 2 trial provide initial data on the safety and efficacy profile of the pembrolizumab, capecitabine, and bevacizumab combination in patients with microsatellite stable colorectal cancer. An Overall Response Rate of 5 percentage of participants and a Disease Control Rate of 25 percentage of participants suggest limited objective responses, while median Overall Survival of 10.1 months and Progression-Free Survival of 4.29 months offer insights into the duration of benefit. The proportion of dose-limiting toxicities at 0.33 proportion of participants indicates the safety considerations for this regimen.
Source
The information for these trial results was sourced from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT03396926, titled "Pembrolizumab, Capecitabine, and Bevacizumab for Treating Colorectal Cancer," were posted on 2025-02-28 on clinicaltrials.gov.