Trial results for the Phase 2 study (NCT02437071) investigating pembrolizumab plus radiotherapy or ablation in patients with metastatic colorectal cancer were posted on ClinicalTrials.gov on 2025-12-05. The study enrolled 34 participants to assess the effects of this combination therapy.
Background
This Phase 2 study investigated pembrolizumab in combination with radiotherapy or ablation in patients with metastatic colorectal cancer.
Trial design
The study (NCT02437071) was a Phase 2 trial that enrolled 34 participants with metastatic colorectal cancer. The trial assessed pembrolizumab in combination with either radiotherapy or ablation. The study aimed to understand the effects of pembrolizumab on the patient and on tumors that did not receive radiation therapy or ablation, when combined with standard local therapy.
Key results
The trial reported outcomes for the number of participants with response and toxicities across the two treatment groups. For the outcome of 'Number of Participants With Response':
- In the Pembrolizumab Plus Radiotherapy group, the number of participants with response was reported as 0, 1, 5, and 18 participants.
- In the Pembrolizumab Plus Ablation group, the number of participants with response was reported as 0, 1, 1, and 7 participants.
For the outcome of 'Number of Participants With Toxicities':
- In the Pembrolizumab Plus Radiotherapy group, 24 participants experienced toxicities.
- In the Pembrolizumab Plus Ablation group, 9 participants experienced toxicities.
What this means
The posted results provide data on the observed participant responses and toxicities when pembrolizumab is combined with either radiotherapy or ablation in patients with metastatic colorectal cancer. As a Phase 2 study, these findings contribute to understanding the safety and preliminary activity of this combination in a small cohort, informing potential future research.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT02437071, titled 'Assess the Efficacy of Pembrolizumab Plus Radiotherapy or Ablation in Metastatic Colorectal Cancer Patients,' were posted on 2025-12-05 on clinicaltrials.gov.