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

Trial Details

NCT ID
NCT05491226
Phase
PHASE2
Sponsor
Stephen Shiao
Status
RECRUITING
Cancer Type
Triple Negative (TNBC) Breast Cancer
Interventions
  • Pembrolizumab
  • Radiation Therapy
  • Axatilimab
Locations (sample)
  • Los Angeles, California, United States|34.05223,-118.24368

Key Eligibility Criteria

  • 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-L…
  • Written informed consent obtained from subject and ability for subject to comply with the requirements of the study, including consent for research…
  • Age ≥ 18 years of age on day of signing informed consent.

For full eligibility, visit ClinicalTrials.gov.

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