Trial results for a Phase 2 study investigating pembrolizumab (Keytruda) with or without axitinib for clear cell kidney cancer were posted on ClinicalTrials.gov on 2025-11-05. In the pembrolizumab monotherapy arm (Cohort A), the objective response rate was 0 proportion of participants.
Background
Pembrolizumab is an antibody designed to bind to and block the activity of PD-1, a molecule in the body that may be responsible for inhibiting the body's immune response against cancer cells. This trial focused on patients with clear cell kidney cancer, including those with metastatic, recurrent, Stage III, or Stage IV renal cell carcinoma.
Trial design
The study (NCT04370509) was a Phase 2 trial, which was subsequently terminated. It enrolled 6 participants with clear cell kidney cancer, including those with metastatic clear cell renal cell carcinoma, recurrent clear cell renal cell carcinoma, Stage III renal cell cancer AJCC v8, Stage IV renal cell cancer AJCC v8, or clear cell renal cell carcinoma. The trial investigated pembrolizumab with or without axitinib in patients undergoing surgery.
Key results
The trial results for Cohort A (Pembrolizumab Monotherapy) included several key measurements:
- The Objective Response Rate (ORR) in pre-operative pembrolizumab-based therapy was 0 proportion of participants.
- The Disease-Free Survival Rate (DFS) at 1 year for participants who obtained CR or PR/SD with R0 resection and were treated 1 year of pembrolizumab-based therapy was 1.0 proportion of participants.
- The Disease-Free Survival Rate (DFS) at 2 years for participants who obtained CR or PR/SD with R0 resection and were treated 1 year of pembrolizumab-based therapy was 0.5 proportion of participants.
- The Median DFS for participants who obtained CR or PR/SD with R0 resection and were treated 1 year of pembrolizumab-based therapy was 651 days.
- Regarding safety, the number of participants reporting treatment-related adverse events was 6 Participants.
- The number of participants reporting surgical complications was 0 Participants.
What this means
The finding of an objective response rate of 0 proportion of participants in the pembrolizumab monotherapy arm suggests a lack of direct tumor response in this specific pre-operative setting for clear cell kidney cancer. While the 1-year disease-free survival rate was 1.0 proportion of participants, it decreased to 0.5 proportion of participants at 2 years. The trial's termination and limited enrollment of 6 participants suggest that these results should be interpreted with caution. The absence of surgical complications in this small cohort is also noted.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT04370509, titled "Pembrolizumab With or Without Axitinib for Clear Cell Kidney Cancer in Patients Undergoing Surgery," were posted on 2025-11-05 on clinicaltrials.gov.