Trial results for a Phase 2 study investigating pembrolizumab and CXCR4 antagonist BL-8040 in patients with metastatic pancreatic cancer were posted on ClinicalTrials.gov on 2025-02-19. The study, involving 20 participants, reported an Overall Response Rate of 1 participant and observed changes in T-cell infiltration and circulating T-cells.
Background
Pembrolizumab (Keytruda) is an immunotherapy drug that helps the body's immune system attack cancer. CXCR4 antagonist BL-8040 aims to stop tumor cell growth by blocking necessary enzymes. This trial investigated their combination for Metastatic Pancreatic Adenocarcinoma, Recurrent Pancreatic Adenocarcinoma, and Stage IV Pancreatic Cancer AJCC v6 and v7.
Trial design
This completed Phase 2 trial (NCT02907099) enrolled 20 participants. The study investigated the combination of pembrolizumab and CXCR4 antagonist BL-8040 in patients diagnosed with Metastatic Pancreatic Adenocarcinoma, Recurrent Pancreatic Adenocarcinoma, or Stage IV Pancreatic Cancer AJCC v6 and v7.
Key results
Results from the Pembrolizumab Plus BL-8040 group included:
- The Overall Response Rate was observed in 1 participant.
- The median Quantity of T-Cell Infiltration was 52.5 T-cells/mm^2, which increased to 112.5 T-cells/mm^2.
- The median Quantity of Circulating T-Cells was 275 T-cells/mm^2, which increased to 450 T-cells/mm^2.
- 9 participants experienced Treatment-Related Adverse Events as assessed by CTCAE v4.0.
Statistical analyses using a t-test, 2-sided, yielded a p-value of 0.5 for two separate analyses related to the observed outcomes.
What this means
The trial results showed an overall response rate of 1 participant out of 20. Increases in median T-cell infiltration and circulating T-cells were observed, but the reported p-value of 0.5 from t-tests indicates these changes were not statistically significant. A notable 9 participants experienced treatment-related adverse events. These findings suggest that further investigation is needed to determine the clinical benefit and statistical significance of pembrolizumab and CXCR4 antagonist BL-8040 in this patient population.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT02907099, titled "Pembrolizumab and CXCR4 Antagonist BL-8040 in Treating Patients With Metastatic Pancreatic Cancer," were posted on 2025-02-19 on clinicaltrials.gov.