NCT03617224

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

Phase I Trial of Pembrolizumab and Total Skin Electron Beam Radiotherapy in Mycosis Fungoides and Sézary Syndrome

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Texas Southwestern Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Cutaneous T-Cell Lymphomas

Interventions

Type	Name	Description
RADIATION	TSEBT	The regimen includes a rule-based "3+3" design for escalating regimen intensity of combined TSEBT and pembrolizumab.
DRUG	TSEBT and pembrolizumab	Dose regimens are sequential therapy of TSEBT with Pembrolizumab.

Timeline

• Start date: 2018-07-24
• Primary completion: 2022-07-24
• Completion: 2024-07-24
• First posted: 2018-08-06
• Last updated: 2020-04-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study