Reinvigorating TNBC Response to Immunotherapy With Combination Myeloid Inhibition and Radiation

This is an open-label prospective, single institution, Phase II study of pembrolizumab in combination with radiation therapy and CSF-1R inhibition in patients with high-risk TNBC. The primary objective is to assess the pathologic complete response (pCR) rate where pCR is defined as the absence of invasive disease in the breast and lymph nodes at the time of standard of care (SOC) treatment. Secondary objectives include evaluating the change in tumor infiltrating lymphocytes (TILs), safety and tolerability of the combination, progression-free survival, event-free survival, overall survival, and node clearance.

NCT Number	NCT05491226
Lead Sponsor	Stephen Shiao Collaborators: Merck Sharp & Dohme LLC, Incyte Corporation
Conditions	TNBC - Triple-Negative Breast Cancer, Breast Cancer
Enrollment	35 participants
Start Date	2023-11-17
Primary Completion	2026-12-01 (estimated)
Study Completion	2026-12-01 (estimated)
Updated on ClinicalTrials.gov	2026-04-20