Trial results for the Phase 1 study (NCT02837263) investigating pembrolizumab (Keytruda) in combination with stereotactic body radiotherapy (SBRT) for liver metastatic colorectal cancer were posted on ClinicalTrials.gov on 2026-05-01. The study reported a 1-year recurrence rate in 6 out of 15 participants, with a median disease-free survival of 1.17 years.
Background
Pembrolizumab is an immunotherapy drug. This study explored its use in patients with colorectal cancer that has metastasized to the liver, specifically Stage IVA and Stage IVB colorectal cancer, and metastatic carcinoma in the liver. The trial aimed to assess the safety and tolerability of combining pembrolizumab with SBRT.
Trial design
The study, titled "PI Pembro in Combination With Stereotactic Body Radiotherapy for Liver Metastatic Colorectal Cancer" (NCT02837263), was a Phase 1 trial that enrolled 15 participants. The conditions studied included colorectal cancer, colorectal adenocarcinoma, Stage IVA colorectal cancer, Stage IVB colorectal cancer, and metastatic carcinoma in the liver. The primary objectives were to evaluate the safety and tolerability of pembrolizumab combined with SBRT, and to assess the recurrence rate of colorectal cancer 1 year after treatment.
Key results
The trial reported the following key measurements for the SBRT + Pembrolizumab group:
- The "Recurrence Rate at 1 Year" was observed in 6 Participants.
- The "Time to Recurrence Estimated Using the Kaplan-Meier Method" had a median of 295 days (95% Confidence Interval).
- "Disease-free Survival Estimated Using the Kaplan-Meier Method" had a median of 1.17 years (95% Confidence Interval).
- "Overall Survival Estimated Using the Kaplan-Meier Method" was reported as NA years (95% Confidence Interval).
What this means
This Phase 1 study provides initial data on the combination of pembrolizumab with SBRT for liver metastatic colorectal cancer. With an enrollment of 15 participants, the findings offer early insights into the recurrence rate and disease-free survival in this specific patient population. The observed recurrence rate of 6 participants at 1 year and a median disease-free survival of 1.17 years will inform further research into this therapeutic approach. As a Phase 1 study, the primary focus was on safety and tolerability, with these efficacy outcomes providing preliminary indications for future larger trials.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT02837263, titled "PI Pembro in Combination With Stereotactic Body Radiotherapy for Liver Metastatic Colorectal Cancer," were posted on 2026-05-01 on clinicaltrials.gov.