drugset / Trial / NCT04454528

BreastVAX: Radiation Boost to Enhance Immune Checkpoint Blockade Therapy

NCT04454528

Phase 1/2 Active not recruiting 27 enrolled Abramson Cancer Center at Penn Medicine
Non-randomizedSequentialOpen-labelTreatment

Summary

The primary objective is to determine the feasibility of combining pembrolizumab with a single fraction radiation boost in patients with early/ operable breast cancer. The secondary objectives are to assess clinical response on pre- and post-treatment clinical, imaging, and histology exams, and to assess immune response on pre and post treatment blood and tissue samples by tracking change in Ki67 + CD8 T cells in peripheral blood and in extent of tumor infiltrating lymphocytes. A clinically significant partial response is defined as \>30% tumor shrinkage post-clinical trial intervention.

Timeline

Start
2020-12-07
Primary completion
2026-08
Completion
2027-08

Drugs

EvaluationDrugModalityDoseRoute
Comparator Pembrolizumab Monoclonal antibody 200 mg

Indications