Clinical Trial

Pembrolizumab, IRX-2, and Chemotherapy in Triple Negative Breast Cancer

Active, Not Recruiting Phase 2
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Summary
This is a Phase II, randomized, open-label trial to evaluate the clinical and immunologic activity of pembrolizumab plus chemotherapy when combined with various immunotherapy induction regimens as neoadjuvant therapy for triple negative breast cancer (TNBC).
Protocol Amendment History 10 amendments
This ClinicalTrials.gov record has been amended 10 times since 2020-04-29; most recent amendment 2026-04-07.
Status change: Recruiting → Active, Not Recruiting 2023-03-23
Status change: Not Yet Recruiting → Recruiting 2021-01-28
Trial Details
NCT Number NCT04373031
Lead Sponsor Providence Health & Services
Collaborators: Merck Sharp & Dohme LLC, Brooklyn ImmunoTherapeutics, LLC
Conditions Breast Cancer, Breast Neoplasms
Enrollment 12 participants
Start Date 2020-12-30
Primary Completion 2023-07-08 (estimated)
Study Completion 2026-12 (estimated)
Updated on ClinicalTrials.gov 2026-04-24