CI

At a glance

ClinicalIndex Comparison Record
Phase 2Active· 12 enrolled
Drug / intervention
Pembrolizumab +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04373031
NCT04373031Phase 2Active
CompareCT.gov

Induction Immunotherapy to Promote Immunologic Priming and Enhanced Response to Neoadjuvant Pembrolizumab + Chemotherapy in Triple Negative Breast Cancer (TNBC)

Providence Health & Services·interventional·Posted May 4, 2020·Updated Apr 24, 2026

In Brief

A Phase 2 clinical trial evaluating Pembrolizumab and IRX 2 for Breast Cancer and Breast Neoplasms. Active but no longer recruiting, targeting 12 participants across 1 site.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer, Breast Neoplasms
CountriesUnited States
CollaboratorsMerck Sharp & Dohme LLC, Brooklyn ImmunoTherapeutics, LLC

Timeline

Phase 2Active
2021202220232024202520262027
First PostedMay 4, 2020
Enrollment StartDec 30, 2020
Primary CompletionJul 8, 2023
Study CompletionDec 1, 2026
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 6.2 years ago

Interventions

Pembrolizumabdrug

Pembrolizumab is a humanized anti-PD-1 mAb of the IgG4/kappa isotype with a stabilizing S228P sequence alteration in the Fc region.

IRX 2drug

IRX-2, is a cell-derived biologic with multiple active cytokine components that acts on multiple cell types of the immune system including T cells, dendritic cells and natural killer cells.