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Life sciences · Phase 1 Trial
ClinicalTrials.gov · October 21, 2026
No summary has been generated for this record yet. What follows is drawn from its source metadata only.
Phase 1 Trial.
No findings were extractable from the material analysed.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
The source did not state who this applies to in practice.
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Registry record from ClinicalTrials.gov (NCT02977468). This is a study registration, not published results. Lead sponsor: Columbia University. Recruitment status: COMPLETED. Phase: PHASE1. Study type: INTERVENTIONAL. Enrollment: 15 participants (ACTUAL). Conditions: Triple Negative Breast Cancer. Interventions: DRUG: Merck 3475 Pembrolizumab; RADIATION: Intraoperative radiation therapy (IORT). Primary outcome measures: Number of subjects with significant mean percent change in TILs , 3 months. Brief summary: Assess response to pembrolizumab in both primary tumor, normal breast stroma, circulating lymphocytes and serum exosomes in treatment naive triple negative breast cancer (TNBC) patients. Assess for change in tumor-infiltrating lymphocytes (TILS) both stromal (sTILS) and intraepithelial (iTILS) in newly diagnosed early stage TNBC patients treated with two doses of MK-3475 prior to lumpectomy.