Trial results for the Phase 2 study (NCT04373031) investigating pembrolizumab, IRX-2, and chemotherapy in triple negative breast cancer were posted on ClinicalTrials.gov on 2025-12-02. The study reported 5 participants in Arm A achieved pathological complete response (pCR) compared to 2 participants in the control group.
Background
The study NCT04373031, titled "Pembrolizumab, IRX-2, and Chemotherapy in Triple Negative Breast Cancer," is a Phase II trial evaluating these agents as neoadjuvant therapy for triple negative breast cancer (TNBC).
Trial design
The study (NCT04373031) is a Phase II, randomized, open-label trial that enrolled 12 participants. It investigates pembrolizumab, IRX-2, and chemotherapy as neoadjuvant therapy for triple negative breast cancer (TNBC). The trial design includes a Control group and an Arm A group, evaluating the combination of pembrolizumab plus chemotherapy with various immunotherapy induction regimens.
Key results
The trial results for the outcome of "Pathological Complete Response (pCR) Rate (ypT0/Tis ypN0)" showed:
- In the Control group, 2 participants achieved pCR.
- In Arm A, 5 participants achieved pCR.
Regarding the "Safety and Tolerability Profile as Assessed by CTCAE v5.0":
- The Control group reported 0 occurrences.
- Arm A reported 2 occurrences.
For "Percent Change in Tumor Infiltrating Lymphocytes (TIL) Quantity Changes":
- The Control group showed a mean change of 11 percentage change of TIL quantity.
- Arm A showed a mean change of -26 percentage change of TIL quantity.
What this means
The preliminary results from this Phase II trial suggest that the combination of pembrolizumab, IRX-2, and chemotherapy in Arm A may lead to a higher rate of pathological complete response (pCR) compared to the control group in patients with triple negative breast cancer. While Arm A also reported more occurrences of adverse events and a decrease in TIL quantity compared to the control, the pCR data provides initial insights into the potential clinical activity of this regimen. These findings warrant further investigation in larger studies.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT04373031, titled "Pembrolizumab, IRX-2, and Chemotherapy in Triple Negative Breast Cancer," were posted on 2025-12-02 on clinicaltrials.gov.