Pembrolizumab and Total Skin Electron Beam Radiotherapy in Mycosis Fungoides and Sézary Syndrome

Summary

Hypothesis: Addition of low dose TSEBT to debulk MF/SS either before or during checkpoint blockade with anti-PD-1 pembrolizumab monoclonal antibody therapy will be safe and well tolerated. Primary Objective: • To determine the maximum tolerated dose (MTD) for the combination of total skin electron beam therapy (TSEBT) and pembrolizumab regimen. Secondary Objectives: * To determine the preliminary efficacy of the combination of TSEBT with pembrolizumab. * To determine the impact on patient-reported health-related quality of life outcomes.

Timeline

Start

2018-07-24

Primary completion

2022-07-24

Completion

2024-07-24

Outcome

Outcome not reported

Stopped (Enrollment): “Unable to enroll patients that met enrollment criteria.”

Drugs

Indications