About this trial
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.
Eligibility criteria
Qualifiers
Female patients diagnosed with high-risk triple negative breast cancer (TNBC) with intent for neoadjuvant therapy.
Low tumor-infiltrating lymphocyte (TIL) score, defined as stromal TIL (sTIL) ≤40%; or node-positive; or combined positive score (CPS) < 10 or PD-L1 tumor positivity <1%.
Written informed consent obtained from subject and ability for subject to comply with the requirements of the study, including consent for research blood draws and use of available archived tissue.
Age ≥ 18 years of age on day of signing informed consent.
Disqualifiers
Evidence of metastatic disease.
Has received prior radiotherapy within 2 weeks of start of study intervention.
Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.
Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
Trial design
Treatments tested in this trial
- Pembrolizumab
- Radiation Therapy
- Axatilimab
Treatment groups
Sponsors and collaborators
Stephen Shiao
Lead sponsor
Cedars-Sinai Medical Center
Sponsor institution
Merck Sharp & Dohme LLC
Collaborator
Incyte Corporation
Collaborator