Actively Recruiting
Reinvigorating TNBC Response to Immunotherapy With Combination Myeloid Inhibition and Radiation
Led by Stephen Shiao · Updated on 2026-04-20
35
Participants Needed
1
Research Sites
158 weeks
Total Duration
On this page
Sponsors
S
Stephen Shiao
Lead Sponsor
M
Merck Sharp & Dohme LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Reinvigorating TNBC Response to Immunotherapy With Combination Myeloid Inhibition and Radiation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 and ability to comply with study requirements including blood draws and tissue use.
- Age 18 years or older at consent.
- Histologically or cytologically-confirmed TNBC (ER <1%, PR <1%, her-2-neu 0-1+ by IHC or FISH-negative).
- Willing to provide tumor tissue if archived tissue is unavailable; tissue obtained up to 6 weeks before treatment.
- ECOG performance status of 0 or 1.
- Adequate organ function.
- Female subjects of childbearing potential must have negative pregnancy test within 14 days before pembrolizumab start and agree to contraceptive guidance during treatment and 120 days after last dose.
You will not qualify if you...
- Evidence of metastatic disease.
- Prior radiotherapy within 2 weeks before study start.
- Participation in another investigational study or use of investigational agents within 4 weeks before first dose.
- Diagnosis of immunodeficiency or recent immunosuppressive therapy within 7 days before treatment.
- Known active tuberculosis.
- Hypersensitivity to pembrolizumab or its components.
- Recent anti-cancer monoclonal antibody within 4 weeks or unresolved adverse events from earlier treatments.
- Recent chemotherapy or targeted therapy within 2 weeks or unresolved adverse events, except for mild neuropathy.
- Additional malignancy progressing or treated in last 5 years except certain skin or cervical cancers.
- Active central nervous system metastases or carcinomatous meningitis, with some exceptions for stable brain metastases.
- Active autoimmune disease requiring systemic treatment in past 2 years.
- History or active pneumonitis or interstitial lung disease.
- Active infection needing systemic therapy.
- Conditions or disorders interfering with participation or study results.
- Psychiatric or substance abuse disorders interfering with compliance.
- Pregnant, breastfeeding, or planning pregnancy during study and 120 days after last dose.
- Known HIV infection.
- Active Hepatitis B or C infection.
- Live vaccine within 30 days before pembrolizumab start.
- History of allogenic tissue or solid organ transplant.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Actively Recruiting
Research Team
C
Clinical Trial Recruitment Navigator
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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