A Phase II Study of Docetaxel and Pembrolizumab plus Interleukin 12 Gene Therapy in Nonmetastatic, Anthracycline-Refractory Triple-Negative Breast Cancer (INTEGRAL)

The combination of docetaxel, pembrolizumab, and intratumoral ADV/IL-12 is associated with high systemic toxicity and minimal efficacy. These results underscore the need for cautious dose optimization and patient selection when integrating immuno-potentiating cytokines into neoadjuvant regimens. Translational insights from this study inform safer design of future IL-12-based strategies in immune-refractory TNBC.