Cutaneous T-Cell Lymphomas Clinical Trial
Official title:
Phase I Trial of Pembrolizumab and Total Skin Electron Beam Radiotherapy in Mycosis Fungoides and Sézary Syndrome
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.
This is a single center phase I clinical trial assessing the safety of combination therapy of
TSEBT and pembrolizumab for treatment of Stage IB-IV relapsed/refractory MF and SS.
Primary Endpoint:
• Primary endpoint will be maximum tolerated dose (MTD).
Secondary Endpoints:
- Efficacy of the combination of TSEBT with pembrolizumab therapy is measured.
- CTCAE v4.0 toxicity beyond the 30 day period following the second therapy in the
combination protocol treatment and up to 30 days following last dose of pembrolizumab.
- Skindex-29 patient-reported HRQOL survey.
Sample Size and Accrual: 18 patients will be enrolled.
Statistical Analysis: Time to event will be estimated using the Kaplan-Meier approach along
with the 95% confidence interval.
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